1. Bimekizumab treatment was shown to be noninferior and superior for greater skin clearance of plaque psoriasis compared to secukinumab treatment.
2. Bimekizumab treatment was shown to have a higher risk for oral candidiasis infection compared to secukinumab treatment.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The pathology of psoriasis involves the overexpression of interleukin-17A and interleukin-17F in tissue lesions. In this randomized controlled trial, the biologic secukinumab, a selective inhibitor of interleukin-17A was compared to bimekizumab, an inhibitor of both interleukin-17A and interleukin-17F, for the treatment of plaque psoriasis. The study determined bimekizumab was both noninferior and superior to secukinumab for complete skin clearance of psoriatic lesions using the Psoriasis Area and Severity Index (PASI) score. Both trial groups experienced similar adverse events, however, the incidence of oral candidiasis was greater in the patients receiving bimekizumab treatment. This study provided strong justification for bimekizumab use compared to secukinumab in patients with plaque psoriasis. The major limitation of this study was its exclusion of patients who had previously failed to respond to an anti-interleukin-17 biologic agent, thereby limiting the generalizability of these findings to all psoriasis patients. Nonetheless, the findings were significant, as more patients achieved full skin clearance on bimekizumab compared to secukinumab.
Click to read the study in NEJM
Relevant Reading: Bimekizumab versus Adalimumab in Plaque Psoriasis
In-Depth [randomized controlled trial]: This multicenter, double-blind, randomized controlled trial enrolled 743 patients between June 13, 2018, and May 8, 2019. Patients aged 18 or older with moderate-to-severe plaque psoriasis which was diagnosed at least six months prior to screening were eligible for participation in the trial. Patients who had previously taken bimekizumab or secukinumab or showed no response to an anti-interleukin-17 biologic agent were excluded from the trial. Patients with a PASI score of 12 or more – score ranges from 0-72, with severity increasing with higher scores – were deemed to have moderate-to-severe psoriasis, and the scoring system was used to measure the effectiveness of treatment. Patients were randomized in a 1:1 ratio to receive either bimekizumab or secukinumab for 16 weeks, respectively. The primary endpoint was the rate of complete skin clearance defined as a 100% reduction of PASI score from baseline. After 16 weeks, 181 (48.9%) patients receiving secukinumab compared to 230 (61.7%) patients receiving bimekizumab had complete skin clearance (adjusted risk difference, 12.7 percentage points; 95% confidence interval [CI], 5.8 to19.6, P < 0.001). At the 16-week time point, patients receiving bimekizumab were further randomized in a 2:1 ratio to receive maintenance therapy every eight weeks or every four weeks, respectively. At 48 weeks, bimekizumab was still shown to be superior after maintenance in patients receiving bimekizumab every four weeks or every eight weeks compared to secukinumab every four weeks. While the incidences of adverse events, serious adverse events, and adverse events leading to discontinuation were similar in patients receiving either medication, oral candidiasis infections occurred in 72 patients (19.3%) receiving bimekizumab compared to 11 patients (3.0%) receiving secukinumab. Overall, bimekizumab treatment was shown to noninferior and superior for greater skin clearance of plaque psoriasis compared to secukinumab treatment; however, bimekizumab treatment was shown to have an increased risk of developing oral candidiasis infections.
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