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An open-label, dose-ranging study of methotrexate for moderate-to-severe adult atopic eczema.
Br J Dermatol. 2007 Feb; 156(2):346-51.BJ

Abstract

BACKGROUND

Treatment options for moderate-to-severe atopic eczema are limited. Although methotrexate (MTX) is a widely used and effective treatment for psoriasis, there have been no previous prospective trials of its use in refractory atopic eczema, despite a few small, retrospective reports suggesting that it is a well-tolerated and effective treatment.

OBJECTIVES

We have assessed the safety and efficacy of oral MTX in 12 adults with moderate-to-severe atopic eczema in an open-label, dose-ranging, prospective trial using objective outcome measures.

METHODS

All patients had previously received other second-line therapies and had disease only partially responsive to potent topical steroids and emollients. During the 24-week MTX treatment period, unrestricted use of standard topical therapy was permitted. We used an incremental MTX dose regime, starting at 10 mg per week (following a 5-mg test dose) and increasing by 2.5 mg weekly until response was achieved or treatment was limited by toxicity. Disease activity [six area six sign atopic dermatitis (SASSAD) score] was assessed every 4 weeks during treatment and 12 weeks after stopping MTX. The primary endpoint was 24-week change in disease activity.

RESULTS

On average, disease activity improved by 52% from baseline (95% confidence interval 45-60%). There were significant improvements in quality of life, body surface area affected and loss of sleep and itch scores. Global response was rated as 'marked improvement' in five of 12 and six of 12 patients, by investigators and patients, respectively. In all patients, the majority of improvement in disease activity was seen by week 12, and, interestingly, patients who had not responded well over this period despite reaching a dose of 15 mg weekly failed to improve with further dose escalation. Only one patient withdrew due to minor adverse effects. MTX was well tolerated by the remaining 11 patients, all of whom completed treatment, achieving a median dose of 15 mg weekly. Importantly, eight of nine patients had a persistent improvement 12 weeks after stopping MTX, with mean disease activity remaining 34% below baseline.

CONCLUSIONS

We have shown that MTX is an effective, well-tolerated treatment for moderate-to-severe atopic eczema, and response appears to compare favourably with other second-line therapies. A randomized, controlled trial is now warranted.

Authors+Show Affiliations

Department of Dermatology, Royal Victoria Infirmary, Newcastle upon Tyne, UK. sophiecw@doctors.org.ukNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

17223876

Citation

Weatherhead, S C., et al. "An Open-label, Dose-ranging Study of Methotrexate for Moderate-to-severe Adult Atopic Eczema." The British Journal of Dermatology, vol. 156, no. 2, 2007, pp. 346-51.
Weatherhead SC, Wahie S, Reynolds NJ, et al. An open-label, dose-ranging study of methotrexate for moderate-to-severe adult atopic eczema. Br J Dermatol. 2007;156(2):346-51.
Weatherhead, S. C., Wahie, S., Reynolds, N. J., & Meggitt, S. J. (2007). An open-label, dose-ranging study of methotrexate for moderate-to-severe adult atopic eczema. The British Journal of Dermatology, 156(2), 346-51.
Weatherhead SC, et al. An Open-label, Dose-ranging Study of Methotrexate for Moderate-to-severe Adult Atopic Eczema. Br J Dermatol. 2007;156(2):346-51. PubMed PMID: 17223876.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, dose-ranging study of methotrexate for moderate-to-severe adult atopic eczema. AU - Weatherhead,S C, AU - Wahie,S, AU - Reynolds,N J, AU - Meggitt,S J, PY - 2007/1/17/pubmed PY - 2007/6/26/medline PY - 2007/1/17/entrez SP - 346 EP - 51 JF - The British journal of dermatology JO - Br J Dermatol VL - 156 IS - 2 N2 - BACKGROUND: Treatment options for moderate-to-severe atopic eczema are limited. Although methotrexate (MTX) is a widely used and effective treatment for psoriasis, there have been no previous prospective trials of its use in refractory atopic eczema, despite a few small, retrospective reports suggesting that it is a well-tolerated and effective treatment. OBJECTIVES: We have assessed the safety and efficacy of oral MTX in 12 adults with moderate-to-severe atopic eczema in an open-label, dose-ranging, prospective trial using objective outcome measures. METHODS: All patients had previously received other second-line therapies and had disease only partially responsive to potent topical steroids and emollients. During the 24-week MTX treatment period, unrestricted use of standard topical therapy was permitted. We used an incremental MTX dose regime, starting at 10 mg per week (following a 5-mg test dose) and increasing by 2.5 mg weekly until response was achieved or treatment was limited by toxicity. Disease activity [six area six sign atopic dermatitis (SASSAD) score] was assessed every 4 weeks during treatment and 12 weeks after stopping MTX. The primary endpoint was 24-week change in disease activity. RESULTS: On average, disease activity improved by 52% from baseline (95% confidence interval 45-60%). There were significant improvements in quality of life, body surface area affected and loss of sleep and itch scores. Global response was rated as 'marked improvement' in five of 12 and six of 12 patients, by investigators and patients, respectively. In all patients, the majority of improvement in disease activity was seen by week 12, and, interestingly, patients who had not responded well over this period despite reaching a dose of 15 mg weekly failed to improve with further dose escalation. Only one patient withdrew due to minor adverse effects. MTX was well tolerated by the remaining 11 patients, all of whom completed treatment, achieving a median dose of 15 mg weekly. Importantly, eight of nine patients had a persistent improvement 12 weeks after stopping MTX, with mean disease activity remaining 34% below baseline. CONCLUSIONS: We have shown that MTX is an effective, well-tolerated treatment for moderate-to-severe atopic eczema, and response appears to compare favourably with other second-line therapies. A randomized, controlled trial is now warranted. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/17223876/An_open_label_dose_ranging_study_of_methotrexate_for_moderate_to_severe_adult_atopic_eczema_ L2 - https://doi.org/10.1111/j.1365-2133.2006.07686.x DB - PRIME DP - Unbound Medicine ER -