Safety and efficacy of oral tofacitinib compared with oral cyclosporin A in cases of refractory chronic spontaneous urticaria, an open label clinical trial

This study aims to compare the efficacy and safety of oral Cyclosporin A (CsA) versus tofacitinib in managing refractory chronic spontaneous urticaria (CSU) and to evaluate patient satisfaction across treatment groups. Conducting it as a randomised, non-blind, open-label study, we will enrol male and female patients diagnosed with refractory CSU at a tertiary care centre. Patients aged 18–60 years, with persistent CSU despite fourfold second generation antihistamine therapy for up to or more than 4 weeks, will be eligible, while those with concurrent immunosuppressive use, positive autologous serum skin test, acute urticaria, specific comorbidities, or hypersensitivity to the study drugs will be excluded. Participants will be randomly assigned to receive either dose dependent CsA or 5 mg tofacitinib twice daily for up to six months or until complete symptom resolution with a post treatment monthly follow-up for 3 months.

 Baseline assessments will include detailed demographic and clinical history, laboratory investigations, and calculation of the urticaria activity score (UAS). Treatment response will be monitored at follow-up visits (monthly), with efficacy determined by UAS7 score reduction. Patient-reported satisfaction and any adverse events will also be recorded to assess tolerability and safety. Statistical analysis will be conducted using SPSS software to compare outcomes between the two treatment groups. The study’s structured approach will yield valuable insights into the comparative effectiveness of CsA and tofacitinib, guiding personalised treatment strategies for refractory CSU. By providing objective data on efficacy, safety, and patient-reported outcomes, this research seeks to enhance therapeutic precision with clinical management optimisation in this challenging dermatologic condition, providing insights into treatment preferences.