High-Dose Intravenous Pulse Methotrexate in Patients With Eosinophilic Fasciitis.

Abstract

Importance:

Eosinophilic fasciitis (EF) is a connective tissue disorder in which conventional treatment leads to disappointing results in a proportion of patients. Therefore, we investigated high-dose intravenous (IV) pulse methotrexate (MTX) as a treatment for EF.

Objective:

To examine safety and effects of monthly high-dose IV pulse MTX in EF.

Design, Setting, and Participants:

For this prospective single-arm study, we recruited 12 patients diagnosed with biopsy specimen-proven EF between 2006 and 2009 from the Department of Dermatology and Rheumatology at the Radboud University Medical Centre.

Interventions:

Intravenous MTX (4 mg/kg) monthly for 5 months with folinic acid rescue 24 hours after MTX administration.

Main Outcomes and Measures:

The primary outcome was improvement of the modified skin score at month 5 vs baseline. Secondary outcomes were durometry, range of motion, visual analog scale scores for disease activity, and 36-Item Short Form Survey health questionnaires.

Results:

Overall, 12 patients (11 women between 37-69 years old) received a median (range) monthly dose of 288 (230-336) mg MTX. Median (range) modified skin score improved from 17.5 (8.0-24.0) at baseline to 8.5 (1.0-20.0) at month 5 (P = .001). Secondary outcome measures improved significantly, except for durometer scores and range of motion of the elbows. Adverse events included gastrointestinal symptoms (n = 9), mild stomatitis (n = 5), and alopecia (n = 4).

Conclusions and Relevance:

High-dose IV pulse MTX is a safe and effective treatment option in EF.

Trial Registration:

clinicaltrials.gov Identifier: NCT00441961.

• Authors: Jorre S Mertens, Manon C Zweers, Wietske Kievit, Hanneke K A Knaapen, Martijn Gerritsen, Timothy R D J Radstake, Frank H J van den Hoogen, Marjonne C W Creemers, Elke M G J de Jong
• Journal: JAMA dermatology (JAMA Dermatol) Vol. 152 Issue 11 Pg. 1262-1265 (11 01 2016) ISSN: 2168-6084 [Electronic] United States
• PMID: 27541801 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Immunosuppressive Agents
• Methotrexate

Topics

• Adult
• Aged
• Eosinophilia (drug therapy)
• Fasciitis (drug therapy)
• Female
• Hospitals, University
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects)
• Male
• Methotrexate (administration & dosage, adverse effects)
• Middle Aged
• Prospective Studies
• Pulse Therapy, Drug (methods)
• Single-Blind Method
• Treatment Outcome