LAUSR

RATIONALE In COPD, inhaled corticosteroids (ICS) are associated with pneumonia highlighting the importance of investigating subgroups of patients who may benefit from prolonged ICS use. Despite this, the WISDOM trial found a greater decline in forced expiratory volume in 1 second (FEV1) in COPD patients who withdrew from inhaled corticosteroids (ICS) compared to patients who remained on triple therapy (TT). OBJECTIVES We investigated the association between ICS withdrawal and rate of FEV1 decline in COPD patients using routinely collected electronic healthcare records. METHODS Using Clinical Practice Research Datalink (CPRD) Aurum and Hospital episode statistics we included COPD patients who had been on TT for at least four months. Patients were categorised into those who withdrew from ICS and those who remained on TT during follow-up. Three cohorts were created: i) patients meeting the WISDOM trial eligibility criteria; ii) patients with COPD not restricted by the WISDOM trial eligibility criteria; and iii) patients who would have been excluded from the WISDOM trial based on their comorbidities. Mixed linear regression was used to model the association between ICS withdrawal and rate of FEV1 decline (ml/year) adjusted for baseline characteristics. RESULTS 6,008 COPD patients met the WISDOM eligibility criteria, of which 9.0% withdrew from ICS. Mean rates of FEV1 decline -7.8 ml/year (95% CI -19.7 to +4.1) for withdrawers and -15.2 ml/year (95% CI -18.7 to -11.8) for those who remained on TT (difference p=0.264). 60,645 COPD patients were not restricted by the WISDOM eligibility criteria. Mean rate of FEV1 decline was -32.6ml/year (-33.6 to -31.5) for withdrawers and -36.4ml/year (-39.4 to -33.4) for those who remained on TT. 32,882 COPD patients were included in the last population representing those would have been excluded from the WISDOM trial due to their comorbidities. Mean rate of FEV1 decline was -29.4ml/year in withdrawers and -31.3ml/year in those who remained on TT. CONCLUSIONS Rate of FEV1 decline was similar between patients on TT and patients who withdrew from ICS regardless of the specific COPD population studied. In routine clinical practice, few COPD patients meet WISDOM eligibility criteria and few patients are withdrawn from ICS.