Unidad de Investigación en Enfermedades Crónico-Degenerativas, Guadalajara, Mexico.
J Rheumatol. 2013 Jul;40(7):1069-73. doi: 10.3899/jrheum.121427. Epub 2013 Jun 1.
Data on when to stop use of biological agents in rheumatoid arthritis (RA) are scant. We assessed the length of remission and the rate of clinical relapse in patients with RA who had to discontinue treatment with tocilizumab (TCZ) because of the ending of longterm (5 yrs) open-label clinical trials.
All patients at 2 participating centers in Mexico were in remission, defined as Disease Activity Score 28 ≤ 2.6, with no swollen joints at the time of the last TCZ infusion. Patients were followed thereafter every 8 weeks for 12 months or until relapse. Relapse was defined as the presence of ≥ 1 swollen joint. Doses of methotrexate and antiinflammatory drugs were not changed during the followup period.
Forty-five patients were analyzed, 87% were women (mean age 52 yrs, mean disease duration 14 yrs). During the 12 months of followup, 44% of patients maintained remission. Relapses occurred in 56% of patients: 14 during the first 3 months after the last TCZ administration. Retreatment using other agents achieved low disease activity or remission.
Longterm clinical remission is possible in a number of patients with RA after suspension of TCZ. This effect has also been reported with other biologic agents. Additional data are required to support recommendations for discontinuing a biological agent after achieving remission.
关于类风湿关节炎(RA)何时停止使用生物制剂的数据很少。我们评估了因长期(5 年)开放性临床试验结束而不得不停止使用托珠单抗(TCZ)治疗的 RA 患者的缓解持续时间和临床复发率。
墨西哥 2 个参与中心的所有患者均处于缓解状态,定义为疾病活动评分 28(DAS28)≤2.6,最后一次 TCZ 输注时无肿胀关节。此后,患者每 8 周随访 12 个月或直至复发。复发定义为出现≥1 个肿胀关节。在随访期间,甲氨蝶呤和抗炎药物的剂量未改变。
分析了 45 例患者,87%为女性(平均年龄 52 岁,平均病程 14 年)。在 12 个月的随访中,44%的患者保持缓解。56%的患者出现复发:14 例发生在最后一次 TCZ 给药后 3 个月内。用其他药物进行再治疗可达到低疾病活动或缓解。
在停止 TCZ 治疗后,许多 RA 患者可长期保持临床缓解。其他生物制剂也有报道有这种效果。需要更多的数据来支持关于在达到缓解后停止使用生物制剂的建议。