Review Unpacks Safety Data in Psoriasis Trials
Key Takeaways
Safety data in psoriasis trials are often inconsistently collected and reported, limiting clinical utility.
Exposure-adjusted incidence rates (EAIRs) provide accurate assessment, but need careful interpretation.
Comparing adverse event rates to psoriasis-specific registries and the general population may provide critical context for dermatologists.
While clinical trials frequently emphasize efficacy, safety data often remain inconsistently analyzed and underreported, according to the authors of a new review in the Journal of Clinical and Aesthetic Dermatology.
"Statistical approaches used to analyze efficacy data tend to be more rigorous than those applied to safety data," the authors wrote. "Safety data are also frequently presented in tabular rather than graphical form, which can hinder the interpretation of results. Therefore, inadequacies exist in the capture, analysis, and reporting of safety data, which can preclude a thorough evaluation of the risk-benefit profile of a new drug."
The review, authored by a multidisciplinary team of clinicians and researchers from Bristol Myers Squibb, emphasized the need for clinicians to scrutinize safety outcomes with the same rigor as efficacy. Unlike crude incidence rates, the report noted, exposure-adjusted incidence rates (EAIRs) account for considerations such as treatment durations and crossover designs by measuring AEs per 100 person-years. This plays an important role in long-term psoriasis trials where treatment exposure is not uniform. The authors cautioned that EAIRs can be misleading if recurrences of the same AE are not accounted for.
“Exposure-adjusted incidence rates should be presented for each AE observed with a new drug, and rates should be compared to those reported in the psoriasis population not receiving the study drug,” the authors write. Registries such as PSOLAR and national databases like SEER can provide valuable comparators.
The authors urged clinicians to also consider specific adverse events of special interest (AESIs), such as serious infections, malignancies, or major adverse cardiovascular events (MACE). However, detection of these signals in trials is limited by sample size and duration. They also noted that boxed warnings, such as those required for Janus kinase (JAK) inhibitors—may reflect class-based risks rather than product-specific data, complicating interpretation. Graphical data presentation and transparent adjudication processes were also recommended to help identify safety trends potentially obscured in tabular reports.
Ultimately, the review writers advocated for standardized reporting of safety outcomes, pointing to a 2019 review showing that just 5% of trials reported AE duration and less than a third disclosed timing of events. Without consistent parameters, comparing trials or conducting meta-analyses becomes challenging.
“Clinical trials are generally limited in size and duration, exclude high-risk patient populations, and have limited statistical power to detect rare but potentially serious AEs,” the authors wrote. “A thorough understanding of the interpretation of safety data [...] is vital to making a well-informed assessment of the safety of a new drug.”
Source: Zirwas Matthew, et al. J Clin Aesthet Dermatol. 2025;18(3–4 Suppl 1):16–23.