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Effect of clinically significant thresholds of eosinophil elevation on health care resource use in asthma

Zenobia Dotiwala, MS; Julian Casciano, BS ; Jill R. Davis, MS; Kathleen Fox, PhD; Gokul Gopalan, M; Sarang Rastogi, PharmD; Lois Lamerato, PhD; Sameer K. Mathur, MD, PhD

BACKGROUND
Blood eosinophil counts correlate with exacerbations, but there is a lack of consensus on a clinically relevant definition of eosinophil count elevation.

OBJECTIVE
To analyze health care resource use among patients with elevated blood eosinophil counts defined at 150 cells/μL or greater and 300 cells/μL or greater.

METHODS
Data on patients who received a diagnosis of asthma between 2007 and 2016 were extracted from EMRClaims + database. Patients were defined as having elevated eosinophil counts if any test result during 3 months before follow-up found blood eosinophil count of 150 cells/μL or more or 300 cells/μL or more. Hospitalizations, emergency department visits, outpatient visits, and associated costs were compared. With logistic regression, likelihood of hospitalization was assessed in the presence of eosinophil elevation.

RESULTS
Among 3687 patients who met the study criteria, 1152 received a test within 3 months before the follow-up period, of whom 644 (56%) had elevated eosinophil counts of 150 cells/μL or greater and 322 (29%) had eosinophil counts of 300 cells/μL or greater. Overall, the mean (SD) number of hospitalizations for patients with elevated eosinophil counts vs the comparator was significantly greater (0.29 [0.92] vs 0.17 [0.57], P < .001 at ≥150 cells/μL and 0.30 [0.95] vs 0.18 [0.61] at ≥300 cells/μL, P = .001). The total mean cost was significantly greater for patients with elevated eosinophil counts (at ≥150 cells/μL: $10,262 vs $7149, P < .001 and at ≥300 cells/μL: $9966 vs $7468, P = .003).

CONCLUSIONS
Patients with asthma incurred greater health care resource use when their blood eosinophil counts were elevated at 150 cells/μL or greater and 300 cells/μL or greater as measured within 3 months of follow-up.

Add-on tiotropium versus step-up inhaled corticosteroid plus long-acting beta-2-agonist in real-world patients with asthma

Bradley Chipps, Giselle Mosnaim, Sameer K Mathur, Asif Shaikh, Samir Khoury, Gokul Gopalan, Swetha R Palli, Lois Lamerato, Julian Casciano, Zenobia Dotiwala, Russell Settipane

BACKGROUND
A step-up approach (increasing inhaled corticosteroid [ICS] dose and/or add-on treatment) is recommended for asthma that is uncontrolled despite ICS plus long-acting beta-2-agonist (LABA) combination treatment. Understanding the impact of different treatment options on health outcomes can help guide treatment decision-making.

OBJECTIVE
To compare the effectiveness of add-on tiotropium 1.25 µg (two puffs once daily) versus an increased ICS plus LABA dose in a real-world cohort of patients with asthma initiated on ICS plus LABA.

METHODS
De-identified data from patients ages ≥12 years and with asthma who were initiated on ICS plus LABA, and then had tiotropium added (Tio group; index date) or an ICS plus LABA dose increased (inc-ICS group; index date) were collected from two medical and pharmacy claims data bases (2014-2018). To account for population/group differences, propensity score matching was performed. The primary end point was the exacerbation risk after the index date. Secondary end points included exacerbation rates 6 and 12 months postindex, health-care resource utilization, costs, and short-acting beta-2-agonist (SABA) refills 12 months postindex.

RESULTS
Overall, 7857 patients (Tio group, 2619; inc-ICS group, 5238) were included. The exacerbation risk was 35% lower in the Tio group than in the inc-ICS group (hazard ratio 0.65 [95% confidence interval, 0.43-0.99]; p = 0.044). Exacerbation rates in the Tio group also were significantly lower within 6 and 12 months postindex (64% and 73%, respectively). All-cause and asthma-related emergency department (ED) visits were 47% and 74% lower, respectively (p < 0.0001 for both), and all-cause and asthma-related hospitalizations were 48% (p < 0.01) and 76% (p < 0.001) lower, respectively, in the Tio group. Also, significantly fewer patients in the Tio group versus the inc-ICS group required SABA refills (56% versus 67%, p < 0.0001).

CONCLUSIONS
Add-on tiotropium significantly decreased the risk and rate of exacerbations, decreased all-cause and asthma-related ED visits and hospitalizations, and reduced SABA refills compared with increasing the ICS plus LABA dose. The findings supported the use of add-on tiotropium for patients with uncontrolled asthma taking ICS plus LABA.