Soong Weily, Patil Dhaval, Pivneva Irina, Signorovitch James, Wells Michael A, Balp Maria-Magdalena, Kuruvilla Merin
AllerVie Health and AllerVie Clinical Research, 504 Brookwood Blvd, Birmingham, AL, 35209, USA.
Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.
World Allergy Organ J. 2023 Dec 3;16(12):100843. doi: 10.1016/j.waojou.2023.100843. eCollection 2023 Dec.
H1-antihistamines (H1AH) are the first-line treatment for chronic spontaneous urticaria (CSU), but 50% of patients have inadequate disease control at standard doses.
To assess the comorbidity burden and healthcare resource utilization (HRU) associated with non-response to H1AH-based treatments; to identify predictors of non-response.
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.
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.
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.
H1抗组胺药（H1AH）是慢性自发性荨麻疹（CSU）的一线治疗药物，但50%的患者在标准剂量下疾病控制不佳。
评估与基于H1AH治疗无反应相关的合并症负担和医疗资源利用（HRU）；确定无反应的预测因素。
使用Optum®去识别化电子健康记录数据集（2007 - 2020年）来识别开始使用H1AH单独治疗或与其他口服非生物制剂联合治疗（索引治疗）的成年CSU患者。根据索引治疗开始后观察到的十二个月治疗模式，患者被分类为反应者（继续索引治疗或仅接受1次后续H1AH治疗且未使用皮质类固醇）或无反应者（继续使用皮质类固醇或有2次或更多次治疗转换）。在索引治疗开始前12个月（基线）和≥12个月后（随访）评估患者特征和HRU。使用机器学习确定与无反应相关的基线预测因素。
有17062名患者符合纳入标准，其中14824名（86.9%）被分类为无反应者。在基线时，与反应者相比，更高比例的无反应者有CSU相关症状、合并症、联合用药和某些实验室检查的记录。在随访期间，拜访过敏症专科医生或皮肤科医生的无反应者比例高于反应者（59.5%对53.0%）。与基线相比，随访期间无反应者的住院率增幅大于反应者（15.7%对 - 2.4%）。无反应的预测因素包括索引和基线治疗类别、就诊的专科类型、慢性肺病、抑郁症和女性性别。
接受基于H1AH治疗的CSU患者中很大一部分疾病未得到控制，导致HRU增加和患者负担加重。无反应者在基线和随访时合并症更多且HRU更高，与基线相比随访期间住院率急剧增加，凸显了早期疾病控制的迫切需求。
