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Review
. 2025 Mar-Apr;18(3-4 Suppl 1):S16-S23.

Interpreting Safety Analyses in Psoriasis Clinical Trials

Matthew Zirwas  1 , Cynthia Trickett  2 , Joe Gorelick  3 , Kejia Wang  4 , Keith Wittstock  4 , Chaya Rosenberg  4 , Douglas DiRuggiero  5
Affiliations
Review

Interpreting Safety Analyses in Psoriasis Clinical Trials

Matthew Zirwas et al. J Clin Aesthet Dermatol. 2025 Mar-Apr.

Abstract

Clinical trials are designed to evaluate the efficacy and safety of new drugs. However, greater focus is often placed on efficacy rather than safety. This review article discusses the fundamentals involved in evaluating the safety of a new drug. In addition, the principal challenges involved in the collection, analysis, reporting, and interpretation of safety data in clinical trials are described using relevant examples. These challenges include the fact that clinical trials are generally limited in size and duration, exclude high-risk populations, and have limited statistical power to detect rare but potentially serious adverse events (AEs) that might occur in real-world situations. Reporting of safety data across clinical trials is also inconsistent. A thorough understanding of the interpretation of safety data, especially the appropriate use of exposure-adjusted incidence rates (EAIRs) in relation to AEs, as well as the importance of comparing rates to those reported in the general population and in patients with psoriasis, is vital for making a well-informed assessment of the safety of a new drug. The information provided in this article could be useful to healthcare providers who must evaluate a large volume of safety data when providing evidence-based treatment suggestions and recommendations to their patients.

Keywords: Adverse events; exposure-adjusted incidence rates; laboratory parameters; randomized controlled trials; safety.

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Conflict of interest statement

DISCLOSURES: Dr. Zirwas has served as a consultant, investigator, and/or speaker for AbbVie, Acrotech, Advanced Derm Solutions, Aldeyra, All Free Clear/Sun, Amgen, AnaptysBio, Apogee, Arcutis, Bausch and Lomb, Beiersdorf, Biocon, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Dermavant, Edessa Biotech, Evelo, Galderma, Google, Incyte, Janssen, L’Oreal, Leo Pharma, Level-Ex, Lilly, LUUM, Meta, Nimbus, Novan, Novartis, Pfizer, Q32 Bio, Regeneron, Sanofi, Sun Pharma, Supernus, Takeda, Trevi, Trifecta, UCB, and Verrica. Ms. Trickett has served as a speaker and consultant for AbbVie, Amgen, Bristol Myers Squibb, Incyte, Janssen, Journey Medical, Leo Pharma, Lilly, Ortho, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. Mr. Gorelick has served as a consultant and/or speaker for AbbVie, Amgen, Arcutis, Beiersdorf, Bristol Myers Squibb, Dermavant, Galderma, Incyte, Janssen, Leo Pharma, Lilly, Lyceum, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Verrica. Ms. Wang, Mr. Wittstock, and Ms. Rosenberg are employees of and shareholders in Bristol Myers Squibb. Mr. DiRuggiero has served as a speaker and consultant for AbbVie, Amgen, Arcutis, Bristol Myers Squibb, EPI Health, Incyte, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi Regeneron, and UCB.

Figures

FIGURE 1.
FIGURE 1.
Safety analyses in clinical trials AE: adverse event
FIGURE 2.
FIGURE 2.
Types of analyses performed during each phase of a psoriasis clinical trial
FIGURE 3.
FIGURE 3.
Comparison of safety across hypothetical psoriasis clinical trials AE: adverse event; AESI: adverse event of special interest; EAIR: exposure-adjusted incidence rate; MACE: major adverse cardiovascular event; PSOLAR: Psoriasis Longitudinal Assessment and Registry; SAE: serious adverse event; VTE: venous thromboembolic event
See this image and copyright information in PMC

References

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