Long‐Term Real‐World Effectiveness of Rupatadine in Chronic Urticaria: A Retrospective Observational Study

ABSTRACT Background Chronic urticaria (CU) impacts health‐related quality of life, particularly when chronic spontaneous urticaria (CSU) is associated with angioedema and/or chronic inducible urticaria (CIndU). The efficacy of second‐generation antihistamines (SgAHs) in treating CU has been demonstrated but there is limited information regarding real‐world data (RWD) effectiveness. Objectives To provide insight into the clinical practice of CU with SgAHs through RWD reporting on rupatadine's long‐term effectiveness. Methods An observational retrospective single‐center study analyzed a cohort of CU outpatients ( n = 1672) from the URTICARIA Registry (Hospital del Mar Research Institute, Barcelona, Spain). Pharmacological therapies were analyzed at baseline (V1), one (V2), three (V3) and five (V4) years of follow‐up. Effectiveness of rupatadine (10–40 mg/day) in monotherapy or combination was assessed, with the Urticaria Activity Score 7 (UAS7) in CSU patients and with the Urticaria Control Test (UCT) in CIndU patients. Results Of the 1081 patients treated at V1, SgAHs at licensed doses was the most frequent regimen, received by 45.3% ( n = 490). Of the 398 patients receiving rupatadine at V1, 56.3% were in monotherapy and 43.7% in combination. Continuous rupatadine treatment along visits ( n = 196) showed a significant improvement at V2 in all types of urticaria, in CSU alone according to UAS7 scores (−13.3 points; 95% CI: −16.3 to −10.3; p < 0.0001) and in CIndU based on UCT scores (1.7 points 95% CI: 0.9 to 2.5; p = 0.0001) and maintained long‐lasting improvements at V3 and V4. Conclusions CSU and CIndU patients were treated commonly with SgAHs according to guidelines, and rupatadine effectively reduced symptoms, being safe over the long term.