Impact of grouping patients by 2017 GOLD strategy assessment criteria: a post hoc analysis of the TONADO and OTEMTO trials

Introduction: Compared to the 2014 scheme, the 2017 GOLD COPD strategy uses only symptoms and exacerbation history to group patients, and no longer gives reference to the severity of airflow limitation. Aims: This post hoc analysis of TONADO and OTEMTO data aims to determine the impact of updated assessment criteria on patient classification and characteristics within these groups. Methods: TONADO (NCT01431274/NCT01431287; N=5162) and OTEMTO (NCT01964352/NCT02006732; N=1621) Phase III trials investigated efficacy and safety of tiotropium+olodatorol fixed-dose combination in COPD patients. In this analysis, patients were classed as GOLD A–D by the 2017 or 2014 criteria. In TONADO the mMRC Dyspnoea Scale and COPD Assessment Test were not used, so distinguishing between A/B and C/D was not possible. Results: In TONADO, assessment using 2017 GOLD criteria led to 35.3% more patients classified as A/B. In OTEMTO, assignment of patients to groups A and B increased; 191 (11.8%) patients moved from C to A and 327 (20.2%) moved from D to B (Figure). No changes in patient demographics were observed in the new groups. The 2017 criteria result in a spread of GOLD stages II–IV (lung function) across groups A–B. Conclusion: When we applied 2017 GOLD assessment criteria, several patients in TONADO and OTEMTO trials shifted into the lower A and B risk groups. This shift may have implications for treatment decisions.