BIMEKIZUMAB EFFICACY AND SAFETY IN BIOLOGIC DMARD-NAÏVE PATIENTS WITH PSORIATIC ARTHRITIS WAS CONSISTENT WITH OR WITHOUT METHOTREXATE: 52-WEEK RESULTS FROM THE PHASE 3 ACTIVE-REFERENCE STUDY BE-OPTIMAL
Authors: McInnes I et al.
Biologic DMARDs may benefit from combination with MTX. Among other potential reasons, MTX might decrease the risk of secondary treatment failure because the formation of anti-drug directed antibodies is inhibited. Therefore, a subanalysis on PsA patients with or without MTX in clinical phase III trials is interesting.
This posthoc analysis of the BE-OPTIMAL trial up to week 52 was undertaken to evaluate efficacy and safety of bimekizumab 160mg every 4 weeks subsequent to a double-blind placebo controlled period of 16 weeks with regard to the concomitant use of MTX.
Baseline characteristics of patients who were on versus those who were not on MTX at baseline were comparable regarding age, BMI, disease duration and gender distribution. Almost 50% of patients had psoriasis affecting > 3% body surface area. By week 52, the proportion of BKZ randomized patients who reached an ACR50 response, PASI 100 and MDA were similar regardless of whether or not MTX was used. Interestingly, fewer patients who used the comparator adalimumab (ADA) without MTX versus those on ADA + MTX achieved an ACR50 or MDA response. The resolution of enthesitis and nail psoriasis but not dactylitis seemed to be numerically higher in patients who received BKZ in combination with MTX versus patients on BKZ alone. The proportion of patients with > 1 treatment-emergent adverse event (TEAE) was similar in patients treated with or without MTX.
This posthoc analysis confirms that the efficacy of anti-IL17 directed bDMARDs in PsA is not dependent on the use of concomitant MTX and that this is different from treatment with TNF inhibitors.