Characteristics of patients receiving mepolizumab in real-world practice – REALITI-A study

Background Mepolizumab (mepo) is an approved add-on treatment for adults with severe refractory eosinophilic asthma (SEA).

Objective To describe the real-world population of patients (pts) with SEA receiving mepo.

Methods REALITI-A is a prospective, observational, multi-country cohort study using integrated data capture methods (eCRFs, claims data, phone app). Study aims to recruit ~ 1,050 pts with asthma, prescribed mepo 100 mg SC in a clinical practice setting. Reimbursement criteria vary by country and often include the following: blood eosinophil counts (BEC; ≥ 150 [baseline] and/or ≥ 300 [prior yr] cells/µL) and 2 – 4 exacerbations [prior yr] or maintenance oral corticosteroid (mOCS) use. Primary objective: to compare clinically significant exacerbations (CSE; requiring OCS and/or ED visit/hospitalisation) pre-/post-mepo use. Baseline characteristics from eCRF of the initial pts are shown here.

Results By 30 Sept 2017, 170 pts were enrolled ([Table 1]). Of the 137 pts with a BEC, 89.8% had counts ≥ 150 cells/µL at baseline (Geo mean [SD log]: 436 (1.2) cells/µL) and ≥ 75% had ≥ 300 cells/µL (prior yr). In total, 85.2% and 56.1% of pts had ≥ 2 and ≥ 4 CSE in the prior yr, respectively, and 56.1% of pts had mOCS use.

Tab. 1 Summary of patient demographics and baseline characteristics. Participating countries and no. pts enrolled by 30 Sept 2016: Belgium (n = 17), Canada (n = 25), Germany (n = 23), Italy (n = 9), Spain (n = 4), UK (n = 92).

Characteristics	Mepolizumab 100 mg SC (n = 170)
Age, years, mean (SD)	51.9 (14.9)
Femiles, n (%)	97 (57.1)
Asthma duration, year, mean (SD)	20.3 (15.8)
Current medication use, n (%)a
High-dose ICSb	137 (86.7)
Additional controller(s)c	132 (85.2)
OCS as maintenance treatmentd	88 (56.1)
Exacerbation history in the prior yeara,c
Clinically significant exacerbations, mean (SD)e	5.3 (4.50)
≥ 2 clinically significant exacerbations, n (%)	132 (85.2)
≥ 4 clinically significant exacerbations, n (%)	87 (56.1)
Exacerbations requiring ED visit/hospitalisation, mean (SD)	1.4 (2.6)
≥ 1 exacerbation requiring ED visit/hospitalisation, n (%)	69 (44.5)
Blood eosinophil countsa,f
At baseline, cells/µL, Geo mean (SD log)	436 (1.2)
< 150 cells/µL, n (%)	14 (10.2)
≥ 150 cells/µL, n (%)	123 (89.8)
Highest in prior 12 months, cells/µL
Geo mean (SD log)	649 (0.9)
Median (IQR)	700 (400, 114)
Lung function, mean (SD)g
Pre-bronchodilator FEV1, Lg	2.0 (0.87)
Pre-bronchodilator FVC, Lg	3.0 (1.06)
Pre-bronchodilator % predicted FEV1 g	64.8 (22.5)
Reversibility, %h	8.6 (9.2)
ACQ-5 score, mean (SD)i	3.1 (1.4)

Conclusions The real-world vs. clinical trial population of pts with SEA receiving mepo have more frequent exacerbations in the past yr and higher BEC. This might be driven by reimbursement criteria.

Abstract previously presented at ERS 2018 (#PA1036).

Funding GSK [204 710]