Park Sun-Kyeong, Lee Min-Young, Jang Eun-Jin, Kim Hye-Lin, Ha Dong-Mun, Lee Eui-Kyung
School of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Department of Information Statistics, Andong National University, Gyeongsangbuk-do, South Korea.
Clin Exp Rheumatol. 2017 Jul-Aug;35(4):689-699. Epub 2017 Jan 5.
The purpose of this study was to compare the discontinuation rates of tofacitinib and biologics (tumour necrosis factor inhibitors (TNFi), abatacept, rituximab, and tocilizumab) in rheumatoid arthritis (RA) patients considering inadequate responses (IRs) to previous treatment(s).
Randomised controlled trials of tofacitinib and biologics - reporting at least one total discontinuation, discontinuation due to lack of efficacy (LOE), and discontinuation due to adverse events (AEs) - were identified through systematic review. The analyses were conducted for patients with IRs to conventional synthetic disease-modifying anti-rheumatic drugs (cDMARDs) and for patients with biologics-IR, separately. Bayesian network meta-analysis was used to estimate rate ratio (RR) of a biologic relative to tofacitinib with 95% credible interval (CrI), and probability of RR being <1 (P[RR<1]).
The analyses of 34 studies showed no significant differences in discontinuation rates between tofacitinib and biologics in the cDMARDs-IR group. In the biologics-IR group, however, TNFi (RR 0.17, 95% CrI 0.01-3.61, P[RR<1] 92.0%) and rituximab (RR 0.20, 95% CrI 0.01-2.91, P[RR<1] 92.3%) showed significantly lower total discontinuation rates than tofacitinib did. Despite the difference, discontinuation cases owing to LOE and AEs revealed that tofacitinib was comparable to the biologics.
The comparability of discontinuation rate between tofacitinib and biologics was different based on previous treatments and discontinuation reasons: LOE, AEs, and total (due to other reasons). Therefore, those factors need to be considered to decide the optimal treatment strategy.
本研究旨在比较托法替布与生物制剂(肿瘤坏死因子抑制剂(TNFi)、阿巴西普、利妥昔单抗和托珠单抗)在类风湿关节炎(RA)患者中因对既往治疗反应不足(IR)而停药的发生率。
通过系统评价确定托法替布和生物制剂的随机对照试验——报告至少一次总停药、因疗效不佳(LOE)停药和因不良事件(AE)停药情况。分别对传统合成改善病情抗风湿药物(cDMARDs)反应不足的患者和生物制剂反应不足的患者进行分析。采用贝叶斯网络荟萃分析来估计生物制剂相对于托法替布的率比(RR)及其95%可信区间(CrI),以及RR<1的概率(P[RR<1])。
对34项研究的分析表明,在cDMARDs反应不足组中,托法替布和生物制剂的停药率无显著差异。然而,在生物制剂反应不足组中,TNFi(RR 0.17,95% CrI 0.01 - 3.61,P[RR<1] 92.0%)和利妥昔单抗(RR 0.20,95% CrI 0.01 - 2.91,P[RR<1] 92.3%)的总停药率显著低于托法替布。尽管存在差异,但因疗效不佳和不良事件导致的停药病例显示托法替布与生物制剂相当。
托法替布和生物制剂的停药率可比性因既往治疗和停药原因(疗效不佳、不良事件及总停药(因其他原因))而异。因此,在决定最佳治疗策略时需要考虑这些因素。