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Objective To assess the real-world effectiveness of targeting biologic DMARDs (bDMARDs) in rheumatoid arthritis (RA) patients negative for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). Methods We retrospectively selected 81 seronegative and 404 seropositive RA patients receiving treatment with abatacept, anti-TNF alpha or tocilizumab. Effectiveness was evaluated by analysing drug survival using Kaplan–Meyer analysis over 10-year follow-up. Survival rates were compared by log rank test, and hazard ratios (HRs) of therapy discontinuation were estimated through multivariate Cox regression. Results Clinical characteristics were similar between the two groups, except for a significantly higher percentage of inadequate responders to prior bDMARDs in the seronegative RA patients (P  = 0.02). Among seronegative RA, tocilizumab demonstrated a survival rate of 73.9% with a mean survival time (MST) of 76.8 months (95% CI 61–92), which was significantly higher than abatacept [37.5%, MST 37.1 months (95% CI 22–51; P  = 0.01)]. Anti-TNF alpha therapy fell in the middle [50.0%, MST 63.5 months (95% CI 47–79)] but the difference was not significant. Nevertheless, seropositive RA patients did not show significantly different drug survival rates. Negative predictors of drug discontinuation were RF/ACPA positivity (HR 0.56) and sex male (HR 0.58), but treatment with abatacept (HR 1.88) or anti-TNF alpha (HR 1.79), no co-therapy with conventional DMARDs (HR 1.74), absence of bone erosions (HR 1.41) and higher HAQ (HR 1.58) were positive predictors. Conclusions To confirm these preliminary findings and to explore the hypothesis of a distinctive therapeutic algorithm in seronegative RA, prospective studies on larger cohorts are needed. [ABSTRACT FROM AUTHOR]

Background: The advent of novel biologics has led to an increase in biologic‐switching as patients and clinicians pursue improved clinical outcomes. However, guidance on treatment sequencing in an Australian setting is sparse. This study examines the patterns of care across two tertiary centres in Australia and characterizes the factors contributing to biologic‐switching. Methods: A retrospective study of patients who attended the outpatient Dermatology biologic clinics across two tertiary hospitals was conducted. Data on treatment sequencing and patients' PASI at every visit from April 2006 to December 2020 were collected. Patterns of biologic‐switching were examined. The speed of treatment response for each biologic was determined by the time to achieve PASI‐90 and ‐100 for each treatment course. Results: A total of 440 treatment courses were analysed. Ustekinumab and adalimumab were the most frequently prescribed first‐line biologics. The highest proportion of biologic‐switching was observed among patients on TNF‐α inhibitors (63.8%). After 2015, more patients were prescribed IL‐12/23 and IL‐17 inhibitors in favour of TNF‐α inhibitors. IL‐17 inhibitors demonstrated the most rapid treatment response and low PASI scores relative to other biologics. Patients who did not switch biologics had lower rates of psoriatic arthritis and lower BMI, compared to patients who switched biologics. The median PASI on discontinuation generally exceeded 3.0, while on continuation, it was less than 1.2, reflecting patients' and clinicians' thresholds for biologic‐switching. Conclusions: This study demonstrates an increased uptake of more novel biologics as they become available, due to improved safety profiles and clinical outcomes. [ABSTRACT FROM AUTHOR]

Background Objective Methods Results Conclusion Long‐term data on the effectiveness and safety of omalizumab for chronic inducible urticaria (CIndU) in large populations are lacking.To evaluate the effectiveness, safety, estimated omalizumab treatment duration and its predictors, as well as differences between CIndU subtypes, in a large long‐term CIndU cohort.A multinational multicenter study was conducted at 14 specialized urticaria centres (UCAREs), including all CIndU patients ever treated with omalizumab from 2009 until July 2022. Kaplan–Meier survival and regression analyses were performed.Across 234 CIndU patients (55% female; mean age 37 years), 76% (n = 178) had standalone CIndU and 24% (n = 56) had predominant CIndU plus minor CSU, with an observation period up to 13 years. Most CIndU patients (73%, n = 145/200 with available data on response) had complete/good response to omalizumab treatment, without significant differences between CIndU subtypes. Sixty‐two (26%) patients discontinued omalizumab; due to well‐controlled disease (47%, n = 29), ineffectiveness (34%, n = 21), side effects (3%, n = 2), combination of ineffectiveness and side effects (3%, n = 2) and other reasons (13%, n = 8). The median estimated omalizumab treatment duration exceeded 5 years (54% drug survival at 5 years) and was mostly determined by well‐controlled disease. Higher age predicted a lower chance to discontinue omalizumab due to well‐controlled disease (HR 0.969, 95%CI 0.945–0.995). CIndU subtype and presence of minor CSU were not related to response and time until omalizumab discontinuation for any reason.Omalizumab is highly effective and safe in CIndU patients, with long estimated treatment duration mainly reflecting long disease duration. Our data show omalizumab's high potential as treatment in any subtype of CIndU and support its clinical use for these patients. [ABSTRACT FROM AUTHOR]

Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan–Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, χ2 = 9.692), without autoimmune thyroiditis (p = 0.007, χ2 = 12.037), and those with higher IgE levels (p = 0.039, χ2 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393–15.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128–8.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness. [ABSTRACT FROM AUTHOR]

Introduction: Attention deficit hyperactivity disorder (ADHD) medication has proven effective for treating ADHD in adults, nonetheless previous studies have shown high rates of medication discontinuation. Objective: To assess drug survival and identify risk factors associated with discontinuation of ADHD medication. Methods: A nationwide registry‐based cohort study in Danish adults who redeemed a prescription for ADHD medication for the first time between 2010 and 2015. All patients were followed for 5 years from the first redeemed prescription. Discontinuation was defined as a gap of 12 months between redemptions. Logistic regression analysis with odds ratio (OR) and Kaplan Meier analysis were used to examine risk factors (sex, age, socioeconomic status, substance use disorders, and comorbidities) associated with discontinuation. Results: Twenty three thousand nine‐hundred and sixteen patients with ADHD were identified. The 5‐year overall drug survival was 29% in women vs. 23.5% in men. The risk of medication discontinuation was significantly higher in men compared to women, OR 1.26 (95% CI 1.19–1.34, p < 0.001). Adults aged 31–50 years had a significantly decreased risk of medication discontinuation compared to adults aged 18–30 years, OR 0.57 (95% CI 0.53–0.61, p < 0.001). Switching ADHD medication two times or three times or more significantly decreased the risk of discontinuation; OR 0.53 (95% CI 0.49–0.56, p < 0.001) and OR 0.26 (95% CI 0.23–0.30, p < 0.001), respectively. Substance use disorders and certain comorbidities were associated with medication discontinuation. Eating disorders, OR 0.71 (95% CI 0.64–0.78, p < 0.001), intellectual disabilities, OR 0.65 (95% CI 0.59–0.73, p < 0.001) and sleep disorders, OR 0.42 (95% CI 0.37–0.49, p < 0.001) were associated with continuation of ADHD medication. Conclusions: The 5‐year overall drug survival was longer in women compared to men. Women with ADHD; adults aged 31–50; and patients with comorbid eating disorder; intellectual disability; sleep disorder and medication switching were individually associated with continuation of ADHD medication. Various factors were associated with medication discontinuation. Discontinuation should be acknowledged as a common phenomenon in patients with ADHD and calls for increased attention from the treatment responsible prescriber or team. Moreover, our findings suggest that timely, frequent medication switching, or temporary regimens may indeed represent optimal management strategies for a significant proportion of the ADHD population. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to evaluate the real-world drug survival, adherence, and discontinuation risk of biologics disease-modifying anti-rheumatic drugs (bDMARDs) among patients with ankylosing spondylitis (AS). Methods: This was a retrospective study using a computerized database. Biologic-naïve and biologic-experienced AS patients who initiated treatment with bDMARDs (tumor necrosis factor alpha inhibitors {TNF-αis} or interleukin-17 inhibitor {IL-17i}) during 2015–2018 were included. Adherence was assessed using the proportion of days covered (PDC) method. Drug survival was analyzed using Kaplan–Meier estimates. Risk of discontinuation was estimated by the Cox proportional hazard model. Results: We identified 343 eligible patients utilizing 481 lines of therapy. The mean age was 44.6 years (SD ± 13.4), 57.7% were males, and 69.7% were biologic-naïve at baseline. The proportion of highly adherent patients (PDC ≥ 0.8) in the biologic-naïve group was 63.5% for golimumab, 69.2% for etanercept, and 71.6% for adalimumab (p > 0.9). Among the biologic-experienced group, secukinumab had the highest proportion of adherent patients (75.7%) and etanercept the lowest (50.0%) reaching statistical difference (p < 0.001). The Kaplan–Meier analysis did not show a significant difference in drug survival in either the biologic-naïve or the biologic-experienced groups (p = 0.85). Multivariable analysis demonstrated a similar risk for discontinuation for etanercept, golimumab, and secukinumab compared with adalimumab, regardless of biologic-experience status. Conclusions: Adherence, drug survival, and risk for discontinuation were similar for all TNF-αis and the IL-17i SEC, regardless of biologic-experience status. As drug survival is an indirect measure of drug efficacy, n, in real-world settings, we believe caregivers can integrate these results into treatment considerations. [ABSTRACT FROM AUTHOR]

Psoriasis, a chronic inflammatory condition, often presents challenges in treatment, particularly in areas such as nails, palms/soles, scalp/face, and genitalia. Monoclonal antibodies (mAb) like risankizumab targeting interleukin-23 (IL-23) have emerged as promising treatments, yet data on long-term efficacy remain limited. This multicenter retrospective study aimed to evaluate the drug survival at 12 and 36 months of 191 psoriasis patients treated with risankizumab, focusing on critical areas. Patients, previously unresponsive to first-line therapies, were treated according to Italian Guidelines. Survival analysis revealed a 97.6% one-year and 95% three-year drug survival rate. Secondary ineffectiveness was the primary reason for discontinuation, particularly in palmoplantar involvement cases. Factors such as BMI, gender, age, disease duration, baseline severity, and previous biologic exposure did not significantly impact drug survival, except for palmoplantar psoriasis (HR 4.72). Risankizumab demonstrated prolonged response with low treatment switch requirements, especially notable in challenging areas. Understanding such factors can aid in optimizing therapeutic approaches for improved patient care and long-term outcomes in managing psoriasis. Further research is warranted to refine treatment strategies in difficult-to-treat areas. [ABSTRACT FROM AUTHOR]

Introduction: Several clinical trials have established the efficacy and safety of dupilumab for treating atopic dermatitis (AD). However, literature remains scarce in reporting the long-term effectiveness, safety, and drug survival of dupilumab in real-world settings. This study aimed to describe the latter outcomes of dupilumab in patients with AD. Methods: This Portuguese, multicentric, observational, retrospective study included consecutive adult patients with AD who initiated dupilumab between January 2019 and September 2023, with a follow-up period up to 30 months. Drug discontinuation and adverse effects data were used to estimate drug survival. Clinical assessments included the Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), and Dermatology Life Quality Index (DLQI). Results: A total of 312 patients were included in the study, with 56.4% being male (median age of 30 years, range 18–83). The 30-month drug survival rate was 82.0%. During the study period, 12.5% of the sample (n = 39 patients) discontinued treatment: 7.3% due to treatment failure, 2.9% due to safety concerns, 1.3% due to complete disease control, 0.6% due to pregnancy, and 0.3% due to lack of compliance. Adverse events not leading to drug discontinuation were noted in 25.6% of the sample (n = 80). Conjunctivitis was the most frequently reported adverse event (17%), followed by facial erythema (9%). At 30 months, the mean EASI decreased significantly from 27.30 ± 11.89 at baseline to 2.92 ± 3.96 (p < 0.001), reflecting an overall improvement of 89.3%. Similarly, pruritus NRS decreased from 7.36 ± 1.90 at baseline to 1.74 ± 2.16 at month 30 (p < 0.001), improving by 76.4%, and mean DLQI changed from 18.0 ± 7.09 at baseline to 2.67 ± 3.95 at month 30 (p < 0.001), decreasing by 85.2%. Conclusions: This study increases our current understanding of dupilumab in real-world settings, demonstrating its long-term effectiveness and safety in treating AD. [ABSTRACT FROM AUTHOR]

Real‐world data on the long‐term effectiveness of the anti‐IL17 agent secukinumab in treating moderate‐to‐severe Hidradenitis suppurativa (HS) are lacking. In this study, 24 patients with moderate–severe HS received five weekly subcutaneous injections followed by maintenance doses every 4 weeks. Primary outcomes included HiSCR, IHS4 reduction, and DLQI measures assessed at 12‐week intervals. The median secukinumab drug survival was 16.0 months (range 3–51), with a 56.5% maximal response rate at 6 months and dropout exceeding 40% at 1 year. Baseline disease burden emerged as a key predictor of treatment response, overshadowing factors like sex or BMI. Prior systemic steroid use negatively impacts drug survival. The study underscores the critical 6‐month window for assessing treatment efficacy, emphasizing the importance of initial induction dosing. Additionally, the newly developed scoring system, IHS4‐55, showed analogies to the older HiSCR score in capturing treatment response. In this real‐life scenario, challenges persist in HS management, necessitating innovative therapeutic approaches and predictive markers. [ABSTRACT FROM AUTHOR]

Background: Drug survival, which refers to the time from treatment initiation to discontinuation, provides a surrogate measure of the effectiveness of a biologic in a real‐world setting (J Invest Dermatol, 2015, 135, 1). The aim of this study was to determine the drug survival of biologics that are currently available in Australia. We also analysed the treatment efficacy of these biologics and reasons for discontinuation. Methods: Retrospective data from outpatient Dermatology biologic clinics in Westmead Hospital and Royal Prince Alfred Hospital (Sydney, Australia) from April 2006 to December 2020 were collected. Kaplan–Meier analysis was used to calculate drug survival. Results: A total of 306 patients who underwent 566 treatment courses were analysed. Guselkumab was observed to have the longest drug survival, with cumulative drug survival rates of 94.2% ± 4.0 at 1‐ and 5‐years. This was followed by ixekizumab which had a 1‐year survival rate of 87.2% ± 4.5 and 5‐year survival rate of 59.4% ± 9.5. Ixekizumab and guselkumab were also noted to have superior treatment efficacy compared with other biologics, with PASI‐75 rates of 94.9% and 93.8%, respectively. The most common reasons for treatment discontinuation were a lack of initial efficacy to treatment and a loss of efficacy over time despite an initial response, respectively. Conclusion: To our knowledge, this is the first Australian study to report on outcomes of multiple new biologics that are currently in use for the treatment of chronic plaque psoriasis. Overall, this study provides insight into patterns of care from a local experience that may help guide the management of moderate‐to‐severe psoriasis. [ABSTRACT FROM AUTHOR]

Objectives To compare the tolerability and effectiveness of two different classes of biological DMARDs [IL-17 and IL-23(p19) inhibitors, IL-17i and IL-23(p19)i] relative to TNF inhibitors (TNFi) regarding the drug survival rates and treatment outcomes in patients with PsA. Methods We emulated a target trial on comparative effectiveness using observational data from a prospective cohort study based on the Parker Institute's PsA cohort (the PIPA cohort). All patients underwent interview and a clinical examination programme at baseline and at follow-up visits at 4 and 12 months. The primary endpoint, drug survival, was assessed up to 12 months from baseline. We estimated hazard ratios from proportional hazards model and used propensity score adjustment in an attempt to deconfound and emulate a random treatment assignment. Results We included a total of 109 patients in the intention-to-monitor population at baseline initiating either TNFi (75 patients), IL-17i (26 patients) or IL-23(19)i (8 patients). Hazard ratios in the propensity adjusted model comparing IL-17i and IL-23(p19)i with TNFi were 1.36 (95% CI 0.59–3.14) and 0.56 (95% CI 0.10–3.24), respectively. TNFi and IL-17i had comparable effects regarding response rates and changes in clinical outcomes after 12 months, whereas IL-23(p19)i tended to perform better overall. Conclusion No decisive differences between drugs were observed at group level regarding drug survival and clinical outcomes after 12 months. TNFi, IL-17i and IL-23(p19)i may all be considered equally effective in the treatment of patients with PsA, advocating for investigating more in personalized treatment strategies. [ABSTRACT FROM AUTHOR]

(1) Objective: The main aims of our study were to explore the drug survival and effectiveness of secukinumab in patients with axial spondyloarthritis (axSpA). (2) Methods: We underwent a retrospective analysis of consecutive axSpA treated with secukinumab as a first line of biologics or at switch in a biologic-experienced population. Efficacy data, indicating improvement in inflammation parameters (such as C-reactive protein and erythrocyte sedimentation rate) and disease activity scores (such as Ankylosing Spondylitis Disease Activity Score [ASDAS-CRP], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), and patient-reported outcomes (pain), were assessed at 6, 12, 24, 36 and 48 months. The drug survival rate, dropout rate and discontinuation reasons (efficacy versus safety) of secukinumab were assessed in subgroup analysis (axSpA with and without exposure to biologics). (3) Results: In total, 46 patients were exposed to the IL-17A inhibitor secukinumab. The drug survival for axSpA patients 59.7% at 12 months and 31.3% at 24 months. There were no statistically significant differences in the median drug survival between biologic-naïve versus biologic-experienced subgroups. (4) Conclusions: Secukinumab has demonstrated effectiveness and safety in treating a cohort of axSpA patients in real-world settings, with a notable retention rate of the drug. [ABSTRACT FROM AUTHOR]

Background: Antimalarial agents (AMAs) are cornerstone drugs in the treatment of systemic lupus erythematosus (SLE), and their use has established benefits, such as improved prognosis and decelerated accrual of organ damage. The aim of this study was to investigate the frequency of discontinuation of AMAs and associated factors in a Swedish SLE population. Methods: We retrieved data from a regional SLE register where all patients fulfilled the 1982 ACR and/or the 2012 SLICC classification criteria. A total of 328 subjects were included in the analysis. Results: Altogether, 92.4% (303/328) had been prescribed AMAs at some point during their disease. At the last available visit, 67.7% (222/328) were currently prescribed AMAs. Among individuals who had discontinued use, 24.7% (20/81) had developed a contraindication. Side effects were also common reasons for discontinuation (n = 38); gastrointestinal symptoms (52.6%, 20/38) were most common. Patients who discontinued had accrued more organ damage at the last visit (mean SDI: 2.9; SD: 2.8) compared with those still on AMAs (mean SDI: 1.4; SD: 1.8; p = 0.001). Conclusions: Most patients had been exposed to AMAs, but 25% discontinued therapy. Among side effects leading to discontinuation, >50% were gastrointestinal, calling for adequate gastroprotection towards drug retention and prevention of organ damage progression. [ABSTRACT FROM AUTHOR]

Biologics for psoriasis are efficient and safe, but very expensive. We investigated the association of the reducing copayment program (RCP) with changes in biologics use patterns depending on the income levels of patients with moderate-to-severe psoriasis. This nationwide cohort study included patients identified as having moderate-to-severe psoriasis between 2014 and 2020. Logistic regression models were used to estimate the odds ratio for the use of biologics according to income levels. Among 57,139 patients with moderate-to-severe psoriasis, 3464 (6.1%) used biologics for psoriasis from 2014 to 2020. After the introduction of RCP in 2017, the proportion of patients with moderate-to-severe psoriasis using biologics rapidly increased from 5.0% in 2016 to 19.2% in 2020; the increase was more remarkable in patients with the lowest or mid-low income compared to those with Medical Aid. Drug survival of biologics was higher in patients with the highest income before the RCP, but became comparable between those with high and low incomes after RCP introduction. The introduction of RCP was associated with an increased use of biologics in patients with moderate-to-severe psoriasis of all income levels; however, the effect was more pronounced in low-income patients. The RCP may contribute to alleviating the disparity in access to biologics. [ABSTRACT FROM AUTHOR]

Introduction: Secukinumab (SEC) has been shown to be highly effective and safe in the treatment of moderate to severe plaque psoriasis (PsO), but data on SEC's long-term drug survival are limited. Aim: To analyse the survival rate of SEC and its predictive factors of survival, together with the drug safety and efficacy. Material and methods: Data of 268 patients who received SEC between May 2018 and April 2022 with moderate to severe psoriasis and/or psoriatic arthritis were analysed retrospectively. Psoriasis Area Severity Index (PASI) was used to define effectiveness. Drug survival was examined using the Kaplan-Meier analysis and Cox regression analysis was used to analyse predictive factors. Results: PASI 75/90/100 responses achieved at week 16 (89.5%, 78%, and 16.2%, respectively) were well maintained at week 52 (96.3%, 90.7%, and 15.4%, respectively). The drug survival probability rates for SEC were 94.4% at 12 months, 88.4% at 24 months, 78.6% after 3 years, 52.7% after 4 years. Concomitant treatments, dose escalation and family history of psoriasis were associated with a higher risk for SEC withdrawal. Conclusions: Close monitoring may improve SEC survival in psoriasis patients who require dose escalation and concomitant drugs. [ABSTRACT FROM AUTHOR]

To characterize disease activity trajectories and compare long-term drug retention between rheumatoid (RA) and spondylarthritis (SpA) patients initiating tumor necrosis factor inhibitor (TNFi) treatment (etanercept). Prospective observational study of RA, axial (AxSpA) and peripheral SpA (PerSpA) patients initiating etanercept during 2004–2020. Kaplan–Meier plots were used for drug retention comparisons and multivariable Cox regression models for predictors of discontinuation. Long-term disease activity trajectories were identified by latent class growth models using DAS28-ESR or ASDAS-CRP as outcome for RA and AxSpA respectively. We assessed 711 patients (450 RA, 178 AxSpA and 83 PerSpA) with a median (IQR) follow-up of 12 (5–32) months. At 5 years, 22%, 30% and 21% of RA, AxSpA and PerSpA patients, respectively, remained on therapy. Etanercept discontinuation was independent of the diagnosis and was predicted by gender and obesity in both RA and SpA groups. Four disease activity (DA) trajectories were identified from 6th month of treatment in both RA and AxSpA. RA patients in remission-low DA groups (33.7%) were younger, had shorter disease duration, fewer comorbidities and lower baseline disease activity compared to moderate (40.6%) & high DA (25.7%) groups. In AxSpA 74% were in inactive-low DA and they were more often males, non-obese and had lower number of comorbidities compared to higher ASDAS-CRP trajectories. In RA and AxSpA patients, disease activity trajectories revealed heterogeneity of TNFi treatment responses and prognosis. Male gender, lower baseline disease activity and fewer comorbidities, characterize a favourable outcome in terms of disease burden accrual and TNFi survival. [ABSTRACT FROM AUTHOR]

Background: Limited real-world data are available on upadacitinib drug survival in patients with atopic dermatitis (AD). Objectives: To investigate upadacitinib drug survival, and the reasons and predictors of drug discontinuation in AD patients. Methods: All consecutive patients aged 18–75 years, affected by moderate-to-severe AD, and treated with upadacitinib for more than 1 month at dermatological clinics were included during November 2020–August 2023. Upadacitinib survival was investigated through Kaplan–Meier survival analysis and the predictors through multivariable logistic regression analysis. Results: Overall, 325 adult AD patients (mean (SD) age, 38.6(15.6) years) had a 1-year and 1.5-year upadacitinib drug survival of 91.5% and 80.2%, respectively. The main reasons for drug discontinuation (25/325, 7.7%) were adverse events (4.9%), including cutaneous or infectious diseases (1.5%), such as acne and herpes zoster; blood test changes (1.2%), including hypercholesterolemia, creatine phosphokinase or liver enzyme elevation, and lymphopenia; urinary or respiratory infections (0.9%); deep venous thrombosis (0.3%); malignancies (0.3%); loss of consciousness (0.3%); and arthralgias (0.3%); followed by ineffectiveness (0.6%). No specific characteristic was significantly associated with an increased risk of upadacitinib discontinuation. Conclusions: Our findings show that upadacitinib was effective in moderate-to-severe AD after more than 1 year of continuous treatment but point to the need for clinical and laboratory monitoring of patients. [ABSTRACT FROM AUTHOR]

Background/aim: Adipose tissue produces several inflammatory mediators. Thus, obesity affects the disease course and the responses to the antirheumatic agents in inflammatory diseases. The aim of the study was to determine whether the body mass index (BMI) is involved in the response to rituximab in rheumatoid arthritis (RA). Materials and methods: This multicenter retrospective study included 206 RA patients who received rituximab from the Turkish Biologic (TURKBIO) registry between 2011 and the end of May 2017. Demographic and clinical data including age, sex, disease type, disease duration, and previous or current treatment with disease-modifying antirheumatic drugs (DMARDs) and biological drug durations are stored in the database. Patients with a BMI =30 kg/m2 were classified as obese, and patients with a BMI <30 kg/m2 were classified as nonobese. Kaplan-Meier survival analysis was performed to estimate the drug survival. The subgroups were compared using the log-rank test. Results: The mean BMI of 206 patients included in the study was 27.05 (17.2-43.4) kg/m2. There were 59 (28.6%) patients in the obese group and 147 (71.4%) patients in the nonobese group. The mean age, female percentage, and baseline disease activity score 28 (DAS28) were higher in the obese group than in the nonobese group. However, the ?DAS28 at both 6 and 12 months were not significantly different between the groups (p = 0.785 and p = 0.512, respectively). Patient pain Visual Analogue Scale (VAS), patient fatigue VAS, and patient global VAS scores were also significantly higher at baseline in the obese group (p = 0.003, p = 0.006, and p = 0.006, respectively). However, no significant difference was found in terms of changes in patient pain VAS, patient fatigue VAS, patient global VAS and physician global VAS scores at 6 and 12 months compared to those at baseline. Rituximab treatment was ongoing for 71.2% of the obese and 63.3% of the nonobese patients (p = 0.279). The median drug survival duration was 77 months in the obese group and 62 months in the nonobese group (p = 0.053). The estimated drug survival rates for rituximab were not statistically significantly different in the obese and nonobese groups. Rituximab-related side effects were also similar between the groups. Conclusion: In obese and nonobese patients with RA, rituximab treatment exhibits similar side effects and similar long-term efficacy. These results suggest that obesity does not alter drug survival for rituximab and response rates, in RA and rituximab may be a favorable treatment agent in patients with RA and obesity. [ABSTRACT FROM AUTHOR]

Randomized controlled trials showed high comparability of biosimilar rituximab (bs-RTX) GP2013 to biologic originator RTX (bo-RTX). Data on effectiveness of switching from bo-RTX to bs-RTX, starting therapy with bs-RTX, and bs-RTX drug survival in real-world setting are sparse. To explore long-term drug effectiveness and survival of bs-RTX GP2013 in rheumatoid arthritis (RA) patients both naïve to and mandatory switched from bo-RTX, and to clarify reasons for treatment cessation. Retrospective observational cohort study including RA outpatient clinic patients treated with bs-RTX between 2018 and 2021 in Norway. Patients were examined and monitored using recommended measures for disease activity and patient-reported outcomes (PROs). For description of population medians and interquartile range were used. Difference between observation times was assessed with Signed-Rank test, drug survival with Kaplan–Meier survival analysis. Reasons for discontinuation were ascertained. Among 110 patients, at baseline, 88 were mandatory switched from bo-RTX and 22 were RTX-naïve. During 2-year follow-up, disease activity and PROs measures remained stable in switchers subgroup and improved in subgroup starting bs-RTX for the first time. Overall drug survival was 80.0% after 1 year and 57.7% after 2 years and was significantly higher in bs-RTX-switched than in bs-RTX-naïve patients (p = 0.036). Two most frequently reported reasons for drug discontinuation were remission (38.6%) and doctor's decision (27.1%). RA patients treated with bs-RTX had satisfactory treatment response and drug retention rates which supports equivalence of bs-RTX GP2013 to bo-RTX, both in patients naïve to and mandatory switched from bo-RTX. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Background and objectives: Information on the performance of ixekizumab (IXE) in patients with psoriatic arthritis (PsA) in clinical practice is scarce. We aimed to analyze the retention rate and safety of IXE in patients with PsA in routine clinical practice. Methods: A retrospective longitudinal observational single-center study of all patients with PsA who had received at least one dose of IXE. Adverse events (AEs) and drug retention rate were the main study focus. Survival was analyzed using Kaplan–Meier curves and predictive factors using multivariate Cox regression analysis. The hazard ratio (HR) was used as a measure of the association. Results: Seventy-two patients were included (52 women and 20 men). Median disease duration was 5 years (IQR 3–9). More than 90% received ≥2 biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) prior to IXE. Ixekizumab showed a 1-year retention rate of 65% and a 2-year retention rate of 57%. Regarding discontinuation due to AEs, 0.18 AEs per person-year were identified. The number of previous biologics did not influence drug survival but prior use of methotrexate (HR 2.31 (95% CI 1.05–5.10), p < 0.05) and depression (HR 2.40 (95% CI 1.07–5.41), p < 0.05) increased the risk of IXE discontinuation. Conclusions: Ixekizumab showed a good retention rate in a PsA population mostly refractory to biologic and targeted synthetic DMARDs. Drug survival was consistently good regardless of age, gender, metabolic comorbidities, smoking status, or prior number of biologic therapies. This information may be of interest to better position this drug in the PsA treatment algorithms. [ABSTRACT FROM AUTHOR]

Several non-randomized clinical trials and retrospective studies have demonstrated encouraging efficacy and well-tolerated safety of tofacitinib in the treatment of alopecia areata. However, there are scarce data on a large cohort of patients with alopecia areata in long-term real-world practice. This single-centre, retrospective, observational cohort study included 126 patients with alopecia areata treated with tofacitinib between February 2021 and December 2022. The aims of this study are to evaluate drug survival, effectiveness and safety of tofacitinib for treatment of alopecia areata, and to identify potential factors influencing long-term outcomes. Median duration of treatment was 23.00 (interquartile range (IQR) 15.00, 47.25) weeks. Median all-cause survival time of 126 patients treated with tofacitinib was 44 weeks (95% confidence interval (95% CI) 36.3, 51.7), and the allcause drug retention rate at 12 weeks, 24 weeks and 48 weeks were 90.0%, 66.4% and 42.3%, respectively. The most common reason for discontinuation was complete remission/satisfaction. A total of 80 patients treated with tofacitinib for over 6 months were included in the efficacy analysis, the overall complete response rate at 24 weeks was 33.8% (27/80). No lifethreatening serious adverse events occurred. Sex is an independent risk factor in predicting patient outcomes. This real-world study confirmed the high effectiveness and acceptable safety profile of tofacitinib in alopecia areata, with a satisfactory drug survival rate, and provides supporting data for the clinical application of tofacitinib in Chinese patients with alopecia areata. [ABSTRACT FROM AUTHOR]

• Ixekizumab shows good efficacy in the treatment of psoriasis, including difficult-to-treat areas. • Ixekizumab has a high survival rate, especially efficacy and safety-related survival. • Ixekizumab has a favourable safety profile in special populations, such as patients with latent TB, HBV, HCV or cancers. • Ixekizumab does not affect the metabolic prameters of the patients. Long-term, real-world studies of the efficacy and metabolic parameters of ixekizumab in difficult-to-treat areas of psoriasis are lacking. A two-year retrospective study was conducted to evaluate the long-term efficacy, safety, drug survival and metabolic parameters of ixekizumab in the real world. A total of 258 patients were enrolled. At 52 weeks, PASI 75/90/100 was achieved in 92.0 %, 79.8 % and 54.6 % of patients, respectively. The efficacy was maintained at week 104 with PASI 75/90/100 of 92.6 %, 81.5 % and 48.1 %, respectively. At week 12, sPGA 0/1 was achieved in 71.0 % of scalp psoriasis, 60.0 % of palmoplantar psoriasis and 68.8 % of genital psoriasis. The probability of drug survival at 12 and 24 months was 67.1 % and 56.3 %, respectively. The most common adverse events included local injection reactions (31.8 %), allergies (11.6 %) and infections (6.1 %). No disease activation was observed in patients with latent tuberculosis or hepatitis B/C. No hyperlipidemia or hyperglycemia was observed. This study confirmed the long-term efficacy, high drug survival and favorable safety of ixekizumab in a real-world setting. [ABSTRACT FROM AUTHOR]

Psoriasis is a chronic, immune‐mediated inflammatory disease for which no definitive cure exists and patients difficult to treat with moderate to severe psoriasis often require life‐long therapy. In general, the use of any biologic agent as monotherapy allows a long‐term efficacy, however survival response may progressively decrease over time. We report real‐world long lasting response data in psoriatic patients on treatment with anti‐TNFα evaluating those on the same anti‐TNFα agent (infliximab, etanercept, adalimumab) from January 2011 and December 2013 to December 31, 2021 as monotherapy. On 210 treated patients, 69 were found to maintain the same anti‐TNFα agent. The median survival rate for etanercept, infliximab and adalimumab was 10, 9.6, and 9.5 years respectively and the efficacy rate was similar (mean PASI96). Our results demonstrate that anti‐TNFα agents are a long‐term effective and safe therapeutic option for a satisfying proportion (33%) of patients with moderate‐to‐severe chronic plaque psoriasis. Further long‐term real life studies are needed to better understand which are the causes of drug failure or persistent response and why these may occur at different time intervals in patients on the same drug. [ABSTRACT FROM AUTHOR]

Purpose: This study provides a comparative survival analysis between the only two drugs approved in Italy for the treatment of moderate-to-severe AD, cyclospoorin, and dupilumab. Materials and methods: A multicenter, retrospective study, was performed to assess drug survival (DS) analysis by comparing cyclosporin (CsA) and dupilumab in 247 AD adult patients. DS was determined through Kaplan Meier survival analysis. For each patient, data regarding age, sex, medical history, and, at every visit, concomitant medications or procedures, adverse events (AEs), and Eczema Area and Severity Index (EASI) were registered. Results: At week 72, 32/247 patients (13.96%) of the dupilumab group had discontinued the drug after a mean time of treatment of 35.27 ± 11.61 weeks; therefore, the DS rate at W72 was 87.04%. The most frequent (13/32; 40.63%) reason of drug discontinuation was the achievement of complete disease remission after a mean duration of treatment of 42.28 ± 2.02 weeks. In CsA-treated patients, DS rate at W72 was 21.05% (20/95 patients). Sixty-seven out of 95 (70.53%) patients had discontinued the drug, while 8/95 (8.42%) of them were lost to follow-up during the first 12 weeks of treatment. The causes of withdrawal among the patients who stopped CsA were AEs (28/67;41.79%). Conclusions: Dupilumab has a significant longer DS when compared to CsA. [ABSTRACT FROM AUTHOR]

To examine the long-term efficacy and side effects of antitumour necrosis factor alpha (anti-TNF) therapy in patients with Crohn's disease (CD), the need for surgery and the clinical outcome after discontinuing anti-TNF therapy. Data were collected from the inflammatory bowel disease (IBD)-TNF register at Østfold Hospital Trust. Clinical and sociodemographic data were recorded for patients initiating anti-TNF therapy from January 2000 until December 2011. Follow-up was conducted until December 2017. Complete remission (CR) was achieved in 40/154 (26%) patients at the last follow-up (median follow-up time 10 years). A total of 40 (26%) patients had to discontinue treatment due to serious side effects, and malignancy was recorded in 10 (6.5%) patients. Surgical resection was performed in 55 (36%) patients during follow-up. Patients with Montreal phenotype B2 before anti-TNF therapy were estimated to have a 2.54-fold greater risk of surgery than patients with phenotype B1 (p =.001). Of those with phenotype B1 before anti-TNF therapy, 19 (24%) of them developed stenosis in need of surgical resection ('phenotype migration'). In patients followed up after discontinuing anti-TNF therapy (n = 89, median observational time six years), CR was achieved in most patients. Long-term complete remission was achieved in only one in four patients receiving anti-TNF therapy, and one in four patients had to discontinue therapy due to side effects. Despite anti-TNF therapy, one in four patients with a baseline luminal disease phenotype needed subsequent surgical resection. [ABSTRACT FROM AUTHOR]

Background: Drug survival measures the rate and duration of adherence to a given therapeutic agent and evaluates its long‐term effectiveness, safety, and real‐world utility. The SUSTAIN study sought to establish the drug survival and effectiveness of secukinumab for patients with severe chronic plaque psoriasis (CPP) in the Australian clinical setting. Methods: Data of all patients (aged ≥18 years) from Australasian Psoriasis Registry (APR) treated with secukinumab were analysed. The primary objective was to describe the drug survival of secukinumab at 9 months. Key secondary objectives included drug survival of secukinumab at 3, 6, 15, and 21 months, stratified by biologic‐naïve vs biologic‐experienced patients; proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100 responses; and changes in health‐related quality of life over time utilising the Dermatology Life Quality Index (DLQI). Results: Of 294 patients included in this analysis, 110 (37.4%) were biologic‐naïve and 184 (62.6%) biologic‐experienced. Kaplan–Meїer drug survival rates in biologic‐naïve vs biologic‐experienced patients were 0.92 vs. 0.86 (9 months) and 0.82 vs. 0.68 (21 months), respectively. The proportion of patients with PASI 75/90/100 responses for biologic‐naïve vs. biologic‐experienced was 100/87.7/38.4 vs 98.5/61.5/27.2 (9 months) and 100/81.0/41.7 vs. 98.4/62.0/24.2 (21 months), respectively. The mean (standard deviation [SD]) DLQI in biologic‐naïve vs. experienced patients was 2.2 (4.1) vs. 3.1 (5.2) (9 months) and 1.4 (2.5) vs. 3.1 (5.3) (21 months). No new safety signals were observed. Conclusions: Secukinumab demonstrated high drug survival and sustained effectiveness in Australian real‐world setting, in biologic‐naïve and biologic‐experienced patients with severe CPP. [ABSTRACT FROM AUTHOR]

There is limited evidence about the real‐world survival of apremilast in patients with psoriasis, especially over the long term. To evaluate the long‐term survival of apremilast and its predictive factors when used to treat psoriasis. A retrospective hospital‐based study, including data collected from 104 patients. Survival curves were estimated using the Kaplan–Meier estimator. Proportional hazard Cox regression models were used for multivariate analysis. The average duration of the treatment before discontinuation was 28.82 months (95% CI, 22.08–35.57 months) and the median was 12 months (95% CI, 2.68–21.31 months). The retention rates were 51% (1 year), and 33% (5 years). The survival study revealed statistically significant differences between patients with PASI<10 and those in the PASI≥10 group (log‐rank test, p < 0.001). The 5‐year prevalences were 64% for patients with a PASI of <10 and 5% for those with an index ≥10. In the PASI < 10‐patient group, the retention rates were 77% (1 year) and 64% (5 years). Furthermore, 66% of patients who continued apremilast treatment for more than 2 years were receiving off‐label doses (30 mg/day). Apremilast may be a suitable and efficient alternative for the treatment of psoriasis patients in the PASI<10 group. [ABSTRACT FROM AUTHOR]

Real-life studies in psoriasis are lacking. Many monoclonal antibodies targeting tumor-necrosis factor (TNF)-alpha, interleukin 17, and 23 are approved drugs for psoriasis treatment. To compare the short and long-term efficacy, safety, and drug survival of anti TNF-alpha, anti-IL-17, and anti-IL-23 in a large case series. Psoriasis area severity index (PASI) and retention rates for adalimumab, secukinumab, guselkumab, ixekizumab, and brodalumab were analised. A total of 263 patients were randomly selected among the five drugs register of the patients attending the Psoriasis Unit at the Turin University Hospital. The mean PASI at baseline was 14.3. Ixekizumab showed a significantly higher efficacy profile compared to other drugs in terms of PASI90 and PASI100 at week 12, 24, and week 48 even when adjusted for other confounding factors. This superiority was not followed by an expected higher drug survival. On the contrary, secukinumab was the only drug that showed a higher drug survival among bio-naïve patients. [ABSTRACT FROM AUTHOR]

Introduction: The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated. Objective: To investigate drug survival of adalimumab biosimilars in patients with chronic plaque psoriasis and factors associated with its discontinuation. Methods: 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. Results: 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. Conclusion: The real-life effectiveness of adalimumab biosimilars in patients with psoriasis is consistent with that previously reported for the originator. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The efficacy of biologics in psoriasis treatment is clinically proven; however, biologics are expensive. In this study, we assessed the real‐world cost‐effectiveness of biologics for psoriasis treatment by evaluating the relationship between biologic drug survival (DS) and total medical‐treatment costs from a pharmacoeconomic viewpoint. Furthermore, the effects of patient factors on cost‐effectiveness were investigated. We retrospectively reviewed the medical records of 135 cases who received either a tumor necrosis factor‐alpha (TNF‐α) monoclonal antibody (TNF‐mab), interleukin (IL)‐17 mab, or IL23p19‐mab for psoriasis from January 2010 to June 2020 at Yamaguchi University Hospital. We compared the monthly medical‐treatment costs according to biologic classification and found that costs of medical services, tests, and external preparations required for the treatment process were significantly higher in the TNF‐mab group than in the other groups, and the total medical costs associated with TNF‐mab treatment were significantly higher than those of IL17‐mab treatment. The total monthly cost of medical care was lower in the long‐term DS group than in the short‐term group. The number of prescriptions for external preparations, comprising Vitamin D3 and corticosteroid, was significantly higher in the long‐term DS group than in the short‐term group; in the TNF‐mab group, the proportion of patients without smoking habits was significantly higher in the long‐term group as well. Our study indicated that when costly biologics are used for psoriasis treatment, the maintenance of long‐term DS and appropriate patient guidance might improve the quality of medical care, thus allowing cost‐effective medical care. [ABSTRACT FROM AUTHOR]

To investigate the drug survival of secukinumab (SEC), ustekinumab (UST), and certolizumab pegol (CZP) in real-world conditions and to identify the predictors and reasons for treatment discontinuation. We performed a 2-year retrospective single-center analysis of 110 treatment courses in 98 patients with moderate to severe plaque-type psoriasis and/or psoriatic arthritis (SEC n = 68; UST n = 29; and CZP n = 13). Drug survival was examined using the Kaplan–Meier analysis and the influence of demographic factors on drug survival with Cox regression analysis. Drug survival rates at 12 and 18 months were respectively 68.5% and 59% for the entire study population, 85% and 69% for UST, 68% and 59% for SEC, and 34% for CZP. Both UST and SEC showed a significantly longer survival rate compared to CZP (p<.05), but not between each other. A total of 30 treatment discontinuations were observed, predominantly due to loss of efficacy and adverse events. Treatment selection predicted the survival rate. Other predictors could not be identified. Drug survival is the resultant of many factors such as long-term effectiveness, safety, compliance, and convenience of use. UST and SEC had higher retention rates in comparison with CZP. [ABSTRACT FROM AUTHOR]

Objectives B cell depletion therapy based on rituximab in patients with RA was pioneered at University College London Hospitals/University College London in 1998. The objective of this study was to evaluate long-term persistence of rituximab and identify factors associated with discontinuation of treatment. Methods Retrospective review of medical records from all rituximab-treated RA patients followed up in a dedicated clinic (1998–2020). Data collected included gender, disease duration, previous DMARDs, autoantibody status, age and concomitant therapy at first cycle, length of follow-up, and number of cycles. Drug survival and factors associated with drug discontinuation were analysed using Kaplan–Meier survival curves, log-rank test and Cox regression analysis. Results A total of 404 patients were included. Median disease duration and age at time of first rituximab cycle were 10 and 57 years, respectively. Median total follow-up was 55 months and median number of cycles five. 93.1% of patients were seropositive. Overall, 31.2% of patients stopped rituximab, with the largest reason for discontinuing being primary inefficacy (42.1%). Comparison of Kaplan–Meier curves showed that rituximab drug survival was lower in seronegative patients and in patients who had previously failed at least one biologic DMARD (bDMARD). Cox regression analysis revealed that rituximab discontinuation was associated with a greater number of previous bDMARDs. Conclusion Many patients with RA achieve good control of their disease with repeated cycles of rituximab treatment. The most common reasons for treatment discontinuation were either primary or secondary inefficacy. Patients who were seronegative and who had previously failed other bDMARDs were more at risk of drug discontinuation. [ABSTRACT FROM AUTHOR]

Objectives: To determine the effectiveness of golimumab (GLM) in improving joint, periarticular structures and cutaneous manifestations in patients with moderate to severe psoriatic arthritis (PsA) with cutaneous psoriasis in different real-life clinical settings and 48-month drug survival. Methods: Clinical and laboratory records were collected from PsA patients treated with GLM at baseline (T0) and after 6, 12, 24, 36, and 48 months of treatment. Comparisons were performed using a paired t-test or Wilcoxon test. Drug survival rates were analyzed using Kaplan–Meier estimates. p value < 0.05 was considered statistically significant. Results: Data from 105 patients were collected. PsO occurred in 80% of patients and enthesitis in 78%, peripheral and axial arthritis in 63.8% and 35.3%, respectively, while erosions in 36.2%. The main comorbidities were cardiovascular diseases (31.4%) and metabolic syndrome (MetS) (19%). A statistically significant improvement in articular and cutaneous psoriasis was registered at T48 of GLM-therapy in clinical (DAPSA p < 0.0001; PASI p < 0.01; BASDAI p < 0.0001) and laboratory (CRP < 0.05) indexes. Gender (p = 0.652), BMI (p = 0.655), smoking habit (p = 0.466), and line of treatment (p = 0.208) did not affect treatment efficacy nor persistence. At T48, 42% of patients discontinued GLM: the most frequent reason was an insufficient response or loss of efficacy (28.6%). Conclusion: A 48-month GLM high drug persistence of PsA patients was observed in real-life, in patients presenting high disease activity, elevated prevalence of comorbidities, and more than one line of treatment at baseline. Patients' characteristics as gender, smoke, BMI, different lines of treatment, and concomitant methotrexate treatment affected treatment persistence, making GLM effective and safe in moderate-severe PsA in a long-term real-life setting. Key Points • Golimumab was effective in psoriatic arthritis, including both musculoskeletal and cutaneous manifestations. • Golimumab effectiveness and drug survival were not affected by comorbidities and patient-related characteristics. • The 4-year drug survival curves confirm the efficacy and safety of golimumab in psoriatic arthritis patients in a real-life setting. [ABSTRACT FROM AUTHOR]

Background/aim: PSORTAKSIS is a psoriasis registry, which is used for follow-up of patients in Kayseri City Education and Research Hospital, Dermatology Clinic since 2016 in Turkey. PSORTAKSIS includes demographic data, follow-up clinical findings, laboratory output, and treatment information of patients. Here, drug survivals of biologic therapeutics (BT) according to three-year data of PSORTAKSIS will be presented. Materials and methods: Drug survival of BT in PSORTAKSIS was analyzed from 2016 to March 2019. Results: 158 patients (111 of them BT-naive) with psoriasis under BT were enrolled in the current study. Drug survival analysis of patients with ongoing BT (158 treatment periods) revealed mean survival time as 15.49 months for ustekinumab, 15.37 months for adalimumab, 14.00 months for etanercept, 5 months for infliximab, and 4.59 months for secukinumab. The differences between drug survivals of BT were statistically significant (log-rank test, χ2 = 79.915, p < 0.0001). Age of onset was found to be the only independent risk factor of drug survival according to regression analysis (p = 0.029). Conclusion: As a conclusion, drug survival of UST was significantly higher than that of TNF-alpha inhibitors and SEC in the treatment of psoriasis. This study revealed that among predictors, age at disease onset may influence drug survival. [ABSTRACT FROM AUTHOR]

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 diseasemodifying 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) overlapping 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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%). [ABSTRACT FROM AUTHOR]

Secukinumab, a full human immunoglobulin G1κ monoclonal antibody that targets interleukin‐17A, has demonstrated remarkable efficacy and appreciable tolerance in patients with moderate‐to‐severe psoriasis. However, data on its real‐life performance, particularly on drug survival in China are limited. To investigate the efficacy, safety, and drug survival of secukinumab in Chinese patients with psoriasis, we conducted a monocentric retrospective study of 66 patients with moderate‐to‐severe psoriasis to followed‐up for 52 weeks. At week 12, 86.4%, 57.6%, and 10.6% of the patients attained 75% improvement in psoriasis area and severity Index (PASI) score from baseline (PASI 75), PASI 90, and PASI 100 responses, respectively. The quality of life of patients markedly improved. The overall survival rate was 74.2%. Adverse events occurred in 30 patients (45.5%). The results revealed favorable efficacy, safety, and tolerability of secukinumab in the treatment of patients with psoriasis and provided data on drug survival in real‐life clinical setting in China for the first time. [ABSTRACT FROM AUTHOR]

Drug survival reflects the real-life efficacy and safety of therapeutic agents. Evidence regarding the durability of adjuvant agents in the treatment of pemphigus is sparse. The aims of this study were to investigate the survival of adjuvant agents used to manage patients with pemphigus, and to identify predictors of treatment dropout. A retrospective population-based cohort study was designed to follow patients with pemphigus managed by adjuvant agents. The study population included 436 patients with pemphigus managed by 608 adjuvant agent courses. The highest median drug survival time was observed for rituximab (43.6 months, 95% confidence interval (95% CI) 5.3-81.9), followed by cyclophosphamide (30.5 months; 95% CI 10.5-50.5), azathioprine (22.9 months; 95% CI 15.6-30.2), and mycophenolate mofetil (20.2 months; 95% CI 10.0-30.4). Compared with azathioprine, cyclosporine (adjusted hazard ratio 2.98; 95% CI 1.57-5.62; p = 0.005) and dapsone (adjusted hazard ratio 1.83; 95% CI 1.07-3.15; p = 0.027) were associated with a significantly increased risk of drug discontinuation. To conclude, rituximab, azathioprine, and mycophenolate mofetil demonstrated better durability, whilst dapsone and cyclosporine were associated with low drug survival and high dropout. [ABSTRACT FROM AUTHOR]

Aim: Rheumatoid arthritis (RA) is a progressive, inflammatory, autoimmune disease that particularly affects the joints. Tofacitinib is the first oral Janus kinase inhibitor approved for RA treatment. We aimed to analyze the 6-month drug survival rate and factors affecting the discontinuation of tofacitinib in RA patients. Materials and Methods: Age, gender, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, whether to continue treatment tofacitinib, if treatment is not continued what treatment is applied, use of biological agent before tofacitinib treatment were retrospectively recorded from the patient data. Results: 30 RA patients included in the study (29 female, 1 male) with a mean age of 50.5 ± 11.3 years. At the 6th month of treatment of tofacitinib, the drug survival rates were 50%. There was no significant difference between CCP positive and negative patients as well as between RF positive and negative patients in terms of drug survival rates (p = 0.92 and p = 0.90, respectively). The drug survival rates were alike in tofacitinib monotherapy and combined therapy of tofacitinib with any conventional DMARD (p = 0.36). The tofacitinib survival rates were similar in biologically naïve patients and in patients who had received at least one previous biological DMARD (p = 0.70). Conclusion: Half of the RA patients receiving tofacitinib treatment continue their treatment at the 6th month. The drug survival rate was not associated with co-treatment with conventional DMARD, auto-antibody positivities, and previously used biological DMARD therapy. These findings support that tofacitinib shows similar efficacy when used as combined or monotherapy, in seronegative or seropositive patients, and in biologic resistant or naive patients. [ABSTRACT FROM AUTHOR]

Background: Evidence on safety and effectiveness of omalizumab for treatment of chronic urticaria in pediatric patients is scarce and limited to case reports. In particular, drug survival of omalizumab has not yet been investigated, which is a key element in the evaluation of its clinical performance. The aim of this study was to investigate safety, effectiveness, and drug survival rates of omalizumab in a daily practice cohort of pediatric patients with chronic urticaria (CU). Methods: This is a multicenter study including all pediatric patients from an academic center (Wilhelmina Children's Hospital) and a general center (Diakonessenhuis Hospital) in the Netherlands, who started omalizumab treatment before the age of 18 years. Data on safety, effectiveness, time to discontinuation, and reasons for discontinuation of treatment were assessed. Drug survival of omalizumab was estimated using the Kaplan‐Meier survival analysis. Results: A total of 38 patients, who started treatment between January 2014 and January 2020, were included. Most patients (68.4%) used omalizumab without reporting any side effects and a complete or good response to treatment was achieved in 76.3% of patients. The 1‐ and 2‐year drug survival rates were 62% and 50%, respectively, with well‐controlled disease activity as the most frequent reason for discontinuation in 69.2% of patients, followed by ineffectiveness in 23.1% and side effects in 7.7% of patients. Conclusions: This study demonstrates high safety and effectiveness of omalizumab treatment in pediatric patients with CU, which will aid clinical decision making and management of expectations when choosing omalizumab treatment for pediatric patients with CU. [ABSTRACT FROM AUTHOR]

Acitretin is a nonimmunosuppresive systemic agent used in the treatment of psoriasis. Despite its frequent use, research on drug survival and adverse effects is limited. This study aims to evaluate drug survival, factors associated with survival, and adverse effects. Database of the six tertiary referral center for psoriasis patients treated with acitretin between November 2014 and April 2020 were retrospectively analyzed. Demographics of patients, adverse effects, and also drug survival were analyzed. Of 412 patients, 61.2% were male, and 38.8% were female. Common clinical adverse effects were cheilitis (71.4%), dry skin (62.5%), and palmoplantar skin peeling (37.2%). High triglyceride and high total cholesterol levels were observed in 50.0% and 49.5% of patients, respectively. Median survival time (95% confidence interval [CI]) was 18 (13.6‐22.4) months. Statistically significant risk factors affecting drug discontinuation were having psoriatic arthritis, age under 65, and receiving previous systemic treatment. Drug survival rates were 56.6%, 25.9%, and 19.8% at 1, 5, and 8 years, respectively. Although mucocutaneous adverse effects of the acitretin were quite frequent, severe, life‐treatining ones were infrequent. This old, relatively inexpensive and safe treatment remains a good alternative for the treatment of psoriasis. [ABSTRACT FROM AUTHOR]

Early response to treatment with biologics might be important for the stability of psoriasis and long-term outcome. The aim of this study was therefore to assess whether risk of flares and drug survival are associated with disease activity in the first 6 months of treatment of psoriasis with biologics. Biologic-naïve patients from the Danish nationwide registry, DERMBIO, were grouped based on absolute Psoriasis Area and Severity Index (PASI) during the first 6 months of treatment, as: PASI = 0, PASI > 0-≤2, PASI > 2-≤ 4, and PASI > 4. Among 1,684 patients, 746 achieved PASI= 0, 485 PASI > 0-≤2, 246 PASI > 2-≤4, and 207 PASI > 4. Longer flare-free period and drug survival were observed for patients with lower PASI in the first 6 months of treatment (adjusted hazard ratios for flares (95% confidence interval) with PASI= 0 as reference: PASI > 0-≤2 (1.35 (1.11-1.72]), PASI > 2-≤ 4 (2.32 [1.80-2.99]), and PASI > 4 (2.38 [1.80-3.15])). In conclusion, a low PASI in the first 6 months of treatment with biologics in biologic-naïve patients with psoriasis was associated with a more stable disease course, lower risk of flares, and longer drug survival. [ABSTRACT FROM AUTHOR]

Psoriasis is a chronic, systemic disease that requires long‐term management. Biologic agents have been used widely against psoriasis, such as infliximab. We analyzed the survival and discontinuation rates of infliximab when treating psoriasis under real‐world conditions in China. Patients with moderate‐to‐severe psoriasis treated with infliximab in Shanghai Skin Disease Hospital from January 2015 to April 2020 were included in our retrospective study. Information from their medical records (clinical characteristics, Psoriasis Area Severity Index [PASI] score, laboratory results, and time of discontinuation) was collected through the Shanghai Skin Disease Hospital database. The survival of infliximab was assessed with Kaplan‐Meier plots and multivariate Cox regression. Forty‐two patients who underwent treatment were assessed retrospectively (38.1% had been diagnosed with psoriatic arthritis [PsA]). The discontinuation rate was 57.1%, the mean survival time of discontinuation was 57 weeks for patients with PsA vs 69 weeks for those without PsA (P =.5993). The cholesterol level (P =.003) and lymphocyte percentage (P =.010) were associated with longer survival of infliximab according to Cox regression analysis. Our study revealed that infliximab had a similar drug survival as previous studies, the high cholesterol level and lymphocyte percentage might function as negative predictor for infliximab persistence. [ABSTRACT FROM AUTHOR]

Apremilast is the first small molecule approved for the treatment of moderate to severe psoriasis and psoriatic arthritis in adult patients. To evaluate survival, efficacy and safety of apremilast in patients with moderate to severe psoriasis and investigate possible associations between apremilast survival and clinical parameters in a real‐world setting. In this retrospective study, a total of 71 patients who started on apremilast treatment between March 2017 and December 2019 were identified and included in the study: 40 (56.3%) males and 31 (43.7%) females, with a mean age of 55.6 ± 13.8 years and a mean Body Mass Index of 28.4 ± 6.9 kg/m2. At the end of the study 49.3% of patients remained on apremilast with mean treatment duration 67.2 ± 41.1 weeks (range 4‐132). Overall, mean drug survival duration was 78.51 weeks (95% CI: 65.8‐91.2 weeks). Mean drug survival was shorter when comorbidities burden was higher (P =.012) and with previous exposure of biological agents (P =.001). Previous exposure to biological agents (HR:3.86, 95% CI: 1.35‐11.04, P =.012) and comorbidities burden (HR: 2.27, 95% CI: 1.25‐4.12, P =.007) were independent predictors of drug discontinuation adjusting for important clinical parameters. In this real‐world setting, apremilast presented better survival rates when introduced early on the onset of moderate psoriasis, especially in biologic naïve patients with less comorbidities. More prospective and larger studies are required to determine clinical parameters affecting drug survival. [ABSTRACT FROM AUTHOR]

Dupilumab and cyclosporin are recommended treatments for moderate‐to‐severe atopic dermatitis (AD). The objective of this study was to investigate drug survival of dupilumab in comparison with CsA, reasons of drug discontinuation, and predictive parameters of drug survival in daily practice. Retrospective study including patients with moderate‐to‐severe AD treated with dupilumab or cyclosporin (CsA) from January 1, 2019 to April 30, 2020. Drug survival analysis was performed using the Kaplan‐Meier method and predictive factors were analyzed using multivariate Cox regression analyses. Adult patients with AD (n = 251) treated with dupilumab (n = 149) or CsA (n = 102) were included. Sixteen months from baseline, 82% of patients receiving dupilumab were still on treatment vs 11% of those treated with CsA. Reason for withdrawing dupilumab were primary inefficacy in 4.7% of patients, persistent clinical remission in 7.4%, and cutaneous adverse effects in 2.0%. Older age at diagnosis and shorter AD duration predicted shorter dupilumab survival. Reasons for CsA withdrawal included adverse effects in 23.5% of patients, persistent clinical remission in 15.6%, and a minimal or absent improvement in 11.7%. Dupilumab has a longer drug survival compared to CsA. Only a limited number of dupilumab patients discontinued treatment due to adverse effects and/or ineffectiveness. [ABSTRACT FROM AUTHOR]

Psoriasis is a chronic, immune‐mediated disease deriving from a polygenic predisposition. Treatment paradigm of the moderate to severe psoriasis has changed in the last two decades as biologics have been developed. Real‐world data concerning biologics in the treatment vary from country to country. We aimed to investigate the efficacy and drug survival of biologic agents in patients treated in our clinic in Turkey. Data for 211 biologic protocols were examined for 125 patients treated with a biologic at least once for a minimum duration of 16 weeks at our department. The drug survival rate for 3 years was highest among ustekinumab (UST) users. The primary failure rate in the present study was higher among tumor necrosis factor‐alpha inhibitors compared to UST (P <.0001). The higher primary failure rate was found in etanercept users and the highest secondary failure rate was observed in infliximab, while the lowest primary and secondary failure rates were determined in UST users. UST use and articular involvement emerged as significant positive predictors of drug survival in naïve patients. Our study is the first study presenting real‐life data and biologic survival in the treatment of psoriasis in Turkey, and UST exhibited significantly higher drug survival scores, particularly in naive patients. [ABSTRACT FROM AUTHOR]

Anti-interleukin-17 agents have recently been developed for the treatment of psoriasis. This study evaluated the tolerance and effectiveness of anti-interleukin-17 agents for psoriasis in elderly patients in daily practice. A multicentre, retrospective study was performed, involving psoriatic patients aged =65 years who had received an anti-interleukin-17 agent, including secukinumab, ixekizumab or brodalumab. A total of 114 patients were included: 72 received secukinumab, 35 ixekizumab, and 7 brodalumab. Treatment was stopped in 32 patients (28.9%), because of relapses in 14 patients (41.2%), primary failures in 11 patients (32.4%), or adverse events in 7 patients (20.6%). The 3 most frequently reported adverse events were injection site reactions (n = 4), oral candidiasis (n = 3), and influenza-like illness (n = 3). Regarding effectiveness, 80 patients (70%) reached a Physician Global Assessment score of 0/1, 6 months after treatment initiation. In conclusion, anti-interleukin-17 therapy appears to be an effective and safe therapeutic option for psoriasis treatment in patients aged = 65 years. [ABSTRACT FROM AUTHOR]