The FDA has granted approval to bimekizumab (Bimzelx; UCB Pharma) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients. This marks the fifth approved indication for the anti-IL-17A and IL-17F monoclonal antibody in the US within the last 13 months. The approval addresses a significant unmet need for effective biologic therapies for this chronic inflammatory skin disorder.
The approval is supported by data from the Phase 3 BE HEARD I and BE HEARD II trials, which collectively enrolled 1014 patients. These trials demonstrated that treatment with bimekizumab resulted in a significant clinical response at week 16, which was sustained through week 48.
Clinical Trial Data
The BE HEARD I and BE HEARD II trials were randomized, double-blind, placebo-controlled, multicenter studies designed to evaluate the efficacy and safety of bimekizumab. The primary endpoint was achieving at least a 50% reduction from baseline in the total abscess and inflammatory nodule count (HiSCR50) at week 16, with no increase from baseline in abscess or draining tunnel count. Secondary endpoints included HiSCR75 and hidradenitis suppurativa-specific skin pain response at week 16.
Patients aged 18 years or older with moderate to severe hidradenitis suppurativa were included in the trials. Participants were randomized to receive bimekizumab subcutaneously at one of four dosages:
- 320 mg every 2 weeks
- 320 mg every 2 weeks to week 16, then every 4 weeks to week 48
- 320 mg every 4 weeks to week 48
- Placebo to week 16, then bimekizumab 320 mg every 2 weeks
Overall, patients in the treatment groups showed greater improvement compared to those who received placebo. In BE HEARD I, 48% of patients treated with bimekizumab achieved HiSCR50 compared to 29% in the placebo group (OR, 2.23; 95% CI, 1.16-4.31; P = .0060). In BE HEARD II, 52% of patients treated with bimekizumab achieved HiSCR50 compared to 32% in the placebo group (OR, 2.29; 95% CI, 1.22-4.29; P = .0032).
Safety Profile
Serious adverse events were reported in 8% of patients in BE HEARD I and 5% of patients in BE HEARD II. The most common adverse events included SARS-CoV-2 infection and diarrhea in BE HEARD I, and oral candidiasis and headache in BE HEARD II.
Expert Commentary
"The approval of BIMZELX in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today," said investigator and lead study author, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and professor of dermatology, Harvard Medical School. "In the phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks."
Ongoing Research
Bimekizumab is also being investigated in the ongoing BE HEARD extension trial (NCT04901195), which includes patients who completed maintenance treatment through week 48 in the BE HEARD I or BE HEARD II trials.
