IG Treatment May Reduce Acute Exacerbations of COPD

Observational studies suggest immune globulin (IG) treatment may reduce the frequency of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). In the randomized controlled trial, the researchers recruited patients with COPD hospitalized for AECOPD or from ambulatory clinics with one severe or two moderate AECOPD in the previous year regardless of their serum IgG level. Patients were allocated in a 1:1 ratio with balanced randomization to monthly intravenous IG (IVIG) or normal saline for one year. The primary outcome was feasibility defined as prespecified accrual, adherence and follow-up rates. Secondary outcomes included safety, tolerance, AECOPD rates, time to first AECOPD, quality of life and healthcare costs.

Seventy patients were randomized (37 female; mean age 67.7) of which 34 (49 percent) adhered to at least 80 percent of planned treatments, and four (5.7 percent) were lost to follow-up. There were 35 serious adverse events, including seven deaths and one thromboembolism, none of which were related to IVIG. There were 56 and 48 moderate and severe AECOPD in the IVIG versus control groups. In patients with at least 80 percent treatment adherence, median time to first moderate or severe AECOPD was 275 versus 114 days, favoring the IVIG group.

According to the researchers, the study met feasibility criteria for recruitment and retention, but adherence was low. As such, a trend toward more robust treatment efficacy in adherent patients supports further study, but future trials must address treatment adherence.