Rupatadine safe, effective for chronic spontaneous urticaria, dermatitis, pruritus
Rupatadine for the management of patients with chronic spontaneous urticaria, dermatitis and pruritus is safe in the short and long term, according to a recent Japan study.
Researchers conducted a multicentre, open-label clinical trial including 206 participants who were given the study medication. Efficacy was assessed primarily through the change in total pruritus score (TPS) from baseline to week 2. Rupatadine was administered initially at 10 mg once daily, though updosing to 20 mg was allowed starting week 3.
Of the participants, majority had eczema or dermatitis (n=132); 58 had pruritus and 16 had chronic spontaneous urticaria.
The primary efficacy analysis revealed a significant 2-week change in TPS (–1.241, 95 percent CI, –1.450 to –1.033; p<0.001). This remained significant even when restricting analysis to adolescents (mean change, –0.745; p=0.008) or adults (mean change, –1.304; p<0.001).
Disaggregating according to disease type likewise did not meaningfully change the results. Mean changes in disease score for those with eczema or dermatitis, pruritus and chronic spontaneous urticaria were –1.071, –1.183 and –2.971, respectively, and all of which were significant (p<0.001).
In terms of safety, the incidence rate of adverse events from baseline to week 2 was 18.9 percent. This climbed to 38.6 percent between weeks 3 and 12, and further to 67.8 percent between weeks 13 and 52. Adverse drug reactions showed an opposite, downward trend, starting at 9.7 percent between weeks 1 and 2 and dropping to 1.7 percent between weeks 13 and 52.