760 results on '"Drug survival"'
Search Results
152. Drug survival of biologic therapies for the treatment of psoriasis: Results of Slovenian national registry.
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Lunder, Tomaz, Marko, Pij, Koser Kolar, Natasa, Kralj, Boris, and Kecelj Leskovec, Nada
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PSORIASIS , *ADALIMUMAB , *DRUG metabolism , *BIOTHERAPY , *MEDICAL care - Abstract
The study was designed as observational retrospective analysis of the data from Slovenian Registry of patients with moderate and severe psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab from 2005 to 2015. The survival rates of biologics were compared using survival analysis, and predictors of discontinuation were evaluated using a Cox regression model. All biologics have been prescribed as a first line therapy for moderate or severe psoriasis; 650 (94.9%) adalimumab, 254 (72.0%) ustekinumab, 76 (69.7%) infliximab, 68 (67.3%) etanercept. The overall biologics survival rate was 83.2% in the first line and 79.1% in the second line treatment. Drug survival for the first and second line of therapy was significantly longer for ustekinumab than for anti-TNFα agents (p < 0.001 and p = 0.014, respectively). Loss of efficacy accounted for 63% of all treatment discontinuations. Multivariate regression analysis showed that younger patients, being on etanercept, systemic conventional co-therapy, lower BSA and higher DLQI were independent predictors for treatment discontinuation. Our data showed the real-life situation in the treatment of moderate to severe psoriasis with biologics. Since longevity of drug survival is considered as a measure of treatment success, this data represents an important information when selecting a biologic treatment for individual patient. [ABSTRACT FROM AUTHOR]
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- 2018
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153. Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival.
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Costanzo, Antonio, Malara, Giovanna, Pelucchi, Claudio, Fatiga, Francesco, Barbera, Giovanna, Franchi, Andrea, and Galeone, Carlotta
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PSORIASIS ,PATIENTS ,PSORIASIS treatment ,SKIN diseases ,DRUG efficacy ,BIOTHERAPY ,BIOLOGICAL assay ,BIOLOGICAL products ,DERMATOLOGIC agents ,DRUGS ,PATIENT compliance ,PATIENT satisfaction ,TIME ,SYSTEMATIC reviews ,THERAPEUTICS - Abstract
Psoriasis is a complex and chronic disease, and, in most cases, therapies are required during all patients' lifetime. The efficacy and safety profiles of biological therapies are well established, but their effectiveness is still open to discussion. We performed a systematic review to summarize how the effectiveness of biological therapies for psoriasis is measured in real-world studies and to understand whether drug survival, a recent alternative outcome to clinical ones, is a recurrent and valid outcome of effectiveness. In March 2017, we searched for quantitative epidemiological data of psoriasis treatments using PubMed/Medline and EMBASE, and we included 65 publications. The retrospective study design (37%) was most frequent, followed by prospective registries (29%), prospective studies (19%), and retrospective administrative databases/claims. Drug survival was reported in over 60% of prospective registries and retrospective studies, and less frequently in prospective studies. A general consensus emerged in the definition of drug survival as the time patients remain under treatment with a specific therapy, and in its interpretation as an overall marker of treatment success and treatment adherence, as it represents simultaneously information on drug efficacy, drug safety, and patient satisfaction. In conclusion, notwithstanding some limitations, drug survival is a useful measurement of biological therapy effectiveness for psoriasis in daily practice. Its major advantage is that it can be computed also in already collected databases without any specific clinical information on psoriasis. This outcome, combined with evidence on clinical markers of effectiveness, can contribute to better understanding the performance of this expensive class of drugs. [ABSTRACT FROM AUTHOR]
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- 2018
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154. Tumour necrosis factor inhibitor survival and predictors of response in axial spondyloarthritis--findings from a United Kingdom cohort.
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Yahya, Fariz, Gaffney, Karl, Hamilton, Louise, Lonsdale, Ellie, Leeder, Jane, Brooksby, Alan, Cavill, Charlotte, Berry-Jenkins, Joshua, Boyle, Cathal, and Bond, Debbie
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ANTIRHEUMATIC agents , *TREATMENT effectiveness , *FORECASTING , *ANKYLOSING spondylitis , *CONFIDENCE intervals , *LONGITUDINAL method , *PROBABILITY theory , *SMOKING , *TUMOR necrosis factors , *DISEASE remission , *RETROSPECTIVE studies , *DESCRIPTIVE statistics , *CHEMICAL inhibitors - Abstract
Objectives. To analyse long-term survival and efficacy of TNFi, reasons for switching or discontinuing, baseline predictors of response and remission in axial spondyloarthritis (axSpA) patients in a UK cohort. Methods. All patients with a physician-verified diagnosis of axSpA attending two specialist centres who fulfilled the eligibility criteria for TNFi were included. Routinely recorded patient data were reviewed retrospectively. Initial TNFi was recorded as the index drug. Results. Six hundred and fifty-one patients (94% AS) were included; adalimumab (n = 332), etanercept (n = 205), infliximab (n = 51), golimumab (n = 40) and certolizumab pegol (n = 23) were index TNFi. The mean (S.D.) duration from symptom onset to time of diagnosis was 8.6 (8.7) years and mean (S.D.) duration from diagnosis to TNFi initiation was 12.6 (11.5) years. A total of 224 (34.4%) stopped index TNFi, and 105/224 switched to a second TNFi. Median drug survival for index and second TNFi were 10.2 years (95% CI: 8.8, 11.6 years) and 5.5 years (95% CI: 2.7, 8.3 years), respectively (P < 0.05). Survival rates were not influenced by choice of TNFi. HLA-B27 predicted BASDAI50 and/or two or more point reduction within 6 months and long-term drug survival (P < 0.05). Low disease activity was predicted by non-smoking and low baseline BASDAI (P < 0.05). Conclusion. We have observed good TNFi survival rates in axSpA patients treated in a real-life setting. This is best for first TNFi and not influenced by drug choice. [ABSTRACT FROM AUTHOR]
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- 2018
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155. Use of biological disease modifying antirheumatic drugs in rheumatoid arthritis in Austria from 2008 to 2011.
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Stamm, Tanja A., Reichardt, Berthold, Zwerina, Jochen, Ritschl, Valentin, and Nell-Duxneuner, Valerie
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Background: Rheumatoid arthritis (RA) is the most prevalent chronic inflammatory joint disease. On a national level in Austria, there are currently no data available on how often and which biological disease modifying antirheumatic drugs (bDMARDs) are prescribed in patients with RA. The aim of the present study was to explore prescription patterns of bDMARDs in RA in Austria with a focus on drug survival.Methods: A retrospective data analysis of bDMARD courses of individual patients with RA that were extracted from the databases of nine Austrian health insurance funds covering 6.1 million (72%) insured people in a 4-year observation period from January 2008 to December 2011. Only patients with first prescriptions of bDMARDs were included. All patients with diagnoses other than RA were excluded.Results: A total of 2906 first prescriptions of bDMARDs were included in the present analysis and 19.35% of RA patients were on bDMARDs in Austria taking into account a prevalence of RA of 0.5%. Tocilizumab showed the longest drug survival after 1 year (73.2%), followed by abatacept which had the longest drug survival after 2 (68.2%) and 3 years (65.2%). The most frequent second bDMARDs switched to were adalimumab (
n = 109, 26%), tocilizumab (n = 83, 20%) and etanercept (n = 82, 20%) and 37% of biological DMARDs were prescribed as monotherapy (ranging from 33% with infliximab to 46% with tocilizumab).Conclusions: Our analysis is based on the largest health care database available in Austria. Tocilizumab and abatacept showed the longest drug survival. Adalimumab, tocilizumab and etanercept were the most frequent DMARDs switched to. Of interest was the high number of bDMARD monotherapies. [ABSTRACT FROM AUTHOR]- Published
- 2018
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156. Effectiveness, Tolerability, and Safety of Belimumab in Patients with Refractory SLE: a Review of Observational Clinical-Practice-Based Studies.
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Trentin, Francesca, Gatto, Mariele, Zen, Margherita, Maddalena, Larosa, Nalotto, Linda, Saccon, Francesca, Zanatta, Elisabetta, Iaccarino, Luca, and Doria, Andrea
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To date, belimumab is the only biological drug approved for the treatment of patients with active refractory SLE. We compared and critically analyzed the results of 11 observational clinical-practice-based studies, conducted in SLE referral centers. Despite the differences in endpoints and follow-up duration, all studies remarked that belimumab provides additional benefits when used as an add-on to existing treatment, allowing a higher rate of patients to reach remission and to taper or discontinue corticosteroids. In the OBSErve studies, 2-9.6% of patients discontinued corticosteroids and 72-88.4% achieved a ≥ 20% improvement by physician’s judgment at 6 months. In Hui-Yuen’s study, 51% of patients attained response by simplified SRI at month 6. In Sthoeger’s study, 72.3% of patients discontinued corticosteroids and 69.4% achieved clinical remission by PGA after a median follow-up of 2.3 years. In the multicentric Italian study, 77 and 68.7% of patients reached SRI-4 response at months 6 and 12, respectively. In all the studies, disease activity indices decreased over time. Retention rates at 6, 9, and 12 months were 82-94.1, 61.2-83.3, and 56.7-79.2%, respectively. The main limitations of these studies include the lack of a control group, the short period of observation (6-24 months) and the lack of precise restrictions regarding concomitant medication management. This notwithstanding, these experiences provide a more realistic picture of real-life effectiveness of the drug compared with the randomized controlled clinical trials, where stringent inclusion/exclusion criteria and changes in background therapy could limit the inference of data to the routine clinical care. [ABSTRACT FROM AUTHOR]
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- 2018
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157. The impact of smoking on rheumatoid arthritis outcomes.
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Vittecoq, Olivier, Richard, Laetitia, Banse, Christopher, and Lequerré, Thierry
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RHEUMATOID arthritis , *SMOKING , *HEALTH , *DISEASE prevalence , *INFLAMMATION - Published
- 2018
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158. Two‐year persistence of golimumab as second‐line biologic agent in rheumatoid arthritis as compared to other subcutaneous tumor necrosis factor inhibitors: real‐life data from the LORHEN registry.
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Favalli, Ennio G., Sinigaglia, Luigi, Becciolini, Andrea, Grosso, Vittorio, Gorla, Roberto, Bazzani, Chiara, Atzeni, Fabiola, Sarzi Puttini, Pier C., Fusaro, Enrico, Pellerito, Raffaele, and Caporali, Roberto
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GOLIMUMAB , *RHEUMATOID arthritis treatment , *ETANERCEPT , *ADALIMUMAB , *TUMOR necrosis factor regulation , *THERAPEUTICS - Abstract
Abstract: Objectives: To evaluate the 2‐year retention rate of golimumab compared with etanercept and adalimumab as second‐line biologic agent in rheumatoid arthritis (RA) patients who failed a previous tumor necrosis factor inhibitor (TNFi). Methods: Data on RA patients treated with a second‐line subcutaneous TNFi were extracted from a multicentric Italian cohort (the LORHEN registry). The analysis was limited to etanercept, adalimumab and golimumab in the period when all were available in Italy (since October 2010). The 2‐year retention rate was calculated by Kaplan–Meier method and the comparative risk for discontinuation among individual TNFi was compared by a stratified log‐rank test. Results: One hundred and ninety‐five RA patients treated with etanercept (
n =n =n =P =P =P =P =P =- Published
- 2018
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159. Survival rates of biological therapies for psoriasis treatment in real‐world clinical practice: A Canadian multicentre retrospective study.
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Marinas, Joseph E. C., Kim, Whan B., Shahbaz, Ali, Qiang, Judy K., Greaves, Simon, and Yeung, Jensen
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MEDICAL care , *BIOLOGICALS , *CLINICAL trials , *INFLIXIMAB , *ADALIMUMAB - Abstract
Abstract: Background/Objectives: Data on biologic drug survival in real‐world psoriasis treatment are limited. There is a need to evaluate long‐term trends of biologic use outside the realm of clinical trials. Methods: A multicentre chart review was conducted with patients' data from September 2005 to September 2014. Kaplan–Meier plot analysis was used to determine 5‐year drug survival rates. A log–rank test was used to compare the rates of drug survival between the studied biologics. Results: For the 398 patients and 545 treatment series analysed, 1, 2, 3, 4 and 5‐year survival rates were 0.826, 0.687, 0.563, 0.475 and 0.420 with etanercept; 0.804, 0.648, 0.553, 0.508 and 0.508 with adalimumab; 0.838, 0.664, 0.554, 0.485 and 0.382 with infliximab; and 0.914, 0.856, 0.800, 0.755 and 0.755 with ustekinumab, respectively. A statistically significant difference was seen between ustekinumab and the other three biologics. Conclusion: A progressive decrease in treatment adherence was seen with all four biologics, as expected, but the survival rate of ustekinumab was highest. [ABSTRACT FROM AUTHOR]
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- 2018
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160. Conséquences du tabac sur le devenir de la polyarthrite rhumatoïde.
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Vittecoq, Olivier, Richard, Laetitia, Banse, Christopher, and Lequerré, Thierry
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Résumé Le tabac, qui est un facteur de risque reconnu de développement d’une polyarthrite rhumatoïde (PR), peut également avoir un impact sur le devenir de la maladie. Les données sont assez bien documentées sur le tabagisme actif. En termes d’activité du rhumatisme, les résultats sont plutôt contradictoires. Il semble associé à une activité articulaire et systémique plus marquée au début de la maladie mais il n’apparaît pas prédictif d’une activité persistante de la maladie. S’agissant de la sévérité de la PR, le tabagisme actif n’est pas prédictif d’une progression structurale plus importante et aurait plutôt des effets « protecteurs ». En revanche, il contribue à la survenue de manifestations extra-articulaires (nodules rhumatoïdes, pneumopathie interstitielle infraclinique et symptomatique, parodontopathie, vascularite) et majore le risque d’infections sévères, d’infection périprothétique, de cancer pulmonaire et de décès. Quel que soit le statut immunologique, le tabagisme est associé à une moindre réponse au méthotrexate et aux 3 antagonistes du TNF (infliximab, etanercept et adalimumab) qui ont été évalués. Nous ne disposons pas d’informations de son impact sur les autres agents biologiques. En outre, les taux de rémission et de maintien thérapeutique sont moindres en cas d’exposition au tabac. Néanmoins, il n’a pas d’effet péjoratif en cas d’allégement ou d’arrêt du traitement. Alors que l’arrêt du tabac, qui reste un objectif difficile à atteindre en raison de plusieurs freins identifiés, ne semble pas modifier l’activité de la maladie, son intérêt demeure pour limiter l’apparition de manifestations extra-articulaires, de complications infectieuses et d’une surmortalité d’origine cardiorespiratoire ou tumorale. Tobacco, that is a well-known risk factor for rheumatoid arthritis (RA) development, can have an impact on disease outcome. Data are rather well-documented about active smoking. Concerning disease activity, there are contradictory results. While smoking is associated to a more important articular and systemic activity in early RA, it is not predictive of a persistent disease activity. In terms of disease severity, current smoking is not related to a higher radiographic progression and would have “protective effects”. But it enhances the occurrence of extra-articular manifestations (nodules, interstitial lung disease, periodontitis, vasculitis) and increases the risk of severe infections, periprosthetic joint infection, lung cancer and mortality. Whatever the immunological status, smoking is linked to a lower response to methotrexate and to the 3 TNF-blocking agents (infliximab, etanercept and adalimumab) that have been assessed until now. No informations are available about the other biologic agents. Moreover, remission and drug survival rates are lower under tobacco exposure. Nevertheless, active smoking has no deleterious effect in case of dose reduction or drug discontinuation. Although smoking cessation, which is an objective difficult to achieve because of several well-identified brakes, does not modify disease activity, its interest remains to reduce the appearance of extra-articular manifestations, severe infections and the risk of premature mortality due to cardiorespiratory comorbidities or cancer. [ABSTRACT FROM AUTHOR]
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- 2018
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161. Adherence to biologics in patients with psoriasis.
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Seale, Lauren, Cardwell, Leah A., and Feldman, Steven R.
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PSORIASIS ,BIOLOGICALS ,INFLIXIMAB ,ADALIMUMAB ,PATIENT compliance - Abstract
Introduction: Psoriasis has a profound impact on patients’ lives, but adherence to topical treatment of psoriasis is still poor. Biologic treatment has revolutionized the management of psoriasis, but adherence to treatment may still be a barrier for some patients. Areas covered: A PubMed search was conducted in August 2017 using the terms ‘biologics psoriasis adherence’ and ‘biologics psoriasis survival.’ Additional articles were obtained by perusing the references of articles identified in the original PubMed search. Articles that did not specifically mention ‘survival,’ ‘adherence,’ or ‘persistence’ were not included. We review the measures used to assess adherence to biologics for psoriasis and the factors impacting drug survival and adherence rates for biologics in psoriasis. Expert commentary: Drug survival and adherence rates for biologic therapy is less than ideal but may be modifiable. Means that may improve adherence and drug survival include individualized choice of biologic and providing additional support for patients who are at increased risk for prematurely stopping treatment. [ABSTRACT FROM PUBLISHER]
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- 2018
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162. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study.
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Iaccarino, Luca, Andreoli, Laura, Bocci, Elena Bartoloni, Bortoluzzi, Alessandra, Ceccarelli, Fulvia, Conti, Fabrizio, De Angelis, Rossella, De Marchi, Ginevra, De Vita, Salvatore, Di Matteo, Andrea, Emmi, Giacomo, Emmi, Lorenzo, Gatto, Mariele, Gerli, Roberto, Gerosa, Maria, Govoni, Marcello, Larosa, Maddalena, Meroni, Pier Luigi, Mosca, Marta, and Pazzola, Giulia
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BELIMUMAB , *PROTEINURIA treatment , *COMORBIDITY , *MULTIVARIATE analysis , *SYSTEMIC lupus erythematosus - Abstract
Objective To investigate efficacy, safety and survival of belimumab and to identify predictors of drug response and drug discontinuation in patients with active SLE in clinical practice. Patients and methods Data of SLE patients, treated with belimumab, from 11 Italian prospective cohorts were analyzed. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-h proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline and every 6 months. SLE Responder Index-4 (SRI-4) was calculated at 12 and 24 months. Demographic and clinical features and comorbidities were included in the univariate and multivariate analysis. Adverse events were recorded at each visit. Statistics was performed using the SPSS software. Results We studied 188 SLE patients, mean follow-up 17.5 ± 10.6 months. The most frequent manifestations, which required the use of belimumab, were polyarthritis (45.2%) and skin rashes (25.5%). SRI-4 was achieved by 77.0% and 68.7% of patients at 12 and 24-months. Independent predictors of 12-month response were SLEDAI-2K ≥ 10 (OR 40.46, p = 0.001) and polyarthritis (OR 12.64, p = 0.001) and of 24-month response were SLEDAI-2K ≥ 10 (OR 15.97, p = 0.008), polyarthritis (OR 32.36, p = 0.006), and prednisone ≥7.5 mg/day (OR 9.94, p = 0.026). We observed a low rate of severe adverse events. Fifty-eight patients (30.8%) discontinued belimumab after a mean follow-up of 10.4 ± 7.5 months. The drug survival was 86.9%, 76.9%, 69.4%, 67.1%, and 61.9% at 6, 12, 18, 24, and 30 months, respectively. No factors associated with drug discontinuation were found. Conclusion Belimumab is effective and safe when used in clinical practice setting. [ABSTRACT FROM AUTHOR]
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- 2018
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163. TNF inhibitors in rheumatoid arthritis and spondyloarthritis: Are they the same?
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Rubbert-Roth, Andrea, Atzeni, Fabiola, Masala, Ignazio Francesco, Caporali, Roberto, Montecucco, Carlomaurizio, and Sarzi-Puttini, Piercarlo
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RHEUMATOID arthritis , *TUMOR necrosis factors , *SPONDYLOLYSIS , *MEDICATION safety , *DRUG efficacy , *PHARMACOKINETICS - Abstract
The advent of anti-tumour necrosis factor (TNF) drugs for rheumatoid arthritis (RA) or spondyloarthritis (SpA) has revolutionised the approach to patients with active disease who do not respond to conventional therapy. Although there are differences in their structure, morphology, pharmacokinetic properties and activity, all anti-TNF drugs ultimately neutralise the TNFα pathway of inflammation. However, despite their similar clinical efficacy, there are disagreements concerning drug survival and safety, with systematic reviews and meta-analyses confirming one result or the other. The fact that 20–30% of patients fail to respond to TNFα inhibitors indicates the possibility of primary resistance or the development of an immune response to the drugs themselves, which may act as antigens. The overall benefit of switching to another anti-TNF drug or a biological agent with a different mechanism of action, may be a valuable option in individual patients. There are few data concerning the use of anti-TNF drugs in patients with SpA but it seems that there are fewer adverse advents and higher drug survival in comparison with patients with RA. [ABSTRACT FROM AUTHOR]
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- 2018
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164. Persistency of Biologic Therapies for Plaque Psoriasis in 2 Large Community Practices.
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Verma, Luvneet, Mayba, Julia N., Gooderham, Melinda J., Verma, Ankush, and Papp, Kim A.
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Background: Biologics have transformed the management of moderate to severe psoriasis. The persistency of biologics lacks real-world data. Objectives: To quantify drug survival of infliximab (IFX), adalimumab (ADA), etanercept (ETA), and ustekinumab (UST) and to identify potential factors affecting drug survival. Methods: An observational, retrospective 2-centre study consisting of 906 patients from private practices in Ontario between July 2003 and June 13, 2016, was conducted, including patients with plaque psoriasis receiving commercial treatment with ADA, ETA, IFX, and UST. Paper and electronic records of each patient were reviewed. Results: Median survival times for UST, IFX, ADA, and ETA were respectively, in months, 68, 23, 33, and 28. Female sex was determined to be a statistically significant positive predictor of drug survival. Our study was consistent with the literature in that UST had the highest survival rate compared to the other biologics, and the shape of our drug survival curve suggested that loss of drug efficacy is a stochastic occurrence. Compared to other studies, our data exhibited lower survival rates at various time points for all the biologics studied, and female sex did not predict drug survival in other studies. We also investigated potential reasons for differences in biologic survival times between different practices; the main differentiator was drug dosage, as higher dosages were associated with greater survival. Conclusion: UST has a higher drug survival rate than ADA, ETA, and IFX, as observed in other studies. When practice patterns are compared, dosage difference is the main factor that may cause differing survival rates. [ABSTRACT FROM AUTHOR]
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- 2018
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165. Drug survival and reasons for discontinuation of the first biological disease modifying antirheumatic drugs in Thai patients with rheumatoid arthritis: Analysis from the Thai Rheumatic Disease Prior Authorization registry.
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Narongroeknawin, Pongthorn, Chevaisrakul, Parawee, Kasitanon, Nuntana, Kitumnuaypong, Tasanee, Mahakkanukrauh, Ajanee, Siripaitoon, Boonjing, Katchamart, Wanruchada, and The Thai Rheumatism Association
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RHEUMATOID arthritis , *RITUXIMAB , *ETANERCEPT , *INFLIXIMAB , *ADVERSE health care events , *PATIENTS , *THERAPEUTICS - Abstract
Abstract: Aim: To evaluate and compare the retention rate of biological disease‐modifying antirheumatic drugs (bDMARDs) in real‐life practice and identify risk factors related to remission and drug discontinuation in patients with rheumatoid arthritis (RA). Method: A total of 256 patients fulfilling criteria for RA and starting bDMARD between December 2009 and October 2014 were selected from the Rheumatic Disease Prior Authorization registry. Baseline demographic and clinical data were recorded. The cumulative probability of bDMARD discontinuation over 5 years of follow‐up and factors associated with RA remission and bDMARD withdrawal were analyzed. Results: Almost half (46%) of patients were initially treated with rituximab (RTX), with 33% treated with etanercept (ETN) and 21% with infliximab (IFX). Fewer than 10% were subsequently switched to a second bDMARD. The 1‐ and 5‐year remission rates in patients continuing their first bDMARD were 7.2% and 21.5%, respectively. At 5 years, the drug survival rates for RTX, ETN and IFX were 50%, 25% and 22%, respectively. Multivariate analysis showed that RTX was significantly associated with highest drug survival. Relative to RTX, the hazard ratios for discontinuation of IFX and ETN were 2.60 (95% confidence interval [CI] 1.53–4.42) and 2.15 (95% CI 1.36–3.42), respectively. Thirty‐nine percent of patients stopped treatments, due to inadequate response (42%), serious adverse events (22%), nonadherence (14%) or remission/low disease activity (13%). Conclusion: Over 5 years, only one‐third of patients continued using their first bDMARD. The leading cause of drug discontinuation was inadequate response. [ABSTRACT FROM AUTHOR]
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- 2018
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166. Drug survival rates and reasons for drug discontinuation in patients with atopic dermatitis: a retrospective study of adult outpatients
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Pino Lopez, Jehane, Kromer, Christian, Herr, Raphael, Schmieder, Astrid, Bayerl, Christiane, and Schaarschmidt, Marthe-Lisa
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- 2021
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167. Treatment Response of Patients with Erythrodermic Psoriasis after Switching to Guselkumab
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Chiang, Cheng-Ying and Tsai, Tsen-Fang
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- 2021
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168. Multicenter Retrospective Study of Secukinumab Drug Survival in Psoriasis Patients in a Daily Practice Setting: A Long-Term Experience in Spain
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Antonio Sahuquillo-Torralba, Eva Villarasa, Gregorio Carretero, Susana Armesto, Ofelia Baniandrés, Mar Llamas-Velasco, David Vidal, Raquel Rivera, Enrique Herrera-Acosta, A. Martorell, Rosa Feltes, Pablo Coto-Segura, Isabel Belinchón, Laura Salgado, F Ballescá, L Rodriguez, Alberto Romero-Maté, Glauber Pacelli Gomes de Lima, Esteban Daudén, Pablo de la Cueva, Josep Pujol-Montcusí, and Mercè Alsina
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medicine.medical_specialty ,business.industry ,Proportional hazards model ,Brief Report ,Hazard ratio ,Retrospective cohort study ,Dermatology ,medicine.disease ,Discontinuation ,Psoriatic arthritis ,Drug survival ,Anti IL-17, Drug survival, Psoriasis, Secukinumab ,Psoriasis ,Internal medicine ,medicine ,Anti IL-17 ,Secukinumab ,business ,Survival rate - Abstract
Introduction There is limited and conflicting evidence over the real-world drug survival of secukinumab (SEC) in patients with psoriasis, especially in the long term. Our objective was to analyze the short- and long-term survival of SEC (S-SEC) and its predictive factors for the treatment of psoriasis. Methods Patients clinically diagnosed with plaque psoriasis and under treatment with secukinumab (n = 384) in a daily practice setting were analyzed in a retrospective, multicenter study performed in a nationwide cohort and followed up for a period of 2 years. Kaplan-Meier curve was plotted to analyze drug survival time, and log-rank test was performed to compare several groups. Factors related to speed of treatment discontinuation were studied with a Cox regression model. Results The overall cumulative secukinumab drug survival rates observed at 6, 12, 18, and 24 months were 97.1%, 89.0%, 81.1%, and 74.3%, respectively. Obesity [hazard ratio (HR), 1.809, CI 95% 1.114-2.962; p = 0.004] and previous experience with biological therapies, particularly those who had been treated with >= 2 biologicals with different mechanisms of action (HR 3.476, CI 95% 1.875-6.444; p = 0.017) were associated with an early discontinuation, whereas psoriatic arthritis was associated with delayed discontinuation, (HR 0.493, CI 95% 0.265-0.917; p = 0.025). Conclusions In our study, we found that cumulative secukinumab drug survival for psoriasis patients for the period 6-18 months was in the range of real-world evidence studies. Additionally, we observed a relatively high long-term survival rate at 24 months (74.3%).
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- 2021
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169. Drug survival of biologics and novel immunomodulators for rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and psoriasis - A nationwide cohort study from the DANBIO and DERMBIO registries
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Egeberg, Alexander, Rosenø, Nana Aviaaja Lippert, Aagaard, David, Lørup, Erik Hillo, Nielsen, Mia-Louise, Nymand, Lea, Kristensen, Lars Erik, Thyssen, Jacob P., Thomsen, Simon Francis, Cordtz, Rene Lindholm, Loft, Nikolai, Skov, Lone, Bryld, Lars Erik, Rasmussen, Mads Kirchheiner, Højgaard, Pil, Kristensen, Salome, Dreyer, Lene, Egeberg, Alexander, Rosenø, Nana Aviaaja Lippert, Aagaard, David, Lørup, Erik Hillo, Nielsen, Mia-Louise, Nymand, Lea, Kristensen, Lars Erik, Thyssen, Jacob P., Thomsen, Simon Francis, Cordtz, Rene Lindholm, Loft, Nikolai, Skov, Lone, Bryld, Lars Erik, Rasmussen, Mads Kirchheiner, Højgaard, Pil, Kristensen, Salome, and Dreyer, Lene
- Abstract
Objective: Drug survival is an important proxy measure for effectiveness of treatments for inflammatory diseases such as rheumatoid arthritis (RA), axial spondyloarthritis (AxSpA), psoriatic arthritis (PsA), and psoriasis. The objective of this study was to examine the real-life drug survival of biologics and novel small-molecule therapies across various disease entities such as RA, AxSpA, PsA, and psoriasis. Methods: We performed a nationwide cohort study using the prospective nationwide registries DANBIO and DERMBIO, comprising all patients treated with biologics or novel small-molecule therapies for RA, AxSpA, PsA, and psoriasis between January 2015 through May 2021 (DANBIO) and November 2009 to November 2019 (DERMBIO). Drug survival was visualized using Kaplan-Meier curves, and Cox proportional hazards models were used to calculate adjusted Hazard Ratios (HRs) with 95% confidence intervals (CIs) for risk of discontinuing therapy. Findings: The study comprised a total of 12,089 patients (17,903 treatment series), including 5,104 RA patients (7,867 series), 2,157 AxSpA patients (3,016 series3), 2,551 PsA patients (3,313 series), and 2,577 psoriasis patients (3,707 series). In confounder-adjusted models drug survival in RA was highest for rituximab followed by baricitinib, etanercept and tocilizumab respectively. For AxSpA, drug survival was high for golimumab compared to all other drugs, followed by secukinumab and etanercept and lowest for infliximab. For PsA, tofacitinib and infliximab had the lowest drug survival compared to all other drugs. All other drugs performed almost equally well with a tendency of a somewhat higher drug survival for golimumab, followed by secukinumab and ixekizumab. For psoriasis, drug survival was generally highest for guselkumab. Interpretation: Differing treatment responses to drugs with various modes of action across RA, AxSpA, PsA and psoriasis emphasize that although these diseases have many overlaps in their pathogenesis, ther
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- 2022
170. Drug Survival of Interleukin (IL)‐17 and IL‐23 Inhibitors for the Treatment of Psoriasis: A Retrospective Multi‐country, Multicentric Cohort Study
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Torres, Tiago, Puig, Lui, Vender, Ron, Yeung, Jensen, Carrascosa, José-Manuel, Piaserico, Stefano, Gisondi, Paolo, Lynde, Charle, Ferreira, Paulo, Bastos, Pedro Mende, Dauden, Esteban, Leite, Luiz, Valerio, Joana, Del Alcázar-Viladomiu, Elena, Rull, Eva Vilarrasa, Llamas-Velasco, Mar, Pirro, Federico, Messina, Francesco, Bruni, Manfredo, Licata, Gaetano, Ricceri, Federica, Nidegger, Alessia, Hugo, Jan, Mufti, Asfandyar, Daponte, Athina-Ioanna, Teixeira, Laetitia, Balato, Anna, Romanelli, Marco, Prignano, Francesca, Gkalpakiotis, Spyridon, Conrad, Curdin, Lazaridou, Elizabeth, Rompoti, Natalia, Papoutsaki, Marina, Nogueira, Miguel, Chiricozzi, Andrea, Chiricozzi, Andrea (ORCID:0000-0002-6739-0387), Torres, Tiago, Puig, Lui, Vender, Ron, Yeung, Jensen, Carrascosa, José-Manuel, Piaserico, Stefano, Gisondi, Paolo, Lynde, Charle, Ferreira, Paulo, Bastos, Pedro Mende, Dauden, Esteban, Leite, Luiz, Valerio, Joana, Del Alcázar-Viladomiu, Elena, Rull, Eva Vilarrasa, Llamas-Velasco, Mar, Pirro, Federico, Messina, Francesco, Bruni, Manfredo, Licata, Gaetano, Ricceri, Federica, Nidegger, Alessia, Hugo, Jan, Mufti, Asfandyar, Daponte, Athina-Ioanna, Teixeira, Laetitia, Balato, Anna, Romanelli, Marco, Prignano, Francesca, Gkalpakiotis, Spyridon, Conrad, Curdin, Lazaridou, Elizabeth, Rompoti, Natalia, Papoutsaki, Marina, Nogueira, Miguel, Chiricozzi, Andrea, and Chiricozzi, Andrea (ORCID:0000-0002-6739-0387)
- Abstract
Background: Drug survival, defined as the length of time from initiation to discontinuation of a given therapy, allows comparisons between drugs, helps to predict patient's likelihood of remaining on a specific treatment, and achieving the best decision for each patient in daily clinical practice. Objective: The aim of this study was to provide data on drug survival of secukinumab, ixekizumab, brodalumab, guselkumab, tildrakizumab, and risankizumab in a large international cohort, and to identify clinical predictors that might have an impact on the drug survival of these drugs. Methods: This was a retrospective, multicentric, multi-country study that provides data of adult patients with moderate to severe psoriasis who started treatment with an interleukin (IL)-17 or IL-23 inhibitor between 1 February 2015 and 31 October 2021. Data were collected from 19 distinct hospital and non-hospital-based dermatology centers from Canada, Czech Republic, Italy, Greece, Portugal, Spain, and Switzerland. Kaplan-Meier estimator and proportional hazard Cox regression models were used for drug survival analysis. Results: A total of 4866 treatment courses (4178 patients)-overall time of exposure of 9500 patient-years-were included in this study, with 3164 corresponding to an IL-17 inhibitor (secukinumab, ixekizumab, brodalumab) and 1702 corresponding to an IL-23 inhibitor (guselkumab, risankizumab, tildrakizumab). IL-23 inhibitors had the highest drug survival rates during the entire study period. After 24 months of treatment, the cumulative probabilities of drug survival were 0.92 (95% confidence interval [CI] 0.89-0.95) for risankizumab, 0.90 (95% CI 0.88-0.92) for guselkumab, 0.80 (95% CI 0.76-0.84) for brodalumab, 0.79 (95% CI 0.76-0.82) for ixekizumab, and 0.75 (95% CI 0.73-0.77) for secukinumab. At 36 months, only guselkumab [0.88 (95% CI 0.85-0.91)], ixekizumab [0.73 (95% CI 0.70-0.76)], and secukinumab [0.67 (95% CI 0.65-0.70)] had more than 40 patients at risk of drug discon
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- 2022
171. Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study
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Parisi, S, Becciolini, A, Ditto, M, Rozza, D, Zanetti, A, Lagana, A, Peroni, C, Centanaro Di Vittorio, C, Degiovanni, R, Realmuto, C, Scire, C, Priora, M, Di Donato, E, Santilli, D, Mozzani, F, Lucchini, G, Ariani, A, Gardelli, L, Girelli, F, Arrigoni, E, Plate, I, Bravi, E, Paroli, M, Caccavale, R, Salvarani, C, Sandri, G, Lumetti, F, Volpe, A, Marchetta, A, Fusaro, E, Parisi S., Becciolini A., Ditto M. C., Rozza D., Zanetti A., Lagana A., Peroni C. L., Centanaro Di Vittorio C., Degiovanni R., Realmuto C., Scire C. A., Priora M., Di Donato E., Santilli D., Mozzani F., Lucchini G., Ariani A., Gardelli L., Girelli F., Arrigoni E., Plate I., Bravi E., Paroli M., Caccavale R., Salvarani C., Sandri G., Lumetti F., Volpe A., Marchetta A., Fusaro E., Parisi, S, Becciolini, A, Ditto, M, Rozza, D, Zanetti, A, Lagana, A, Peroni, C, Centanaro Di Vittorio, C, Degiovanni, R, Realmuto, C, Scire, C, Priora, M, Di Donato, E, Santilli, D, Mozzani, F, Lucchini, G, Ariani, A, Gardelli, L, Girelli, F, Arrigoni, E, Plate, I, Bravi, E, Paroli, M, Caccavale, R, Salvarani, C, Sandri, G, Lumetti, F, Volpe, A, Marchetta, A, Fusaro, E, Parisi S., Becciolini A., Ditto M. C., Rozza D., Zanetti A., Lagana A., Peroni C. L., Centanaro Di Vittorio C., Degiovanni R., Realmuto C., Scire C. A., Priora M., Di Donato E., Santilli D., Mozzani F., Lucchini G., Ariani A., Gardelli L., Girelli F., Arrigoni E., Plate I., Bravi E., Paroli M., Caccavale R., Salvarani C., Sandri G., Lumetti F., Volpe A., Marchetta A., and Fusaro E.
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We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, pre-viously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontin-uation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients.
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- 2022
172. Secukinumab: supervivencia en práctica clínica real
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Ricardo Ruiz-Villaverde, Manuel Galán-Gutierrez, J.C. Armario-Hita, Leandro Martinez-Pilar, and L. Rodríguez Fernández-Freire
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medicine.medical_specialty ,business.industry ,Retrospective cohort study ,General Medicine ,Dermatology ,RC31-1245 ,Clinical Practice ,Drug survival ,Psoriasis Area and Severity Index ,Internal medicine ,RL1-803 ,Ustekinumab ,medicine ,Psoriasis ,Secukinumab ,Immunoglobulin G1 ,Interleukin 17 ,business ,medicine.drug - Abstract
Resumen: Secukinumab es un anticuerpo monoclonal selectivo a la interleucina 17A de tipo IgG1/κ para el tratamiento de la psoriasis en placas de moderada a grave en adultos candidatos a tratamientos sistémicos. Las comparaciones indirectas de eficacia entre fármacos anti-TNF, ustekinumab y secukinumab nos han ido revelando que este último presenta menores tasas de supervivencia libre de enfermedad a pesar de su rápido inicio de acción y eficacia, pues un elevado número de pacientes alcanzan PASI90 y PASI100. Aportamos los datos de un estudio retrospectivo de 5 hospitales de la comunidad autónoma andaluza que incluyen 171 pacientes con una supervivencia global de secukinumab del 87% incluyendo pacientes con dosis de 300 y 150 mg/4 semanas. Estos datos contrastan con las series previamente publicadas en la literatura. Abstract: Secukinumab, an immunoglobulin G1/κ monoclonal antibody that selectively targets interleukin 17a, is used to treat moderate to severe plaque psoriasis in adults who are eligible for systemic treatment. Indirect comparisons of the efficacy of secukinumab, ustekinumab, and anti-tumor necrosis factor agents have found lower drug survival rates for patients on secukinumab, in spite of that biologic's rapid onset of action and efficacy as demonstrated by the large number of patients reaching a Psoriasis Area and Severity Index of 90 or 100. We present data from a retrospective study of 171 patients treated with doses of 300 mg or 150 mg of secukinumab every 4 weeks in 5 hospitals in the Spanish autonomous community of Andalusia. Eighty-seven percent continued on treatment at 132 weeks, contrasting with reports from previously published case series.
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- 2021
173. Secukinumab: Drug Survival in Clinical Practice Settings
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Ruiz-Villaverde, R, Rodríguez Fernández-Freire, L, Galán-Gutiérrez, M, Armario-Hita, J C, and Martinez-Pilar, L
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Adult ,Supervivencia ,Histology ,Dermatology ,Antibodies, Monoclonal, Humanized ,Severity of Illness Index ,Pathology and Forensic Medicine ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Pharmaceutical Preparations ,Drug survival ,Psoriasis ,Humans ,030212 general & internal medicine ,Secukinumab ,Retrospective Studies - Abstract
Secukinumab, an immunoglobulin G1/κ monoclonal antibody that selectively targets interleukin 17a, is used to treat moderate to severe plaque psoriasis in adults who are eligible for systemic treatment. Indirect comparisons of the efficacy of secukinumab, ustekinumab, and anti-tumor necrosis factor agents have found lower drug survival rates for patients on secukinumab, in spite of that biologic's rapid onset of action and efficacy as demonstrated by the large number of patients reaching a Psoriasis Area and Severity Index of 90 or 100. We present data from a retrospective study of 171 patients treated with doses of 300mg or 150mg of secukinumab every 4 weeks in 5 hospitals in the Spanish autonomous community of Andalusia. Eighty-seven percent continued on treatment at 132 weeks, contrasting with reports from previously published case series.
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- 2021
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174. A cluster analysis of patients with axial spondyloarthritis using tumour necrosis factor alpha inhibitors based on clinical characteristics
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Lee, Seulkee, Kang, Seonyoung, Eun, Yeonghee, Won, Hong-Hee, Kim, Hyungjin, Cha, Hoon-Suk, Koh, Eun-Mi, and Lee, Jaejoon
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- 2021
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175. Serum golimumab concentration and anti-drug antibodies are associated with treatment response and drug survival in patients with inflammatory joint diseases: data from the NOR-DMARD study
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G. L. Goll, Trine Bjøro, Nils Bolstad, E. Lie, A. Wierød, David J. Warren, Joseph O. Sexton, J. E. Gehin, Tore K Kvien, S. W. Syversen, and Liz Loli
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Male ,Drug ,Oncology ,Treatment response ,medicine.medical_specialty ,media_common.quotation_subject ,Immunology ,MEDLINE ,Arthritis, Rheumatoid ,03 medical and health sciences ,0302 clinical medicine ,Text mining ,Rheumatology ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,In patient ,030212 general & internal medicine ,media_common ,030203 arthritis & rheumatology ,biology ,business.industry ,Arthritis, Psoriatic ,Antibodies, Monoclonal ,General Medicine ,Golimumab ,Drug survival ,Treatment Outcome ,Antirheumatic Agents ,biology.protein ,Joint Diseases ,Antibody ,business ,Axial Spondyloarthritis ,medicine.drug - Abstract
Objectives: This study aimed to identify the therapeutic target concentration and frequency of anti-drug antibodies (ADAbs) in golimumab-treated patients with inflammatory joint disease (IJD). Method: Associations between golimumab concentration, ADAbs, and treatment response were examined in 91 patients with IJD [41 axial spondyloarthritis (axSpA), 20 rheumatoid arthritis (RA), and 30 psoriatic arthritis (PsA)] included in the NOR-DMARD study. Treatment response was defined by Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement in axSpA, European League Against Rheumatism (EULAR) good/moderate response in RA, and improvement of ≥ 50% in modified Disease Activity index for PSoriatic Arthritis (DAPSA) (28 swollen/tender joint counts) in PsA. Serum drug concentrations and ADAbs were analysed using automated in-house assays. Results: At inclusion, 42% were biological disease-modifying anti-rheumatic drug naïve and 42% used concomitant synthetic disease-modifying anti-rheumatic drug. The median golimumab concentration was 2.2 (interquartile range 1.0–3.5) mg/L. The proportions of responders after 3 months among patients with golimumab concentration < 1.0, 1.0–3.9, and ≥ 4.0 mg/L were 19%, 49%, and 74%, respectively. A higher rate of treatment discontinuation was seen in patients with serum golimumab concentration < 1.0 compared to ≥ 1.0 mg/L (hazard ratio 3.3, 95% confidence interval 1.8–6.0, p < 0.05). ADAbs were detected in 6%, and were associated with lower drug concentrations and both reduced treatment response and drug survival. Conclusions: Golimumab concentrations ≥ 1.0 mg/L were associated with improved treatment response and better drug survival, although some patients may benefit from higher concentrations. This study suggests a rationale for dosing guided by therapeutic drug monitoring in golimumab-treated patients with IJD. The results should be confirmed in larger studies including trough samples, and the efficacy of such a strategy must be examined in randomized controlled trials.
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- 2021
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176. Real-world adherence to topical therapies in patients with moderate acne
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Thierry Simonart, Viviane De Maertelaer, and Xuân-Lan Lam Hoai
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benzoyl peroxide ,medicine.medical_specialty ,Benzoyl peroxide ,A/BPO, fixed combination of adapalene 0.1% and BPO 2.5% ,law.invention ,LTFU, lost to follow-up ,BPO, benzoyl peroxide ,Randomized controlled trial ,drug survival ,law ,Adapalene ,Internal medicine ,medicine ,topical ,Lost to follow-up ,acne ,Acne ,business.industry ,Clindamycin ,clindamycin ,medicine.disease ,Discontinuation ,Private practice ,Clin-RA, fixed combination of clindamycin 1.2% and tretinoin 0.025% gel ,Original Article ,RCT, randomized controlled triaL ,business ,adapalen ,medicine.drug - Abstract
Background Real-life data on topical treatments in daily practice in patients with moderate acne are poorly characterized. Objective To investigate the drug survival of topical treatments administered to patients with moderate acne in a daily practice. Methods Survival analysis was performed on subjects (Belgian university hospital and private practice outpatient dermatology patients) with moderate acne who received topical therapies according to the current published guidelines. Results A total of 1160 treatment series (1029 patients) were included, including benzoyl peroxide (BPO, n = 93), azelaic acid (n = 246), adapalene (n = 254), a fixed combination of adapalene 0.1% and BPO 2.5% (A/BPO, n = 264), and a fixed combination of clindamycin 1.2% and tretinoin 0.025% gel (Clin-RA, n = 303). The calculated overall median treatment duration of all drugs was 2 months. The probability of treatment discontinuation after only 3 months was 50%. Overall, the drugs were discontinued for the following reasons: controlled acne (9%), side effects (9%), ineffectiveness (52%), combination of side effects and ineffectiveness (3%), and other reasons (1%). Overall, 27% patients were lost to follow-up. Limitations The post hoc study design and generalizability limit interpretation of the data. Conclusion Overall, the median treatment duration of topical anti-acne therapies was short (2 months). The main reason for discontinuation was ineffectiveness.
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- 2021
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177. Similar biologic drug response regardless of radiographic status in axial spondyloarthritis: data from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis registry
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Sizheng Steven Zhao, Linda E Dean, Gareth T. Jones, Xabier Michelena, Sayam Dubash, and Helena Marzo-Ortega
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Adult ,Male ,medicine.medical_specialty ,Disease ,Rheumatology ,drug survival ,Internal medicine ,ankylosing spondylitis ,Epidemiology ,medicine ,Humans ,Spondylitis, Ankylosing ,Pharmacology (medical) ,Prospective Studies ,Registries ,Prospective cohort study ,AcademicSubjects/MED00360 ,Societies, Medical ,Biological Products ,Ankylosing spondylitis ,business.industry ,Hazard ratio ,axial spondyloarthritis ,Clinical Science ,Middle Aged ,medicine.disease ,Radiography ,Natural history ,biological therapy ,Antirheumatic Agents ,Cohort ,epidemiology ,Female ,business ,Follow-Up Studies - Abstract
Objective To describe the baseline characteristics, biologic DMARD (bDMARD) response and drug survival of axial SpA (axSpA) patients in the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) according to radiographic status. Methods The BSRBR-AS is a national prospective cohort including axSpA participants classified according to the Assessment of SpondyloArthritis international Society criteria. In this analysis, baseline data of patients starting bDMARDs were compared. Ankylosing Spondylitis Disease Activity Scores (ASDASs) for low disease status, clinically important improvement (CII) and major improvement (MI) at 1 year were used to assess treatment response. Cox proportional hazards analysis was performed after adjusting for clinically relevant confounders. Results A total of 1145 axSpA patients were included. Higher male prevalence, older age and longer disease duration were seen in the radiographic axSpA (r-axSpA) subgroup. Based on a complete case analysis (290 patients), two-thirds of patients achieved an ASDAS low disease state at 1 year regardless of radiographic status [non-radiographic axSpA (nr-axSpA) 64.2% vs r-axSpA 66.1]. No statistically significant differences were seen between the subgroups in attaining ASDAS CII (nr-axSpA 50.7% vs r-axSpA 44.7%) or MI (nr-axSpA 20% vs r-axSpA 18.7%). Drug survival probability curves were similar for both subgroups and the hazard ratio for nr-axSpA/axSpA was 0.94 (95% CI 0.69, 1.28) when adjusted for sex, age, baseline ASDAS with CRP, smoking status, disease duration, HLA-B27 and prescribed biologic. Conclusions Although there appeared to be some differences in the baseline characteristics when exploring this cohort according to radiographic status, which are likely related to the natural history of the disease, the level of biologic response and drug survival was comparable between nr-axSpA and r-axSpA.
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- 2021
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178. Drug survival analysis of dupilumab and cyclosporin in patients with atopic dermatitis: a multicenter study
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Napolitano, Maddalena, Mariano, Maria, Cristaudo, Antonio, Dastoli, Stefano, Di Guida, Adriana, De Lucia, Mario, Guerrasio, Gianluca, Nisticò, Steven Paul, Passante, Maria, Pigliacelli, Flavia, Fabbrocini, Gabriella, Patruno, Cataldo, Napolitano, Maddalena, Mariano, Maria, Cristaudo, Antonio, Dastoli, Stefano, Di Guida, Adriana, De Lucia, Mario, Guerrasio, Gianluca, Nisticò, Steven Paul, Passante, Maria, Pigliacelli, Flavia, Fabbrocini, Gabriella, and Patruno, Cataldo
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safety ,Adult ,immunosuppressive therapie ,Antibodies, Monoclonal ,Dermatology ,Dupilumab ,Antibodies, Monoclonal, Humanized ,Severity of Illness Index ,Survival Analysis ,Dermatitis, Atopic ,Treatment Outcome ,drug survival ,Cyclosporine ,Humans ,Retrospective Studies - Abstract
Atopic dermatitis (AD) is a chronic inflammatory skin disease with a prevalence of about 2%-10% in the adult.Cyclosporin is a traditional immunosuppressive drug efficacious for treating AD, but its use is limited by several adverse event. Dupilumab is a monoclonal antibody blocking the effects of both of interleukin (IL)-4 and IL-13, pivotal cytokines in the pathogenesis of atopic diseases.For chronic conditions, such as AD, the efficacy and safety of a drug can be evaluated by drug survival (DS) analysis which gives a reflection of daily practice by evaluating the time from initiation to discontinuation of therapy.This study provides a comparative survival analysis between the only 2 drugs approved in Italy for the treatment of moderate-to-severe AD, cyclospoorin and dupilumab.
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- 2022
179. Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis.
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Iannone, Florenzo, Santo, Leonardo, Anelli, Maria Grazia, Bucci, Romano, Semeraro, Angelo, Quarta, Laura, D’Onofrio, Francesca, Marsico, Antonio, Carlino, Giorgio, Casilli, Oriana, Cacciapaglia, Fabio, Zuccaro, Carmelo, Falappone, Paola Chiara, Cantatore, Francesco Paolo, Muratore, Maurizio, and Lapadula, Giovanni
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Objectives To assess the drug survival of golimumab, and predictors thereof, in patients affected with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) in a prospective observational cohort. Methods This is a non-interventional, longitudinal study on RA, SpA, and PsA patients starting treatment with golimumab. Endpoints were the 2 years persistence rate of golimumab and predictors of therapy discontinuation. Drug retention was analyzed using Kaplan–Meier and Cox models. Hazard ratios (HR) of golimumab discontinuation were estimated by Cox-regression hazard models. Results Of 416 patients starting golimumab, 171 biologic-naïve and 245 inadequate responders to prior biologic drugs, 88 had RA, 147 SpA, and 181 PsA. Global 2 years drug retention was 70.2%, with no different hazard of discontinuation among diseases or line of biologic treatment. The strongest predictor of golimumab discontinuation was female gender (HR = 1.95). Golimumab monotherapy was associated with higher risk drug interruption (HR = 1.67). Within SpA, predictors of golimumab discontinuation were female sex (HR = 4.19), and absence of extra-articular manifestations (HR = 4.60). In PsA, duration of disease was negatively associated to drug interruption (HR = 0.93), whereas golimumab monotherapy was positively (HR = 2.21) associated. Interestingly, failing to achieve a good EULAR response at 3 months was the only predictor of golimumab discontinuation for RA patients (HR = 3.03). Conclusions This study provided evidence that golimumab has high retention rate in real-life settings. SpA male patients with extra-articular manifestations, PsA patients on co-therapy with DMARDs, and RA patients attaining an early clinical response had the highest probability to continue golimumab over 2 years. [ABSTRACT FROM AUTHOR]
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- 2017
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180. Effectiveness and drug survival of TNF-inhibitors in the treatment of psoriatic arthritis: A prospective cohort study.
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Aaltonen, Kalle, Heinonen, Arto, Joensuu, Jaana, Parmanne, Pinja, Karjalainen, Anna, Varjolahti-Lehtinen, Tuire, Uutela, Toini, Puurtinen-Vilkki, Maija, Arstila, Leena, Blom, Marja, Sokka, Tuulikki, and Nordström, Dan
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Background and objectives Tumor necrosis factor (TNF)-inhibitors are used to treat psoriatic arthritis (PsA), but only a limited number of observational studies on this subject have been published thus far. The aim of this research was to analyze the effectiveness and drug survival of TNF-inhibitors in the treatment of PsA. Methods PsA patients identified from the National Register for Biologic Treatment in Finland (ROB-FIN) starting their first, second, or third TNF-inhibitor treatment between 2004 and 2014 were included. Effectiveness was measured using ACR and EULAR response criteria and modeled using ordinal logistic regression. Treatment persistence was analyzed using Kaplan–Meier survival analysis and Cox proportional hazards model. Results The study comprised 765 patients and 990 TNF-inhibitor treatment courses. EULAR moderate treatment responses at 6 months were achieved by 68% and 37% of the users of the first and the second or the third biologic, respectively. The probabilities of discontinuing the treatment within 12 and 24 months were 20% and 28%, respectively. Adjusted treatment responses to all TNF-inhibitors were similar; however, co-therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) was not associated with better effectiveness. Adalimumab [hazard ratio (HR) = 0.62; 95% confidence interval (CI): 0.44–0.88] was superior to infliximab in drug survival while etanercept (HR = 0.77, 95% CI: 0.55–1.1) and golimumab (HR = 0.75, 95% CI: 0.46–1.2) did not differ from it. Co-medication with csDMARDs did not statistically improve drug survival. Conclusion All available TNF-inhibitors showed similar treatment responses with or without csDMARDs. Adalimumab was associated with better drug survival when compared to infliximab. [ABSTRACT FROM AUTHOR]
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- 2017
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181. Efficacy, safety and drug survival of conventional agents in pediatric psoriasis: A multicenter, cohort study.
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Ergun, Tulin, Seckin Gencosmanoglu, Dilek, Alpsoy, Erkan, Bulbul‐Baskan, Emel, Saricam, Merve Hatun, Salman, Andac, Onsun, Nahide, and Sarioz, Abdullah
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The data on long-term efficacy, safety and drug survival rates of conventional systemic therapeutics in pediatric psoriasis is lacking. The primary aim of this study is to investigate acitretin, methotrexate, cyclosporin efficacy, safety and drug survival rates in pediatric patients as well as predictors of drug survival. This is a multicenter study including 289 pediatric cases being treated with acitretin, methotrexate and cyclosporin in four academic referral centers. Efficacy, adverse events, reasons for discontinuation, 1, 2- and 3-year drug survival rates, and determinants of drug survival were analyzed. A 75% reduction of Psoriasis Area and Severity Index score or better response rate was obtained in 47.5%, 34.1% and 40% of the patients who were treated with acitretin, methotrexate and cyclosporin, respectively. One-year drug survival rates for acitretin, methotrexate and cyclosporin were 36.3%, 21.1% and 15.1%, respectively. The most significant determinant of drug survival, which diminished over time, was treatment response whereas arthritis, body mass index and sex had no influence. Although all three medications are effective and relatively safe in children, drug survival rates are low due to safety concerns at this age group. Effective disease control through their rational use can be expected to improve survival rates. [ABSTRACT FROM AUTHOR]
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- 2017
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182. Body mass does not impact the clinical response to intravenous abatacept in patients with rheumatoid arthritis. Analysis from the 'pan-European registry collaboration for abatacept (PANABA).
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Iannone, Florenzo, Courvoisier, Delphine, Gottenberg, Jacques, Hernandez, Maria, Lie, Elisabeth, Canhão, Helena, Pavelka, Karel, Hetland, Merete, Turesson, Carl, Mariette, Xavier, Choquette, Denis, and Finckh, Axel
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RHEUMATOID arthritis treatment , *ABATACEPT , *OBESITY , *BODY mass index , *OVERWEIGHT persons , *THERAPEUTICS - Abstract
Some evidences suggest that obesity impairs the effectiveness of TNF inhibitors. We examined the impact of body mass index (BMI) on the clinical effectiveness of abatacept in rheumatoid arthritis (RA) patients. This is a pooled analysis of 10 prospective cohorts of RA patients. All patients with available BMI were included in this study. The primary endpoint was drug retention of abatacept in the different BMI categories. Multivariable Cox regression was used to estimate hazard ratios (HRs) for drug discontinuation. A secondary endpoint was EULAR/LUNDEX response rates at 6/12 months. Of the 2015 RA patients initiating therapy with IV abatacept, 380 (18.9%) were classified as obese. Obese patients had more functional disability, and were less often RF positive. The median abatacept retention time was 1.91 years for obese RA patients compared to 2.12 years for non-obese patients ( p = 0.15). The risk of abatacept discontinuation was not significantly different for overweight (HR 1.03 (95% CI 0.89-1.19)), or for obese (HR 1.08 (95% CI 0.89-1.30)) compared to normal-weight patients. Rheumatoid factor positivity reduced the risk of abatacept discontinuation (HR 0.83 (95% CI 0.72-0.95)), while previous biologic therapy was positively associated with drug interruption (HRs increasing from 1.68 to 2.16 with the line of treatments). Obese and non-obese patients attained similar rates of EULAR/LUNDEX clinical response at 6/12 months. Drug retention and clinical response rates to abatacept do not seem to be decreased by obesity in RA patients. [ABSTRACT FROM AUTHOR]
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- 2017
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183. 432 Comparative treatment persistence of different advanced-therapies in patients with atopic dermatitis.
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Sanfilippo, Eric, Iyer, Sneha, and Silverberg, Jonathan I
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ATOPIC dermatitis , *DUPILUMAB , *TERTIARY care , *RACE , *CYCLOSPORINE - Abstract
Multiple advanced therapies are used to treat atopic dermatitis (AD), each with different efficacy, safety, tolerability, accessibility and treatment success that can affect treatment persistence. Little is known about how treatment persistence rates compare between different therapies. We compared treatment persistence for subcutaneous dupilumab, oral cyclosporine, mycophenolate, and upadacitinib, and narrowband ultraviolet B (NB-UVB) treatment of AD. A retrospective observational study was performed of patients with physician-diagnosed atopic AD from a large metropolitan tertiary care medical center. Medical records were reviewed for race, ethnicity, disease severity and use of therapies from 10/01/2015 to 10/1/2021. The AD cases were identified using Hanifin–Rajka criteria. Drug persistence was assessed using proportion of patients who discontinued therapy and median time to discontinuation. Chi-square tests were used to assess if there were differences in drug discontinuation rates by advanced therapy. Overall, 766 patients with AD were identified, including 139 (18.1%) prescribed dupilumab, 10 (1.3%) cyclosporine, 21 (2.7%) mycophenolate, 5 (0.7%) upadacitinib and 64 (8.4%) NB-UVB; no patients were treated with methotrexate. Drug persistence was highest for upadacitinib (100%), followed by dupilumab (86.3%), mycophenolate (38.1%), cyclosporine (30.0%) and NB-UVB (12.5%) (Chi-square, P < 0.0001). Highest median (days) time to discontinuation was observed with dupilumab (638), followed by cyclosporine (539), mycophenolate (274) and NB-UVB (167). Lack of efficacy was the most common reason for discontinuation of dupilumab, cyclosporine, mycophenolate and NB-UVB alike. Discontinuation due to adverse-events was highest for cyclosporine (42.9%), followed by dupilumab (31.6%), mycophenolate (30.8%) and NB-UVB (16.1%). Dupilumab had the most patients who discontinued due to disease improvement and no longer requiring advanced-therapy (21.1%). Our data suggest that drug persistence varies substantially across different advanced therapies for AD. Recently approved advanced therapies, including dupilumab and upadacitinib, showed the highest proportion of drug persistence. [ABSTRACT FROM AUTHOR]
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- 2023
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184. Real-world evidence for secukinumab in UK patients with psoriatic arthritis or radiographic axial spondyloarthritis: interim 2-year analysis from SERENA.
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Gaffney K, Gullick N, MacKay K, Patel Y, Sengupta R, Sheeran T, Hemmings L, and Pamies P
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Objectives: The aim was to evaluate retention rates for secukinumab in patients with active PsA or radiographic axial spondyloarthritis (r-axSpA) treated in routine UK clinical practice., Methods: SERENA (CAIN457A3403) is an ongoing, non-interventional, international study of patients with moderate-to-severe chronic plaque psoriasis, active PsA or active r-axSpA, who had received secukinumab for ≥16 weeks before enrolment. The primary objective of this interim analysis was to assess treatment retention rates in patients with PsA or r-axSpA who were enrolled and followed for ≥2 years at centres in the UK. The safety analysis set includes all patients who received at least one dose of secukinumab. The target population set includes all patients who fulfilled the patient selection criteria., Results: The safety set comprised 189 patients (PsA, n = 81; r-axSpA, n = 108), and the target population set comprised 183 patients (PsA, n = 78; r-axSpA, n = 105). In the safety set, 107 patients (45 of 81 with PsA and 62 of 108 with r-axSpA) had previously received a biologic agent. Retention rates were similar between patients with PsA and r-axSpA after 1 year (PsA 91.0%, 95% CI: 84.0, 98.0; r-axSpA 89.2%, 95% CI: 82.7, 95.7) and 2 years (PsA 77.6%, 95% CI: 67.6, 87.7; r-axSpA 76.2%, 95% CI: 67.4, 85.0) of observation. Overall, 17.5% of patients (33 of 189) experienced at least one treatment-related adverse event, and 12.7% of patients (24 of 189) discontinued secukinumab because of adverse events., Conclusion: This analysis of real-world data from the UK demonstrates high retention rates for secukinumab over 2 years in patients with PsA or r-axSpA, with a favourable safety profile., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2023
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185. Drug survival of apremilast in a real‐world setting.
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Kishimoto, Megumi, Komine, Mayumi, Kamiya, Koji, Sugai, Junichi, and Ohtsuki, Mamitaro
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Apremilast is a novel oral phosphodiesterase‐4 inhibitor approved for treatment of plaque psoriasis and psoriatic arthritis in Japan in December 2016. We have treated a substantial number of patients with psoriasis with apremilast and investigated the length of the treatment period with apremilast (drug survival of apremilast) in 138 patients with psoriasis who were treated at the Department of Dermatology in Jichi Medical University Hospital from 1 March 2017 to 31 August 2018 using the Kaplan–Meier survival curve. The drug survival rate of apremilast at 1 year was 53.4%. The median length of the drug survival period was 453 days. There were no statistical differences in the drug survival rate in terms of the type of psoriasis, previous systemic treatment or presence of one or more adverse events. Drug efficacy was investigated in 115 patients who were followed for more than 16 weeks. There was no correlation between drug efficacy and sex, previous systemic treatment or presence of one or more adverse events; however, there was a correlation between drug efficacy and plaque size (P < 0.01, rs = −0.29). The result of our study indicates that apremilast is effective regardless of the history of prior systemic treatment, and it supports our previous finding that small plaque‐type psoriasis is more sensitive to treatment with apremilast. [ABSTRACT FROM AUTHOR]
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- 2019
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186. Two-year efficacy, safety, and drug survival of dupilumab for atopic dermatitis: A real-world Canadian multicenter retrospective study
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Tina Felfeli, Christine E. Jo, Vincent Piguet, Jorge R. Georgakopoulos, Aaron M. Drucker, and Jensen Yeung
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safety ,medicine.medical_specialty ,Letter ,atopic dermatitis ,business.industry ,efficacy ,adverse event ,Retrospective cohort study ,Atopic dermatitis ,Dermatology ,medicine.disease ,Dupilumab ,Drug survival ,drug survival ,dupilumab ,RL1-803 ,medicine ,business ,Adverse effect - Published
- 2021
187. Effectiveness and clinical predictors of drug survival in psoriasis patients receiving apremilast: A registry analysis
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Roland Lichem, Alexandra Gruber-Wackernagel, Paul-Gunther Sator, Werner Saxinger, Hannes Trattner, Igor Vujic, Nina Häring, Constanze Jonak, Martina Schütz-Bergmayr, Robert R. Müllegger, Gudrun Ratzinger, Franz J. Legat, Wolfgang Weger, Clemens Painsi, Wolfram Hoetzenecker, Claudia Kölli, Alexander Mlynek, Knut Prillinger, Adrian Tanew, Angelika Hofer, Hans Skvara, Wolfgang Salmhofer, Christina Ellersdorfer, Franz Quehenberger, Barbara Gruber, Erich Schmiedberger, Thomas Graier, and Peter Wolf
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Drug ,medicine.medical_specialty ,PP, per protocol ,media_common.quotation_subject ,Arthritis ,apremilast ,Dermatology ,Intertriginous ,LOCF, last observation carried forward ,Psoriasis Area and Severity Index ,drug survival ,Internal medicine ,Psoriasis ,Medicine ,media_common ,business.industry ,Hazard ratio ,psoriasis ,medicine.disease ,HR, hazard ratio ,PASI, psoriasis area and severity index ,PsoRA, Psoriasis Registry Austria ,Concomitant ,Original Article ,Apremilast ,business ,SD, standard deviation ,medicine.drug - Abstract
Background Little is known about the effectiveness and drug survival associated with apremilast under real-world conditions. Objective To investigate the influence of patient and disease characteristics on drug survival associated with apremilast and to elucidate clinical effectiveness with regard to the psoriasis area and severity index (PASI) reduction. Methods This was an observational, retrospective, multicenter analysis from the Austrian Psoriasis Registry. Results Data from 367 patients were eligible for analysis. The 12-month drug survival rate associated with apremilast (ie, the proportion of patients on the drug) was 57.3% and decreased significantly in patients younger than 40 years (relative hazard ratio = 1.49, P = .007918). Sex; concomitant arthritis; previous biologic therapy; obesity; and palmoplantar, scalp, nail, and intertriginous involvement did not significantly affect drug survival. At 12 months, the response rates in patients receiving apremilast per protocol with a PASI of 50, 75, 90, and 100 were 80.0%, 56.4%, 38.2%, and 22.7%, respectively. Limitations Inclusion of a substantial number of patients with no record of absolute PASI at study entry and lack of PASI reduction follow-up data of 103 patients (28.1%) after starting apremilast treatment. Conclusion Apremilast is a robust antipsoriatic drug for which the drug survival is not strongly influenced by most patient- or disease-related factors except age. Drug survival is significantly shorter in patients younger than 40 years.
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- 2020
188. Long-term Safety of Oral Systemic Therapies for Psoriasis: A Comprehensive Review of the Literature
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L. Salgado-Boquete, Aurora Parodi, Sascha Gerdes, and Deepak M.W. Balak
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medicine.medical_specialty ,Combination therapy ,Review ,Dermatology ,Acitretin ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Long-term ,Drug survival ,Psoriasis ,Medicine ,Adverse effect ,Systemic therapy ,business.industry ,medicine.disease ,Ciclosporin ,Discontinuation ,030220 oncology & carcinogenesis ,Adverse events ,RL1-803 ,Toxicity ,Apremilast ,Safety ,business ,medicine.drug - Abstract
Oral systemic therapies are important treatment options for patients with moderate-to-severe psoriasis, either as monotherapy or in therapy-recalcitrant cases as combination therapy with phototherapy, other oral systemics or biologics. Long-term treatment is needed to maintain sufficient disease control in psoriasis, but continuous use of systemic treatments is limited by adverse events (AEs) and cumulative toxicity risks. The primary aim of this comprehensive literature review was to examine the long-term safety profiles of oral agents commonly used in the treatment of adults with psoriasis. Searches were conducted in EMBASE and PubMed up to November 2018, and 157 relevant publications were included. Long-term treatment with acitretin could be associated with skeletal toxicity and hepatotoxicity, although evidence for skeletal toxicity is mixed and hepatotoxicity is rare, particularly at low doses. Other safety issues include hyperlipidaemia and potential for teratogenicity up to 2–3 years after discontinuation of treatment. There is a paucity of data on long-term treatment with apremilast. Continued exposure to apremilast does not seem to increase the incidence of common AEs, such as gastrointestinal (GI) AEs, upper respiratory tract infections and headache, while the long-term risks for depression, suicidal thoughts and weight loss are unknown. Long-term ciclosporin treatment is associated with renal toxicity, hypertension, non-melanoma skin cancer, neurological AEs and GI AEs. Long-term methotrexate treatment is associated with hepatotoxicity, GI AEs, haematological toxicity, renal toxicity and alopecia. Finally, long-term treatment with fumaric acid esters (FAE) is associated with GI AEs, flushing, lymphocytopenia, proteinuria and elevated liver enzymes. Median drug survival estimates varied considerably: ~ 2.9–9.7 months for apremilast; ~ 5.4 months for ciclosporin; ~ 8.6 months for acitretin; ~ 12.1–21.6 months for methotrexate; and ~ 54.8 months for FAE. These long-term safety profiles may help to guide clinicians to select the optimal oral systemic treatment for the long-term treatment of psoriasis in adults. Electronic supplementary material The online version of this article (10.1007/s13555-020-00409-4) contains supplementary material, which is available to authorized users.
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- 2020
189. Tofacitinib in Patients with Rheumatoid Arthritis: Single-center Experience Rheumatoid Arthritis and Tofacitinib
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Serdar Sezer, Emine Gözde Aydemir Gülöksüz, Murat Turgay, Gülay Kinikli, Murat Torgutalp, Aşkın Ateş, Müçteba Enes Yayla, Didem Şahin, Mehmet Levent Yüksel, and Ayşe Bahar Keleşoğlu Dinçer
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rheumatoid arthritis ,lcsh:R5-920 ,medicine.medical_specialty ,tofacitinib ,Tofacitinib ,business.industry ,Single Center ,medicine.disease ,Dermatology ,drug survival ,Rheumatoid arthritis ,Medicine ,In patient ,lcsh:Medicine (General) ,business - Abstract
Objectives:In this study, we aimed to determine the clinical, laboratory and demographic characteristics of patients with rheumatoid arthritis (RA) using tofacitinib, and the drug survival rates.Materials and Methods:A total of 78 RA patients who were prescribed tofacitinib between May 2016 and July 2019 were retrospectively evaluated and included in the study. The clinical, laboratory and demographic features of the patients were recorded. Drug survival rates were analyzed using Kaplan-Meier survival analysis. P
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- 2020
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190. Predictors of drug survival of biologic therapies in psoriasis patients
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Ozge Zorlu, Deniz Sigirli, Kenan Aydogan, Hayriye Sarıcaoğlu, Emel Bülbül Başkan, Ferah Budak, Serkan Yazici, and Lacin Cevhertas
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Oncology ,Drug ,medicine.medical_specialty ,media_common.quotation_subject ,Dermatology ,Etanercept ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Psoriasis ,medicine ,Humans ,Retrospective Studies ,media_common ,030203 arthritis & rheumatology ,business.industry ,Biologic therapies ,Adalimumab ,medicine.disease ,Infliximab ,Biological Therapy ,Drug survival ,Pharmaceutical Preparations ,Tumor Necrosis Factor Inhibitors ,Tumor necrosis factor alpha ,business - Abstract
We aimed to investigate the clinical, immunological, and genetic factors affecting the response to anti-TNFα (tumor necrosis factor-α) and interleukin-12/23 therapies and drug survivals.A total of 180 patients were divided into two groups: 89 patients who used at least two biologic agents, with the initial biologic agent used less than 12 months (group A), and 91 biologic-naive patients who have been receiving a single biologic agent for more than 12 months (group B). ELISA (enzyme-linked immunosorbent assay) was used to analyze anti-drug antibodies (ADAs) in blood samples. Clinical data of the patients were retrospectively analyzed. HLA-SSO (sequence-specific oligonucleotide) Typing Kits were used for HLA-C typing. IBM SPSS v.21 was used for statistical analysis.RAlthough our study is retrospective of a relatively low number of patients, this is a preliminary study focusing on two different patient populations based on therapy response.
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- 2020
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191. Two‐year drug survival of dupilumab in a large cohort of difficult‐to‐treat adult atopic dermatitis patients compared to cyclosporine A and methotrexate: Results from the BioDay registry
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Ilona de Ridder, Geertruida L E Romeijn, Lotte S. Spekhorst, Marijke Kamsteeg, Lieneke F.M. Ariëns, Marie L A Schuttelaar, Marlies de Graaf, Jorien van der Schaft, A. J. Oosting, Annemiek Sloeserwij, Marjolein S. de Bruin-Weller, Daphne S. Bakker, Inge Haeck, Judith L. Thijs, and Public Health Research (PHR)
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Adult ,medicine.medical_specialty ,Immunology ,MEDLINE ,Antibodies, Monoclonal, Humanized ,Dermatitis, Atopic ,medicine ,Immunology and Allergy ,Humans ,Registries ,Letters to the Editor ,Letter to the Editor ,Adult atopic dermatitis ,biology ,business.industry ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,Dupilumab ,Dermatology ,Large cohort ,Drug survival ,Methotrexate ,Pharmaceutical Preparations ,Monoclonal ,biology.protein ,Cyclosporine ,Antibody ,business ,medicine.drug - Abstract
Contains fulltext : 225155.pdf (Publisher’s version ) (Open Access)
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- 2020
192. Treatment modalities and drug survival in a systemic sclerosis real-life patient cohort
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Maria G Tektonidou, Georgios Georgiopoulos, P.P. Sfikakis, Dimitrios T. Boumpas, Stamatis-Nick C. Liossis, V.-K. Bournia, Theodoros Dimitroulas, Lazaros I. Sakkas, Κ. Chatzidionysiou, Stylianos Panopoulos, Konstantinos Thomas, Alexandros A. Drosos, D. Daoussis, G. Vosvotekas, Dimitrios Vassilopoulos, Paraskevi V. Voulgari, Prodromos Sidiropoulos, Α. Garyfallos, and G. Bertsias
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Adult ,Endothelin Receptor Antagonists ,Male ,medicine.medical_specialty ,lcsh:Diseases of the musculoskeletal system ,Cyclophosphamide ,Sildenafil ,Azathioprine ,Gastroenterology ,Cohort Studies ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Tocilizumab ,Drug survival ,Internal medicine ,medicine ,Humans ,Vasoconstrictor Agents ,030212 general & internal medicine ,Aged ,Retrospective Studies ,Treatment patterns ,030203 arthritis & rheumatology ,Scleroderma, Systemic ,business.industry ,Middle Aged ,3. Good health ,Discontinuation ,Pharmaceutical Preparations ,chemistry ,Systemic sclerosis ,Female ,Rituximab ,Methotrexate ,lcsh:RC925-935 ,business ,Cohort study ,Immunosuppressive Agents ,Research Article ,medicine.drug ,Iloprost - Abstract
Background European data indicate that systemic sclerosis (SSc)-related death rates are increasing, thus raising concerns about SSc’s optimal management. Herein, we describe current treatment modalities and drug survival in a real-life SSc cohort. Methods Details on immunosuppressive/antiproliferative (methotrexate, mycophenolate, cyclophosphamide, azathioprine, rituximab, tocilizumab) and vasoactive agent [(endothelin receptor antagonists (ERAs), sildenafil, iloprost, and calcium channel blockers (CCB)] administration during the disease course (11.8 ± 8.4 years, mean + SD) of 497 consecutive patients examined between 2016 and 2018 were retrospectively recorded. Drug survival was assessed by Kaplan–Meier analysis. Results Methotrexate was the most frequently administered immunosuppressive/antiproliferative agent (53% of patients), followed by cyclophosphamide (26%), mycophenolate (12%), and azathioprine (11%). Regarding vasoactive agents, CCB had been ever administered in 68%, ERAs in 38%, iloprost in 7%, and sildenafil in 7% of patients; 23% of patients with pulmonary fibrosis had never received immunosuppressive/antiproliferative agents, 33% of those with digital ulcers had never received ERAs, iloprost, or sildenafil, whereas 19% of all patients had never received either immunosuppressive/antiproliferative or other than CCB vasoactive agents. Survival rates of methotrexate, cyclophosphamide, and mycophenolate differed significantly, being 84/75%, 59/43%, and 74/63% at 12/24 months, respectively, with inefficacy being the most frequent discontinuation cause. Conversely, CCB, ERAs, and sildenafil had high and comparable retention rates of 97/91%, 88/86%, and 80/80%, respectively. Conclusions Existing therapeutic limitations indicate that more evidence-based treatment is warranted for successful management of SSc. Vasculopathy seems to be managed more rigorously, but the low retention rates of immunosuppressive/antiproliferative drugs suggest that effective and targeted disease-modifying agents are warranted.
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- 2020
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193. Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study
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Neil M.H. Graham, Joel M. Gelfand, Mette Deleuran, Chen Wang, Abhijit Gadkari, Peter Foley, Diamant Thaçi, John D. Davis, Marie L A Schuttelaar, Kristian Reich, Jean-David Bouaziz, Heribert Staudinger, Michihiro Hide, Zhen Chen, Bolanle Akinlade, Andrew Blauvelt, Iftikhar Hussain, Marjolein S. de Bruin-Weller, Weily Soong, Robert Bissonnette, Marius Ardeleanu, Gianluca Pirozzi, Lisa A. Beck, Laurent Eckert, Manoj Rajadhyaksha, Lawrence Sher, Seth Forman, and Public Health Research (PHR)
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Male ,Time Factors ,PERSISTENT ASTHMA ,MedDRA ,efficacy ,GUIDELINES ,Severity of Illness Index ,Eczema Area and Severity Index ,Cohort Studies ,DOUBLE-BLIND ,030207 dermatology & venereal diseases ,0302 clinical medicine ,QUALITY-OF-LIFE ,ADULT PATIENTS ,PLACEBO ,atopic dermatitis ,open label ,Atopic dermatitis ,Dermatology Life Quality Index ,Middle Aged ,Dupilumab ,Treatment Outcome ,IL-13 ,030220 oncology & carcinogenesis ,Female ,Adult ,safety ,medicine.medical_specialty ,ECZEMA ,Dermatology ,Antibodies, Monoclonal, Humanized ,Dermatitis, Atopic ,03 medical and health sciences ,dupilumab ,Internal medicine ,MANAGEMENT ,medicine ,Humans ,DRUG SURVIVAL ,biologic therapy ,Adverse effect ,long-term ,business.industry ,IL-4 ,medicine.disease ,Clinical trial ,Regimen ,DAILY PRACTICE COHORT ,quality of life ,monoclonal antibody ,business - Abstract
Background: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).Objective: To assess the long-term safety and efficacy of dupilumab in patients with AD.Methods: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.Results: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.Limitations: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks.Conclusion: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
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- 2020
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194. Serial biologic therapies in psoriasis patients: A 12-year, single-center, retrospective observational study
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Alessio Signori, Yiran Wei, Aurora Parodi, Martina Burlando, and Emanuele Cozzani
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Adult ,Male ,medicine.medical_specialty ,biologic drugs ,drug survival ,psoriasis ,switch ,Kaplan-Meier Estimate ,Dermatology ,Risk Assessment ,Severity of Illness Index ,Drug Administration Schedule ,Etanercept ,030207 dermatology & venereal diseases ,03 medical and health sciences ,0302 clinical medicine ,Psoriasis Area and Severity Index ,Internal medicine ,Ustekinumab ,Humans ,Psoriasis ,Medicine ,Survival analysis ,Aged ,Proportional Hazards Models ,Academic Medical Centers ,Biological Products ,Drug Substitution ,business.industry ,Proportional hazards model ,Hazard ratio ,Adalimumab ,Retrospective cohort study ,Odds ratio ,Middle Aged ,Prognosis ,Long-Term Care ,Discontinuation ,Biological Therapy ,Italy ,030220 oncology & carcinogenesis ,Female ,business ,medicine.drug - Abstract
Background Biologic therapy for psoriasis is effective but not always long-lasting and sometimes needs to be switched. Objective We aimed to evaluate the drug survival (ie, the time from initiation to discontinuation) of each biologic and the factors affecting survival to identify better switching strategies and improve drug survival. Methods In total, 195 psoriasis patients treated in our unit during 2006-2018 were retrospectively observed. Descriptive statistical analyses and logistic regression models were performed. Kaplan–Meier survival curves and multivariate Cox models adjusted for confounding variables were used to estimate and compare drug survival. Results Overall, 90.6% of patients achieved an ≥75% reduction in their baseline Psoriasis Area and Severity Index score. In 2018, the most frequently used biologic was ustekinumab (47/169, 27.8%). Patients with higher baseline Psoriasis Area and Severity Index scores were more likely to be switched (P = .0399, odds ratio 1.08). In naive patients, ustekinumab showed longer drug survival (>7.0 years), but in biologic-experienced patients, we found no significant differences in drug survival. Previous biologic therapies increased the need for switching (P = .014, hazard ratio 1.20). Switching between biologic classes yielded longer drug survival than switching within biologic classes (P = .003, hazard ratio 0.48). Limitations As a single-center, retrospective real-life study, the data were not perfectly homogeneous. Conclusion Switching between biologic classes might increase drug survival but retrospective studies designed ad hoc are needed to confirm this better switching strategy.
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- 2020
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195. Evolution of Drug Survival with Biological Agents and Apremilast Between 2012 and 2018 in Patients with Psoriasis from the PsoBioTeq Cohort
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Olivier Chosidow, Hervé Bachelez, Thomas Bettuzzi, Marie Beylot-Barry, Pascal Joly, Alain Dupuy, Florence Tubach, Emmanuel Mahé, Nathalie Beneton, Manuelle Viguier, Marie-Aleth Richard, Denis Jullien, Hugo Arlegui, Emilie Sbidian, Carle Paul, CHU Henri Mondor [Créteil], Epidemiology in Dermatology and Evaluation in Therapeutics (EpiDermE), Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Bordeaux Research In Translational Oncology [Bordeaux] (BaRITOn), Université de Bordeaux (UB)-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Unité différenciation épidermique et auto-immunité rhumatoïde (UDEAR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Victor Dupouy, Centre Hospitalier Le Mans (CH Le Mans), Hospices Civils de Lyon (HCL), Hôpital de la Timone [CHU - APHM] (TIMONE), Physiopathologie, Autoimmunité, maladies Neuromusculaires et THErapies Régénératrices (PANTHER), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Pontchaillou, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Dynamic Microbiology - EA 7380 (DYNAMIC), École nationale vétérinaire - Alfort (ENVA)-Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)-Université Paris-Est (UPE)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), AOM 09 195, Amgen, Pfizer, Novartis, AbbVie, Meso Scale Diagnostics, MSD, Novartis Pharma, Janssen Pharmaceuticals, MSD France, Ministère des Affaires Sociales et de la Santé, Société Française de Dermatologie et de Pathologie Sexuellement Transmissible, SFD: JMD/MDM/177-11, NCT01617018, Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM, LEO Pharma Research Foundation, Assistance publique-Hôpitaux de Paris, Jonchère, Laurent, CHU Henri Mondor, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)
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medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,Dermatology ,Biological Factors ,Primary outcome ,drug survival ,Psoriasis ,Internal medicine ,apre-milast ,medicine ,Humans ,Biological Products ,treatment ,business.industry ,Proportional hazards model ,Hazard ratio ,General Medicine ,psoriasis ,Middle Aged ,[SDV.MHEP.DERM] Life Sciences [q-bio]/Human health and pathology/Dermatology ,medicine.disease ,Thalidomide ,Drug survival ,[SDV] Life Sciences [q-bio] ,Antirheumatic Agents ,Cohort ,Observational study ,Female ,Apremilast ,business ,biologic ,[SDV.MHEP.DERM]Life Sciences [q-bio]/Human health and pathology/Dermatology ,medicine.drug - Abstract
International audience; Drug survival reflects treatment effectiveness and safety in real life. There is limited data on the variation of drug survival with the availability of systemic treatments with additional biological disease-modifying antirheumatic drugs (bDMARDs) or synthetic disease-modifying antirheumatic drugs (sDMARDs). The aim of this study was to determine whether the increasing number of available systemic treatments for psoriasis affects drug survival over time. Patients were selected from the PsoBioTeq cohort, a French prospective observational cohort enrolling patients with moderate to severe psoriasis. All patients initiating a first bDMARD or sDMARD were included. The primary outcome was comparison of drug survival over time. A multivariate Cox proportional hazard ratio model was computed. A total of 1,866 patients were included; 739 females (39%), median age 47 years. In the multivariate Cox model, no association was found between the calendar year of initiation and drug survival (hazard ratio) over-lapping from 0.80 (0.42–1.52) to 1.17 (0.64–2.17), p = 0.633). In conclusion, drug survival in psoriasis is not affected by the year of initiation.
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- 2022
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196. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study
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Laure Gossec, Stefan Siebert, Paul Bergmans, Kurt de Vlam, Elisa Gremese, Beatríz Joven-Ibáñez, Tatiana V Korotaeva, Frederic Lavie, Wim Noël, Michael T Nurmohamed, Petros P Sfikakis, Elke Theander, Josef S Smolen, Rheumatology, ACS - Atherosclerosis & ischemic syndromes, and AII - Inflammatory diseases
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Settore MED/16 - REUMATOLOGIA ,PHASE-3 ,tumor necrosis factor inhibitors ,Immunology ,MULTICENTER ,Interleukin Inhibitors ,THERAPY ,General Biochemistry, Genetics and Molecular Biology ,DOUBLE-BLIND ,ADHERENCE ,Rheumatology ,Humans ,Immunology and Allergy ,DRUG SURVIVAL ,Prospective Studies ,PREDICTORS ,DISEASE-ACTIVITY STATES ,Science & Technology ,Arthritis, Psoriatic ,EFFICACY ,Interleukin-12 ,Treatment Outcome ,arthritis ,biological therapy ,Antirheumatic Agents ,SAFETY ,Ustekinumab ,psoriatic ,Life Sciences & Biomedicine - Abstract
ObjectiveWe evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).MethodsPsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed.ResultsAt 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups.ConclusionIn the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA.
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- 2022
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197. Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study
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Simone Parisi, Andrea Becciolini, Maria Chiara Ditto, Davide Rozza, Anna Zanetti, Angela Laganà, Clara Lisa Peroni, Chiara Centanaro Di Vittorio, Rosanna Degiovanni, Cristina Realmuto, Carlo Alberto Scirè, Marta Priora, Eleonora Di Donato, Daniele Santilli, Flavio Mozzani, Gianluca Lucchini, Alarico Ariani, Lucia Gardelli, Francesco Girelli, Eugenio Arrigoni, Ilaria Platè, Elena Bravi, Marino Paroli, Rosalba Caccavale, Carlo Salvarani, Gilda Sandri, Federica Lumetti, Alessandro Volpe, Antonio Marchetta, Enrico Fusaro, Parisi, S, Becciolini, A, Ditto, M, Rozza, D, Zanetti, A, Lagana, A, Peroni, C, Centanaro Di Vittorio, C, Degiovanni, R, Realmuto, C, Scire, C, Priora, M, Di Donato, E, Santilli, D, Mozzani, F, Lucchini, G, Ariani, A, Gardelli, L, Girelli, F, Arrigoni, E, Plate, I, Bravi, E, Paroli, M, Caccavale, R, Salvarani, C, Sandri, G, Lumetti, F, Volpe, A, Marchetta, A, and Fusaro, E
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Biosimilar ,General Medicine ,anti-TNF ,biosimilar ,drug survival ,inflammatory arthritis ,SB4 ,Anti-TNF ,Drug survival ,Inflammatory arthritis ,Medicine ,Inflammatory arthriti - Abstract
We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 ± 13.8 years and with an ETA duration of 4.1 ± 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients.
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- 2022
198. Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis
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Francesco Bellinato, Paolo Gisondi, Elena Mason, Paolo Ricci, Martina Maurelli, and Giampiero Girolomoni
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Drug survival ,Biosimilar ,Adalimumab ,Psoriasis ,Dermatology ,Early intervention - Abstract
The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated.To investigate drug survival of adalimumab biosimilars in patients with chronic plaque psoriasis and factors associated with its discontinuation.We carried out a retrospective observational study including all consecutive patients with chronic plaque psoriasis who initiated adalimumab biosimilar MSB11022 (Idacio), ABP501 (Amgevita), or SB5 (Imraldi) between 1 January 2018 and 1 January 2021. The 1-year drug survival of adalimumab biosimilar and independent factors associated with its discontinuation were investigated. Cox regression models were fit to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the risk of adalimumab discontinuation. A propensity score matching (PSM) model was adopted as sensitivity analysis.The study involved a total of 410 patients with follow-up of 549.84 person-years, 271 (66.1%) men, a mean (SD) age of 51.8 (14.5) years, and a baseline PASI of 14.54 (5.02). Among adalimumab biosimilars, 250 (61%) patients received MSB11022, 98 (24%) received ABP501, and 62 (15%) received SB5. Drug survival of adalimumab biosimilars at 1 year was 81.5% in the overall study population. Obesity was associated with increased risk of adalimumab discontinuation (HR = 2.01; 95% CI 1.33-3.03), whereas psoriatic arthritis (aHR = 0.32; 95% CI 0.16-0.64) and receiving adalimumab as first systemic treatment (aHR = 0.44; 95% CI 0.27-0.70) were associated with lower risk.The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator.
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- 2022
199. Drug Survival of Interleukin (IL)-17 and IL-23 Inhibitors for the Treatment of Psoriasis: A Retrospective Multi-country, Multicentric Cohort Study
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Tiago Torres, Luis Puig, Ron Vender, Jensen Yeung, José-Manuel Carrascosa, Stefano Piaserico, Paolo Gisondi, Charles Lynde, Paulo Ferreira, Pedro Mendes Bastos, Esteban Dauden, Luiz Leite, Joana Valerio, Elena del Alcázar-Viladomiu, Eva Vilarrasa Rull, Mar Llamas-Velasco, Federico Pirro, Francesco Messina, Manfredo Bruni, Gaetano Licata, Federica Ricceri, Alessia Nidegger, Jan Hugo, Asfandyar Mufti, Athina-Ioanna Daponte, Laetitia Teixeira, Anna Balato, Marco Romanelli, Francesca Prignano, Spyridon Gkalpakiotis, Curdin Conrad, Elizabeth Lazaridou, Natalia Rompoti, Marina Papoutsaki, Miguel Nogueira, Andrea Chiricozzi, Torres, Tiago, Puig, Lui, Vender, Ron, Yeung, Jensen, Carrascosa, José-Manuel, Piaserico, Stefano, Gisondi, Paolo, Lynde, Charle, Ferreira, Paulo, Bastos, Pedro Mende, Dauden, Esteban, Leite, Luiz, Valerio, Joana, Del Alcázar-Viladomiu, Elena, Rull, Eva Vilarrasa, Llamas-Velasco, Mar, Pirro, Federico, Messina, Francesco, Bruni, Manfredo, Licata, Gaetano, Ricceri, Federica, Nidegger, Alessia, Hugo, Jan, Mufti, Asfandyar, Daponte, Athina-Ioanna, Teixeira, Laetitia, Balato, Anna, Romanelli, Marco, Prignano, Francesca, Gkalpakiotis, Spyridon, Conrad, Curdin, Lazaridou, Elizabeth, Rompoti, Natalia, Papoutsaki, Marina, Nogueira, Miguel, and Chiricozzi, Andrea
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Adult ,Treatment Outcome ,drug survival ,Interleukin-17 ,Humans ,Interleukin Inhibitors ,Psoriasis ,Dermatology ,General Medicine ,Settore MED/35 - MALATTIE CUTANEE E VENEREE ,Interleukin-23 ,Severity of Illness Index ,Retrospective Studies - Abstract
Background Drug survival, defined as the length of time from initiation to discontinuation of a given therapy, allows comparisons between drugs, helps to predict patient's likelihood of remaining on a specific treatment, and achieving the best decision for each patient in daily clinical practice. Objective The aim of this study was to provide data on drug survival of secukinumab, ixekizumab, brodalumab, guselkumab, tildrakizumab, and risankizumab in a large international cohort, and to identify clinical predictors that might have an impact on the drug survival of these drugs. Methods This was a retrospective, multicentric, multi-country study that provides data of adult patients with moderate to severe psoriasis who started treatment with an interleukin (IL)-17 or IL-23 inhibitor between 1 February 2015 and 31 October 2021. Data were collected from 19 distinct hospital and non-hospital-based dermatology centers from Canada, Czech Republic, Italy, Greece, Portugal, Spain, and Switzerland. Kaplan-Meier estimator and proportional hazard Cox regression models were used for drug survival analysis. Results A total of 4866 treatment courses (4178 patients)-overall time of exposure of 9500 patient-years-were included in this study, with 3164 corresponding to an IL-17 inhibitor (secukinumab, ixekizumab, brodalumab) and 1702 corresponding to an IL-23 inhibitor (guselkumab, risankizumab, tildrakizumab). IL-23 inhibitors had the highest drug survival rates during the entire study period. After 24 months of treatment, the cumulative probabilities of drug survival were 0.92 (95% confidence interval [CI] 0.89-0.95) for risankizumab, 0.90 (95% CI 0.88-0.92) for guselkumab, 0.80 (95% CI 0.76-0.84) for brodalumab, 0.79 (95% CI 0.76-0.82) for ixekizumab, and 0.75 (95% CI 0.73-0.77) for secukinumab. At 36 months, only guselkumab [0.88 (95% CI 0.85-0.91)], ixekizumab [0.73 (95% CI 0.70-0.76)], and secukinumab [0.67 (95% CI 0.65-0.70)] had more than 40 patients at risk of drug discontinuation. Only two drugs had more than 40 patients at risk of drug discontinuation at 48 months, with ixekizumab demonstrating to have a higher cumulative probability of drug survival [0.71 (95% CI 0.68-0.75)] when compared with secukinumab [0.63 (95% CI 0.60-0.66)]. Secondary failure was the main cause for drug discontinuation. According to the final multivariable model, patients receiving risankizumab, guselkumab, and ixekizumab were significantly less likely to discontinue treatment than those receiving secukinumab. Previous exposure to biologic agents, absent family history of psoriasis, higher baseline body mass index (BMI), and higher baseline Psoriasis Area and Severity Index (PASI) were identified as predictors of drug discontinuation. Conclusion The cumulative probability of drug survival of both IL-17 and IL-23 inhibitors was higher than 75% at 24 months, with risankizumab and guselkumab demonstrating to have overall cumulative probabilities >= 90%. Biological agent chosen, prior exposure to biologic agents, higher baseline BMI and PASI values, and absence of family history of psoriasis were identified as predictors for drug discontinuation. Risankizumab, guselkumab, and ixekizumab were less likely to be discontinued than secukinumab.
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- 2022
200. Long-term survival of biological therapy in psoriatic arthritis: 18-year analysis of a cohort in a tertiary hospital
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Lourdes Mateo Soria, María Aparicio-Espinar, Mihail Mihaylov Grigorov, Melania Martínez-Morillo, Susana Holgado-Pérez, Águeda Prior-Español, and Alejandro Olivé-Marqués
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medicine.medical_specialty ,Anti-TNF alpha ,Immunology ,Comorbidity ,Etanercept ,Tertiary Care Centers ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,Drug survival ,Internal medicine ,Ustekinumab ,Adalimumab ,medicine ,Immunology and Allergy ,Humans ,030212 general & internal medicine ,Retrospective Studies ,030203 arthritis & rheumatology ,Biological Products ,business.industry ,Depression ,Arthritis, Psoriatic ,medicine.disease ,Golimumab ,Infliximab ,Biological Therapy ,Antirheumatic Agents ,Secukinumab ,Tumor Necrosis Factor Inhibitors ,Apremilast ,business ,medicine.drug ,Biologic therapy - Abstract
To study retention of biologic disease-modifying anti-rheumatic drugs (bDMARDs) or apremilast and potential predictors of lack of response in patients with psoriatic arthritis (PsA). A single-center retrospective analysis of PsA patients who received ≥ 1 bDMARD or apremilast during 2000–2018. The main endpoint was lack of response (primary or secondary failure). Analyses included retention of DMARDs (Kaplan–Meier curves) and potential predictors of lack of response (bivariate and multivariate logistic regression models). A total of 159 patients with PsA received up to 8 DMARDs: etanercept (34%), adalimumab (30%), infliximab (9%), golimumab (9%), apremilast (7%), ustekinumab (5%), certolizumab (4%), and secukinumab (2%). Therapy was discontinued in 96 cases (60%), mainly owing to secondary failure (37%), followed by primary failure (25%) and adverse effects (24%). Retention was analyzed based on 313 units of analysis. Duration of follow-up was 846.1 treatment-years (maximum 14.8 years, median 2.75 years). A total of 172 DMARDs were discontinued. The probability of continuing the initial treatment was 37% at 5 years, 22% at 10 years, and 12% at 14 years. The longest medium retention time was observed for infliximab (6.2 years) and etanercept (4.5 years). Predictors of lack of response included male sex, number of swollen joints, and, especially, depression (OR = 35.2). The sensitivity and specificity of the model were 86.4% and 85.7%, respectively, with a coefficient of determination (R2) of 45.6 (ROC, 0.912). Rates of discontinuation due to primary and secondary failure are high in PsA. Retention is better for anti-TNF agents than for other agents.
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- 2022
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