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Methotrexate linked with adverse events in pediatric psoriasis

Methotrexate was associated with a higher rate of treatment-related adverse events than tumor necrosis factor inhibitors in a cohort of children with moderate to severe psoriasis.

The retrospective analysis included data for 390 consecutive pediatric patients who used systemic therapies or phototherapy at 20 centers in North America and Europe. Eligible participants underwent at least 3 months of treatment between Dec. 1, 1990, and Sept. 16, 2014.

A cross-section of demographic, disease-related, systemic medication-related, adverse event and discontinuation data underwent analysis. Participants were treated with one or more systemic medications and waited a median interval of 3 years between diagnosis and initiation of systemic therapy.

The most commonly used medication was methotrexate (69.2%), followed by biologic agents (primarily etanercept [Enbrel, Amgen]) at 27.2%, acitretin (14.6%), cyclosporine (7.7%) and fumaric acid esters (4.9%). Nearly one-fifth of the cohort (18.7%) underwent therapy with more than one systemic treatment.

Researchers reported one or more adverse events in 48.1% of children in the methotrexate group, with more than half of those occurrences being gastrointestinal. Gastrointestinal events were mitigated more effectively by folic acid treatment 6 days per week (OR = 0.16; P < .001) or 7 days per week (OR = 0.21; P = .003) than by a weekly dose, independent of the total dosage per week.

Hepatic transaminase elevations due to methotrexate therapy were linked to obesity in 13%; a similar association was not found with a folic acid regimen.

The most commonly reported events in children treated with TNF inhibitors were injection site reactions, which occurred in 18.9% of those patients. However, these events did not result in discontinuation.

Methotrexate was more likely than TNF inhibitors to be associated with one or more treatment-related events, gastrointestinal events, lab abnormalities or events leading to discontinuation. However, TNF inhibitors were associated with an increased likelihood of one or more medication-associated infections.

There were three serious treatment-related adverse events among patients receiving methotrexate, two among those receiving fumaric acid esters and one in a patient receiving adalimumab (Humira, AbbVie). However, the researchers noted that the treatment duration for methotrexate and biologic agents was twice as long as the duration for cyclosporine or fumaric acid esters. Tuberculosis or malignant neoplasm was not reported in the cohort.

There were slightly more girls than boys in the study, and the mean age at diagnosis was 8.4 years. – by Rob Volansky

Disclosures: Bronckers reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.