Tony Hans-Peter, Feist Eugen, Aries Peer Malte, Zinke Silke, Krüger Klaus, Ahlers Jonas, Albrecht Inka, Barrionuevo Christian, Kalus Stefanie, Burkhardt Harald
Department of Internal Medicine 2, Universitätsklinikum Würzburg, Würzburg.
Rheumatology and Clinical Immunology, HELIOS Fachklinik Vogelsang/Gommern, Vogelsang.
Rheumatol Adv Pract. 2022 Feb 1;6(1):rkac002. doi: 10.1093/rap/rkac002. eCollection 2022.
The aim was to evaluate the safety and effectiveness of sarilumab in RA patients after inadequate response (IR) to janus kinase inhibitors (JAKi) and tocilizumab.
The prospective, observational, 24-month single-arm PROSARA study (SARILL08661) is currently running in Germany at 96 sites. RA patients were prospectively selected at the physician's discretion according to label. This interim analysis included 536 patients over a treatment course of ≤6 months. Patients were stratified in four groups according to pretreatment before the start of sarilumab therapy: last prior treatment JAKi (JAKi-IR); last prior treatment tocilizumab (tocilizumab-IR); any other biological DMARD (bDMARD) in treatment history (bDMARD TH); and patients who had not received any bDMARDs or targeted synthetic (ts) DMARDs (b/tsDMARD naive) before.
For this preplanned interim analysis, 536 patients were included in the baseline population, of whom 502 patients had at least one corresponding post-baseline effectiveness assessment documented (main analysis population). In all analysed cohorts, safety was consistent with the anticipated profile of sarilumab, without new safety signals. Six months of sarilumab treatment attenuated disease activity in JAKi-IR, tocilizumab-IR, bDMARD TH and b/tsDMARD-naive patients to a very similar extent. Physical function did not change substantially over the course of treatment. Rates of premature study discontinuation were comparable between cohorts.
Sarilumab treatment was effective in patients with IR to JAKi and tocilizumab, with an expectable safety profile and drug retention over 6 months. Confirmation of these promising results should encourage further studies on this treatment sequence, which is of high practical relevance.
Paul-Ehrlich-Institut-Federal Institute for Vaccine and Biomedics, SARILL08661.
旨在评估在对托法替布和托珠单抗反应不足（IR）的类风湿关节炎（RA）患者中，沙瑞鲁单抗的安全性和有效性。
前瞻性、观察性、为期24个月的单臂PROSARA研究（SARILL08661）目前正在德国的96个地点开展。RA患者由医生根据标签前瞻性地酌情选择。这项中期分析纳入了536名治疗疗程≤6个月的患者。在沙瑞鲁单抗治疗开始前，根据预处理情况将患者分为四组：上一次使用托法替布治疗（托法替布反应不足组）；上一次使用托珠单抗治疗（托珠单抗反应不足组）；治疗史中使用过任何其他生物性改善病情抗风湿药（bDMARD）（bDMARD治疗史组）；以及之前未接受过任何bDMARD或靶向合成（ts）DMARD治疗的患者（b/tsDMARD初治组）。
对于这项预先计划的中期分析，基线人群纳入了536名患者，其中502名患者至少有一次相应的基线后有效性评估记录（主要分析人群）。在所有分析的队列中，安全性与沙瑞鲁单抗预期的特征一致，没有新的安全信号。沙瑞鲁单抗治疗6个月在托法替布反应不足组、托珠单抗反应不足组、bDMARD治疗史组和b/tsDMARD初治组患者中，对疾病活动的缓解程度非常相似。在治疗过程中，身体功能没有实质性变化。各队列之间提前终止研究的发生率相当。
沙瑞鲁单抗治疗对托法替布和托珠单抗反应不足的患者有效，具有可预期的安全性特征，且药物保留率超过6个月。这些有前景的结果得到证实，应会鼓励对这一具有高度实际相关性的治疗顺序开展进一步研究。
保罗·埃利希研究所 - 联邦疫苗和生物医学研究所，SARILL08661。
