medwireNews: Bimekizumab has shown positive efficacy and safety results in the BE COMPLETE and BE OPTIMAL phase 3 psoriatic arthritis (PsA) trials presented at the EULAR 2022 Congress in Copenhagen, Denmark.
Introducing BE COMPLETE, Joseph Merola (Brigham and Women’s Hospital, Boston, Massachusetts, USA) said that the dual interleukin (IL)-17A and IL-17F inhibitor previously demonstrated “rapid and sustained efficacy and good tolerability up to week 152” in patients with PsA in the phase 2b BE ACTIVE trial.
Joseph Merola talks about the BE COMPLETE and BE OPTIMAL trials, which showed that the dual IL-17A/IL-17F inhibitor bimekizumab is a promising treatment option for psoriatic arthritis patients with and without prior exposure to TNF inhibitors (6:27).
He said that BE COMPLETE included 400 people with active PsA and an inadequate response or intolerance to one or two tumor necrosis factor (TNF) inhibitors who were randomly assigned to receive subcutaneous bimekizumab 160 mg every 4 weeks or placebo. These people had an average disease duration of approximately 10 years.
At week 16, ACR50 response rates were significantly higher among patients treated with bimekizumab (n=267) versus placebo (n=133), at 43.4% versus 6.8% and an odds ratio of 11.1. Merola also pointed to a strong PASI90 response rate in the bimekizumab group, at 68.8% compared with 6.8% in the placebo arm, a significant difference.
“I’d like to in particular highlight the PASI100 data,” representing complete skin clearance, with 58.5% of bimekizumab-treated patients meeting this endpoint compared with 4.5% in the placebo arm, said Merola. He noted that this finding is “very much in line with the high efficacy skin data we’ve also seen from the psoriasis program with bimekizumab.”
In all, treatment-emergent adverse events (TEAEs) occurred in 40.1% and 33.3% of participants in the bimekizumab and placebo arms, respectively. The most frequently occurring TEAEs with bimekizumab treatment were fungal infections (4.5 vs 0.0% in the placebo arm), nasopharyngitis (3.7 vs 0.8%), oral candidiasis (2.6 vs 0.0%), and upper respiratory tract infection (2.2 vs 1.5%).
Merola summarized that bimekizumab had a “good safety and tolerability profile in line with what we have seen from bimekizumab in the past.”
BE OPTIMAL, which was presented by Iain McInnes (University of Glasgow, UK), focused on a different PsA patient population, and included 852 people with active PsA and no prior exposure to biologic DMARDs, with an average disease duration of approximately 6 years. Participants were randomly assigned to receive bimekizumab 160 mg every 4 weeks (n=431), placebo (n=281), or adalimumab 40 mg every 2 weeks (n=140).
The BE OPTIMAL investigators found that ACR50 response rates at week 16 were significantly higher among patients treated with bimekizumab versus placebo, at 43.9% versus 10.0%. The ACR50 response rate in the adalimumab reference arm was 45.7%.
The presenter said that PASI90 response rates also showed “clear statistical significance favoring bimekizumab over placebo,” at 61.3% and 2.9%, respectively.
Comparing these results with those from the TNF inhibitor-experienced population in BE COMPLETE reveals “remarkably similar response rates across the two clinical trials, suggesting consistent efficacy with disease duration progressing,” remarked McInnes.
When asked by an audience member about how the efficacy of bimekizumab compares to that of adalimumab, he said that the BE OPTIMAL trial was not designed “to perform any statistical comparison between adalimumab and bimekizumab,” and noted the need for head-to-head studies to draw such comparisons.
McInnes said that the safety profile of bimekizumab in BE OPTIMAL was “consistent with previous studies,” with fungal infections occurring more frequently in the bimekizumab than the placebo group (4.6 vs 1.4% at week 0–16).
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