Resources for Clinical Research in the JID
- Clinical trials have several important limitations for evaluating the safety of new medications, leading to many adverse events not being identified until the postmarketing period. Descriptive studies, including case reports, case series, cross-sectional, and ecologic studies, help identify potential safety signals and generate hypotheses. Further research using analytic study methods, including case-control studies and cohort studies, are necessary to determine if an association truly exists and to better understand the potential for causation.
- Over the last decade a large body of epidemiological, translational, and animal model research has suggested that psoriasis may be a risk factor for cardiovascular and metabolic disease. Outcome based studies often suggest that patients with more severe psoriasis have an increased risk of major cardiovascular events independent of traditional risk factors that are captured in electronic health data. The study by Parisi and colleagues finds that incident severe psoriasis is associated with a non-statistically significant increased risk of major cardiovascular events, HR 1.28 (95% CI 0.96–1.69) in their primary model and a statistically significant increased risk, HR 1.46 (95% CI 1.11, 1.92), in a sensitivity analysis that excludes patients with inflammatory arthritis.
- The Psoralen plus Ultraviolet-A (PUVA) cohort study has been a tremendous success in determining how a novel treatment (i.e., PUVA) affects the long-term risk of keratinocyte carcinoma. The ability to follow patients from the initial multicenter clinical trial for more than three decades has been a remarkable achievement in dermatoepidemiology. In this issue, Stern and Huibregtse report results from the PUVA follow-up study and conclude that only patients with exceptionally severe psoriasis have an increased overall mortality risk and that there is no significant risk of cardiovascular mortality associated with psoriasis.
- In this issue, Wakkee and colleagues report a self-described exploratory cohort study and conclude that psoriasis may not be an independent risk factor for ischemic heart disease (IHD) hospitalization and that there is only a slight and borderline increased risk of ischemic heart disease among psoriasis patients. This negative result should be interpreted in light of the study’s limitations, the complex relationship among levels of psoriasis severity, patient age, and cardiovascular (CV) risk, and the context of the rapidly growing literature.