Department of Musculoskeletal Regenerative Medicine, Osaka University, Graduate School of Medicine, Osaka, Japan.
Department of Respiratory Medicine and Clinical Immunology, Osaka University, Graduate School of Medicine, Osaka, Japan.
Clin Rheumatol. 2021 Jul;40(7):2673-2680. doi: 10.1007/s10067-021-05609-7. Epub 2021 Jan 29.
The aim of this multicenter, retrospective study was to clarify the retention rates of sarilumab (SAR), baricitinib (BAR), and tofacitinib (TOF) in patients with rheumatoid arthritis (RA).
Patients treated with either SAR (n = 62), BAR (n = 166), or TOF (n = 185) (females, 80.9%; age, 61.0 years; disease duration, 11.1 years; rheumatoid factor positivity, 84.4%; Disease Activity Score in 28 joints using erythrocyte sedimentation rate, 4.3; concomitant prednisolone dose, 5.3 mg/day [47.0%] and methotrexate dose, 8.8 mg/week [58.4%]; biologics- or Janus kinase inhibitors-switched cases 78.4%) were included. The reasons for drug discontinuation were classified into 4 major categories (lack of effectiveness, toxic adverse events, non-toxic reasons, and remission) by each attending physician. The drug retention rate was estimated at 18 months using the Kaplan-Meier method and adjusted for potential confounders by Cox proportional hazards modeling.
The discontinuation rates of SAR, BAR, and TOF for the corresponding reasons were as follows, respectively: lack of effectiveness (15.7%, 15.6%, and 21.5%; P = 0.84), toxic adverse events (15.8%, 12.1%, and 12.3%; P = 0.35), non-toxic reasons (10.9%, 7.7%, and 6.8%; P = 0.35), and remission (0.0%, 2.8%, and 0.0%; P = 1.0). The overall retention rates excluding non-toxic reasons and remission were as follows: 68.8% for SAR, 72.5% for BAR, and 66.7% for TOF (P = 0.54).
After adjustment by potent confounders, SAR, BAR, and TOF showed similar discontinuation rates due to lack of effectiveness and toxic adverse events. Key Points • This is the first retrospective multicenter study that aimed to clarify the retention rates and reasons for discontinuation of SAR, BAR, and TOF in patients with RA.
本多中心回顾性研究旨在阐明在类风湿关节炎（RA）患者中，sarilumab（SAR）、baricitinib（BAR）和 tofacitinib（TOF）的保留率。
纳入接受 SAR（n=62）、BAR（n=166）或 TOF（n=185）治疗的患者（女性，80.9%；年龄，61.0 岁；病程，11.1 年；类风湿因子阳性率，84.4%；红细胞沉降率 28 个关节疾病活动评分，4.3；同时使用泼尼松龙剂量，5.3mg/天[47.0%]和甲氨蝶呤剂量，8.8mg/周[58.4%]；生物制剂或 Janus 激酶抑制剂转换病例 78.4%）。每位主治医生将停药原因分为 4 大类（无效、毒性不良反应、非毒性原因和缓解）。采用 Kaplan-Meier 法估计 18 个月的药物保留率，并采用 Cox 比例风险模型调整潜在混杂因素。
SAR、BAR 和 TOF 相应原因的停药率分别为：无效（15.7%、15.6%和 21.5%；P=0.84）、毒性不良反应（15.8%、12.1%和 12.3%；P=0.35）、非毒性原因（10.9%、7.7%和 6.8%；P=0.35）和缓解（0.0%、2.8%和 0.0%；P=1.0）。排除非毒性原因和缓解后，总体保留率分别为：SAR 为 68.8%、BAR 为 72.5%和 TOF 为 66.7%（P=0.54）。
调整潜在混杂因素后，SAR、BAR 和 TOF 因无效和毒性不良反应而停药的发生率相似。
关键点 • 这是第一项旨在阐明 SAR、BAR 和 TOF 在 RA 患者中的保留率和停药原因的回顾性多中心研究。
