An open label extension of a phase 2b clinical trial of bimekizumab demonstrated sustained disease control with no new safety signals through 3 years in psoriatic arthritis (PsA) through 3 years, according to a study published in Arthritis and Rheumatology.
The study reported on the results through year 3 of the open label extension of the 48-week phase 2b randomized clinical trial, BE ACTIVE (ClinicalTrials.gov Identifier: NCT02969525).
In the BE ACTIVE trial, bimekizumab dosages of 160 mg or 320 mg every 4 weeks for up to 48 weeks were found to be safe and effective at improving joint and skin outcomes. After completing the trial, patients were eligible to enter the open label extension (ClinicalTrials.gov Identifier: NCT03347110) to continue treatment (160 mg bimekizumab every 4 weeks) for up to a total of 152 weeks. Patients received a follow-up visit 20 weeks after their last dose of bimekizumab.
Non-responder imputation analysis was used to determine endpoints; it was assumed that patients who did not enroll in the open label extension had PsA that did not respond to treatment. For treatment emergent adverse events (TEAEs), exposure-adjusted incidence rates (EAIRs) per 100 patient-years were calculated to assess the safety profile of bimekizumab.
Among a total of 206 patients in the trial, 184 patients enrolled in the open label extension and 161 patients continued through week 152. From week 0 to 152, 184 patients (89.3%) had at least one TEAE (EAIR=126.4) and 22 patients (10.7%) had at least 1 serious TEAE (EAIR=4.1). The most frequently reported TEAEs (EAIR) included nasopharyngitis (7.6), upper respiratory tract infection (6.8), bronchitis (3.5), and oral candidiasis (3.5). A total of 47 patients reported fungal infections (EAIR=9.7), including 24 patients with Candida infections (EAIR=9.7) and 19 with oral candidiasis (EAIR=3.5). All fungal infections were localized and most resolved with systemic or topical treatment. Four patients (EAIR=0.7) had serious infections (each patient experienced either cellulitis, chronic otitis media, hepatitis E, or chronic sinusitis). There were no reported cases of active tuberculosis, major adverse cardiac events, or death.
Nonresponder imputation analyses showed that at week 152, 52.9% of patients achieved American College of Rheumatology criteria 50% response (compared with 57.3% at week 48), 57.7% achieved Psoriasis Area and Severity Index 100% skin clearance (compared with 64.2% at week 48), and 51.5% achieved minimal disease activity (compared with 51.0% at week 48). Patients also maintained improvements in pain, physical function, and health-related quality of life from week 48 to 152.
Limitations of the study included the lack of a comparator group beyond week 12 of the trial and a small sample size.
The study authors concluded, “Despite the limited sample size, the present study supports the further development of bimekizumab to address an unmet need for improved and sustained efficacy on skin and joint disease in patients with PsA.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Coates LC, McInnes IB, Merola JF, et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: 3-year results from a phase 2b randomized controlled trial and its open-label extension study. Arthritis Rheumatol. Published online July 13, 2022. doi:10.1002/art.42280