Source: DGNews  |  Posted 1 year ago

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