Disease burden and predictors associated with non-response to antihistamine-based therapy in chronic spontaneous urticaria

Weily Soong; Dhaval Patil; Irina Pivneva; James Signorovitch; Michael A Wells; Maria-Magdalena Balp; Merin Kuruvilla

doi:10.1016/j.waojou.2023.100843

Disease burden and predictors associated with non-response to antihistamine-based therapy in chronic spontaneous urticaria

World Allergy Organ J. 2023 Dec 3;16(12):100843. doi: 10.1016/j.waojou.2023.100843. eCollection 2023 Dec.

Authors

Weily Soong¹, Dhaval Patil², Irina Pivneva³, James Signorovitch⁴, Michael A Wells², Maria-Magdalena Balp⁵, Merin Kuruvilla²

Affiliations

¹ AllerVie Health and AllerVie Clinical Research, 504 Brookwood Blvd, Birmingham, AL, 35209, USA.
² Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
³ Analysis Group, Inc., 1190 avenue des Canadiens-de-Montréal, Montréal, QC, H3B 0G7, Canada.
⁴ Analysis Group, Inc., 111 Huntington Ave, Boston, MA, 02199, USA.
⁵ Novartis Pharma AG, Forum 1, Novartis Campus, CH-4056 Basel, Switzerland.

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.

Keywords: Chronic spontaneous urticaria; Comorbidity burden; Healthcare resource utilization; Non-response; Predictors.