A safety checklist before initiating second-generation immunomodulating drugs for inflammatory dermatoses: a systematic review
Clinical Snapshot
PICO Framework
| P — Population | Clinicians prescribing second-generation immunomodulating drugs for inflammatory dermatoses |
| I — Intervention | Safety checklist based on regulatory contraindications and warnings |
| C — Comparator | Current practice without standardised safety checklist |
| O — Outcomes | Identification of contraindications, special warnings, and boxed warnings for drug classes |
Bottom Line
This systematic review compiles regulatory safety information into a practical checklist for second-generation immunomodulating drugs in inflammatory dermatoses. While methodologically limited as a regulatory data compilation rather than traditional systematic review, it addresses a genuine clinical need. The work identifies infection risks as the most common concern across drug classes, with herpes zoster and hepatitis reactivation being particularly prevalent warnings. Malignancy risks were noted for most classes except newer interleukin inhibitors. The resulting safety checklist provides immediate clinical utility for dermatologists and other specialists prescribing these agents. However, clinicians should recognise this represents regulatory warnings rather than evidence-based risk quantification, and individual patient risk assessment remains essential. The checklist format enhances systematic safety evaluation before treatment initiation, potentially improving patient safety outcomes.
Key Findings
Effect Size: Not applicable - descriptive synthesis
Primary Outcome: Safety checklist covering contraindications and warnings for second-generation immunomodulating drugs
Nnt Or Sensitivity: Infection warnings most common across drug classes, with herpes zoster risk in 5 classes and hepatitis reactivation in 6 classes
Clinical Application
Highly feasible - provides practical checklist for routine clinical use Directly applicable to Australian practice - TGA warnings align with EMA/FDA, relevant for PBS prescribing requirements and specialist dermatology practice All clinicians prescribing biologics and targeted synthetic DMARDs for inflammatory dermatoses
Abstract
BACKGROUND/AIM: Second-generation immunomodulating drugs for inflammatory dermatoses have expanded over the past decades. Contraindications and special warnings must be considered before starting any treatment, but identifying all relevant safety information can be time-consuming. The objective is to provide an overview of contraindications, special warnings, and boxed warnings with the aim to establish a safety checklist, covering second-generation immunomodulatory therapies. METHODS: We identified contraindications, special warnings and boxed warnings provided by the European Medicines Agency and the US Food and Drug Administration, for second-generation immunomodulating drugs approved for inflammatory dermatoses. Both topical and systemic therapies were included. RESULTS: Most drug classes had warnings related to infections. Herpes zoster was listed for anti-CD20, IL-12/23i, INFi, JAKi and TYK2i, where hepatitis reactivation was reported for anti-CD20, TNFi, IL-17i, anti-BAFF, JAKi and TYK2i. Malignancy risk including skin cancer was mentioned for most classes, except IL-23i, IL-17i, IL-13i, IL-4/13i, IL-31i, IL-36i and PDE4i. Other serious warnings included neurological, cardiovascular, thrombotic, hepatic, renal, gastrointestinal, and psychiatric adverse events. CONCLUSION: This work provides a simple stepwise approach to managing contraindications and special warnings. Our safety checklist gives clinicians a rapid overview of contraindications, special warnings, and boxed warnings for the available drug classes approved for inflammatory dermatoses.
References
- 1.Haysen, S. R., Skaarup, L., Poulsen, S., Kragstrup, T. W., Vestergaard, C., & Thomsen, K. (2026). A safety checklist before initiating second-generation immunomodulating drugs for inflammatory dermatoses: a systematic review. The Journal of Dermatological Treatment. https://doi.org/10.1080/09546634.2026.2665068
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