The Safety and Efficacy of Infliximab in Moderate to Severe Chronic Obstructive Pulmonary Disease

TLDR: Subjects with moderate to severe COPD did not benefit from treatment with infliximab and the impact of inflIXimab on malignancy risk in patients with COPD needs to be further elucidated.

Abstract: Rationale: Chronic obstructive pulmonary disease (COPD) is a progressive, smoking-related, inflammatory lung disease in which tumor necrosis factor-α is overexpressed and has been suggested to play a pathogenic role.Objectives: To determine if infliximab, an anti–TNF-α antibody, results in clinical benefit and has an acceptable safety profile in patients with moderate to severe COPD.Methods: In a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study, subjects with moderate to severe COPD received infliximab (3 mg/kg [n = 78] or 5 mg/kg [n = 79]) or placebo (n = 77) at Weeks 0, 2, 6, 12, 18, and 24. Efficacy, health status, and safety were assessed through Week 44.Measurements and Main Results: Infliximab was generally well tolerated, but showed no treatment benefit as measured by the primary endpoint, Chronic Respiratory Questionnaire total score. Similarly, there was no change in secondary measures, including prebronchodilator FEV1, 6-min walk distance, SF-36 physi...