Eficácia, segurança e custo-efetividade do omalizumabe para urticária crônica espontânea em pacientes maiores de 12 anos refratários aos anti-histamínicos

Abstract

Technology: Omalizumab, from NOVARTIS Biosciences, is a nonspecific anti-IgE immunotherapy. It is registered as Xolair® in Brazilian Health Surveillance Agency. Indication: Treatment of moderate to severe chronic spontaneous urticaria (CSU) after failure with overdosage of H1 antihistamines. Question: Is omalizumab effective, safe and cost-effective to promote symptomatic control compared to H1 (second-line) antihistamines in patients over 12 years of age with moderate to severe CSU refractory to second-line treatment? Methods: Bibliographic survey was performed in databases EMBASE, PUBMED, Cochrane Library and NICE Evidence, with structured search strategies. The methodological quality of the systematic reviews and economic studies with AMSTAR and QHES tools was evaluated. Results: 452 reference abstracts were identified. After reading them, 5 systematic reviews and 5 economic studies were selected. Conclusion: Omalizumab is effective and safe to promote symptomatic control of moderate to severe CSU in people aged 12 years and over, refractory to treatment with second-generation antihistamines in overdose. Omalizumab was considered cost-effective for the British, Dutch, French, and Turkish health systems, and for the Brazilian supplementary private health system, but promotes increased costs for these systems. Economic evaluation studies for Brazilian Public Health System are necessary for the proper incorporation of this medication. Ciclosporin is a thid-line therapeutic option for CSU, avaliable on Brazilian Public Health System.