1. Disease burden and predictors associated with non-response to antihistamine-based therapy in chronic spontaneous urticaria.
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Soong W, Patil D, Pivneva I, Signorovitch J, Wells MA, Balp MM, and Kuruvilla M
- Abstract
Background: H1-antihistamines (H1AH) are the first-line treatment for chronic spontaneous urticaria (CSU), but 50% of patients have inadequate disease control at standard doses., Objective: To assess the comorbidity burden and healthcare resource utilization (HRU) associated with non-response to H1AH-based treatments; to identify predictors of non-response., Methods: Optum® de-identified Electronic Health Record dataset (2007-2020) was used to identify adult patients with CSU who initiated a H1AH, alone or in combination with other oral non-biologics (index treatment). Based on twelve-month treatment patterns observed after index treatment initiation, patients were categorized as responders (continued index treatment or had only 1 next H1AH treatment without corticosteroids) or non-responders (continued corticosteroids or had 2 or more treatment switches). Patient characteristics and HRU were assessed in the 12 months before (baseline) and ≥12 months after (follow-up) index treatment initiation. Baseline predictors associated with non-response were identified using machine learning., Results: There were 17 062 patients who met inclusion criteria, and 14824 (86.9%) were classified as non-responders. A higher proportion of non-responders had records of CSU-related symptoms, comorbidities, polypharmacy, and certain laboratory tests than responders at baseline. A higher proportion of non-responders than responders visited an allergist or dermatologist during follow-up (59.5% vs 53.0%). Non-responders had a larger increase in hospitalizations (15.7% vs -2.4%) than responders during follow-up vs baseline. Predictors of non-response included index and baseline treatment classes, types of specialists seen, chronic pulmonary disease, depression, and female sex., Conclusion: A large proportion of CSU patients treated with H1AH-based therapies had uncontrolled disease, contributing to increased HRU and patient burden. Non-responders had more comorbidities and HRU at baseline and follow-up, with steep increases in follow-up hospitalizations relative to baseline, highlighting an urgent need for early disease control., Competing Interests: WS has served on Research, Consultant and Advisory Boards for Novartis, Regeneron, Sanofi, Genentech, AstraZeneca, and Amgen, and Speaker's Bureau for Regeneron, Sanofi, AstraZeneca, and Amgen. DP, MAW, and MK are employees of Novartis Pharmaceuticals Corporation. MMB is an employee of Novartis Pharma AG. IP and JS are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Novartis Pharmaceuticals Corporation, which funded the development and conduct of this study and manuscript., (© 2023 The Authors.)
- Published
- 2023
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