medwireNews: Follow-up results from the BE ACTIVE and BE AGILE phase 2b trials show that the efficacy and safety profiles of bimekizumab, a dual inhibitor of interleukin (IL)-17A and IL-17F, are maintained for up to 3 years in patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS).
The long-term results of BE ACTIVE – involving patients with PsA – are published as two studies, with one focusing on the main efficacy and safety endpoints, and the other on patient-reported outcomes (PROs).
For the first, Laura Coates (University of Oxford, UK) and colleagues evaluated data from 161 of 206 patients with active PsA who took part in the initial 48-week BE ACTIVE dose-ranging trial and went on to complete the subsequent 104-week open-label extension (OLE) study. These people were all given bimekizumab 160 mg every 4 weeks in the extension phase.
The researchers report in Arthritis & Rheumatology that “[e]fficacy demonstrated at Week 48 was sustained in the OLE” for both joint and skin responses, with an ACR50 response rate of 52.9% and a PASI100 response rate of 57.7% at the 152-week follow-up.
Moreover, “bimekizumab was found to be well tolerated in patients with PsA up to three years of treatment,” they add, with no new safety signals identified in the long-term study. The most frequently reported treatment-emergent adverse events (TEAEs) were nasopharyngitis, upper respiratory tract infection, and bronchitis.
“The three-year duration of this phase 2b study provides the most comprehensive evidence to date of the long-term safety and efficacy of bimekizumab in patients with PsA,” say Coates et al.
The second PsA study, by Philip Mease (Swedish Medical Center and University of Washington, Seattle, USA) and colleagues, found sustained improvements in a range of PROs, including measures of pain, fatigue, and physical function, with bimekizumab treatment in the OLE.
“These long-term improvements could help to improve the treatment landscape for patients with PsA, addressing an unmet need in those who continue to be affected by the burdensome and impactful symptoms of pain and fatigue,” write Mease et al in Rheumatology.
The BE AGILE OLE, focused on the long-term efficacy and safety for bimekizumab in the AS population, is reported by Xenofon Baraliakos (Ruhr-University Bochum, Germany) and colleagues in Arthritis & Rheumatology.
It had a similar design to that of the PsA study; people with AS who completed the 48-week dose-ranging study could enroll in the OLE and were treated with bimekizumab 160 mg every 4 weeks for an additional 204 weeks. Of the 303 participants initially randomized at baseline, 255 subsequently enrolled in the OLE and received bimekizumab.
Baraliakos and team report that the IL-17A/IL-17F inhibitor had sustained efficacy “following the rapid and clinically meaningful improvements within the first year of bimekizumab treatment.” The ASAS40 response rate at week 156 was 53.7%, and this was greater than 50% at all measured timepoints between week 48 and 156. The team also observed sustained reductions in inflammation, spinal pain, fatigue, stiffness, as well as improvements in physical function.
In accordance with the PsA study, no new safety signals were identified in the BE AGILE extension study, and the most common TEAEs were nasopharyngitis, upper respiratory tract infection, and bronchitis.
“Overall, these results support bimekizumab as a promising potential treatment option in AS,” conclude Baraliakos and colleagues.
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Arthritis Rheumatol 2022; doi:10.1002/art.42280
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