Higher efficacy of rupatadine 20 mg and 10 mg versus placebo in patients with perennial allergic rhinitis: a pooled responder analysis.

BACKGROUND

The clinical efficacy of rupatadine in terms of responders has not been previously explored in perennial allergic rhinitis (PAR).

METHODS

This pooled analysis included data from 6 randomised, double-blind, placebo-controlled trials conducted in PAR patients treated with rupatadine 10 mg or 20 mg, or placebo. Participants were aged ≥ 18 years, with diagnosis of PAR and a Total 4 Nasal Symptom Score (T4NSS) ≥ 5. We evaluated the T4NSS and Total 5 Symptom Score (T5SS) for 28 days of treatment, the responder proportion (50% and 75% response), and the time to response.

RESULTS

Efficacy data from 1486 patients were analysed: 585 received placebo, 682 rupatadine 10 mg, and 219 rupatadine 20 mg. Compared with placebo, rupatadine promoted greater symptom improvements and higher responder proportions (50% and 75% response) for T4NSS and T5SS over 28 days. Symptom improvements and responder proportions were higher in the rupatadine 20 mg group vs the 10 mg group. The time to response was shorter in the rupatadine 20 mg group vs the 10 mg group for T4NSS (16 and 9 days for the 50% and 75% responses, respectively) and for T5SS (13 and 8 days for the 50% and 75% responses, respectively).

CONCLUSIONS

Rupatadine was efficacious in reducing allergic rhinitis symptoms, showing high responder proportions. The faster and stronger effect of rupatadine 20 mg may suggest its use in patients with severe PAR or not responding to the standard dose.

Informations de copyright

© The Author(s) 2020.

Déclaration de conflit d'intérêts

Competing interestsAV has previously received honoraria for speaking at sponsored meetings from Uriach, GSK, AstraZeneca, Chiesi and Novartis, and is a consultant and grants for research for AstraZeneca, Menarini, Uriach, Novartis, Mylan-MEDA Pharma and Sanofi-Aventis. II is an employee of Uriach. MLK is a member of the International Advisory Board of Rupatadine and received honoraria for lectures from GSK, Astra-Zeneca, Sandoz and TAKEDA. GKS has received research grants from Bayer, Regeneron, GSK and ALK; honoraria for articles, lectures/chairing and advisory boards for AstraZeneca, Brittania Pharmaceuticals, Capnia, Church & Dwight, Circassia, GSK, Uriach, Meda, Merck, MSD, OnoPharmaceuticals, Oxford Therapeutics, Sanofi-Aventis and UCB; travel funding from Bayer and GSK. JB reports personal fees from Chiesi, Cipla, Hikma, Menarini, Mundipharma, Mylan, Novartis, Purina, Sanofi-Aventis, Takeda, Teva, Uriach, and KYomed-Innov. JM has been a member of national and international scientific advisory boards (consulting), received fees for lectures, and grants for research projects from Allakos, ALK-Abelló, AstraZeneca, Genentech-Roche, Glenmark, GSK, Hartington Pharmaceuticals, Menarini, Mitsubishi-Tanabe, MSD, Mylan-MEDA Pharma, Novartis, Sanofi-Aventis, UCB, and Uriach.