A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria.
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Date
2014-03
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Abstract
Background: Chronic urticaria not responsive to antihistamines is a diffi cult disease to manage.
Methotrexate has been used in diffi cult chronic urticarias with some benefi t. Objective: To
evaluate the effi cacy of methotrexate in the treatment of chronic spontaneous urticaria poorly
responsive to H1 antihistaminics. Methods: In a randomized double-blind trial at the Department
of Dermatology and Venereology of a tertiary care centre, 29 patients with chronic spontaneous
urticaria not responding well to H1 antihistaminics were recruited. Patients were randomly
allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo (calcium
carbonate) for a total duration of 12 weeks, after which treatment was stopped and patients
were followed up for relapse of urticaria. Each group also received levocetrizine 5 mg once daily
for symptom control. Primary outcome measured was a reduction by >2/3rd of baseline urticaria
scores after 12 week therapy. Secondary outcome was a reduction in antihistamine requirement
after stopping therapy. Results: Fourteen patients were randomized to the methotrexate
group and fi fteen patients to the placebo group. Out of 17 patients who completed therapy,
the primary outcome was achieved by 3.5 ± 1.9 (out of 10) patients in the methotrexate group
and by 3.67 ± 1.03 (out of 7) patients in the placebo group (P > 0.05). Ten patients followed
up, after stopping therapy, for a mean period of 3.5 ± 2.4 months; 3 remained in remission and
7 had relapsed. One patient had uncontrollable nausea and vomiting after taking methotrexate
and was withdrawn from the study. The placebo group did not experience any side effects.
Conclusions: Methotrexate 15 mg weekly for 3 months did not provide any additional benefi t
over H1 antihistamines in this study but an adequately powered study with longer follow up is
required to assess its utility.
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Keywords
Antihistamine resistant urticaria, chronic idiopathic urticaria, chronic spontaneous urticaria, methotrexate in urticaria, randomized controlled trial in chronic urticaria
Citation
Sharma Vinod K, Singh Saurabh, Ramam M, Kumawat Mahesh, Kumar Rakesh. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria. Indian Journal of Dermatology, Venereology and Leprology. 2014 Mar-Apr; 80(2): 122-128.