Bimekizumab was associated with greater 100% skin clearance than comparator biologic secukinumab (Cosentyx) in both short-term and long-term treatment periods in new data from the phase 3b BE RADIANT trial.
In a UCB Pharma-funded study presented at the American Academy of Dermatology (AAD) 2021 Virtual Meeting Experience this weekend, investigators provided a comparison of the 2 interleukin-17 (IL-17) inhibitor biologic therapies for patients with moderate to severe plaque psoriasis.
The findings, conducted by Kristian Reich, MD, PhD, of the University Medical Center Hamburg-Eppendorf, and Richard B. Warren, MD, PhD, of the University of Manchester, show significant improvement in 100% Psoriasis Area Severity Index (PASI) scores at weeks 16 and 48 with bimekizumab. However, they also indicated a greater risk of oral candidiasis with investigative therapy.
Bimekizumab is a humanized monoclonal antibody which selectively inhibits the IL-17A and IL-17F pathway—both of which are believed to drive inflammation and plaque psoriasis pathobiology in affected patients. Comparatively, secukinumab only blocks the IL-17A pathway.
Investigators randomly assigned patients with moderate to severe plaque psoriasis 1:1 to either 320 mg bimekizumab every 4 weeks or 300 mg secukinumab once weekly for 4 weeks, followed by every 4 weeks. The trial treatment duration was 48 weeks.
Reich, Warren and colleagues sought a primary endpoint of PASI 100 from baseline at week 16 of treatment. Originally, the primary analysis sought the noninferiority of bimekizumab to secukinumab by -10 percentage points on PASI 100 prevalence, before being tested for treatment superiority.
Eligible patients were aged 18 years or older with plaque psoriasis for at least 6 months prior to screening, with moderate to severe disease defined as a PASI score of ≥12 at baseline, at least 10% body-surface area affected by psoriasis, and an Investigator’s Global Assessment (IGA) score of ≥3.
A total of 743 patients were assigned to either bimekizumab (n = 373) or secukinumab (n = 370). More than 60% (230 [61.7%]) of patients to receive bimekizumab achieved PASI 100 at week 16, versus just 48.9% (181) patients receiving secukinumab, indicating a 12.7 percentage-point adjusted-risk difference (95% CI, 5.8 – 19.6).
Investigators additionally observed a noninferiority and superiroirty to secukinumab (P <.001) based on this outcome.
By week 48, two thirds (67.0%) of patients treated with bimekizumab achieved PASI 100 response, while the rate of secukinumab-treated patients to achieve the mark had decreased to 46.2% (171). The adjusted risk difference increased to 20.9 percentage points in the extended time period (95% CI, 14.1 – 27.7; P <.001).
However, Riech, Warren and colleagues observed a significantly greater prevalence of oral candidiasis in the bimekizumab arm (72 [19.3%]) than the secukinumab arm (11 [3.0%]). All but 2 cases among the bimekizumab arm were mild or moderate in severity, and none led to treatment discontinuation.
Investigators concluded the data suggest IL-17A and IL-17F inhibition may be associated with greater clinical benefit in moderate to severe plaque psoriasis treatment than lone IL-17A inhibition.
Though the trial was limited by a lacking placebo group, insignificant patient racial diversity, and exclusion of IL-17 inhibitor-unresponsive patients, the team emphasized the BE RADIANT findings warrant a greater understanding of specific IL-17 pathway targeting in the treatment of plaque psoriasis.
“Longer and larger trials are required to determine the relative effects of interleukin-17A and interleukin-17F inhibition as compared with inhibition of interleukin-17A alone in psoriasis,” they wrote.
The study, “Bimekizumab versus Secukinumab in Plaque Psoriasis,” was published online in The New England Journal of Medicine.