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. 2022 Jul 1;158(7):735-744.
doi: 10.1001/jamadermatol.2022.1185.

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials

Kenneth B Gordon  1 , Richard G Langley  2 , Richard B Warren  3 , Yukari Okubo  4 , Linda Stein Gold  5 , Joseph F Merola  6 , Luke Peterson  7 , Krista Wixted  7 , Nancy Cross  7 , Delphine Deherder  8 , Diamant Thaçi  9
Affiliations

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials

Kenneth B Gordon et al. JAMA Dermatol. .

Abstract

Importance: Psoriasis 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 ≥12, ≥10% body surface area affected by psoriasis, and an Investigator's Global Assessment score ≥3 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 measures: Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation are reported using exposure-adjusted 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 relevance: In 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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gordon reported receiving grants and nonfinancial support from UCB Pharma during the conduct of the study; personal fees from AbbVie, Almirall, Amgen, Arcutis, Dermira, Galderma, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Eli Lilly, Novartis, Ortho, Pfizer, Sun, Sanofi/Genzyme, and UCB Pharma; and grants from AbbVie, BMS, Janssen, Eli Lilly, and UCB Pharma outside the submitted work BMS. Dr Langley reported receiving grants and fees for serving on the scientific advisory board and speaking fees from AbbVie, Janssen, Novartis, Eli Lilly, LEO Pharma, UCB Pharma, Amgen, Pfizer, and Boehringer Ingelheim during the conduct of the study; and receiving grants and fees for serving on the scientific advisory board and speaking fees from AbbVie, Sun, Novartis, Eli Lilly, UCB Pharma, Boehringer Ingelheim, and Amgen outside the submitted work. Dr Warren reported receiving grants from AbbVie, Almirall, LEO Pharma, and Eli Lilly outside the submitted work; and personal fees from Novartis, UCB Pharma, UNION Therapeutics, DiCE, Janssen, and LEO Pharma outside the submitted work. Dr Okubo reported receiving grants from AbbVie, Eisai, Maruho, Shiseido, and Sun Pharma; and personal fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen Pharma, Jimro, Kyowa Hakko Kirin, LEO Pharma, Maruho, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho, Tanabe-Mitsubishi, Torii, and UCB Pharma outside the submitted work. Dr Stein Gold reported receiving grants and speaking fees from UCB Pharma during the conduct of the study. Dr Merola reported receiving consultant fees from AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Biogen, Pfizer, and LEO Pharma outside the submitted work. Mr Peterson, Ms Wixted, Dr Cross, and Ms Deherder reported being UCB Pharma employees and shareholders. Dr Thaçi reported receiving fees for consulting and advisory board membership and nonfinancial support from UCB Pharma during the conduct of the study; lecture, consulting, and advisory board fees from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, LEO Pharma, Novartis, and Pfizer; consulting fees from Galapagos; and grants from LEO Pharma and Novartis. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Incidence Rates of Treatment-Emergent Adverse Events (TEAEs) by Treatment Period
Data are reported as the exposure-adjusted incidence rate (EAIR) per 100 person-years for TEAEs that occurred during the initial 16-week treatment period of the phase 2/3 trials (weeks 0-16), during the maintenance period (weeks 16-52) and during the second year (weeks 52-104). Error bars represent 95% CIs.
Figure 2.
Figure 2.. Cumulative Incidence Rates for Selected Treatment-Emergent Adverse Events (TEAEs) of Interest
Serious infections (A), oral candidiasis (B), inflammatory bowel disease (C), malignant neoplasms other than nonmelanoma skin cancer (NMSC) (D), adjudicated major adverse cardiac event (MACE) (E), and adjudicated suicidal ideation and behavior (F) are reported as the exposure-adjusted incidence rate (EAIR) per 100 person-years. Data reported for weeks 0-16 were pooled from 3 pivotal phase 3 studies (BE VIVID, BE READY, and BE SURE). All patients assigned to bimekizumab received bimekizumab, 320 mg, every 4 weeks (Q4W). Longer-term data through to 1 year (clinical cutoff date November 1, 2019) and 2 years (clinical cutoff date November 9, 2020) of bimekizumab treatment were pooled from 4 phase 2 and 4 phase 3 randomized clinical trials. Error bars represent 95% CIs.
Figure 3.
Figure 3.. Incidence and Recurrence of Oral Candidiasis Treatment-Emergent Adverse Events (TEAEs) Over 1 and 2 Years
A, Data are reported as the exposure-adjusted incidence rate (EAIR) per 100 person-years for events that occurred during the initial 16-week treatment period of the phase 2/3 trials (weeks 0-16), during the maintenance period (weeks 16-52), and during the second year (weeks 52-104). B, Data are reported as the EAIR per 100 person-years for all patients who received 1 or more doses of bimekizumab at week 16 or later and received continuous bimekizumab maintenance dosing (every 4 weeks [Q4W] or every 8 weeks [Q8W]) during the maintenance periods of the BE READY and BE SURE phase 3 studies and the BE BRIGHT open-label extension. All patients received bimekizumab, 320 mg, Q4W during the initial 16-week period of BE READY and BE SURE. C, Data are reported to 1 year and 2 years of treatment for all patients in the phase 2/3 trials who received 1 or more doses of bimekizumab. Error bars represent 95% CIs.
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