Bimekizumab Response is Sustained Over 4 Years in Plaque Psoriasis

In patients with moderate to severe plaque psoriasis (PsO) treated with bimekizumab who were enrolled in the open-label extension trial, high rates of health-related quality of life (HRQoL) and clinical responses were rapidly achieved, according to data presented at the SDPA Annual Summer Dermatology Conference.¹ These responses were sustained through 4 years.

The proportions of patients achieving ≥90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI 90/PASI 100), body surface area (BSA) ≤1%,Dermatology Life Quality Index (DLQI) 0/1, and PASI ≤ 2 were comparable between the patients enrolled in the open-label extension who were treated with 320 mg every 4 weeks to week 16 and then ever 8 weeks thereafter.

“Psoriasis is a chronic disease; assessing long-term treatment efficacy is imperative,” wrote a team of investigators led by Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University School of Medicine.¹ “Bimekizumab is a monoclonal immunoglobulin G1 (lgG1) antibody thatselectively inhibits interleukin (IL)-17F in addition to IL-17A. [It] has demonstrated rapid and superior efficacy in the treatment ofpsoriasis versus ustekinumab, adalimumab, and secukinumab, withestablished long‑term durability of response.”

To evaluate the efficacy of treatment with bimekizumab among this patient population, investigators pooled data across the 52-week BE VIVID, 56-week BE SURE, and BE READY trials, along with the open-label extension BE BRIGHT (week 144). Another objective of note was to obtain a comprehensive view of drug efficacy over 4 years in terms of clinical and HRQoL outcomes using the largest pool of global phase 3 clinical data to date.

Enrolled patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W) until week 16, receive bimekizumab Q4W or every 8 weeks (Q8W) thereafter, and were recruited to the open-label extension trial.

Proportions of patients achieving PASI ≥ 90%/100%, BSA ≤ 1%, and DLQI 0/1 were examined at baseline through year 4. Any missing data was attributed using modified non-responder imputation (mNRI). Those who discontinued treatment due to a lack of efficacy or treatment-related adverse events were categorized as non-responders at subsequent timepoints and multiple imputation was implemented for other missing information.

At baseline, the mean age of patients in the bimekizumab cohort was 45.4 years, 71.3% (n = 550) were male, and the median disease duration was 18.6 years. Mean PASI was 21.1 ± 7.6 20.4 ± 6.9, mean BSA (%) was 27.0 ± 15.6, and the mean DLQI total score was 10.5 ± 6.3.

Among the patients who were treated with bimekizumab over 4 years (n = 771), 90.9% achieved PASI 90, 65.8% achieved PASI 100 and 91.7% achieved PASI ≤ 2 at week 16. Additionally, 78.5% obtained BSA ≤ 1% and 71.5% obtained DLQI 0/1.

The responses were highly durable throughout 4 years of bimekizumab treatment. A total of 86.1% achieved PASI 90, 64.7% achieved PASI 100, and 86.4% achieved PASI ≤ 2. Further, 79.8% obtained BSA ≤ 1% and 78.7% obtained DLQI 0/1.

Among the subset of participants who achieved bimekizumab Q4W/Q8W/Q8W in the initial, maintenance, and open-label extension phases (n = 197), 88.0% and 72.6% achieved PASI 90 and PASI 100, respectively, 89.2% reported PASI ≤ 2, and 83.2% and 83.3% had a BSA ≤ 1% and DLQI 0/1, respectively, at year 4.

References

1. ^{Strober B, Lebwohl M, Foley P, Langley R, et al. Bimekizumab efficacy from treatment initiation through 4 years in patients with plaque psoriasis: A comprehensive, long-term, pooled analysis from BE BRIGHT. Presented at: SDPA Annual Summer Dermatology Conference. San Diego, CA. June 5 – 9, 2024.}