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Brief Report |

High-Dose Intravenous Pulse Methotrexate in Patients With Eosinophilic Fasciitis ONLINE FIRST

Jorre S. Mertens, MD1,2; Manon C. Zweers, MD, PhD1; Wietske Kievit, PhD3; Hanneke K. A. Knaapen, MD4; Martijn Gerritsen, MD, PhD5; Timothy R. D. J. Radstake, MD, PhD2,6; Frank H. J. van den Hoogen, MD, PhD4; Marjonne C. W. Creemers, MD, PhD7; Elke M. G. J. de Jong, MD, PhD1
[+] Author Affiliations
1Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands
2Laboratory of Translational Immunology, University Medical Centre Utrecht, Utrecht, the Netherlands
3Department of Epidemiology, Health Evidence, Radboud University Medical Centre, Nijmegen, the Netherlands
4Department of Rheumatology, Radboud University Medical Centre & Sint Maarstenskliniek, Nijmegen, the Netherlands
5Department of Rheumatology, Westfriesgasthuis, Hoorn, the Netherlands
6Department of Rheumatology and Clinical immunology, University Medical Centre Utrecht, Utrecht, the Netherlands
7Department of Rheumatology, Jeroen Bosch Hospital-Hertogenbosch, the Netherlands
JAMA Dermatol. Published online August 17, 2016. doi:10.1001/jamadermatol.2016.2873
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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

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Figure.
Skin Induration and Improvement Scored With Modified Skin Score

A, The primary outcome measure, skin induration, scored with modified skin score (mSS) at baseline and at month 5 for each patient. B, Improvement in mSS at month 5 compared with baseline (Δ mSS); Δ mSS for MTX-naive (left column) and MTX nonnaive (right column) are displayed by scatter plot and median.Comparison of median Δ mSS scores between the 2 subgroups showed no significant difference (P = .97). For 2 patients (Nos. 6 and 8) mSS scores were missing at month 5 and observations from month 4 were carried forward.

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