Abstract The standard bimekizumab dosing regimen for adult patients with plaque psoriasis is 320 mg administered as a subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks (Q8W) thereafter. However, dose optimization may be required due to variability in treatment response. We conducted a real-world, multicentre, retrospective review of bimekizumab dose optimization for plaque psoriasis in adults. From a total cohort of 91 patients, we identified 15 (16.5%) that underwent dose optimization from Q8W to every 4 weeks (Q4W; 93.3%, 14/15) or every 6 weeks (Q6W; 6.7%, 1/15) in the maintenance period. All patients underwent dose optimization due to lack of efficacy. Mean age was 47.7 (range: 23–74) years, with 60% (9/15) being female. Mean time to dose optimization was 42.4 (range: 15.6–99) weeks. At the time of dose escalation (n = 15), mean psoriasis area and severity index (PASI) score was 3.4 (mean improvement from baseline: 50.5%) and mean body surface area (BSA) was 3.2% (mean improvement from baseline: 51%), with Investigator Global Assessment (IGA) scores of 1 (33.3%, 5/15), 2 (46.7%, 7/15), 3 (13.3%, 2/15), and 4 (6.7%, 1/15). Prior to dose escalation, there were 33.3% (5/15), 46.7% (7/15), and 20% (3/15) of IGA 0/1, 75% improvement in PASI (PASI75), and 90% improvement in PASI (PASI90) responders. Following a mean follow-up period of 17.5 (range: 2.9–35.6) weeks after dose optimization, there were 86.7% (13/15), 66.7% (10/15), 66.7% (10/15), and 60% (9/15) responders in IGA 0/1, PASI75, PASI90, and PASI100. From the time of dose escalation, mean improvement in PASI and BSA were 79.2% (85.2% from baseline) and 81.2% (90.6% from baseline), respectively. There was 1 (6.7%) discontinuation due to persistent lack of efficacy following dose optimization. Five treatment-related adverse events (AEs) occurred, including candidiasis (13.3%, 2/15), folliculitis (6.7%, 1/15), recurrent cellulitis (6.7%, 1/15), and recurrent urinary tract infection (UTI; 6.7%, 1/15). Of these, only the UTI patient (6.7%, 1/15) experienced an AE following dose escalation. There were no safety-related treatment discontinuations, nor any serious infections, suicidal ideation/behaviour, malignancies, hypersensitivity reactions, major adverse cardiac events, or hepatic abnormalities. In Phase III clinical trials, while IGA 0/1 and PASI90 rates were comparable between dosing regimens, Q4W maintenance dosing of bimekizumab was associated with a higher PASI100 rate than Q8W dosing [73.5–83% (Q4W) vs. 66–70.8% (Q8W)] at 1-year. Furthermore, AEs were comparable between dosing regimens with slightly higher rates of oral candidiasis and UTI with Q4W dosing. Our real-world results show increased achievement of IGA 0/1, PASI90, and PASI100 with dose optimization and no new safety signals. Study limitations include its small sample and retrospective nature.
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