Bimzelx effective, well-tolerated in hidradenitis suppurativa up to 2 years

Key takeaways:

• Hidradenitis Suppurativa Clinical Response 50 was achieved by 85.4% of patients by week 96.
• An approximate one in three patients reported minimal or no impact of disease on their quality of life after 2 years.

Bimzelx maintained improvements in hidradenitis suppurativa for up to 2 years, according to an oral presentation on two phase 3 studies and one extension trial at the European Academy of Dermatology and Venerology Congress.

“In moderate to severe hidradenitis suppurativa, health care professionals and patients value long-term data when they are making treatment decisions,” Fiona du Monceau, MBA, executive vice president and head of patient evidence at UCB, said in a company press release. “We are proud to present, for the first time, the bimekizumab 2-year results at EADV 2024.”

Two of the studies, BE HEARD I and BE HEARD II, evaluated the efficacy and safety of Bimzelx (bimekizumab, UCB) up to 48 weeks. Patients aged 18 years or older with moderate to severe HS in BE HEARD I (n = 505) and BE HEARD II (n = 509) were randomly assigned to receive either subcutaneous bimekizumab 320 mg twice weekly; bimekizumab 320 mg twice weekly 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 twice weekly.

Results showed that of the 556 total patients across both studies that completed treatment through week 48, 79.9%, 64%, 42.3% and 30.2% achieved Hidradenitis Suppurativa Clinical Response (HiSCR)50, HiSCR75, HiSCR90 and HiSCR100, respectively.

The 556 patients who completed treatment up to week 48 enrolled in the long-term extension trial, BE HEARD EXT, which lasted up to 96 weeks. Results of the long-term trial was also promising, with 85.4%, 77.1%, 57.6% and 44.2% of the 446 Bimzelx-treated patients who completed 96 weeks of treatment achieving HiSCR50, HiSCR75, HiSCR90 and HiSCR100.

The long-term trial also showed that patients who achieved an improvement in their severity from baseline in the 48-week trials maintained that change at 96 weeks (–70.3 ± 39.6 and –79.8 ± 28.1, respectively).

At week 48, the average draining tunnel count per patient was down 57.5% from baseline and continued to decrease, reaching 73.7% by week 96.

By the 2-year mark, approximately one in three patients reported minimal or no impact of hidradenitis suppurativa on their quality of life.

Bimzelx also proved to be well-tolerated, according to the press release. Of the 995 patients who received one or more dose, 917 experienced a treatment-emergent adverse event with 122 of those patients reporting a serious adverse event. The most common treatment-emergent adverse events per 100 person-years were hidradenitis at 20.5 (95% CI, 18.2-23), coronavirus infection at 15.3 (95% CI, 13.4-17.4) and oral candidiasis at 10.5 (95% CI, 8.9-12.2).

Reference:

• Zouboulis CC, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. Presented at: European Academy of Dermatology and Venereology Congress; Sept. 25-28, 2024; Amsterdam.