PsA Trial Design Can Improve Patient Safety, Outcomes

Drs. Coates and Ogdie also expressed concerns about the ethics and value of including placebo arms in trials. Both emphasized the need to design studies with active comparator arms and measures of deeper response. In addition, phase 4 trials and longitudinal observational studies in PsA would better address safety than long-term extension studies, Dr. Coates said.

Vanessa Caceres is a medical writer in Bradenton, Fla.

References

1. Orbai A-M, de Wit M, Mease P, et al. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis. 2017 Apr;76(4):673–680.
2. European Medicines Agency. Letter of support for Minimal Disease Activity Score as primary outcome instrument for clinical studies in psoriatic arthritis. 2022 Feb 22. https://www.ema.europa.eu/en/documents/other/letter-support-minimal-disease-activity-score-mda-primary-outcome-instrument-clinical-studies_en.pdf.