Department of Medicine Solna, Karolinska Institutet, Stockholm.
Department of Clinical Sciences Lund.
Rheumatology (Oxford). 2021 May 14;60(5):2217-2222. doi: 10.1093/rheumatology/keaa553.
To compare mortality risk over up to 14 years of follow-up in methotrexate-refractory patients with early RA randomized to a strategy starting with addition of infliximab vs addition of SSZ and HCQ.
Data was from the two-arm, parallel, randomized, active-controlled, open-label Swefot trial in which patients with early RA (symptom duration <1 y) were recruited from 15 rheumatology clinics in Sweden (2002-2005). Patients who did not achieve low disease activity after 3-4 months of MTX were randomized to addition of infliximab (n = 128) or SSZ and HCQ (n = 130). Participants were followed until death, emigration, or end of follow-up, whichever came first. Analyses were by intention-to-treat.
Over an average follow-up of 13 years, there were 13 and 16 deaths, respectively [8.8 vs 10.6 deaths per 1000 person-years; mortality hazard ratio 1.2 (95% CI: 0.6, 2.5); P =0.62]. The 1-year mortality was 0.8% in both treatment arms, the 5-year mortality was 2.3% for the infliximab arm compared with 1.5% for the conventional combination treatment arm, while the 10-year mortality was 7.8% and 7.7%, respectively. After 5 years, ∼50% of patients in the conventional combination therapy arm had switched to biologic treatment, and 50% in the biologic arm had discontinued treatment with a biologic DMARD.
No difference in mortality risk could be observed over up to 14 years of follow-up between treatment strategy groups. At 5 years (3 years after trial cessation), 50% of patients remained on their assigned therapy, reflecting that DMARD combination is an adequate treatment strategy in 50% of patients.
clinicaltrials.gov, identifier: NCT00764725.
比较在最多 14 年的随访中，对接受甲氨蝶呤治疗后无效的早期类风湿关节炎患者采用依那西普与柳氮磺胺吡啶和羟氯喹联合方案起始治疗策略的死亡率风险。
该研究为一项双臂、平行、随机、主动对照、开放性标签的 Swefot 试验，招募了来自瑞典 15 个风湿病诊所的早期类风湿关节炎（症状持续时间<1 年）患者（2002-2005 年）。在接受甲氨蝶呤治疗 3-4 个月后未达到低疾病活动度的患者被随机分为依那西普组（n=128）或柳氮磺胺吡啶和羟氯喹组（n=130）。参与者随访至死亡、移民或随访结束，以先发生者为准。分析采用意向治疗。
在平均 13 年的随访中，分别有 13 例和 16 例死亡[每 1000 人年死亡 8.8 例和 10.6 例；死亡率风险比为 1.2（95%CI：0.6，2.5）；P=0.62]。两组的 1 年死亡率均为 0.8%，依那西普组的 5 年死亡率为 2.3%，而常规联合治疗组为 1.5%，10 年死亡率分别为 7.8%和 7.7%。5 年后，常规联合治疗组约有 50%的患者转为生物治疗，生物治疗组有 50%的患者停止使用生物 DMARD。
在最多 14 年的随访中，两种治疗策略组之间的死亡率风险无差异。在 5 年（试验停止后 3 年）时，仍有 50%的患者接受其分配的治疗，这反映了 DMARD 联合治疗在 50%的患者中是一种有效的治疗策略。
clinicaltrials.gov，标识符：NCT00764725。
