1. Significantly more patients in the bimekizumab group reached ACR50 at week 16 compared to the placebo.
2. Fungal infections occurred with a higher frequency in the bimekizumab group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Psoriatic arthritis is a complex, immune-mediated inflammatory disease that is managed using synthetic disease-modifying antirheumatic drugs (DMARDs). Studies suggest that biologic therapies may play a role in reducing disease burden, although the extent to which they do so is unclear. This randomized controlled trial aimed to compare the safety and efficacy of bimekizumab, an IgG1 antibody that inhibits interleukin (IL)-17A and IL-17F, to placebo and adalimumab (reference group) in patients naïve to biologic DMARDs. The primary outcome was at least a 50% improvement in the American College of Rheumatology criteria (ACR50) at week 16. According to study results, more patients in the bimekizumab group reported improvement in psoriatic arthritis compared to those in the placebo group at the 16-week follow-up. Improvements were seen as early as 2-weeks after treatment initiation and among patients who crossed over from placebo after week 16. This study was strengthened by a large sample size with patients from multiple countries, thus increasing its validity.
Relevant Reading: Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis
In-depth [randomized-controlled trial]: Between Apr 3, 2019, and Oct 25, 2021, 1163 patients were assessed for eligibility from 135 clinical sites in 14 countries. Included were patients ≥ 18 years old with ≥ 6 months of adult-onset psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis. Altogether, 852 patients (431 in bimekizumab, 281 in placebo, and 140 in adalimumab or ‘the reference group’) were included in the final analysis. The primary outcome of ACR50 at week 16 was significantly more common in the bimekizumab group (44%) than placebo (10%, odds ratio [OR] 7.1, 95% confidence interval [CI] 4.6-10.9, p<0.0001), and comparable to the reference group (46%). A similar trend was noted for treatment-related adverse events. Although most adverse events were mild-moderate in nature, patients in the bimekizumab (60%) and adalimumab (59%) groups reported greater side effects than those in the placebo (49%) group. A greater proportion of patients receiving bimekizumab (5%) had fungal infections (vs. 1% and 1% in placebo and adalimumab, respectively) with overall half of those caused by Candida species. Overall, findings from this study suggest that bimekizumab may be superior to a placebo for the management of active psoriatic arthritis in patients naïve to biologic DMARDs.
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