Methotrexate for inflammatory skin disease in pediatric patients: Consensus treatment guidelines

Elaine C. Siegfried, SSM Cardinal Glennon Children's Hospital, St. Louis, Missouri, USA.
Lisa M. Arkin, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Yvonne E. Chiu, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Adelaide A. Hebert, UTHealth McGovern Medical School at Houston, Houston, Texas, United States.
Jeffrey P. Callen, University of Louisville School of Medicine, Louisville, Kentucky, USA.
Leslie Castelo-Soccio, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Dominic O. Co, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Kelly M. Cordoro, University of California, San Francisco, California, USA.
Megan L. Curran, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado, USA.
Austin M. Dalrymple, SSM Cardinal Glennon Children's Hospital, St. Louis, Missouri, USA.
Carsten Flohr, Department of Paediatric Dermatology, St John's Institute of Dermatology, Guy's & St Thomas' NHS Foundation Trust, London, UK.
Ken B. Gordon, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Diane Hanna, Modern Dermatology, Shawnee, Kansas, USA.
Alan D. Irvine, Trinity College Dublin, Dublin, Ireland.
Susan Kim, University of California, San Francisco, California, USA.
A Yasmine Kirkorian, George Washington University School of Medicine & Health Sciences, Washington, DC, USA.
Irene Lara-Corrales, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Jill Lindstrom, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.
Amy S. Paller, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Melissa Reyes, US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
Wendy Smith Begolka, National Eczema Association, Novato, California, USA.
Wynnis L. Tom, University of California, San Diego School of Medicine, San Diego, California, USA.
Abby S. Van Voorhees, Eastern Virginia Medical School, Norfolk, Virginia, USA.
Ruth Ann Vleugels, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts, USA.
Lara Wine Lee, Medical University of South Carolina, Charleston, South Carolina, USA.
Olivia M. Davies, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Heather A. Brandling-Bennett, Seattle Children's Hospital, Seattle, Washington, USA.

Document Type

Journal Article

Publication Date

6-14-2023

Journal

Pediatric dermatology

DOI

10.1111/pde.15327

Keywords

adolescent; child; guideline; infant; methotrexate

Abstract

Methotrexate (MTX) is a readily accessible drug, first used in 1948 and employed for a wide variety of indications since then. However, despite widespread off-label use, FDA labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata, among others. Without published treatment guidelines, some clinicians may be hesitant to use MTX off-label, or uncomfortable prescribing MTX in this population. To address this unmet need, an expert consensus committee was convened to develop evidence- and consensus-based guidelines for use of MTX to treat pediatric inflammatory skin disease. Clinicians with experience and expertise in clinical research, drug development, and treating inflammatory skin disease in pediatric patients with MTX were recruited. Five committees were created based on major topic areas: (1) indications and contraindications, (2) dosing, (3) interactions with immunizations and medications, (4) adverse effects (potential for and management of), and (5) monitoring needs. Pertinent questions were generated and addressed by the relevant committee. The entire group participated in a modified Delphi process to establish agreement on recommendations for each question. The committee developed 46 evidence- and consensus-based recommendations, each with >70% agreement among members, across all five topics. These are presented in tables and text, along with a discussion of supporting literature, and level of evidence. These evidence- and consensus-based recommendations will support safe and effective use of MTX for the underserved population of pediatric patients who may benefit from this valuable, time-honored medication.

Department

Dermatology

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