Bimekizumab triumphs over secukinumab in improving skin clearance in plaque psoriasis
Bimekizumab appeared to be more effective than secukinumab in improving skin clearance in patients with moderate-to-severe plaque psoriasis, according to the multinational, phase IIIb BE RADIANT trial presented at AAD 2021.
A total of 743 adults with moderate-to-severe plaque psoriasis (PASI* score ≥12, IGA* score ≥3, psoriasis on ≥10 percent of body surface area) were randomized 1:1 to receive subcutaneous bimekizumab (320 mg Q4W; mean age 45.9 years, 67.3 percent male) or secukinumab (300 mg/week to week 4, followed by Q4W to week 48; mean age 44.0 years, 63.5 percent male). Bimekizumab recipients were randomized again (1:2) at week 16 to receive maintenance bimekizumab Q4W or Q8W to week 48.
Patients were primarily White. PASI score at baseline was approximately 20, and 64.3 and 72.4 percent of patients assigned to bimekizumab and secukinumab, respectively, had IGA score 3. About one-third of patients had prior exposure to biologics.
At week 16, complete skin clearance, determined as 100 percent reduction from baseline in PASI score (PASI 100), was achieved in significantly more bimekizumab than secukinumab recipients (61.7 percent vs 48.9 percent; adjusted risk difference, 12.7 percentage points, 95 percent confidence interval [CI], 5.8–19.6; p<0.001 for noninferiority and superiority). [N Engl J Med 2021;doi:10.1056/NEJMoa2102383]
The benefit with bimekizumab vs secukinumab persisted at week 48 with 67.0 percent vs 46.2 percent achieving PASI 100 (adjusted risk difference, 20.9 percentage points, 95 percent CI, 14.1–27.7; p<0.001).
PASI 100 at week 48 was higher with bimekizumab vs secukinumab regardless of bimekizumab maintenance dosing (73.5 percent [bimekizumab Q4W] and 66.0 percent [bimekizumab Q8W] vs 48.3 percent [secukinumab]; adjusted risk differences, 26.5 and 17.3 percentage points, respectively, vs secukinumab; p<0.001 for both).
At week 4 following one dose of the treatments, more bimekizumab than secukinumab recipients experienced a ≥75 percent reduction from baseline in PASI score (PASI 75; 71.0 percent vs 47.3 percent; adjusted risk difference, 23.7 percentage points, 95 percent CI, 17.0–30.4; p<0.001).
PASI 90 at week 16 was achieved in 85.5 and 74.3 percent of bimekizumab and secukinumab recipients, respectively, and PASI 75 in 93.3 percent vs 91.1 percent, while 85.5 percent vs 78.6 percent achieved IGA 0/1. PASI 90 and IGA 0/1 were achieved in more bimekizumab than secukinumab recipients at week 48 regardless of bimekizumab dosing schedule. Dermatology Life Quality Index (DLQI) score of 0/1 at week 48 was reported in 77.7 and 70.3 percent of patients assigned to bimekizumab and secukinumab, respectively.
Adverse event (AE) rates were comparable between the bimekizumab and secukinumab groups at week 48 (86.1 percent vs 81.4 percent), as were serious AEs (5.9 percent vs 5.7 percent), and AEs leading to discontinuation (3.5 percent vs 2.7 percent).
Upper respiratory tract infections, oral candidiasis, and urinary tract infections were the most commonly occurring AEs. Oral candidiasis occurred more frequently with bimekizumab than secukinumab (19.3 percent vs 3.0 percent), though the events with bimekizumab were mostly mild or moderate, with none leading to treatment discontinuation. Serious infection rates were comparable between groups.
“[B]imekizumab was noninferior and superior to secukinumab with respect to complete clearance of psoriatic lesions through 48 weeks of treatment. These data suggest that inhibition of both interleukin-17A and interleukin-17F with bimekizumab may provide greater clinical benefit for patients with moderate-to-severe plaque psoriasis than inhibition of interleukin-17A [with secukinumab] alone,” the authors said.
They recommended longer trials in larger populations to establish the role of dual interleukin-17A and interleukin-17F inhibition vs interleukin-17A inhibition alone in this patient population.
*PASI: Psoriasis Area and Severity Index; IGA: Investigator’s Global Assessment