St. George's Respiratory Questionnaire Scores in Patients With Chronic Obstructive Pulmonary Disease Receiving Mepolizumab: Post Hoc Analysis of the Matinee Phase III Randomized Controlled Trial

Abstract Rationale: Chronic obstructive pulmonary disease (COPD) is highly heterogeneous with multiple presentations. In patients with raised blood eosinophil count (BEC), increased exacerbation rates lead to poor prognosis and place various burdens on patients’ health. This analysis of MATINEE assessed the impact of mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, on health-related quality of life in patients with COPD. Methods: MATINEE (NCT04133909), a Phase III, randomized, placebo-controlled, parallel-group trial, assessed mepolizumab 100 mg, administered subcutaneously every 4 weeks for 52-104 weeks, versus placebo, in addition to background inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid [fluticasone propionate ≥500 μg/day or equivalent]) in patients with COPD, a history of exacerbations, and screening BEC ≥300 cells/µL. Here, we report the Week 52 prespecified change from baseline in St. George's Respiratory Questionnaire (SGRQ) for COPD total score, and individual domains: Activity (addressing disturbances to daily physical activities); Impacts (addressing disturbances of psycho-social function); and Symptoms (assessing patient perception of recent respiratory problems). Individual domains were also assessed at Week 104. Results: 804 patients were randomized and treated (403 mepolizumab/401 placebo). At Week 52, the least squares mean reduction (95% confidence interval [CI]) from baseline in SGRQ total score with mepolizumab versus placebo was −8.0 (−9.7, −6.3) versus −5.7 (−7.4, −4.0), with a mean difference (95% CI) of −2.3 (−4.6, 0.1). Improvement from baseline at Week 52 favored mepolizumab versus placebo in all SGRQ domains (Figure). There was a high overall change (mean [standard deviation]) in the Symptoms domain for both mepolizumab and placebo groups (-10.7 [19.5] vs -9.0 [18.8]; difference vs placebo [Δ]=-1.7), but a greater differentiation between mepolizumab versus placebo scores in the Activity ( -7.4 [19.9] vs -4.9 [18.7]; Δ=-2.5) and Impacts domains (-9.4 [20.5] vs -5.4 [20.9]; Δ=-4.0). By Week 104, the differentiation between mepolizumab versus placebo was more pronounced in the Symptoms domain (-12.1 [20.8] vs -9.0 [20.7]; Δ=-3.1); change from baseline at Week 104 in other domain scores is detailed in the Figure. Conclusions: By Week 52, mepolizumab versus placebo showed a trend towards improvement in all SGRQ domain scores, with a numerically greater effect on Activity and Impacts domains, and a lesser effect on COPD Symptoms. By Week 104, the magnitude of benefit from mepolizumab was greater on Symptoms. These findings suggest that mepolizumab may have positive impacts on health impairment and symptom disturbances in patients with COPD.

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