Abstract
Background: Evidence on effectiveness and safety of methotrexate (MTX) in pediatric psoriasis is scarce. Objectives: To study the effectiveness and safety of MTX in pediatric plaque-type psoriasis and its influence on quality of life (Qol) in daily clinical practice. Methods: Subset analysis of prospectively collected data extracted from the Child-CAPTURE registry, a single center, longitudinal, long-term, observational daily practice cohort of pediatric psoriasis patients. A maximum dose between 0.14 and 0.63 mg/kg once weekly was prescribed in 25 children. Primary endpoints were percentages of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index (PASI) at week 12 and 24. Results: PASI75 was achieved in 4.3% and 33.3% of patients at week 12 and 24, whereas 40% and 28.6% reached PASI 75 at week 36 and 48. Median PASI and body surface area decreased from 10.0 (range 3.8–42.4) and 11.0 (range 3.5–72.0) at baseline to 4.3 (range 0–19.8) and 2.6 (range 0.0–39.6) at week 24, respectively. Physician Global Assessment improved significantly from 3.0 to 1.2 at week 24. A significant decrease in Children’s Dermatology Life Quality Index from 9.0 to 3.8 at week 24 was found. Most reported adverse events were severe nausea (n = 5), infections requiring antibiotics (n = 5) and tiredness (n = 4). Conclusions: MTX shows a positive effect on PASI scores, improves Qol and has a reasonable safety profile.
Declaration of interest
This study was supported by a grant from Pfizer. Pfizer had no role in the design of the study, collection, analysis and interpretation of the data, nor in preparation, review or approval of the manuscript. Medical writers were not used.
M. J. v. G. carried out clinical trials for Abbvie, Astellas, Leo Pharma and Pfizer. M. J. v. G. has received speaking fees from MSD and reimbursement for attending a symposium from Pfizer and Janssen. A. M. O. carried out clinical trials for Abbvie, Astellas, Leo Pharma and Pfizer. A. M. O. has received reimbursement for attending a symposium from Pfizer. E. P. A. H. H. carries out a clinical trial for Novartis and has travelled with Roche, Pfizer and Abbvie to congresses. J. C. M. H. none declared. P. C. M. v. d. K. has consultancy services for Schering Plough, Celgene, Centocor, Allmirall, Pfizer, Abbvie, Actelion, Galderma, Novartis, Jansen, Leo Pharma, Sandoz and Eli Lilly. He carries out clinical trials for Centocor, Pfizer, Schering Plough, Abbvie, Philips Lighting, Novartis, GalaxoSmithKline, Eli Lilly, Amgen and Allmiral. E. M. G. J. d. J. has received research grants for the independent research fund of the Department of Dermatology of Radboud university medical center, Nijmegen, the Netherlands from Abbvie, Pfizer and Janssen. She has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including Abbvie, Janssen, MSD and Pfizer. M. M. B. S. received grants from/was involved in clinical trials from Abbvie, Astellas, Leo Pharma and Pfizer. She served as a consultant for Abbvie, Astellas and Pfizer, gave lectures for Pfizer and travelled with Abbvie, Pfizer and Leo Pharma to meetings; fees were paid directly to the institution.