For treatment of chronic spontaneous urticaria methotrexate not superior to placebo

France: Methotrexate is not superior to placebo+H1-antihistamines for the treatment of chronic spontaneous urticaria, so methotrexate may be used as third-line therapy, suggests a recent study in the Journal of the American Academy of Dermatology.

"In the current chronic spontaneous urticaria guidelines, second-generation H1-antihistamines is recommended as first-line treatment and in case of inadequate control increasing the dose of H1-antihistamines is recommended. The third-line management includes the addition of other drugs, largely omalizumab or immunosuppressive drugs, write the authors.

Sophie Leducq, from the department of dermatology, University Hospital of Tours, France, and colleagues conducted a multicenter, randomized, placebo-controlled, double-blinded, two parallel-group trials that included 75 adults with chronic spontaneous urticaria. The participants had previously received at least three different molecules of H1-antihistamines or H1-antihistamines with at least a double dose from 2011 to 2016. They were randomized in the ratio 1:1 to receive orally for 18 weeks or placebo in addition to H1-antihistamines. Thirty-nine patients receive methotrexate, and 36 received a placebo.

Complete urticaria remission at week 18, which was defined as no urticarial lesions within the 30 days before week 18, was the primary outcome. The secondary outcomes were pruritus, number of outbreaks per week, duration of lesions, number of lesions on the face and neck, quality of sleep, quality of life and safety.

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Key findings include:

• Three patients who received methotrexate and none of the patients who received placebo had complete remission at week 18.


• Over time, the quality of life score decreased; however, there was no significant difference in the change from baseline to week 18 between the two groups.


• The secondary outcomes also did not differ.


• The proportion of adverse events was similar between the two groups.


• Researchers did not attribute two serious adverse events in the methotrexate group to the drug.

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“In our study, H1-antihistamines were not always at quadruple dosage, but the regimen could not be changed during the study. We chose a hard criterion (ie, complete remission), and the study was double-blinded to allow high-level evidence,” wrote the authors.

To read the complete study log on to https://doi.org/10.1016/j.jaad.2019.07.097