November 4, 2015 • By
From Jan. 1, 2008, to Dec. 31, 2012, the long-term safety and outcomes of systemic treatments for moderate to severe psoriasis in adults (n=2,444) were investigated in 251 dermatology centers through the German Psoriasis Registry, PsoBest.1 Serious adverse events, which include infections, malignancies and major cardiac events, were the study’s main focus. Only prospectively observed adverse events were considered. Infections were further divided into serious, severe and non-severe categories.
Forty percent of patients were women, with a mean age of 47 years, a mean disease duration of 18.2 years (SD 14.7) and a mean Psoriasis Area and Severity Index (PASI) of 14.7 at study inclusion. Of the participants, 1,791 patients were treated with conventional agents, and 908 were treated with biological agents. Conventional agents included methotrexate, cyclosporine, retinoids and fumaric acid esters (not available in the U.S.). Biologic agents included adalimumab, etanercept, infliximab and ustekinumab. A total exposure time to conventional agents was 1,733 years and 1,463 years for biologics. These patients had significant co-medication and comorbidity compared with patients without psoriasis, including being smokers or ex-smokers, obesity (BMI>30), hypertension, diabetes and hyperlipidemia.
The overall rate of serious adverse events was 1.3 (SD 0.9) per 100 patient-years for conventional treatments and 1.5 (SD 1.2) per 100 patient-years for biologic treatments (p>0.5, no significant difference). The rates per 100 patient-years for single serious adverse events were: 0.33/0.65 (CI [confidence interval] 0.13–0.54/0.35–0.98) for systemic/biologic serious infections; 0.56/0.77 (CI 0.29–0.97/0.41–1.31) for major cardiac events; and 0.46/0.49 (CI 0.22–0.84/0.21–0.97) for malignancies (except nonmelanoma skin cancer). No significant differences between single drugs were noted in any of the safety parameters.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
1.Reich K, Mrowietz U, Radtke Ma, et al. Drug Safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Arch Dermatol Res. 2015 Sep 10. [Epub ahead of print]