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Drug survival measures the length of time until discontinuation of a drug. The length of time a patient remains on a biologic drug is impacted by several factors such as tolerability, side effects, safety profile and effectiveness. To evaluate the long-term drug survival, data of the most commonly prescribed biologic medications used in the treatment of psoriasis, a systematic review was conducted. A literature search using PubMed, the Cochrane Library and the Cumulative Index to Nursing and Allied Health Literature from January 1 2010 to October 28 2016 identified 3734 abstracts. Of which, 36 publications with over 40,000 patients met the inclusion criteria. The median overall drug survival for ustekinumab, adalimumab, infliximab and etanercept was 38.0, 36.5, 26.6 and 24.7 months, respectively. The mean annual drug survival rate of TNF inhibitors was 70%, 57%, 51%, 45% and 41% at years-1, 2, 3, 4 and 5, respectively. The 5-year mean annual drug survival rate of ustekinumab was 87%, 78%, 70%, 71% and 51%, respectively. Based on our findings, ustekinumab appears to have a longer drug survival with lower rates of discontinuation compared to tumor necrosis factor inhibitors. [ABSTRACT FROM AUTHOR]

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]

The article offers information about a study which aims to evaluate drug survival of secukinumab in a daily practice psoriasis cohort. Information on the collection of data from several hospitals and the analysis of drug survival using Kaplan– Meier survival curves as well as the treatment of secukinumab, which is the first interleukin-17 inhibitor registered for treatment of plaque psoriasis, is presented.

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]

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]

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]

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]

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]

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 = 76), adalimumab (n = 68) or golimumab (n = 51) were included in the analysis. The 2‐year retention rate (40% with a median time‐on‐drug of 12.9 months in the whole population) was significantly lower for adalimumab (31.2%, P = 0.018) and numerically lower for etanercept (39.8%, P = 0.068) compared with golimumab (53.4%) because of a higher discontinuation rate due to adverse events (P = 0.042 and P = 0.038 versus golimumab, respectively). Drug survival was greater in concomitant synthetic disease modifying anti‐rheumatic drug (sDMARD) users (44.2%) compared with TNFi monotherapy (22.5%, P = 0.036). No difference was found in survival analysis according to first‐line TNFi reason for discontinuation and pattern of TNFi switch (antibody‐receptor, antibody‐antibody or receptor‐antibody). Conclusions: Our real‐life data confirmed switching to a second TNFi as a good option for treating first‐line TNFi failures in RA, especially in combination with sDMARDs. Second‐line golimumab showed an overall better 2‐year drug survival compared with adalimumab and etanercept. [ABSTRACT FROM AUTHOR]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks., Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts., Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6-positive and HLA-Cw6-negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6-positive and HLA-Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings., Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile., Competing Interests: F. Russo has acted as a speaker/consultant for AbbVie, Novartis and Sanofi; M. Galluzzo has acted as a speaker and/or consultant for AbbVie, Almirall, Eli Lilly, Janssen-Cilag, LeoPharma, Novartis and Sanofi; L. Stingeni has acted as a speaker and board member for AbbVie, Almirall, Celgene, Eli Lilly, Janssen, LeoPharma, Novartis and Sanofi; A. Conti has acted as a consultant for AbbVie, Abbott, Amgen, Celgene, Eli Lilly, Janssen Cilag, Leo Pharma, MSD, Novartis, Sandoz, Schering Plough, UCB Pharma and Wyeth; F. Bardazzi has acted as a speaker and/or consultant for Almirall, AbbVie, Celgene, Eli Lilly, Janssen, Leo Pharma and UCB Pharma; G. Girolomoni has received personal fees from AbbVie, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Fresenius Kabi, Galderma, Genzyme, Leo Pharma, Novartis, Pfizer, Regeneron, Samsung bioepis, Sanofi and UCB; M. Venturini served as a speaker or advisory board member for AbbVie, Almirall, Amgen, Eli Lilly, Galderma, LeoPharma, Novartis, Pierre Fabre and UCB Pharma; M.C. Fargnoli has served on advisory boards, received honoraria for lectures and received research grants from AbbVie, Almirall, Amgen, BMS, Galderma, Janssen, Kyowa Kyrin, Leo Pharma, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Sanofi-Regeneron, Sunpharma and UCB; M.L. Musumeci has served as a consultant/investigator for AbbVie, Biogen, Eli Lilly, Janssen Cilag and Novartis; P. Malleoli has acted as a consultant or had advisory board agreements for AbbVie, Almirall, Amgen, Eli Lilly, Janssen, Leo Pharma, Novartis and UCB Pharma; F. Loconsole reports no conflicts of interest; A. Offidani has received honoraria as speaker, scientific board member and consultant from AbbVie, Eli Lilly, Galderma, Leo Pharma, Novartis, Pfizer, Sanofi and UCB Pharma; V. Di Lernia has received honoraria as speaker, consultant or advisory board member from AbbVie, Amgen, Janssen and Novartis; Iris Zalaudek has received honoraria for lectures, advisory boards from Almirall, Novartis, MSD, BMS, Philogen, Sunpharma, Sanofi, Celgene, Kyowa Kyrin, Mallinckrodt, Janssen and Eli Lilly; G. Gigante, M. Bartezaghi, P. Ursoleo and E. Aloisi are employees of Novartis. The authors report no other conflicts of interest in this work., (© 2023 Russo et al.)

Competing Interests: Conflicts of interest None disclosed.

Aims: Topical rapamycin is used to reduce facial angiofibromas in patients with tuberous sclerosis (TSC). In the absence of a commercially available preparation, numerous formulations have been tested clinically, although only in the short term., Methods: The pharmacy at Angers University Hospital (France) produced a cream formulation that was administered to people presenting this genetic disease. We conducted a questionnaire-based survey among 79 patients with TSC about their perceptions regarding the short-, medium- and long-term efficacy and safety of a topical rapamycin preparation in relation to facial angiofibromas., Results: This formulation was very well tolerated and its efficacy was sustained over the long term with a mean treatment duration of 33 months (extremes 1-60). Efficacy was rated ≥ 8/10 by 67.1% of patients while safety was rated ≥ 8/10 by 84.8% of patients., Conclusion: This survey supports the safety and efficacy of topical rapamycin in the short-, medium- and long-term in the treatment of facial angiofibromas in a cohort of 79 patients with TSC., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Objectives: The purpose of this study was to analyze the drug survival rate of dupilumab up to 2 years in a large real-world cohort of adult patients affected by moderate/severe atopic dermatitis (AD), and to investigate the clinical, demographic and predictive factors influencing the patients' treatment persistence., Material and Methods: This study included adult patients affected by moderate-to-severe AD treated with dupilumab for at least 16 weeks who visited 7 dermatologic outpatient clinics in Lazio, Italy, from January 2019 until August 2021., Results: A total of 659 adult patients (345 male [52.3%], mean age: 42.8 years) with an average treatment duration of 23.3 months were enrolled in the study. Overall, 88.6% and 76.1% of patients were still on treatment after 12 and 24 months, respectively. The drug survival rate for discontinuation due to AEs and dupilumab ineffectiveness was 95.0% at 12 months and 90.0% at 24 months. The main reasons for drug discontinuation included inefficacy (29.6%), failed compliance (17.4%), persistent efficacy (20.4%) and adverse events (7.8%). Adult AD onset (≥18 years) and EASI score severity measured at the last follow-up visit were the only factors significantly associated with lower drug survival., Conclusion: This study revealed an increased cumulative probability of dupilumab survival at 2 years, reflected by a sustained effectiveness and a favorable safety profile of the drug.

Background: Omalizumab (OMA) dramatically improves disease control and quality of life in patients with chronic urticaria (CU)., Objective: We aimed to evaluate the discontinuation patterns of OMA and their determinants in a cohort of French patients with CU., Methods: We conducted a retrospective multicenter study in 9 French tertiary referral hospitals. All patients diagnosed with either spontaneous (CSU) and/or inducible (CIndU) CU who received at least 1 injection of OMA between 2009 and 2021 were included. We analyzed OMA drug survival and investigated possible determinants using Kaplan-Meier curves and log-rank tests., Results: A total of 878 patients were included in this study; 48.8% had CSU, 10.1% CIndU, and 41.1% a combination of both. OMA was discontinued in 408 patients, but the drug was later reintroduced in 50% of them. The main reason for discontinuing treatment was the achievement of a well-controlled disease in 50% of patients. Half of the patients were still being treated with OMA 2.4 years after the initiation of treatment. Drug survival was shorter in patients with CIndU and in those with an autoimmune background. In atopic patients, OMA was discontinued earlier in patients achieving a well-controlled disease. A longer OMA drug survival was observed in patients with a longer disease duration at initiation., Conclusion: In French patients with CU, the drug survival of OMA appears to be longer than that observed in previous studies conducted elsewhere, highlighting discrepancies in prescription and reimbursement possibilities. Further studies are warranted to develop customized OMA treatment schemes based on individual patterns., (Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Introduction: Biologic disease-modifying anti-rheumatics drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) are important treatments for rheumatoid arthritis (RA). As more of these drugs become available, there is a greater need to assess their real-world adherence and drug survival., Methods: Treatment-naïve and treatment-experienced patients with RA who initiated treatment with bDMARDs and tofactinib during 2015-2018 in a large Israeli health maintenance organization were included. Adherence and time to treatment suspension were recorded. Odds for adherence were estimated using a multivariable logistic regression model. Risk for treatment suspension was estimated using a mixed-effect Cox proportional hazard model., Results: The analysis included 753 eligible patients (61.8% treatment-naïve) treated with 1287 treatment episodes (tofacitinib 24.2%, tocilizumab 17.5%, etanercept 16.0%, adalimumab 10.4%, abatacept 9.9%, rituximab 9.0%, golimumab 6.9%, certolizumab pegol 3.6%, infliximab 1.9%, and sarilumab 0.5%). Good adherence was measured for almost all drugs, yet over 50% of all treatment episodes were suspended. Older age was associated with reduced risk for treatment suspension while higher number of primary care visits and higher Charlson's comorbidity score were associated with increased risk. Compared to etanercept, treatment with adalimumab, certolizumab, or rituximab was associated with increased risk for treatment suspension (HR 1.68 95% CI 1.27-2.22, HR 1.62 95% CI 1.00-2.60, and HR 2.72 95% CI 2.02-3.67, respectively)., Conclusion: Treatment choice primarily depends on disease activity and prognosis. Real-world data, showing differences in drug survival of bDMARDs and tsDMARD, can also be used in the variety of considerations when choosing treatment. Future studies could separate patients with RA into subgroups, which would also account for potential drug survival differences and enable personalized therapy., (© 2023. The Author(s).)

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]

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]