(13) Real-World Effectiveness and Persistence of Methotrexate Versus Adalimumab: A Comparative Study from The British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR)

Publication Number: 1058

Background:

Background: There are limited real-world data comparing effectiveness and persistence of methotrexate (MTX) versus adalimumab (ADN) prescribed to patients with moderate-to-severe psoriasis.

Objectives: To determine the real-world comparative effectiveness and persistence of MTX and ADN in patients with moderate-to-severe psoriasis registered to the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR).

Methods: Data from BADBIR, a prospective pharmacovigilance register investigating the long term safety of systemic and biologic therapies prescribed to patients with moderate-to-severe psoriasis in the UK and the Republic of Ireland, were analysed. Eligible patients were ≥16 years receiving a first course of MTX or ADN between 2007-2021 with ≥6 months’ follow-up and biologic-naïve at registration. Effectiveness was defined as achieving absolute Psoriasis Area and Severity Index (PASI) ≤2 using a minimum PASI (in case of multiple PASI records per individual) reported ≥13 weeks after treatment start date until stop date. Average treatment effects (ATE) was estimated using inverse probability of treatment weighting with propensity score included age, gender, Body Mass Index, disease severity and duration, smoking, alcohol consumption, previous non-biologic systemics, comorbidities and psoriatic arthritis. Results of ATE was presented as Risk Ratio (RR). Exposure time was calculated from therapy initiation to censor at stop date, latest follow-up, or death. Flexible parametric model estimated adjusted standardised average survival (persistence) (AS), defined as treatment discontinuation due to the lack of effectiveness, occurrence of adverse events or other reasons, at 6, 12 and 24 months. Multiple imputed datasets for missing baseline and outcome data were used.

Results: In total, 6575 patients (median age 44 years; 44% female) were analysed with 2659 (40%) prescribed MTX and 3916 (60%) prescribed ADN. The proportion of patients achieving PASI≤2 was lower in the MTX cohort (37%) compared with the ADN cohort (77%). Patients prescribed ADN were 2x more likely to achieve effectiveness than patients prescribed MTX [RR 2.2, 95% confidence interval (CI) 2.0-2.5]. Persistence was lower on MTX compared with ADN patients at 6 months [AS 66.6%, 95% CI 64.8%-68.5% vs. 89.1%, 88.3%-90.0%], 12 months [47.3%, 45.2%-49.5% vs. 77.9%, 76.7%-79.1%], and 24 months [28.2%, 26.2%-30.5% vs. 64.0%, 62.5%-65.4%], respectively.

Conclusions: Effectiveness and persistence were superior for patients prescribed ADN compared to MTX. Findings from this large cohort provide important effectiveness and persistence information to aid clinicians managing psoriasis patients with systemic and biologic therapies.