SAN ANTONIO – Regardless of COPD patients’ bronchodilator reversibility at baseline, versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.
FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.
The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients,, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.
The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.
“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.
Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV1 of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.
Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.
Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.
Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.
The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the(SGRQ) in both groups.
Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.
Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.
Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.
Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.
SOURCE: Wise R et al. Chest. 2018 Oct.