Effectiveness and survival of methotrexate versus adalimumab in patients with moderate-to-severe psoriasis: A cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).

Abstract

Most information on the comparative effectiveness and survival of methotrexate and adalimumab in the treatment of psoriasis is from randomised control trials which may not translate to the every-day clinical setting. To determine the real-world effectiveness and survival of methotrexate and adalimumab in patients with moderate-to-severe psoriasis registered to the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Eligible patients were registered to BADBIR, ≥ 16 years of age, receiving a first course of methotrexate or adalimumab between 2007-2021 and with ≥6 months' follow-up. Effectiveness was defined as achieving absolute Psoriasis Area and Severity Index (PASI) ≤ 2 reported ≥13 weeks after treatment start date until stop date. Average treatment effect (ATE) was estimated using inverse probability of treatment weighting with propensity score including baseline covariates. Results of ATE were presented as Risk Ratios (RR). Flexible parametric model estimated adjusted standardised average survival, defined as treatment discontinuation associated with ineffectiveness or occurrence of adverse events (AEs) at 6, 12 and 24 months. Restricted mean survival time (RMST) at 2 years of treatment exposure was calculated. 6,575 patients (median age 44 years; 44% female) were analysed with 2,659 (40%) prescribed methotrexate and 3,916 (60%) adalimumab. The proportion of patients achieving PASI ≤ 2 was higher in the adalimumab cohort (77%) compared with methotrexate (37%). Adalimumab was more effective than methotrexate [RR (95% confidence interval (CI)), 2.20 (1.98, 2.45)]. Overall survival associated with ineffectiveness or AEs was lower in methotrexate compared with adalimumab cohort at 6 months [Survival estimate (95% CI), 69.7 (67.9, 71.5) vs. 90.6 (89.8, 91.4)], 1 year [52.5 (50.4, 54.8) vs. 80.6 (79.5, 81.8)] and 2 years [34.8 (32.5, 37.2) vs. 68.6 (67.2, 70.0), respectively]. The difference in RMST for overall, or when stratified by ineffectiveness and AEs was [RMST (95% CI) years, 0.53 (0.49, 0.58), 0.37 (0.33, 0.42) and 0.29 (0.25, 0.33), respectively]. Patients on adalimumab were twice as likely to be clear or nearly clear of psoriasis and were less likely to discontinue their medication as compared to patients on methotrexate. Findings from this real-world cohort provide important information to aid clinicians managing psoriasis patients.