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
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).