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| |  Meta-analysis Reveals Low Infection Rates With Methotrexate in Psoriasis: Presented at AAD By Micheal Casasnovas MIAMI BEACH, Fla -- March 10, 2010 -- A meta-analysis of more than a score of randomised clinical trials of the administration of methotrexate in psoriasis and rheumatoid arthritis indicated the rate of serious infectious events to be about 2 per 100 patient-year exposures, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). “This rate is consistent with past large observational studies,” said Jennifer Gloeckner Powers, MD, Grand Rapids Medical Research Center, Grand Rapids, Michigan, who explained on March 8 that data on serious infectious events from methotrexate in psoriasis and psoriatic arthritis are limited and cannot provide meaningful conclusions, unless researchers can use meta-analysis to put the data into perspective. Dr. Powers examined literature from EMBASE, MEDLINE, CINAHL, and the Cochrane Library from January 2005 until May 2009 to estimate serious infectious events occurring in randomised, placebo-controlled trials of oral methotrexate 7.5-30.0 mg weekly for psoriasis, psoriatic arthritis, and rheumatoid arthritis. To be included in the meta-analysis the trials were conducted for a minimum of 12 weeks with dropout rates of <=20%. Of 79 potential articles examined, the meta-analysis included 27 studies on the use of methotrexate. Researchers used 5 relevant psoriasis studies to determine 2.2 serious infectious events per 100 patient-years (P = .220). Five studies on psoriatic arthritis revealed 0.9 serious infectious events per 100 patient-years (P = .263). After review of 17 related rheumatoid arthritis studies, researchers found 2.3 serious infectious events per 100 patient-years. Although the infection rate was marginally different from the psoriasis and psoriatic arthritis groups, the larger number of studies and patients produced a statistically significant value for the rheumatoid arthritis group (P < .001). “There are a lot of interesting case reports about opportunistic infections,” said Dr. Powers. “I think these data at least give us an idea of the inherent risk with methotrexate.” She said the study was spurred by the decision in 2009 by the US Food and Drug Administration to phase withdrawal of efalizumab from the US market because of increasing concerns of a link to progressive multifocal leucoencephalopathy. “Biologic agents have transformed psoriasis treatment, but they are associated with increased serious infectious events and significant expense, which revives interest in the comparative efficacy of standard versus new therapies,” she said. The feasibility of standard therapies like methotrexate as psoriasis treatment hinges on a more accurate measurement of serious adverse events such as serious infectious events. [Presentation title: Incidence of Serious Infectious Events With Methotrexate Treatment: Metaanalysis of Randomized Controlled Trials. Abstract P207]
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