Methotrexate may be used as a third-line therapy for treating chronic spontaneous urticaria, but it was not superior to placebo added to H1-antihistamines, according to a research letter in the Journal of the American Academy of Dermatology.
"Current guidelines for chronic spontaneous urticaria recommend second-generation H1-antihistamines as first-line treatment and to increase the H1-antihistamines dose in case of inadequate control. The third-line management includes the addition of other drugs, largely omalizumab or immunosuppressive drugs," Sophie Leducq, MD, from the department of dermatology, University Hospital of Tours, France, and colleagues wrote.
A multicenter, randomized, placebo-controlled, double-blinded, two parallel-group trial included 75 adults with chronic spontaneous urticaria who had previously received at least three different molecules of H1-antihistamines or H1-antihistamines with at least a double dose from 2011 to 2016. The patients were randomly selected 1:1 to receive methotrexate orally for 18 weeks or placebo in addition to H1-antihistamines.
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.
Thirty-nine patients receive methotrexate, and 36 received placebo. Three patients who received methotrexate and none of the patients who received placebo had complete remission at week 18 (difference, 7.9 percentage points [95% CI, –4.0 to 20.8]). 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.
“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,” Leducq and colleagues wrote. – by Alexandria Brooks
Disclosures: Leducq reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.