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Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential.

ABSTRACT: Plaque psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with several comorbidities, including arthritis. The increasing knowledge of psoriasis pathogenesis led to the identification of novel targeted therapeutic interventions. Among them, anti-IL-17A and anti-IL-17F antibodies are currently being investigated for the treatment of PsO and/or psoriatic arthritis (PsA). Bimekizumab is one of these agents, capable ofsimultaneously neutralizing both IL-17A and IL-17F cytokines. In this review we included preclinical and clinical data related to this highly promising agent that shows a peculiar molecular structure differing from other bispecific agents.

SUBMITTER: Chiricozzi A

PROVIDER: S-EPMC6538010 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential.

Chiricozzi Andrea A De Simone Clara C Fossati Barbara B Peris Ketty K

Psoriasis (Auckland, N.Z.) 20190524

Plaque psoriasis (PsO) is a chronic inflammatory skin disorder that may be associated with several comorbidities, including arthritis. The increasing knowledge of psoriasis pathogenesis led to the identification of novel targeted therapeutic interventions. Among them, anti-IL-17A and anti-IL-17F antibodies are currently being investigated for the treatment of PsO and/or psoriatic arthritis (PsA). Bimekizumab is one of these agents, capable ofsimultaneously neutralizing both IL-17A and IL-17F cyt ...[more]

PMID: 31214486

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Project description:ImportancePsoriasis is a chronic disease requiring long-term management; understanding the long-term safety profiles of psoriasis treatments, such as bimekizumab, is important.ObjectiveTo evaluate the 2-year safety profile of bimekizumab in patients with moderate to severe plaque psoriasis.Design, setting, and participantsSafety 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.InterventionsIncluded 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 exposure-adjusted incidence rates (EAIRs) per 100 person-years.ResultsA 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.

Dataset Information

Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential.

Publications

Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential.

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