COMMENTARY

New Psoriasis Treatments: A Primer

Jeffrey Liu; April W. Armstrong, MD, MPH

Disclosures

August 17, 2021

A Novel IL-17A and IL-17F Inhibitor on the Horizon

Bimekizumab is an emerging biologic agent that targets IL-17A and IL-17F isoforms, both of which play an important role in the pathogenesis of psoriasis. Several phase 3 studies have shown highly robust efficacy of bimekizumab.

BE READY, a multicenter, double-blinded, placebo-controlled, phase 3 trial assessed the efficacy and safety of bimekizumab 320 mg compared with placebo (4:1) every 4 weeks for patients with moderate to severe psoriasis. Bimekizumab-treated patients who achieved a PASI 90 response at week 16 were rerandomized (1:1:1) to receive either bimekizumab 320 mg every 4 weeks, bimekizumab 320 mg every 8 weeks, or placebo for weeks 16-56. Patients in both bimekizumab groups had high levels of treatment response, with 91% achieving a PASI 90 response and 93% achieving an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear); treatment responses were durable in both maintenance dose groups over 56 weeks. Bimekizumab was generally well tolerated; although oral candidiasis was reported in approximately 10% of patients, the vast majority of patients had mild infections that did not necessitate discontinuation of treatment.

In addition to findings from BE READY, three phase 3 trials with active comparators have demonstrated the superiority of bimekizumab over ustekinumab (BE VIVID), adalimumab (BE SURE), and secukinumab (BE RADIANT) in treating plaque psoriasis.

BE VIVID was a 52-week trial wherein patients with moderate to severe psoriasis were randomized to receive bimekizumab 320 mg every 4 weeks; ustekinumab 45 mg or 90 mg (baseline weight-dependent dosing) at weeks 0 and 4, then every 12 weeks; or placebo every 4 weeks (4:2:1). At week 16, bimekizumab-treated patients achieved higher rates of PASI 90 responses compared with ustekinumab-treated patients and placebo-treated patients (85% vs 50% vs 5%).

The BE SURE trial randomized patients with moderate to severe psoriasis to receive bimekizumab 320 mg every 4 weeks for 56 weeks; bimekizumab 320 mg every 4 weeks for 16 weeks, then every 8 weeks for weeks 16 to 56; or adalimumab 40 mg every 2 weeks for 24 weeks, followed by bimekizumab 320 mg every 4 weeks to week 56. At week 56, a little more than 86% of patients treated with bimekizumab achieved a PASI 90 response compared with just over 47% of patients treated with adalimumab.

BE RADIANT was a 48-week trial that randomized patients to receive bimekizumab 320 mg every 4 weeks or secukinumab 300 mg weekly to week 4, followed by every 4 weeks to week 48. At week 48, 67% of patients treated with bimekizumab had a PASI 100 response, compared with a little more than 46% of patients treated with secukinumab. Regarding safety, in the BE SURE and BE RADIANT trials, bimekizumab was associated with higher frequency of mild to moderate oral candidiasis.

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