Bimekizumab rates of oral candidiasis in patients with moderate to severe plaque psoriasis: Results from up to 4 years of five phase 3/3b studies
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Keywords
Psoriasis
Abstract
Introduction: Bimekizumab (BKZ) selectively inhibits interleukin (IL)-17A and IL-17F. As IL-17A/F protect against oral candidiasis, understanding BKZ’s impact on oral candidiasis rates is important. We report long-term oral candidiasis rates in BKZ-treated patients with moderate to severe plaque psoriasis.
Procedure: Final data were pooled from BE SURE (NCT03412747), BE VIVID (NCT03370133), BE READY (NCT03410992), their open-label extension (OLE), BE BRIGHT (NCT03598790; 4-year data), and BE RADIANT (NCT03536884; 3-year data). Patients received BKZ 320mg every 4 weeks (Q4W) or Q8W; all received Q8W from Week 64 (BE RADIANT)/OLE Week 48 (BE BRIGHT).
Exposure-adjusted incidence rates/100 patient‑years (EAIR/100PY), recurrence and treatment of oral candidiasis treatment-emergent adverse events (TEAEs) are reported for patients who received ≥1 BKZ dose.
Results: To Year 4 (N=2,186), Candida infection EAIR was 10.4/100PY. Most were oral candidiasis (8.9/100PY); 99.1% were mild/moderate (no serious cases). Eight patients discontinued the study due to oral candidiasis (one severe case; six recurrent cases).
To Year 4, 78.8% had no oral candidiasis TEAEs. In patients with ≥1 oral candidiasis TEAE, most had one/two; 10.3% had one, 5.4% two, 2.1% three, 1.7% four and 1.8% had five or more.
71.1% of patients with oral candidiasis experienced their first occurrence within treatment Year 1. Most cases were treated with nystatin and/or fluconazole; median (interquartile range) antifungal therapy duration: 13.0 (7.0–26.0) days.
Conclusion: To Year 4, ~80% of BKZ-treated patients did not experience oral candidiasis; in those who did, most had one/two events. >99% of events were mild/moderate; very few led to study discontinuation.
Funding: These studies were funded by UCB. Medical writing support was provided by Costello Medical.
References
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