ArticleDermatology and therapy2025
Analysis of Predefined Safety Events Across Spesolimab Trials in Dermatological and Non-Dermatological Conditions.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- IL-36-Driven Inflammation in Generalized Pustular Psoriasis: Immunological Insights from Plaque Psoriasis and Implications for Targeted Therapy.International journal of molecular sciences · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSpesolimab, a selective, humanised monoclonal antibody targeting the interleukin-36 receptor, is approved for the treatment of generalised pustular psoriasis (GPP). As a result of the limited patient numbers in GPP trials of spesolimab, analysing safety events across dermatological and non-dermatological diseases helps to further characterise the known safety profile of spesolimab. Here, we analyse predefined safety events from nine randomised, placebo-controlled spesolimab trials across dermatological (including GPP) and gastrointestinal conditions.
methodsPredefined safety events were based on the known safety profile of spesolimab across all diseases investigated to date and potential risks of biological therapeutics, and included serious/severe/opportunistic infections, hypersensitivity, malignancies and peripheral neuropathy.
resultsIncluding placebo-controlled trials and open-label periods/trials, 589 patients received ≥ 1 dose of spesolimab (772.2 patient-years; mean exposure 1.31 patient-years). Overall, 452 patients had long-term exposure (≥ 6 months) to spesolimab, with 31 patients up to ≥ 3 years. In placebo-controlled periods, 445 patients had exposure to spesolimab (162.0 patient-years; mean exposure 0.36 patient-years). Severe/serious/opportunistic infections occurred in 0-3.2% of spesolimab-treated patients and 0-14.3% of placebo-treated patients. Malignancies occurred infrequently across trials (0-6.7% in spesolimab, 0-2.3% in placebo). Peripheral neuropathy events also occurred infrequently, with single events reported in the placebo arm of EFFISAYIL
conclusionsAcross placebo-controlled periods of spesolimab trials in dermatological and non-dermatological conditions, severe/serious/opportunistic infections, malignancies and peripheral neuropathy events were low, with no evidence for an increased risk with spesolimab versus placebo. Potential hypersensitivity events were similar between spesolimab and placebo. These results support the favourable safety profile of spesolimab observed in EFFISAYIL
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