Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

Abstract

IMPORTANCEPsoriasis is a chronic disease requiring long-term management; understanding the long-term safety profiles of psoriasis treatments, such as bimekizumab, is important. OBJECTIVE To evaluate the 2-year safety profile of bimekizumab in patients with moderate to severe plaque psoriasis.DESIGN, SETTING, AND PARTICIPANTS Safety data were pooled from a cohort of patients from 4 phase 2 randomized clinical trials (BE ABLE 1, BE ABLE 2, PS0016, and PS0018) and 4 phase 3 randomized clinical trials (BE VIVID, BE READY, BE SURE, and BE BRIGHT) to include 2 years of study treatment. Data were obtained on adults with moderate to severe plaque psoriasis (Psoriasis Area and Severity Index level Ն12, Ն10% body surface area affected by psoriasis, and an Investigator's Global Assessment score Ն3 on a 5-point scale) who were eligible for systemic psoriasis therapy and/or phototherapy.INTERVENTIONS Included patients received 1 or more doses of bimekizumab during the phase 2 or phase 3 trials. MAIN OUTCOMES AND MEASURESTreatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation are reported using exposureadjusted incidence rates (EAIRs) per 100 person-years.RESULTS A total of 1789 patients (1252 [70.0%] men; mean [SD] age, 45.2 [13.5] years) were treated with 1 or more doses of bimekizumab across the phase 2/3 trials and were included in these analyses; total bimekizumab exposure was 3109.7 person-years. TEAEs occurred at an EAIR of 202.4 per 100 person-years and did not increase with longer duration of bimekizumab exposure. The 3 most frequently reported TEAEs were nasopharyngitis (19.1 per 100 person-years; 95% CI, 17.4-20.9 per 100 person-years), oral candidiasis (12.6 per 100 person-years; 95% CI, 11.3-14.0 per 100 person-years), and upper respiratory tract infection (8.9 per 100 person-years; 95% CI, 7.8-10.1 per 100 person-years). Most oral candidiasis events were mild or moderate; 3 events led to discontinuation. The EAIRs of inflammatory bowel disease (0.1 per 100 person-years; 95% CI, 0.0-0.3 per 100 person-years), adjudicated suicidal ideation and behavior (0.0 per 100 person-years; 95% CI, 0.0-0.2 per 100 person-years), and adjudicated major adverse cardiac events (0.5 per 100 person-years; 95% CI, 0.3-0.8 per 100 person-years) were low. CONCLUSIONS AND RELEVANCEIn these pooled analyses of data from a cohort of patients from 8 randomized clinical trials, bimekizumab was well tolerated aside from an increased incidence of mild to moderate oral candidiasis. No safety signals were observed compared with previous reports, and there was no increased risk of AEs with longer duration of bimekizumab exposure.

Real‐world effectiveness and safety of bimekizumab in Japanese patients with psoriasis: A single‐center retrospective study

“…The safety profile for bimekizumab in this real‐world study (Table 7) was similar to that in the previous clinical trial 11 . No new AEs were observed with bimekiuzmab.…”

“…The safety profile of bimekizumab in this real-world study was akin to that in a previous clinical trial. 11 In this study, there were three cases of oral candidiasis (8.3%), which appeared to be lower than the frequency in the clinical trial (15.6% or 19.3%) Note: Correlations between variables were examined using Spearman's correlation coefficient.…”

“…was similar to that in the previous clinical trial. 11 No new AEs were observed with bimekiuzmab. TEAEs occurred in 12 patients (33.3%).…”

Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis

“… 21 Emerging data from clinical studies indicate that inhibiting both IL-17A and IL-17F is efficacious for treating psoriasis, but can lead to an increase in candidiasis. 22 , 23 A recent pooled analysis of Phase 2 and Phase 3 study data for bimekizumab (selectively binding to IL-17A and IL-17F) in patients with moderate to severe plaque psoriasis which evaluated the mAb’s 2-year safety profile showed that it was well tolerated, aside from an increased incidence of oral candidiasis. 23 Evidence also suggests that dual IL-17A and IL-17F inhibition may not be more efficacious than blocking IL-17A alone and that more potent inhibition of IL-17A may provide added benefit to patients with IL-17-mediated disease.…”

JAMA Dermatology—The Year in Review, 2022

“…The journal broadened its digital reach, with more than 5.2 million full-text views and downloads in the past year (an approximately 20% increase), and expanded its connections to more than 68 000 followers on the social media channels Twitter, Facebook, and Instagram, a 15% increase compared with the previous year. The highest-viewed papers included randomized clinical trials for psoriasis and atopic dermatitis . The article by Simpson et al presented long-term (52 weeks) efficacy and safety data for upadacitinib treatment in patients with atopic dermatitis.…”