Real-World Safety of Treatment in Patients With Psoriasis Appears Comparable to Clinical Trial Reports

A 5-year analysis of adverse events in patients prescribed apremilast identified no new safety concerns with the medication, according to a study published in Drug Safety.

“These results provide evidence that the long-term safety profile of apremilast in psoriasis and psoriatic arthritis in a real-world setting is comparable to that reported in clinical trials and other real-world publications,” researchers wrote.

The longitudinal, prospective cohort study used data from a large United Kingdom general practice database to compare incidence rates of adverse events of special interest in 341 patients prescribed apremilast with 4981 patients prescribed other systemic treatments for psoriasis or psoriatic arthritis. The study period spanned January 2015 through June 2020.

Researchers identified no incident cases of vasculitis, hematologic malignancy, nonmelanoma skin malignancy, treated depression, treated anxiety, or suicidal behaviors in patients prescribed apremilast, according to the study. Incidence rates of all-cause mortality, major adverse cardiac events, tachyarrhythmias, and solid malignancies were similar in the apremilast cohort and the non-apremilast cohorts.

Incidence rates of opportunistic and serious infections per 1000 person-years were 64 in the apremilast-exposed cohort, 57 in the oral and injectable non-apremilast cohort, 50 in the oral non-apremilast cohort, and 20 in the injectable non-apremilast cohort.

“Of the 18 apremilast-exposed infection cases, five patients were also exposed to nonbiologic disease-modifying antirheumatic drugs or a steroid,” researchers wrote. “However, as the rates of infections were similar between the apremilast, oral-only, and oral and injectable cohorts, this increased risk of infections in the apremilast-exposed cohort compared with the injectable-only cohort should be considered in this greater context.”

Limitations of the study included the small number of patients prescribed apremilast as well as the potential for misclassification of exposure due to missing information on biologic and other specialty treatments, the authors noted.

Reference:
Persson R, Cordey M, Paris M, Jick S. Safety of apremilast in patients with psoriasis and psoriatic arthritis: findings from the UK Clinical Practice Research Datalink. Drug Saf. Published online September 23, 2022. doi:10.1007/s40264-022-01235-7