Thomas, Vicky, Gefen, Eran, Gopalan, Gokul, Mares, Rafael, McDonald, Rosie, Wan Yau Ming, Simon, and Price, David
Affordable treatment alternatives are needed to prevent and treat chronic obstructive pulmonary disease (COPD) exacerbations and reduce the economic burden of COPD. This study evaluated whether the effectiveness of Steri-Neb™ (Teva Pharmaceuticals, Inc.), the comparator ipratropium/salbutamol (I/S) nebulizer solution, is non-inferior to DuoNeb®(Mylan Specialty L.P.), the originator with the same chemical composition, the first FDA-approved product of this kind, for the prevention of COPD exacerbations. I/S comparator versus originator safety also was examined. Both the I/S comparator and the originator are indicated (EU/USA) for bronchospasm management in patients with COPD. This matched, historical USA cohort study used Clinformatics™ claims data and included a 1-year baseline, starting 1 year before the index prescription date, and 1-year outcome period. Patients received either I/S comparator or originator treatment. The primary outcome was rate of moderate and severe COPD exacerbations. Non-inferiority for I/S comparator versus originator was satisfied if the 95% confidence interval (CI) upper limit for mean difference in proportions between treatments was <15%. The secondary outcome examined safety through rate of adverse events (AEs). After matching, 550 I/S comparator and 1535 originator patients were included. Adjusted upper 95% CI for the difference in proportion of patients experiencing moderate and severe exacerbations between I/S comparator and originator cohorts was 0.092 (9.2%), and for severe exacerbations was 0.040 (4.0%), demonstrating non-inferiority. No significant differences were found in rates of moderate and severe exacerbations (rate ratio [RR] 0.96; 95% CI 0.89, 1.04), severe exacerbations (RR 1.00; 95% CI 0.81, 1.24), or any AE (RR 1.06; 95% CI 0.92, 1.22) after adjusting for baseline confounders. The real-world clinical outcomes of this matched cohort study support the I/S comparator as non-inferior to the originator, providing an effective and safe treatment alternative for COPD exacerbations. European Network Centres for Pharmacoepidemiology and Pharmacovigilance: ENCePP/SDPP/7753. Teva Branded Pharmaceutical Products, R&D, Inc.