Real-World Treatment Persistence with Biologic Disease-Modifying Antirheumatic Drugs Among German Patients with Psoriatic Arthritis—A Retrospective Database Study (original) (raw)
Related papers
Treatment persistence of biologics among patients with psoriatic arthritis
Arthritis Research & Therapy, 2021
Background Persistence of biologic therapy in psoriatic arthritis (PsA) patients is an important factor in individualized patient treatment planning and healthcare policy and guideline development. Objective To estimate the persistence of biologic agents prescribed to PsA patients in a real-life setting as well as factors associated with improved biologic drug survival in these patients. Methods Patients with PsA from a large healthcare provider database with at least two consecutive dispensed prescriptions of a biologic agent indicated for PsA from January 1, 2002, until December 31, 2018, were identified and followed until medication stop date or the end of observation period. Patients were considered non-persistent whenever a permissible lag time of 6 months from the time of prescription issuance until medication filling date was exceeded. Treatment changes were based on physician decisions and patient preferences. Demographic data including age, sex, body mass index (BMI), ethni...
HAL (Le Centre pour la Communication Scientifique Directe), 2023
Objectives To evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years. Methods PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months. Safety data were collected over 3 years. Analyses to compare the modes of action were adjusted on baseline differences by propensity scores (PS). Results In 895 patients (mean age 49.8 years, 44.7% males), at 3 years, the proportion of patients still on their initial treatments was similar with ustekinumab (49.9%) and TNFi (47.8%). No difference was seen in the risk of stopping/switching; PS-adjusted hazard ratio (95% CI) for stopping/switching ustekinumab versus TNFi was 0.87 (0.68 to 1.11). In the overall population, cDAPSA LDA/remission was achieved in 58.6%/31.4% ustekinumab-treated and 69.8%/45.0% TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63 to 1.26) for cDAPSA LDA; 0.72 (0.50 to 1.05) for remission. MDA/VLDA was achieved in 41.4%/19.2% of ustekinumab-treated and 54.2%/26.9% of TNFitreated patients with overlapping PS-adjusted ORs. A greater percentage of TNFi-treated patients achieved effectiveness outcomes. Both treatments exhibited good long-term safety profiles, although ustekinumab-treated patients had a lower rate of adverse events (AEs) versus TNFi. Conclusion At 3 years, there was generally comparable persistence after ustekinumab or TNFi treatment, but AE rates were lower with ustekinumab. HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY ⇒ These 3-year results from the PsABio study provide long-term real-world evidence on effectiveness, safety and persistence with biologics in PsA treatment, which may help inform treatment decisions in clinical practice.
Clinical and Experimental Rheumatology
Objective. To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA). Methods. One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st-to 3rd-line treatment with ustekinumab or TNFi) were evaluated. Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models. Proportions of patients reaching clinical effectiveness endpoints were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation if treatment was stopped/switched. Results. Among 222 participants with follow-up data (effectiveness set), 101 received ustekinumab and 121 TNFi. In the ustekinumab group, 74.3% continued treatment up to 12±3 months compared to 63.6% in the TNFi group. Ustekinumab showed better persistence than TNFi, overall and in specific subgroups (females, monotherapy without methotrexate, BMI <25 or >30 kg/m 2 , patients receiving ustekinumab as 2nd-line treatment instead of a second TNFi). Overall, the PS-adjusted HR of treatment discontinuation was 0.46 (95% CI: 0.26-0.82) for ustekinumab vs TNFi. cDAPSA LDA/remission was achieved in 43.5% of ustekinumab and 43.6% of TNFi-treated patients, while MDA was achieved in 24.2% and 28.0% of patients, respectively. After PS adjustment, odds ratios of clinical effectiveness did not differ significantly. Both treatments showed an acceptable safety profile. 5 Conclusion. This prospective, real-life study found a better persistence of ustekinumab than TNFi in PsA patients. At 1 year, both treatments showed similar effectiveness.
Dermatology and Therapy, 2022
Introduction: Biologics are a standard therapy for patients with moderate-to-severe psoriasis, yet treatment persistence is essential to achieve disease control. Compared with other biologics, ustekinumab has been associated with lower rates of discontinuation and better adherence among patients with psoriasis, but prior studies have included limited data from the period after approval of self-administration for ustekinumab. This study was conducted to assess discontinuation risk among patients with plaque psoriasis initiating ustekinumab or other biologics. Methods: Adults with psoriasis and one or more claim for ustekinumab, secukinumab, adalimumab, or ixekizumab were identified in Optum's de-identified Clinformatics Data Mart Database (1 January 2010 to 30 June 2019). Treatment discontinuation was defined as a gap in days of therapy supply based on (1) each drug's per-label frequency of administration (main analysis) or (2) [ 90 days (sensitivity analysis). Differences in baseline characteristics between the ustekinumab and other cohorts were adjusted with entropy balancing. Risk of discontinuation was compared with Cox proportional hazard models. Results: Overall, 2230 patients were included in the ustekinumab cohort, with 1807 in the secukinumab, 4483 in the adalimumab, and 535 in the ixekizumab cohorts (mean age 49.0 years, 49.3% female for all cohorts). In the main analysis, risk of discontinuation for the ustekinumab cohort was 62.2% lower than for adalimumab, 46.4% lower than for secukinumab, and 43.8% lower than for ixekizumab
To evaluate the persistence and adherence of subcutaneous biologics in patients with psoriatic arthritis (PsA). Patients & methods: Psoriatic arthritis patients who initiated adalimumab, certolizumab pegol, etanercept, golimumab or secukinumab between 15 January 2016 and 31 July 2017 were identified in the Truven Databases. Outcomes included discontinuation rate, persistence and adherence over 12 months. Results: Of 1558 patients included, the 12-month discontinuation rate was lowest with secukinumab (36.5%), followed by adalimumab, golimumab, etanercept and certolizumab pegol (42.6-51.6%). Mean persistence ranged from 240.7 (certolizumab pegol) to 282.8 days (secukinumab). The mean proportion of days covered was highest with secukinumab (0.67) and lowest with certolizumab pegol (0.49). Conclusion: Patients who initiated secukinumab had the lowest discontinuation rate and highest persistence and adherence over 12 months.
Annals of the Rheumatic Diseases, 2013
Objective To investigate the possibility of drug-free remission in patients with psoriatic arthritis (PsA) in continuous remission. Methods Prospective observational study in diseasemodifying antirheumatic drug (DMARD)-treated PsA patients in continuous disease remission (no musculoskeletal symptoms, no or minimal skin/nail disease) for at least 6 months. Demographic, diseasespecific and ultrasound parameters were assessed at baseline. DMARDs (traditional or biologic) were discontinued at the initial visit, and patients were followed for a maximum of 6 months for recurrence of disease. Results 26 patients (methotrexate monotherapy: N=14; tumour necrosis factor inhibitors: N=12) with a mean age of 55.2 years, absence of musculoskeletal symptoms and minimal skin disease (mean Psoriasis Area Severity Index (PASI): 0.21) were enrolled. Incidence of recurrence of disease was high (N=20, 76.9%) and occurred rapidly (74.50±51.72 days) after treatment discontinuation. Male PsA patients were significantly more likely to lose remission. Long disease duration, more severe skin involvement and the presence of synovial hypertrophy by ultrasonographic examination at baseline decreased the likelihood for drug-free remission. Reinitiation of DMARDs promptly restored remission in all PsA patients with recurrence of disease. Conclusions This study shows that the chance to reach drug-free remission in PsA patients is low. Discontinuation of DMARD therapy cannot be recommended in patients with PsA.
Drug Persistence of Biologic Treatments in Psoriasis: A Swedish National Population Study
Dermatology and Therapy
Introduction: Biologic treatments for psoriasis are commonly switched. Treatment persistence represents an important parameter related to long-term therapeutic performance. The objective of the study was to analyse the real-world persistence with biologics over time in the treatment of psoriasis. Methods: A retrospective observational study of adults with psoriasis was conducted based on Swedish national registry data from 2010 to 2018. Patients included were treated with a biologic between 2010 and 2018. Treatment episodes were identified from the drug's date of dispensation recorded in the Prescribed Drug Register to the end of supply of the drug. Median persistence was estimated by Kaplan-Meier survival curves for patients who received adalimumab, etanercept, secukinumab, ustekinumab and ixekizumab. Descriptive analysis of change in persistence over time for 3-year running cohorts was also carried out. Results: A total of 2292 patients were analysed. Patients who received ustekinumab had the longest median persistence [49.3 months, 95% confidence interval (CI) 38.0-59.1] and etanercept the shortest (16.3 months, 95% CI 14.5-19.0). Median persistence was longer in biologic-naive than biologic-exposed patients. Persistence for ustekinumab decreased by almost 50% over the study period, from a median of 62.3 (95% CI 45.6-?) months in 2010-2011 to 32.7 (21.2-49.3) months in 2014-2016. Conclusions: Persistence with biologics was, on average, relatively low, given the chronic nature of psoriasis. Changes in persistence over time seemed to be attributable to changes in the therapeutic landscape, providing patients with more options to switch biologic treatments if their current management was considered suboptimal.
Rheumatology international, 2018
The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of go...
The Journal of investigative dermatology, 2015
Drug survival reflects a drug's effectiveness, safety, and tolerability. We assessed the drug survival of biologics used to treat psoriasis in a prospective national pharmacovigilance cohort (British Association of Dermatologists Biologic Interventions Register (BADBIR)). The survival rates of the first course of biologics for 3,523 biologic-naive patients with chronic plaque psoriasis were compared using survival analysis techniques and predictors of discontinuation analyzed using a multivariate Cox proportional hazards model. Data for patients on adalimumab (n=1,879), etanercept (n=1,098), infliximab (n=96), and ustekinumab (n=450) were available. The overall survival rate in the first year was 77%, falling to 53% in the third year. Multivariate analysis showed that female gender (hazard ratio (HR) 1.22; 95% confidence interval (CI): 1.09-1.37), being a current smoker (HR 1.19; 95% CI: 1.03-1.38), and a higher baseline dermatology life quality index (HR 1.01; 95% CI: 1.00-1.02...