Abstract
Abstract While open-label extension studies have investigated the long-term utility of bimekizumab, a novel interleukin-17A/IL-17F inhibitor for plaque psoriasis, real-world evidence (RWE) is limited. This RWE study reports on 2-year bimekizumab use. Our retrospective multicentre study included adult patients with plaque psoriasis from four Canadian institutions initiated on bimekizumab. Effectiveness outcomes included Investigator Global Assessment (IGA), psoriasis area and severity index (PASI), body surface area (BSA), and IGA × BSA scores. Safety was assessed via treatment-related adverse events (AEs). A nonresponder imputation (NRI) analysis was used to account for missing data regarding treatment-related discontinuations prior to 104 ± 8 weeks. This analysis included 37 patients. Mean age was 44.4 (range: 19–74) years, with 59.5% (22/37) being male. At Weeks 104 ± 8 (n = 37): IGA 0/1 was achieved by 72.7% (24/33); mean PASI, BSA, and IGA × BSA improvements from baseline were 73% (11.3–2.7), 72.6% (14–3.5%), and 71.8% (31.4–3.4), respectively; 73% (27/37), 64.9% (24/37), and 59.5% (22/37) achieved PASI75, 90% improvement in PASI (PASI90), and 100% improvement in PASI (PASI100), respectively; 73% (27/37), 73% (27/37), and 67.6% (25/37) achieved absolute PASI scores <3, <2, and <1; and 59.5% (22/37) achieved BSA <1%. Furthermore, for patients not achieving IGA 0/1, PASI75, PASI90, and PASI100 at Week 52 ± 6, these responses were subsequently achieved in 100% (3/3), 60% (3/5), 33.3% (2/6), and 28.6% (2/7) of patients at Week 104 ± 8, respectively. Loss of initial Week 52 ± 6 IGA 0/1, PASI75, PASI90, and PASI100 responses occurred in 12.5% (2/16), 4% (1/25), 4.2% (1/24), and 4.5% (1/22) of patients by Week 104 ± 8, respectively. During the maintenance period, dose escalation from every 8 weeks to every 4 weeks was required in 29.7% (11/37) of patients. Twelve treatment-related AEs occurred (32.4%, 12/37), including candidiasis [10.8%, 4/37; oral (n = 3); intertriginous (n = 1)], and bacterial folliculitis (8.1%, 3/37). Nine treatment discontinuations (24.3%) were documented [lack of efficacy (n = 4); AEs: anxiety (n = 1), inflammatory bowel disease (n = 1); nasopharyngitis (n = 1), recurrent respiratory infection (n = 1); pregnancy (n = 1)]. No serious infections, suicidal ideation/behaviour, malignancies, hypersensitivity reactions, major adverse cardiac events, or hepatic abnormalities were observed over 73.6 patient-years of safety follow-up. To date, three open-label extension studies (BE RADIANT; BE BRIGHT; BE SURE) have evaluated 2-year outcomes of bimekizumab. In these studies, NRI outcomes for IGA 0/1, PASI90, and PASI100 ranged from 74.7–85.9%, 76.6–87%, and 64.6–68.9%, respectively. Our real-world effectiveness outcomes are comparable to these results with no new safety signals. Overall, we highlight the sustained long-term effectiveness and safety of bimekizumab up to 2 years. Study limitations include small sample size and retrospective nature.
Published Version
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