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Narrow Band Ultraviolet B Phototherapy is Non-Inferior to Oral Cyclosporine In Patients with Antihistamine Refractory Chronic Spontaneous Urticaria: Results of A Randomised, Active Controlled Non-Inferiority Study
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  • Roshini N,
  • Hitaishi Mehta,
  • Anuradha B,
  • Vinod Kumar,
  • Ashok Kumar,
  • Davinder Parsad,
  • Muthu Sendhil Kumaran
Roshini N
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology
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Hitaishi Mehta
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology
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Anuradha B
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology
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Vinod Kumar
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology
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Ashok Kumar
Post Graduate Institute of Medical Education and Research
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Davinder Parsad
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology
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Muthu Sendhil Kumaran
Post Graduate Institute of Medical Education and Research Department of Dermatology Venereology and Leprology

Corresponding Author:[email protected]

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Abstract

Background: Cyclosporine is currently recommended as a third-line therapy for chronic spontaneous urticaria (CSU), while narrowband ultraviolet B (NB-UVB) phototherapy has shown promise. Objective: To compare the efficacy and safety of NB-UVB phototherapy versus cyclosporine in antihistamine-refractory CSU. Methods: This randomized, prospective, non-inferiority study recruited 50 patients with antihistamine-refractory CSU. Participants received either NB-UVB (thrice weekly) or cyclosporine (3 mg/kg/day) for 90 days alongside maximum-regulated doses of antihistamines, with a post-treatment follow-up of 90 days. Primary outcome was the Urticaria Activity Score over 7 days (UAS7), with secondary outcomes including Urticaria Control Test (UCT), Chronic Urticaria Quality of Life (CU-QoL), and biomarkers such as IL-6 and IL-31. Results: Both treatments significantly reduced UAS7 by day 15. NB-UVB provided sustained symptom control post-treatment, while cyclosporine achieved rapid relief but led to rebound flares upon discontinuation. The non-inferiority test showed that NB-UVB was not significantly worse than cyclosporine for UAS7 reduction. Both therapies reduced serum IgE, with IL-6 and IL-31 significantly decreasing in the cyclosporine group. Limitations: Single-center design, short follow-up duration. Conclusions: NB-UVB phototherapy is an effective and well-tolerated alternative to cyclosporine for antihistamine-refractory CSU, offering sustained disease suppression post-treatment. Further research is needed to explore long-term outcomes and broader applicability. Trial Registration: Clinical Trials Registry of India (CTRI/2022/11/047799).