Background: Chronic spontaneous urticaria (CSU) is a refractory dermatosis characterized by recurrent wheals and pruritus. Although omalizumab is recommended for patients failing antihistamine therapy, some patients remain unresponsive. Tofacitinib is an oral JAK inhibitor that exerts immunosuppressive effects by blocking the key intracellular inflammatory signaling pathway (JAK-STAT). Currently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and other conditions, it is also widely used in clinical practice for atopic dermatitis, vitiligo, and refractory chronic urticaria. Thus, tofacitinib may offer a novel therapeutic option for such patients. Methods: This retrospective study enrolled 10 CSU patients with suboptimal response to omalizumab who received tofacitinib (5 mg bid) for 24 weeks. Primary outcome was the proportion of patients achieving UCT (Urticaria Control Test) ≥ 12 at 12 weeks. Secondary outcomes included UAS7 (Urticaria Activity Score over 7 days) and UCT scores, along with safety events.Furthermore, through the review of medical records from the abovementioned 10 patients, it was found that all patients had completed blood routine, liver function, thyroid function, total IgE, antinuclear antibody, and coagulation tests prior to the initiation of this study’s treatment, or had undergone the same tests within the previous three months. After treatment began, the clinicians re-evaluated the above indicators within 3 to 6 months based on the patients’ specific conditions. Results: The median UAS7 score decreased significantly from baseline 21 points to a nadir of 0 points at week 8, maintaining a median of 7 points at week 24. 57.1% of patients remained in remission. The median UCT score increased from 6.5 points at baseline to 12 points at week 8, with continued improvement through week 24. Mild adverse reactions occurred in 3 patients (2 upper respiratory tract infections, 1 abnormal liver function), with no serious adverse events. Conclusion: Tofacitinib shows potential in treating CSU patients with inadequate response to omalizumab, offering significant early symptom improvement in some cases with manageable safety. Larger randomized controlled trials are needed for further validation. Keywords: chronic spontaneous urticaria, JAK inhibitor, tofacitinib, omalizumab, inadequate response
Zhang et al. (Sun,) studied this question.