Bimekizumab tops adalimumab in moderate-to-severe plaque psoriasis
Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin-17A and interleukin-17F, was superior to adalimumab in reducing the severity of plaque psoriasis, according to results of a phase III trial presented at AAD 2021.
Investigators of the multinational, double-blind BE SURE trial recruited 478 adults (mean age 44.9 years, 88.1 percent White, mean baseline PASI* score 19.8) with moderate-to-severe plaque psoriasis (PASI score ≥12, IGA* ≥3, psoriasis on >10 percent of body surface area). The patients were randomized to receive subcutaneous bimekizumab 320 mg Q4W for 56 weeks (n=158), bimekizumab 320 mg Q4W for 16 weeks followed by Q8W for weeks 16 to 56 (Q4W–Q8W; n=161), or subcutaneous adalimumab** 40 mg Q2W for 24 weeks followed by bimekizumab 320 mg Q4W up to week 56 (n=159).
At 16 weeks, a significantly greater proportion of patients assigned to the bimekizumab groups (combined) achieved ≥90 percent reduction from baseline in PASI score (PASI 90 response) than those assigned to adalimumab (86.2 percent vs 47.2 percent; adjusted risk difference [adjRD], 39.3 percentage points, 95 percent confidence interval [CI], 30.9–47.7; p<0.001 for noninferiority and superiority). [N Engl J Med 2021;doi:10.1056/NEJMoa2102388]
More patients assigned to bimekizumab than adalimumab achieved IGA 0 or 1 (indicating clear or almost clear skin, respectively) at week 16 (85.3 percent vs 57.2 percent; adjRD, 28.2 percentage points, 95 percent CI, 19.7–36.7; p<0.001 for noninferiority and superiority).
Complete skin clearance – or PASI 100 – at week 16 was achieved by more patients assigned to bimekizumab than adalimumab (60.8 percent vs 23.9 percent; adjRD, 37.0 percentage points; p<0.001). PASI 75 at week 4 after just one treatment dose was achieved in more patients assigned to bimekizumab than adalimumab (76.5 percent vs 31.4 percent; adjRD, 44.8 percentage points; p<0.001). At week 24, significantly more patients assigned to bimekizumab than adalimumab had achieved PASI 100, PASI 90, or IGA score 0 or 1.
Dermatology Life Quality Index (DLQI) score of 0 or 1 was achieved by 67.1 percent of each of the bimekizumab dosing groups and 47.8 percent of those assigned to adalimumab at week 24, and in 74.1 [Q4W], 78.9 [Q4W–Q8W], and 73.0 percent, respectively, at week 56, with adalimumab recipients having switched to bimekizumab at week 24. In this latter group, PASI 90 was achieved by 51.6 percent of adalimumab recipients at week 24, which increased to 81.8 percent at week 56. Among those assigned to adalimumab who did not have a PASI 90 response or DLQI score of 0 or 1 at week 24, 83 and 70 percent, respectively, achieved these endpoints by week 56, with 62 percent achieving PASI 100 post-switch to bimekizumab.
Up to week 24, adverse events (AEs) were reported in 70.9, 72.0, and 69.8 percent of patients in the bimekizumab Q4W, Q4W–Q8W, and adalimumab groups, respectively, and serious AEs in 2.5, 0.6, and 3.1 percent, respectively. AE-related discontinuations occurred in 1.9, 3.7, and 3.1 percent, respectively. There was one death in the adalimumab group.
Between weeks 24 and 56, AEs occurred in 66.4, 69.8, and 74.5 percent of the bimekizumab Q4W, Q4W–Q8W, and adalimumab switched to bimekizumab groups, respectively, and serious AEs in 1.3, 5.4, and 6.0, respectively.
Oral candidiasis and diarrhoea were more commonly reported in bimekizumab than adalimumab recipients up to week 24. Of the 76 cases of oral candidiasis occurring in the bimekizumab group up to week 56, 36 and two were deemed moderate and severe, respectively, with none leading to discontinuation. Serious infection rates were comparable between groups.
“In this 56-week trial, bimekizumab was noninferior and superior to adalimumab through 16 weeks in reducing symptoms and signs of plaque psoriasis,” the investigators said.
They noted that 24 weeks may have been too short a period to assess safety outcomes and called for longer trials with larger populations to compare the efficacy and safety outcomes of bimekizumab vs other treatments.