Within the BE HEARD trial, bimekizumab treatment resulted in significant benefits in the treatment of hidradenitis suppurativa (HS). About half of the patients achieved a 50% HS clinical response (HiSCR50) after 48 weeks of treatment.
Alexa B. Kimball, MD, MPH, presented these findings at the 2023 American Academy of Dermatology annual meeting.1
In total, 1,014 patients with moderate-to-severe HS with at least five lesions and 20 or more draining tunnels participated in the pivotal, phase 3 BE HEARD I trial and BE HEARD II trial. Patients receiving concomitant antibiotics were classified as non-responders.
The study treatment varied among the four study arms of the two studies, with an initial period up to week 16 and thereafter, a maintenance part up to week 48. The breakdown was as follows:
- group 1 received 320 mg of bimekizumab every 2 weeks over both study periods (Q2W/Q2W),
- group 2 started with bimekizumab at 320 mg bi-weekly and switched to a 4G weekly regimen after week 16 (Q2W/Q4W),
- group 3 was kept on a 4-weekly dose of bimekizumab 320 mg (Q4W/Q4W) from start to week 48, and
- group 4 began with a placebo until week 16 and continued on 320 mg of bimekizumab every second week (PCO/Q2W).
The primary endpoint was delineated as the HiSCR50 response at week 16.
Baseline measures in BE HEARD I and BE HEARD II included: 63.0% and 50.7% were women, mean age of 36.7 and 36.6, mean duration of HS of 9 and 7 years, Hurley stage 3 in 49.7% and 38.9%, along with a proportion of 25% and 13.2% of patients with previous biologic medication.
At the primary endpoint, in BE HEARD I, a HiSCR50 was reached in 45.3% of patients in Q4W (P=0.03 vs placebo), 47.8% in Q2W (P=0.006 vs placebo), and 28.7% in the placebo group.
The corresponding results from BE HEARD II were 53.8% (P<0.01), 52.0% (P<0.01), and 32.2%, respectively. As can be expected, the rates for achieving HiSCR75 at week 16 were overall lower. In BE HEARD II, the rates were 33.7% and 35.7% in the two bimekizumab arms versus 15.6% in the placebo arm (P<0.01 for both comparisons).
The responses were overall sustained during the maintenance period with a HiSCR75 in 59.8% (PCO/Q2W), 53.9% (Q4W/Q4W), 48.8% (Q2W/Q4W), and 47.3% (Q2W/Q2W) in BE HEARD 2 at week 48. Patients in the placebo group also demonstrated clinical response within the range of the other treatment arms.
“In particular the HiSCR results we achieved in the BE HEARD 2 trial are a huge milestone for our patients,” Dr. Kimball said.
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