Bimekizumab offers ‘rapid and deep’ response in HS

Medicines

By Geir O'Rourke

26 Jun 2024

Bimekizumab is well tolerated by patients with hidradenitis suppurativa and produces rapid and deep clinically meaningful responses that are maintained up to 48 weeks, data from two trials suggest.

The results support the monoclonal antibody as a “promising new therapeutic option” for patients with moderate-to-severe HS, with a safety profile consistent with other bimekizumab indications, researchers say.

It follows analysis of the identical, phase 3, BE HEARD I and II industry-funded trials, including 505 and 509 adult HS patients, respectively.

Patients were randomly assigned 2:2:2:1 to receive subcutaneous bimekizumab 320 mg every two weeks; bimekizumab 320 mg every two weeks to week 16, then every four weeks to week 48; bimekizumab 320 mg every four weeks to week 48; or placebo to week 16, then bimekizumab 320 mg every two weeks.

The primary outcome of each trial was hidradenitis suppurativa clinical response (HiSCR50), assessed independently at week 16, and defined as a reduction in total abscess and inflammatory nodule count of at least 50% from baseline, with no increase from baseline in abscess and inflammatory nodule or draining tunnel count.

This was met in both trials: in 48% of patients on active treatment showing a clinical response per this criteria versus 29% of those on placebo in BE HEARD I and 52% versus 32% in BE HEARD II, the researchers said.

Responses were maintained or increased to week 48, they reported in The Lancet (link here).

Serious treatment-emergent adverse events were reported in 8% of patients in BE HEARD I and 5% of patients in BE HEARD II treated with bimekizumab over 48 weeks, consistent with other bimekizumab indications, and with secukinumab, they noted.

“With bimekizumab treatment, clinical responses were sustained or improved over 48 weeks, with rapid improvements (within 4 weeks) observed in patients who switched from placebo to bimekizumab from week 16 onwards,” the authors wrote.

“Given the limited efficacy of current therapeutic options available for patients with hidradenitis suppurativa, the rapid, deep, and maintained clinical response improvements offered by bimekizumab provide a potential additional treatment option.”

The investigators did stress that, due to the heterogeneous nature of the disease, clinical response might have been affected by an individual patient’s underlying disease aetiology.

Thus IL-17F and IL-17A, which were directly targeted by bimekizumab, should not be considered as the only drivers of disease among patients with HS, they added.

“Given the heterogeneity and complexity of HS, future research should include studies targeting optimal pharmacological, surgical, and adjuvant therapies to optimise treatment goals meaningful to patients,” they wrote.

“Real-world evidence studies and network meta-analyses could also help to inform future clinician decision making in the management of moderate-to-severe HS.”

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