Bimekizumab Phase 3 data in hidradenitis suppurativa show clinically meaningful, deep and maintained response over 48 weeks
UCB, a global biopharmaceutical company, today announced detailed positive results from two Phase 3 studies (BE HEARD I and BE HEARD II) evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa (HS). (1) Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48. (1),± Clinical responses with bimekizumab were observed from the first dose with some patients achieving HiSCR50 at week four. (1) These new data were presented today at a late-breaking platform presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, U.S., 17th-22nd March.
“Hidradenitis Suppurativa is a chronic, debilitating inflammatory skin disease for which only one approved treatment is available today,” said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S. “Treating moderate to severe cases with bimekizumab has shown promising results in phase 3 patient trials, with sustained improvement after one year.”
The two studies (n=505 in BE HEARD I; n=509 in BE HEARD II) evaluated two dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 mg every four weeks [Q4W]) versus placebo over the 16-week initial and the 32-week maintenance treatment periods. (1) Data presented at AAD 2023 show that:
A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved HiSCR50, the primary endpoint, at week 16 vs. placebo in BE HEARD I and BE HEARD II (47.8 percent vs. 28.7 percent [p=0.006] and 52.0 percent vs. 32.2 percent [p=0.003], respectively). (1)
A greater proportion of patients treated with bimekizumab (Q4W) achieved HiSCR50 at week 16 than placebo in BE HEARD I and BE HEARD II, with statistical significance achieved in BE HEARD II (45.3 percent vs. 28.7 percent [p=0.030] and 53.8 percent vs. 32.2 percent [p=0.004], respectively). (1)
Patients treated with bimekizumab achieved deep levels of clinical response with a greater proportion achieving HiSCR75, a key secondary endpoint, at week 16 than placebo, with statistical significance in BE HEARD II with both dose regimens and for Q2W in BE HEARD I. (1)
Patients treated with bimekizumab experienced improved health-related quality of life (change from baseline in the dermatology life quality index) compared with placebo at week 16 (BE HEARD I and BE HEARD II, Q2W and Q4W). (1)
Clinical responses (HiSCR50 and HiSCR75) were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75 at week 48 (observed case analysis; BE HEARD I and BE HEARD II, Q2W and Q4W). (1)
“Today, at the largest dermatology meeting of the year, we unveiled 48-week data from our Phase 3 bimekizumab program in hidradenitis suppurativa. Results from the Phase 3 program highlight the meaningful clinical outcomes achieved by targeting IL-17F in addition to IL-17A,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “We are now focused on the next steps with global regulatory filings for bimekizumab in hidradenitis suppurativa planned for later this year.”
The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed. (1) The most common (frequency of >5 percent) treatment emergent adverse events on bimekizumab over 16 weeks were hidradenitis (7.2 percent in BE HEARD I and 8.8 percent in BE HEARD II), oral candidiasis (4.4 percent in BE HEARD I and 6.7 percent in BE HEARD II), headache (7.0 percent in BE HEARD I and 5.8 in BE HEARD II) and diarrhea (7.0 percent in BE HEARD I and 5.3 percent in BE HEARD II). (1)
UCB expects to submit global regulatory applications for bimekizumab in moderate to severe HS starting in Q3 2023.
In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration. In the European Union and Great Britain, bimekizumab is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. (2,3) UCB is investigating bimekizumab in HS. The efficacy and safety of bimekizumab in HS have not been established, and it is not approved for use in this indication by any regulatory authority worldwide.
References
Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicenter studies. Late-Breaking Platform Presentation at the 2023 American Academy of Dermatology Annual Meeting.
BIMZELX® (bimekizumab) EU Summary of Product Characteristics, March 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf . Last accessed: March 2023.
BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834/smpc#gref . Last accessed: March 2023.