Analysis of Predefined Safety Events Across Spesolimab Trials in Dermatological and Non-Dermatological Conditions
Across 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<sup>®</sup> 2, the largest GPP trial conducted to date.
Authors
- Siew Eng Choon (ORCID: https://orcid.org/0000-0002-7796-5746)
- Ming Tang (ORCID: https://orcid.org/0000-0002-6451-8648)
- Kenneth B. Gordon (ORCID: https://orcid.org/0000-0002-9347-0292)
- Boni E. Elewski (ORCID: https://orcid.org/0000-0002-1475-2874)
- Christian Thoma (ORCID: https://orcid.org/0000-0002-0967-2028)
- Thomas Haeufel
- Yayoi Tada (ORCID: https://orcid.org/0000-0003-3743-135X)
- Milan J. Anadkat (ORCID: https://orcid.org/0000-0002-0723-3953)
- Juliet N. Barker (ORCID: https://orcid.org/0000-0002-9030-183X)
- Arash Mostaghimi (ORCID: https://orcid.org/0000-0002-6084-5617)
- Diamant Thaçi (ORCID: https://orcid.org/0000-0001-8513-550X)
- Kilian Eyerich (ORCID: https://orcid.org/0000-0003-0094-2674)
Institutions
- Brigham and Women's Hospital (US)
- Boehringer Ingelheim (Germany) (DE)
- Harvard University (US)
- University of Freiburg (DE)
- King's College London (GB)
- Medical College of Wisconsin (US)
- Washington University in St. Louis (US)
- Sultanah Aminah Hospital (MY)
- University of Alabama at Birmingham (US)
- King's College School (GB)
- Boehringer Ingelheim (China) (CN)
- Teikyo University (JP)
- University of Lübeck (DE)
Publication Details
- Journal
- Dermatology and Therapy
- Published
- 2025-02-01
- DOI
- https://doi.org/10.1007/s13555-024-01325-7
- Primary Topic
- Drug-Induced Adverse Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Boehringer Ingelheim