Results of Phase 3 BE HEARD Trials of Bimekizumab for HS Published in The Lancet

Image credit: © JHVEPhoto - stock.adobe.com

UCB recently announced that results from the phase 3 BE HEARD I and BE HEARD II clinical trials evaluating the safety and efficacy of bimekizumab (Bimzelx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS) were published in The Lancet. According to the announcement, the results in The Lancet represent the primary publication of bimekizumab data from the 2 pivotal phase 3 trials.¹

"Publication of results from the BE HEARD I and II trials in The Lancet, a world-leading medical journal, reflects the significance of these data to the dermatology community. People living with hidradenitis suppurativa face high unmet medical needs. The positive results from these trials support global regulatory submissions for BIMZELX in this chronic inflammatory skin disease," said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB, in the news release.

BE HEARD I (n=505) and BE HEARD II (n=509) were 2 identical, 48-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 trials. Eligible patients that were aged 18 years and older with moderate to severe HS were randomly assigned 2:2:2:1 and stratified by worst Hurley Stage at baseline and baseline systemic antibiotic use to receive subcutaneous bimekizumab320 mg every 2 weeks; bimekizumab 320 mg every 2 weeks to week 16, then every 4 weeks to week 48; bimekizumab 320 mg every 4 weeks to week 48; or placebo to week 16, then bimekizumab 320 mg every 2 weeks.²

The primary end point was an HS clinical response of at least 50%, defined as a reduction in total abscess and inflammatory nodule count of at least 50% from baseline with no increase from baseline in abscess or draining tunnel count (HiSCR50) at week 16. The primary end point was achieved by the patient group who received bimekizumab every 2 weeks using modified non-responder imputation. Higher responder rates were observed with bimekizumab versus placebo in both trials: 138 (48%) of 289 patients versus 21 (29%) of 72 patients in BE HEARD I (odds ratio [OR] 2·23 [97·5% CI 1·16–4·31]; p=0·0060) and 151 (52%) of 291 patients versus 24 (32%) of 74 patients in BE HEARD II (2·29 [1·22–4·29]; p=0·0032).²

In BE HEARD II, HiSCR50 was achieved by the patient group who were administered bimekizumab every 4 weeks (77 [54%] of 144 vs 24 [32%] of 74 with placebo; 2·42 [1·22–4·80]; p=0·0038). Responses were maintained or increased to week 48. Serious treatment-emergent adverse events were reported in 40 patients (8%) in BE HEARD I and in 24 patients (5%) in BE HEARD II treated with bimekizumab over 48 weeks. The most frequently reported treatment-emergent adverse events to week 48 were hidradenitis in both trials, in addition to coronavirus infection and diarrhea in BE HEARD I, and oral candidiasis and headache in BE HEARD II. One death was reported across the 2 trials and was due to congestive heart failure in a patient with substantial cardiovascular history treated with bimekizumab every 2 weeks in BE HEARD I and was considered unrelated to bimekizumab treatment by the investigator. No new safety signals were observed.²

“Bimekizumab was well tolerated by patients with hidradenitis suppurativa and produced rapid and deep clinically meaningful responses that were maintained up to 48 weeks. Data from these two trials support the use of bimekizumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa,” wrote Kimball et al.²

Additional key data on bimekizumab for HS was presented at the 2024 American Academy of Dermatology Annual Meeting, which included:³

• At week 48, 64.6% to 75.7% of patients achieved an HSSQ skin pain response.
• HSSQ skin pain score of 0 at week 48 was achieved by 12.7% to 19.8% of patients.
• From weeks 0 to 48, HSSQ skin pain scores reduced by 36.9% to 43.7% across treatment groups.
• At week 48, 55.9% to 63.7% of patients rated their skin pain as "much better" using PGI-C-SP.
• At week 48, the percentage of patients rating PGI-S-SP as "severe" decreased to 3.9% to 7.8%, compared to 28.5% to 33.3% at baseline.

In April 2024, the US Food and Drug Administration accepted UCB’s biologics license application (BLA) for bimekizumab for the treatment of HS. UCB’s BLA was based on data from the BE HEARD I and BE HEARD II trials.⁴ Later in April, UCB received European Commission approval of bimekizumab for HS.⁵

“HS is a disease with lots of ups and downs. Having stable improvement tells you that the drug [bimekizumab] is really working. They didn't just happen to get better on the day they were measured at the week 16 time point. They're clearly moving in the right direction very steadily over time for patients,” said Christopher Sayed, MD, a dermatologist at the University of North Carolina Chapel Hill’s HS clinic and an investigator of the BE HEARD trials, in a previous interview at the 2024 American Academy of Dermatology Annual Meeting.

References

1. UCB announces publication in The Lancet of phase 3 BIMZELX (bimekizumab-bkzx) trials in moderate-to-severe hidradenitis suppurativa. News release. UCB. May 23, 2024. Accessed May 23, 2024. https://www.prnewswire.com/news-releases/ucb-announces-publication-in-the-lancet-of-phase-3-bimzelx-bimekizumab-bkzx-trials-in-moderate-to-severe-hidradenitis-suppurativa-302153768.html
2. 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. The Lancet. Published Online May 22, 2024. https://doi.org/10.1016/S0140-6736(24)00101-6
3. BIMZELXI 48-week phase 3 analyses in moderate-to-severe hidradenitis suppurativa showed sustained improvements in skin pain and draining tunnel count. News release. UCB. March 8, 2024. Accessed May 23, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/bimzelx-48-week-phase-3-analyses-in-moderate-to-severe-hidradenitis-suppurativa-showed-sustained-improvements-in-skin-pain-and-draining-tunnel-count
4. FDA accepts supplemental biologics license applications for BIMZELX (bimekizumab-bkzx) for moderate-to-severe hidradenitis suppurativa and additional 2ml device presentations. News release. UCB. April 4, 2024. Accessed May 23, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/fda-accepts-supplemental-biologics-license-applications
5. UCB receives European Commission approval for BIMZELX (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa. News release. UCB. April 22, 2024. Accessed May 23, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-European-Commission-approval-for-BIMZELXRVbimekizumab-as-the-first-IL-17A-and-IL-17F-biologic-for-moderate-to-severe-hidradenitis-suppurativa