Blockade of the IL-17 signaling pathway increased susceptibility of psoriasis patients to superficial fungal infections

Hiruma, Junichiro; Harada, Kazutoshi; Hirayama, Maho; Egusa, Chizu; Tobita, Rie; Masuda-Kuroki, Kana; Abe, Namiko; Tsuboi, Ryoji; Okubo, Yukari

doi:10.1016/j.jdermsci.2020.12.003

Cited by 11 publications

(7 citation statements)

References 8 publications

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“…Interleukin-17 is involved in mucosal host defenses against fungal infections; therefore, anti–IL-17 biologics can be associated with an increased risk of oral mucocutaneous candidiasis . Consistent with individual study data, oral candidiasis was one of the most common TEAEs reported with bimekizumab (12.6 per 100 person-years), and the EAIR was higher than that reported in pooled studies up to 5 years with other IL-17 inhibitors (secukinumab: 1.9 per 100 person-years; ixekizumab: 0.8-1.2 per 100 person-years) .…”

Section: Discussionmentioning

confidence: 99%

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

et al. 2022

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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.

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Section: Discussionmentioning

confidence: 99%

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

et al. 2022

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“…Over 52 weeks, the occurrence of common TEAEs was comparable between bimekizumab and ustekinumab, except for oral candidiasis. As the IL-17 pathway controls fungal infections of the oral mucosa, and is subject to heightened inhibition through bimekizumab's inhibition of IL-17F and IL-17A [38][39][40][41][42], oral candidiasis would be expected to be more common in bimekizumab-versus ustekinumab-treated patients. Moreover, the frequency of oral candiasis infections was similar to observations in previous bimekizumab trials [19,24,43,44], and was higher than observations with other IL-17 inhibitors [13,14].…”

Section: Discussionmentioning

confidence: 99%

Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study

Asahina

Okubo

Morita

et al. 2023

Dermatol Ther (Heidelb)

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Introduction: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. Methods: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimek-

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“…The immunomodulatory effects of systemic treatments, microbiota dysbiosis of the skin and nails, and immunologic disturbance of capillary units are contributing factors, while the abundance of antimicrobial peptides and fast turnover of the skin and nails are inhibitory factors [1][2][3] . Previous meta-analyses or large cohort studies were limited to onychomycosis or mucocutaneous candidiasis 2,4,5 . Therefore, we conducted this retrospective nationwide population-based cohort study to assess the incidence and risk of super cial fungal infections among patients with psoriasis receiving systemic treatment.…”

Section: Main Textmentioning

confidence: 99%

Increased risk of superficial fungal infections among psoriasis patients receiving systemic treatment: A nationwide retrospective population-based cohort study

Seo,

Kim,

Lee

et al. 2024

Preprint

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Previous meta-analyses or large cohort studies of risk for onychomycosis or mucocutaneous candidiasis in psoriasis patients has been reported. We conducted the retrospective nationwide population-based cohort study to assess the incidence and risk of superficial fungal infections among patients with psoriasis receiving systemic treatment. Our study showed an increased risk of superficial fungal infection among patients with psoriasis receiving systemic treatment regardless of treatment type.

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Blockade of the IL-17 signaling pathway increased susceptibility of psoriasis patients to superficial fungal infections

Cited by 11 publications

References 8 publications

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis

Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study

Increased risk of superficial fungal infections among psoriasis patients receiving systemic treatment: A nationwide retrospective population-based cohort study

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