Keystone Edward C, Breedveld Ferdinand C, van der Heijde Désirée, van Vollenhoven Ronald F, Emery Paul, Smolen Josef S, Sainsbury Iain, Florentinus Stefan, Kupper Hartmut, Chen Kun, Kavanaugh Arthur
Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.
To evaluate the achievement of comprehensive disease control (CDC) following 1 year of treatment with adalimumab+methotrexate versus methotrexate alone and whether early achievement of remission (at week 24 or 26) is associated with CDC at week 52 in patients with either early or established rheumatoid arthritis (RA).
Post hoc analyses were conducted in three clinical studies assessing treatment with adalimumab+methotrexate: DE019 (NCT00195702) enrolled patients with established RA who were methotrexate inadequate responders; OPTIMA (NCT00420927) and PREMIER (NCT00195663) enrolled methotrexate-naive patients with early RA. In OPTIMA, patients not achieving stable low disease activity at weeks 22 and 26 in the placebo+methotrexate group could receive open-label adalimumab+methotrexate for 52 weeks (Rescue ADA arm). CDC was defined as the simultaneous achievement of clinical remission (DAS28(CRP)<2.6), normal function (HAQ-DI<0.5) and absence of radiographic progression (ΔmTSS≤0.5).
Regardless of disease duration, significantly more patients receiving adalimumab+methotrexate achieved CDC compared with methotrexate alone. In the adalimumab+methotrexate group, a numerically greater proportion of patients with early RA (25%) versus established RA (14%) achieved CDC at 1 year; achievement of CDC was notably greater among patients who met criteria for remission at week 24 or 26 (50% of patients with early RA and 39% with established RA).
Treatment with adalimumab+methotrexate increases the likelihood of achieving CDC in patients with either early or established RA. Clinical remission at week 24 or 26 is associated with achievement of CDC at week 52.
DE019 (NCT00195702), OPTIMA (NCT00420927), PREMIER (NCT00195663); Post-results.
评估阿达木单抗联合甲氨蝶呤治疗1年与单用甲氨蝶呤相比，在早期或确诊类风湿关节炎（RA）患者中综合疾病控制（CDC）的达成情况，以及早期缓解（第24周或26周时）与第52周时的CDC是否相关。
在三项评估阿达木单抗联合甲氨蝶呤治疗的临床研究中进行事后分析：DE019（NCT00195702）纳入确诊RA且对甲氨蝶呤反应不足的患者；OPTIMA（NCT00420927）和PREMIER（NCT00195663）纳入初治的早期RA患者。在OPTIMA中，安慰剂联合甲氨蝶呤组在第22周和26周未达到稳定低疾病活动度的患者可接受开放标签的阿达木单抗联合甲氨蝶呤治疗52周（救援阿达木单抗组）。CDC定义为同时达到临床缓解（DAS28(CRP)<2.6）、功能正常（HAQ-DI<0.5）且无影像学进展（ΔmTSS≤0.5）。
无论病程长短，与单用甲氨蝶呤相比，接受阿达木单抗联合甲氨蝶呤治疗的患者实现CDC的比例显著更高。在阿达木单抗联合甲氨蝶呤组中，早期RA患者（约25%）与确诊RA患者（14%）在1年时实现CDC的比例在数值上更高；在第24周或26周达到缓解标准的患者中，实现CDC的比例显著更高（早期RA患者约50%，确诊RA患者39%）。
阿达木单抗联合甲氨蝶呤治疗可提高早期或确诊RA患者实现CDC的可能性。第24周或26周时的临床缓解与第52周时的CDC达成相关。
DE019（NCT00195702）、OPTIMA（NCT00420927）、PREMIER（NCT00195663）；结果后。
