Background Recently, we demonstrated the noninferiority of COBRA-light therapy compared to original COBRA therapy after 26 weeks in patients with early active RA .
Objectives To assess the one-year results of these two protocolized strategies, aiming minimal disease activity, in terms of disease activity (DAS44), functional outcome (HAQ), and radiographic progression (SHS), and to assess the effect of addition of etanercept.
Methods An open, randomized controlled, noninferiority trial in 164 patients with active early RA, following a treat-to-target protocol incorporating the addition of etanercept if DAS44 ≥1.6 at weeks 26 or 39.
Results Both groups showed major mean improvements in DAS44 after 52 weeks: –2.40 (±1.2) in COBRA, and –2.05 (±1.0) in the COBRA-light group (ns). Most improvement in DAS44 was reached after 26 weeks treatment: mean decrease in DAS44 between weeks 26 and 52 was 0,2 in COBRA and 0.4 in COBRA-light therapy. In both groups, functional ability improved, and minimal radiological progression of joints was found. Treatment actually instituted was often less intensive than required by protocol: of the total population (n=164), 110 patients (67%) required etanercept (more in COBRA-light), and of those only 57 patients (52%) actually received etanercept.
Conclusions Intensive treatment with COBRA or COBRA-light therapy both have major, comparable favorable effects on disease activity, functional ability and radiological outcome after one year in early RA patients. Protocolized addition of etanercept was often not implemented by treating rheumatologists, and patients receiving it appeared to have limited added benefit, probably due to low disease activity levels at initiation of etanercept.
den Uyl D, ter Wee MM, Boers M, et al. A non-inferiority trial of an attenuated combination strategy ('COBRA-light') compared to the original COBRA strategy: clinical results after 26 weeks. Ann Rheum Dis Published Online First: 31 May 2013. doi: 10.1136/annrheumdis-2013-202818
Acknowledgements We would like to thank all patients as well as all physicians who enrolled patients in this study and all research nurses who were involved in patient management. We would like to thank B. Blomjous and E. Kooijmans for their work in the past years for data entry in the COBRA-light therapy database; drs L Burgemeister, and dr M Gerritsen for their work as independent committee judging protocol deviations and SAE's; dr K. Britsemmer, and dr J. van Nies for scoring all radiographs. This research was performed within the framework of project T1–106 of the Dutch Top Institute group, and additionally funded by an unrestricted grant from Pfizer.
Disclosure of Interest None declared