BIOBADADERM Registry Identifies, Compares Safety Profiles of Several Systemic Treatments for Psoriasis

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2 syringes and various colored and shaped pills
Comparative safety data in real-life settings from 9 psoriasis treatments could aid clinicians in selecting the most appropriate treatments for their patients.

Treatment of moderate to severe psoriasis with either ustekinumab or secukinumab is associated with substantially lower adverse events (AEs) than other systemic drugs and biologic agents, including cyclosporine and infliximab, according to study data published in the Journal of the American Academy of Dermatology.

A total of 2845 patients with moderate to severe psoriasis from the national, multicenter BIOBADADERM registry were included in this study. Patients who started a biologic agent or apremilast were compared with patients who received non-biologic classic systemic therapy for the first time. Systemic drugs assessed in the BIOBADADERM included acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab.

The analysis examined the rates of AEs, including any serious AE (SAE) that led to a therapy change, unplanned healthcare demand, prolonged hospitalization, persistent disability, or death. Only AEs that occurred during treatment or within 90 days after the last dose were considered related to the drug.

At the time of the analysis, patients had 8954 treatment cycles for a total of 9642 patient-years. The number of AEs and SAEs were 6225 and 604, respectively. Approximately 0.78% (n=49) of AEs were associated with a fatal outcome. Ustekinumab and secukinumab exhibited the lowest AE rate for several of the system organ class with a significantly decreased incidence rate ratio of <1. Cyclosporine and infliximab, however, featured the highest AE rate with a corresponding increased rate ratio of ≥5.

Limitations of the study included its observational design, the lack of a randomization protocol for drug allocation, as well as the lack of data on prescribed drug doses.

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The researchers suggest their findings can facilitate “the therapeutic selection decision through the detailed comparative knowledge of the safety profile of each drug in the real-life setting, as well as the potential risks to the different associated pathologies that patients may present.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Daudén E, Carretero G, Rivera R, et al; BIOBADADERM Study Group. Long term safety of nine systemic medications for psoriasis: a cohort study using the Biobadaderm Registry [published online March 22, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.03.033