| Title | High remission and low relapse with prolonged intensive DMARD therapy in rheumatoid arthritis (PRINT) A multicenter randomized clinical trial |
| Authors | Li, Ru Zhao, Jin-Xia Su, Yin He, Jing Chen, Li-Na Gu, Fei Zhao, Cheng Deng, Xue-Rong Zhou, Wei Hao, Yan-Jie Xue, Yu Liu, Hua-Xiang Zhao, Yi Zou, Qing-Hua Liu, Xiang-Yuan Zhu, Ping Sun, Ling-Yun Zhang, Zhuo-Li Zou, He-Jian Li, Xing-Fu Liu, Yi Fang, Yong-Fei Keystone, Edward McInnes, Iain B. Li, Zhan-Guo |
| Affiliation | Peking Univ, Peoples Hosp, Dept Rheumatol & Immunol, 11 Xizhimen South St, Beijing 100044, Peoples R China. Peking Univ, Dept Rheumatol & Immunol, Hosp 3, Beijing, Peoples R China. Fourth Mil Med Univ, Dept Clin Immunol, Xijing Hosp, Xian, Peoples R China. Nanjing Univ, Affiliated Drum Tower Hosp, Dept Rheumatol & Immunol, Sch Med, Nanjing, Jiangsu, Peoples R China. Peking Univ, Dept Rheumatol & Clin Immunol, Hosp 1, Beijing, Peoples R China. Fudan Univ, Dept Rheumatol & Immunol, Huashan Hosp, Shanghai, Peoples R China. Shandong Univ, Dept Rheumatol & Immunol, Qilu Hosp, Jinan, Peoples R China. Sichuan Univ, Dept Rheumatol & Immunol, West China Hosp, Chengdu, Peoples R China. Third Mil Med Univ, Dept Rheumatol & Immunol, Southwest Hosp, Chongqing, Peoples R China. Univ Toronto, Mt Sinai Hosp, Rebecca MacDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON, Canada. Univ Glasgow, Inst Infect Immun & Inflammat, Coll Med Vet & Life Sci, Glasgow, Lanark, Scotland. Peking Univ, Peoples Hosp, Dept Rheumatol & Immunol, 11 Xizhimen South St, Beijing 100044, Peoples R China. Keystone, E (reprint author), Univ Toronto, Mt Sinai Hosp, Rebecca MacDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON, Canada. McInnes, IB (reprint author), Univ Glasgow, Inst Infect Immun & Inflammat, Coll Med Vet & Life Sci, Glasgow, Lanark, Scotland. |
| Keywords | DMARDs (synthetic) outcomes research rheumatoid arthritis LOW DISEASE-ACTIVITY METHOTREXATE COMBINATION CRITERIA RECOMMENDATIONS LEFLUNOMIDE MANAGEMENT RITUXIMAB STRATEGY 2-YEAR |
| Issue Date | 2016 |
| Publisher | MEDICINE |
| Citation | MEDICINE.2016,95(28). |
| Abstract | Objectives: To determine whether prolonged intensive disease-modifying antirheumatic drug (DMARD) treatment (PRINT) leads to high remission and low relapse rates in patients with severe rheumatoid arthritis (RA). Methods: In this multicenter, randomized and parallel treatment trial, 346 patients with active RA (disease activity score (28 joints) [DAS28] (erythrocyte sedimentation rate [ESR]) > 5.1) were enrolled from 9 centers. In phase 1, patients received intensive treatment with methotrexate, leflunomide, and hydroxychloroquine, up to 36 weeks, until remission (DAS28 < 2.6) or a low disease activity (2.6 < DAS28 < 3.2) was achieved. In phase 2, patients achieving remission or low disease activity were followed up with randomization to 1 of 2 step-down protocols: leflunomide plus hydroxychloroquine combination or leflunomide monotherapy. The primary endpoints were good European League Against Rheumatism (EULAR) response (DAS28 (ESR) < 3.2 and a decrease of DAS28 by at least 1.2) during the intensive treatment and the disease state retention rate during step-down maintenance treatment. Predictors of a good EULAR response in the intensive treatment period and disease flare in the maintenance period were sought. Results: A good EULAR response was achieved in 18.7%, 36.9%, and 54.1% of patients at 12, 24, and 36 weeks, respectively. By 36 weeks, 75.4% of patients achieved good and moderate EULAR responses. Compared with those achieving low disease activity and a high health assessment questionnaire (HAQ > 0.5), patients achieving remission (DAS28 <= 2.6) and low HAQ (<= 0.5) had a significantly higher retention rate when tapering the DMARDs treatment (P=0.046 and P=0.01, respectively). There was no advantage on tapering to combination rather than monotherapy. Conclusions: Remission was achieved in a proportion of patients with RA receiving prolonged intensive DMARD therapy. Low disease activity at the start of disease taper leads to less subsequent flares. Leflunomide is a good maintenance treatment as single treatment. |
| URI | http://hdl.handle.net/20.500.11897/492004 |
| ISSN | 0025-7974 |
| DOI | 10.1097/MD.0000000000003968 |
| Indexed | SCI(E) PubMed |
| Appears in Collections: | 人民医院 第三医院 第一医院 |
