FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa

The FDA approved bimekizumab-bkzx (Bimzelx; UCB) for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The drug is the first and only approved medication that targets both interleukin (IL) 17F and IL-17A.¹

Hidradenitis Suppurative, FDA, Dermatology, Bimzelx | Image Credit: © Gorodenkoff | stock.adobe.com

“The approval of [bimekizumab-bkzx] in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School, said in a news release. “In the phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”¹

HS is a chronic inflammatory skin condition accompanied by painful lesions. Although the condition causes physical discomfort, it is also associated with pain, drainage, malodor, and scarring, which can have psychosocial effects on patients. Currently, treatment includes lifestyle medications, antibiotics, anti-inflammatory medications, and procedures such as laser therapy and excision with skin graphing, according to the National Institutes of Health.²

The approval is based on data from 2 phase 3 studies, BE HEARD I (NCT04242446; n=505) and BE HEARD II (NCT04242496; n=509). The studies were identical 48-week, double-blinded, phase 3 trials including patients 18 years and older with moderate-to-severe HS. Patients received either subcutaneous bimekizumab-bkzx 320 mg every 2 weeks; bimekizumab-bkzx 320 mg every 2 weeks to week 16 followed by every 4 weeks to week 28; bimekizumab-bkzx 320 every 4 weeks to week 48; or the placebo to week 16 followed by bimekizumab-bkzx 320 every 2 weeks. The primary outcome included a clinical response of at least 50% at week 16.^1,3

The results of the studies showed that a high proportion of individuals receiving bimekizumab-bkzx achieved a 50% or greater improvement in signs and symptoms at week 16 compared to those receiving the placebo. These responses were sustained to week 48, according to the data. In BE HEARD I, approximately 48% of patients treated with the drug achieved the primary outcome compared with 29% on the placebo, and 52% compared with 32%, respectively, in BE HEARD II. Furthermore, the Hidradenitis Suppurativa Clinical Response 50 was reached for those in the every-4-week group at 54% compared with the placebo at 32%.^1,3

Serious treatment-emergent adverse events were reported in 8% of patients in BE HEARD I and 5% in BE HEARD II, with COVID-19, diarrhea, oral candidiasis, and headache most reported. There was 1 death reported due to congestive heart failure for a patient with substantial cardiovascular history and was considered unrelated to treatment, according to the study investigators.³

Bimekizumab-bkzx was previously approved for treatment of active psoriatic arthritis, active non-radiographic axial spondylarthritis with objective signs of inflammations, and active ankylosing spondylitis. It was first approved in October 2023 for adults with moderate-to-severe plaque psoriasis and were candidates for systemic therapy or phototherapy.¹

REFERENCES

1. UCB Receives U.S. FDA Approval for Bimzelx (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa. News release. UCB. November 20, 2024. Accessed November 20, 2024.

2. Ballard K, Shuman VL. Hidradenitis Suppurativa. [Updated 2024 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK534867/

3. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519. doi:10.1016/S0140-6736(24)00101-6