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Safety of systemic agents for the treatment of pediatric psoriasis

JAMA Dermatology Nov 12, 2017

Bronckers IMGJ, et al. - Patterns of use and relative risks of systemic agents for moderate to severe psoriasis in children were evaluated. Compared with methotrexate, medication-related adverse events (AEs) occurred less often with tumor necrosis factor inhibitors. As compared to weekly administration, folic acid administration 6 or 7 times per week protected more against methotrexate-induced gastrointestinal AEs.

Methods

  • The researchers conducted a retrospective review at 20 centers in North America and Europe.
  • They included all consecutive children with moderate to severe psoriasis who used systemic medications or phototherapy for at least 3 months from December 1, 1990, to September 16, 2014.

Results

  • The mean interval between diagnosis and starting systemic therapy was 3.0 years for 390 children (203 girls and 187 boys; mean [SD] age at diagnosis, 8.4 [3.7] years) with psoriasis who used 1 or more systemic medications.
  • Two hundred and seventy patients (69.2%) used methotrexate, 106 (27.2%) used biologic agents (primarily etanercept), 57 (14.6%) used acitretin, 30 (7.7%) used cyclosporine, 19 (4.9%) used fumaric acid esters, and more than 1 medication was used by 73 (18.7%).
  • One hundred and thirty (48.1%) reported 1 or more AEs associated with methotrexate [primarily gastrointestinal (67 [24.8%])] among 270 children taking methotrexate.
  • Regardless of the total weekly dosage, folic acid 6 days per week (odds ratio, 0.16; 95% CI, 0.06-0.41; P < .001) or 7 days per week (OR, 0.21; 95% CI, 0.08-0.58; P=.003) protected against gastrointestinal AEs more than once-weekly folic acid.
  • Methotrexate-associated hepatic transaminase elevations were correlated with obesity (35 of 270 patients [13.0%]), but a folic acid regimen was not.
  • Out of 106 patients (18.9%) treated with tumor necrosis factor inhibitors, injection site reactions occurred in 20 but did not lead to discontinuation of treatment.
  • With methotrexate vs tumor necrosis factor inhibitors, having 1 or more AEs associated with the medication, gastrointestinal AE, laboratory abnormality, or AE leading to discontinuation of the drug was more likely, but having 1 or more infections related to medication (predominantly upper airway) was less likely.
  • A serious treatment-related AE was observed in 6 patients (methotrexate, 3; fumaric acid esters, 2; and adalimumab, 1).
  • However, methotrexate and biologic agents were taken for a mean duration that was 2-fold greater than the mean duration for cyclosporine or fumaric acid esters.
  • Tuberculosis or a malignant neoplasm was not reported by any patient.

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