Ceccarelli Fulvia, Massafra Umberto, Perricone Carlo, Idolazzi Luca, Giacomelli Roberto, Tirri Rosella, Russo Romualdo, Pistone Giovanni, Ruscitti Piero, Parisi Simone, Sainaghi Pier Paolo, Cacciapaglia Fabio, Zullo Alessandro, Marino Valentina, Migliore Alberto, Valesini Guido
Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy.
U.O.S. Reumatologia, Medicina Interna, Ospedale S.Pietro Fatebenefratelli, Rome, Italy.
Clin Exp Rheumatol. 2017 Jan-Feb;35(1):24-32. Epub 2016 Dec 9.
Rheumatoid arthritis (RA) patients with moderate disease activity show progression of joint damage and have impaired quality of life, physical function, work and daily activities. Little is known about management of patients with moderate RA. The aim of the study was to assess the 1-year response to anti-TNF in biologic-naïve RA patients with moderate (3.2 <DAS28 ≤5.1) disease activity despite DMARD treatment, in the Italian clinical practice.
The MODERATE study is a multicentre prospective, cohort non-interventional study, conducted in 19 Italian rheumatology sites. Patients with moderate RA, diagnosed according to the 2010 American College of Rheumatology (ACR)/EULAR criteria, were enrolled if they also were aged ≥18 years, had disease onset after 16 years old, moderate disease at baseline (DAS28 score >3.2 and ≤5.1), and were naïve to anti-TNF treatment.
Among 157 RA patients, 93 (59%) underwent etanercept, 43 (22%) adalimumab, 26 (17%) certolizumab, 10 golimumab and 2 infliximab; 80% of patients were still in treatment after 12-month observation. One-year clinical remission was achieved by 27 RA patients (21%), reduction of DAS28 score greater than 1.2 was observed in 75 (58%) patients. Moderate and good response according to EULAR criteria was observed in 59 (46%) and 45 (35%) patients, respectively.
Results confirm the efficacy of anti-TNF alpha also in moderate RA patients, who may achieve a substantial decrease of disease activity, and improve their quality of life. The low rate of patients achieving remission may suggest that therapeutic strategies should be more timely and aggressive.
疾病活动度为中度的类风湿关节炎(RA)患者会出现关节损伤进展,生活质量、身体功能、工作及日常活动均受损。关于中度RA患者的管理知之甚少。本研究旨在评估在意大利临床实践中,初治的疾病活动度为中度(3.2<DAS28≤5.1)且接受过改善病情抗风湿药(DMARD)治疗的RA患者使用抗TNF药物治疗1年的反应。
“中度”研究是一项多中心前瞻性队列非干预性研究,在意大利19个风湿病治疗点开展。根据2010年美国风湿病学会(ACR)/欧洲抗风湿病联盟(EULAR)标准诊断为中度RA的患者,若年龄≥18岁、发病年龄在16岁之后、基线疾病为中度(DAS28评分>3.2且≤5.1)且未接受过抗TNF治疗,则纳入研究。
157例RA患者中,93例(59%)接受了依那西普治疗,43例(22%)接受了阿达木单抗治疗,26例(17%)接受了赛妥珠单抗治疗,10例接受了戈利木单抗治疗,2例接受了英夫利昔单抗治疗;12个月观察期后,80%的患者仍在接受治疗。27例(21%)RA患者实现了1年临床缓解,75例(58%)患者的DAS28评分降低超过1.2。分别有59例(46%)和45例(35%)患者根据EULAR标准表现出中度和良好反应。
结果证实抗TNF-α在中度RA患者中也有效,这些患者可能实现疾病活动度大幅降低,并改善生活质量。缓解患者比例较低可能表明治疗策略应更及时、积极。