PT - JOURNAL ARTICLE AU - Janet E Pope AU - Boulos Haraoui AU - J Carter Thorne AU - Andrew Vieira AU - Melanie Poulin-Costello AU - Edward C Keystone TI - The <span class="underline">Ca</span>nadian <span class="underline">M</span>ethotrexate and <span class="underline">E</span>tanercept <span class="underline">O</span>utcome Study: a randomised trial of discontinuing versus continuing methotrexate after 6 months of etanercept and methotrexate therapy in rheumatoid arthritis AID - 10.1136/annrheumdis-2013-203684 DP - 2014 Dec 01 TA - Annals of the Rheumatic Diseases PG - 2144--2151 VI - 73 IP - 12 4099 - http://ard.bmj.com/content/73/12/2144.short 4100 - http://ard.bmj.com/content/73/12/2144.full SO - Ann Rheum Dis2014 Dec 01; 73 AB - Objective To determine if withdrawing methotrexate (MTX) after 6 months of combination etanercept (ETN)+MTX, in MTX-inadequate responders with active rheumatoid arthritis (RA), is non-inferior to continuing ETN+MTX. Methods Tumour necrosis factor-inhibitor naïve RA patients with disease activity score 28 (DAS28)≥3.2, swollen joint count≥3, despite stable MTX, were treated with ETN+MTX for 6 months, followed by randomisation to either continue ETN+MTX or switch to ETN monotherapy for an additional 18 months. The primary endpoint was change in DAS28 from 6-month randomisation to 12 months. The non-inferiority margin of change in DAS28 was 0.6, with prespecified analyses (DAS28&lt;3.2 vs DAS28≥3.2). Results 205 patients were randomised. DAS28 was stable in patients on ETN+MTX and increased slightly in patients on ETN monotherapy from 6 to 12 months. Non-inferiority was not achieved, with an adjusted difference of 0.4 (0.1 to 0.7) between the ETN and the ETN+MTX groups, for the month 6–12 change in DAS28. However, patients who achieved low disease activity (LDA; DAS28&lt;3.2) at 6 months had a similar disease activity at 12 months, whether on monotherapy or combination therapy (DAS28 change 0.7 ETN vs 0.57 ETN+MTX, p=0.8148). Conversely, for patients who did not reach LDA at 6 months, those on ETN monotherapy had increased disease activity at 12 months, while disease activity continued to decrease for patients on combination therapy, at 12 months (DAS28 change 0.4 ETN vs −0.4 ETN+MTX, p=0.0023). Conclusions Non-inferiority was not achieved. Withdrawing MTX after 6 months of continuation ETN+MTX in MTX inadequate responders did not yield the same degree of improvement between 6 and 12 months compared with continuing ETN+MTX. Trial Registration ClinicalTrials.gov−NCT00654368.