• Kristina Vermeersch, Ann Belmans, Kris Bogaerts, Iwein Gyselinck, Nina Cardinaels, Maria Gabrovska, Joseph Aumann, Ingel K Demedts, Jean-Louis Corhay, Eric Marchand, Hans Slabbynck, Christel Haenebalcke, Stefanie Vermeersch, Geert M Verleden, Thierry Troosters, Vincent Ninane, Guy G Brusselle, Wim Janssens, and BACE trial investigators.
• Laboratory of Respiratory Diseases, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Herestraat 49, O&NI, box 706, B-3000, Leuven, Belgium.
• Resp Res. 2019 Oct 29; 20 (1): 237.

BackgroundIn the BACE trial, a 3-month (3 m) intervention with azithromycin, initiated at the onset of an infectious COPD exacerbation requiring hospitalization, decreased the rate of a first treatment failure (TF); the composite of treatment intensification (TI), step-up in hospital care (SH) and mortality.Objectives(1) To investigate the intervention's effect on recurrent events, and (2) to identify clinical subgroups most likely to benefit, determined from the incidence rate of TF and hospital readmissions.MethodsEnrolment criteria included the diagnosis of COPD, a smoking history of ≥10 pack-years and ≥ 1 exacerbation in the previous year. Rate ratio (RR) calculations, subgroup analyses and modelling of continuous variables using splines were based on a Poisson regression model, adjusted for exposure time.ResultsAzithromycin significantly reduced TF by 24% within 3 m (RR = 0.76, 95%CI:0.59;0.97, p = 0.031) through a 50% reduction in SH (RR = 0.50, 95%CI:0.30;0.81, p = 0.006), which comprised of a 53% reduction in hospital readmissions (RR = 0.47, 95%CI:0.27;0.80; p = 0.007). A significant interaction between the intervention, CRP and blood eosinophil count at hospital admission was found, with azithromycin significantly reducing hospital readmissions in patients with high CRP (> 50 mg/L, RR = 0.18, 95%CI:0.05;0.60, p = 0.005), or low blood eosinophil count (<300cells/μL, RR = 0.33, 95%CI:0.17;0.64, p = 0.001). No differences were observed in treatment response by age, FEV1, CRP or blood eosinophil count in continuous analyses.ConclusionsThis post-hoc analysis of the BACE trial shows that azithromycin initiated at the onset of an infectious COPD exacerbation requiring hospitalization reduces the incidence rate of TF within 3 m by preventing hospital readmissions. In patients with high CRP or low blood eosinophil count at admission this treatment effect was more pronounced, suggesting a potential role for these biomarkers in guiding azithromycin therapy.Trial RegistrationClinicalTrials.gov number. NCT02135354 .

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