(AD) receiving systemic therapy in a real-world setting, according to a recently published population-based study.
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When compared with methotrexate, there was a significant reduction in risk of serious infection at 6 months for patients with AD receiving cyclosporine. Prednisone, azathioprine, and mycophenolate carried higher risks of serious infections at 6 months than methotrexate or cyclosporine, researchers said in the study, which appeared in the Journal of the American Academy of Dermatology.
“Among non-biologic systemic agents, cyclosporine and methotrexate appear to have better safety profiles than mycophenolate, azathioprine, and systemic prednisone with regard to serious infections,” they concluded. “These findings may help inform clinicians in their selection of medications for patients requiring systemic therapy for atopic dermatitis,” Maria C. Schneeweiss, MD, from the departments of dermatology and medicine and Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, Boston, and colleagues wrote in their study.
Using population-based claims data, the researchers evaluated rates of serious infection requiring hospitalization in 232,611 patients between January 2003 and January 2017 who received methotrexate, cyclosporine, azathioprine, prednisone or mycophenolate for treatment of AD. Patients first received the same level of corticosteroids before moving to systemic therapy or phototherapy. They also compared results with 23,908 patients in a second cohort who were new users of dupilumab (391 patients) or non-biologic systemic immunomodulators (23,517).
Overall, the rate of serious infections was 7.53 per 1,000 for patients receiving systemic non-biologic therapy at 6 months compared with 7.38 per 1,000 for patients receiving phototherapy, and 2.6 per 1,000 for patients receiving dupilumab.
When matching using propensity scores, the researchers found a significantly reduced risk at 6 months of serious infections from cyclosporine compared with methotrexate (relative risk, 0.87; 95% confidence interval, 0.59-1.28). Compared with methotrexate, there was an increased risk of serious infection at 6 months for azathioprine (RR, 1.78; 95% CI, 0.98-3.25), prednisone (RR, 1.89; 95% CI, 1.05-3.42) and mycophenolate (RR, 3.31; 95% CI, 1.94-5.64).
According to preliminary data, when compared with patients who received non-biologic systemic therapy, there was no increased risk for patients receiving dupilumab (RR, 0.33; 95% CI, 0.03-3.20). Dupilumab was approved in March 2017, and “with one year of data resulting in one event among 391 patients, this analysis is limited but does not show an obvious signal for increased risk” for dupilumab, they wrote.
Dr. Schneeweiss and colleagues noted some of their analyses had wide confidence intervals, they did not account for dosing schemes or cumulative dose exposure over the study period, and the data on dupilumab showing no increase were preliminary and not conclusive.
“Our findings on systemic non-biologics are highly plausible, given the known risk of systemic immunomodulators in patients treated for other indications, the meaningful effect size, and the methodologically robust approach with a new-user active-comparator design and propensity score matching,” the researchers said.
This study was funded in part by Brigham and Women’s Hospital in Boston. One author reported being a consultant for multiple pharmaceutical companies. The other authors report no relevant conflicts of interest.
SOURCE: Schneeweiss M, et al. J Am Acad Dermatol. 2019. doi:10.1016/j.jaad.2019.05.073.