Long-term safety and efficacy of rupatadine in Japanese patients with itching due to chronic spontaneous urticaria, dermatitis, or pruritus: A 12-month, multicenter, open-label clinical trial

J Dermatol Sci. 2019 Jun;94(3):339-345. doi: 10.1016/j.jdermsci.2019.05.008. Epub 2019 Jun 1.


Background: Rupatadine is a novel H1 antihistamine with platelet-activating factor antagonist activity. Its efficacy and safety on pruritic skin diseases have been demonstrated by 10mg/day rupatadine in a two weeks clinical trial.

Objective: To investigate the long-term efficacy and safety of rupatadine in the management of pruritus, and the clinical effect of updosing to 20mg in Japanese adult and adolescent patients.

Methods: In this 52-week, multicenter, open-label clinical trial (JapicCTI-152787), 206 patients (132, eczema or dermatitis; 58, pruritus; and 16, chronic spontaneous urticaria) received the study medication. The primary efficacy endpoint was change from baseline in the total pruritus score to Week 2 by treatment with rupatadine 10mg once daily. From Week 3 to Week 52, rupatadine updosing to 20mg was allowed.

Results: The mean [95% CI] change from baseline to Week 2 in the total pruritus score was -1.241 [-1.450, -1.033] (paired t test, P< 0.001). The therapeutic effect persisted up to Week 52 (paired t test, P< 0.001). Adverse drug reactions (ADRs) were reported at an overall incidence of 18.0% (45 events in 37 patients). No serious or clinically significant ADRs were reported. Somnolence was the most common ADR (14.1%).

Conclusions: This clinical trial demonstrated the short- and long-term benefits of rupatadine in the management of patients with chronic spontaneous urticaria, dermatitis, and pruritus. Rupatadine 10 and 20mg doses are effective for the treatment of itch in adults and adolescents, and can be used safely on a long-term basis.

Keywords: Chronic spontaneous urticaria; Dermatitis/eczema; Pruritus; Rupatadine; Second-generation antihistamine.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Chronic Urticaria / complications
  • Chronic Urticaria / drug therapy*
  • Cyproheptadine / administration & dosage
  • Cyproheptadine / analogs & derivatives*
  • Dose-Response Relationship, Drug
  • Eczema / complications
  • Eczema / drug therapy*
  • Female
  • Histamine H1 Antagonists, Non-Sedating / administration & dosage*
  • Histamine H1 Antagonists, Non-Sedating / adverse effects
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Pruritus / diagnosis
  • Pruritus / drug therapy*
  • Pruritus / etiology
  • Severity of Illness Index
  • Sleepiness
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Histamine H1 Antagonists, Non-Sedating
  • rupatadine
  • Cyproheptadine