FDA Approves Bimekizumab in Hidradenitis Suppurativa

With the FDA’s approval today of bimekizumab (Bimzelx; UCB Pharma) for use against moderate to severe hidradenitis suppurativa in adult patients who have the chronic inflammatory skin disorder,¹ the anti–IL-17A, IL-17F, and IL-17AF humanized immunoglobulin G1 monoclonal antibody now has 5 approved indications overall in the US—and they all have come through in the past 13 months.

On September 23, 2024, the medication was approved to treat psoriatic arthritis, nonradiographic axial spondyloarthritis, and ankylosing spondylitis,² and on October 18, 2023, it received an indication to treat moderate to severe plaque psoriasis³—which was originally delayed following an FDA inspection of UCB’s Belgium manufacturing facility in April 2023.⁴

Bimekizumab now has 5 FDA approved indications in the US. | Image Credit: © Deni - stock.adobe.com

This newest indication is supported by data from the phase 3 BE HEARD I trial (NCT04242446) completed in 2023⁵ and the BE HEARD II trial (NCT04242498) completed in 2022,⁶ which had a total enrollment of 1014 patients (505 and 509, respectively), and showed treatment response noted at week 16 endured through week 48.¹ It also follows the recent presentation of positive long-term data on bimekizumab for sustained treatment response in psoriatic arthritis out to 1 and 2 years at ACR Convergence 2024, the annual meeting of the American College of Rheumatology,⁷ and helps to fill the treatment gap of effective biologic therapy for cases of moederate to severe hidradenitis suppurativa.¹

“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 a statement. “In the phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel group, 48-week multicenter studies that evaluated the efficacy and safety of bimekizumab; their primary end point was at least a 50% clinical response (HiSCR50) at week 16, which the authors defined as “at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.” Their secondary end points were HiSCR75 and hidradenitis suppurativa–specific skin pain response at week 16.¹

To be included in these trials, patients had to be 18 years or older and have moderate to severe hidradenitis suppurativa. They were randomly assigned 2:2:2:1, and stratified by worst Hurley Stage at baseline—from 1 (mild) to 3 (severe) depending on both the presence and severity of boils, abscesses, and tracts⁸—and baseline systemic antibiotic use to receive bimekizumab subcutaneously at 1 of 4 dosages⁹:

• Option 1: 320 mg every 2 weeks
• Option 2: 320 mg every 2 weeks to week 16, then every 4 weeks to week 48
• Option 3: 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 saw greater improvement compared with those who received placebo: 48% vs 29% in BE HEARD I, for a 123% greater chance of improved disease control (OR, 2.23; 95% CI, 1.16-4.31; P = .0060), and 52% vs 32% in BE HEARD II, for a 129% greater chance of improved disease control (OR, 2.29; 95% CI, 1.22-4.29; P = .0032).

HiSCR50, the primary end point, was achieved by the patients randomized to option 1 overall and by those randomized to option 3 in BE HEARD II.

Serious adverse events were reported by 8% of patients in BE HEARD I and 5% of patients in BE HEARD II, with the most common being SARS-CoV-2 infection and diarrhea in BE HEARD I and oral candidiasis and headache in BE HEARD II.

“Long-term results are very important for patients living with hidradenitis suppurativa,” Jeff Stark, MD, vice president and head of medical immunology at UCB, told The American Journal of Managed Care^® in April. “It's a chronic condition; we consider it a condition that we might aim for remission but we don't yet have a cure for. So, being able to provide long-term and sustainable results is really quite important.”¹⁰

Bimekizumab is being investigated in the ongoing BE HEARD extension trial (NCT04901195), with patients eligible for inclusion if they completed maintenance treatment through week 48 in BE HEARD I or BE HEARD II and were still eligible to receive the medication when those studies concluded.¹¹

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 Pharma. November 20, 2024. Accessed November 20, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa

2. McNulty R. FDA approves bimekizumab for psoriatic arthritis, nonradiographic axspa, ankylosing spondylitis. AJMC^®. September 23, 2024. Accessed November 19, 2024. https://www.ajmc.com/view/fda-approves-bimekizumab-for-psoriatic-arthritis-non-radiographic-axspa-ankylosing-spondylitis

3. Bimzelx approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. News release. UCB Pharma. October 18, 2023. Accessed November 20, 2024. https://www.ucb.com/stories-media/press-releases/article/bimzelxr-approved-by-the-us-fda-for-the-treatment-of-adults-with-moderate-to-severe-plaque-psoriasis

4. Bader K. FDA delays UCB’s bimekizumab approval. Dermatology Times^®. September 20, 2023. Accessed November 20, 2024. https://www.dermatologytimes.com/view/fda-delays-ucb-s-bimekizumab-approval

5. A study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Updated March 18, 2024. Accessed November 20, 2024. https://clinicaltrials.gov/study/NCT04242446

6. A study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa. ClinicalTrials.gov. Updated October 17, 2023. Accessed November 20, 2024. https://clinicaltrials.gov/study/NCT04242498

7. Shaw ML. New PsA data highlight long-term benefits of bimekizumab. AJMC. November 19, 2024. Accessed November 20, 2024. https://www.ajmc.com/view/new-psa-data-highlight-long-term-benefits-of-bimekizumab

8. Cherney K. Hurley Stages of hidradenitis suppurativa (HS). Healthline. November 13, 2023. Accessed November 20, 2024. https://www.healthline.com/health/hidradenitis-suppurativa-stages

9. 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

10. Steinzor P, McCormick B. Dr Jeff Stark: bimekizumab shows long-term efficacy when used to treat patients with HS. AJMC^®. April 1, 2024. Accessed November 20, 2024. https://www.ajmc.com/view/dr-jeff-stark-bimekizumab-shows-long-term-efficacy-when-used-to-treat-patients-with-hs

11. A study to test the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD EXT). ClinicalTrials.gov. Updated November 8, 2024. Accessed November 20, 2024. https://clinicaltrials.gov/study/NCT04901195