Pope Janet E, Lee Yvonne C, Curtis Jeffrey R, Mo Daojun, Xie Li, Dickson Christina L, Schlichting Douglas E, Cardoso Anabela, Simon Lee S, Taylor Peter C
St Joseph's Hospital, Western University, London, Canada.
Northwestern University, Chicago, Illinois.
ACR Open Rheumatol. 2022 Mar;4(3):254-258. doi: 10.1002/acr2.11380. Epub 2021 Dec 16.
Pain reduction with baricitinib was assessed in patients with rheumatoid arthritis (RA) who either used opioids or did not use opioids during three randomized, double-blind phase 3 trials.
Analysis populations were as follows: i) baricitinib 4 mg once daily versus placebo groups integrated from RA-BEAM (NCT01710358) for patients with inadequate response (IR) to methotrexate, RA-BUILD (NCT01721057) with IR to conventional disease-modifying antirheumatic drugs, and RA-BEACON (NCT01721044) with IR to at least one tumor necrosis factor inhibitors; ii) baricitinib 2 mg versus placebo from RA-BUILD and RA-BEACON; and iii) adalimumab 40 mg every other week versus placebo from RA-BEAM. Pain was measured by the Patient Assessment of Pain Visual Analog Scale. Analysis of covariance modeling assessed differences in pain reduction between treatments at each time point through Week 24, with an interaction term to test heterogeneous treatment effects across opioid users and nonusers.
Baricitinib 4 mg had greater pain reduction versus placebo in opioid users and nonusers (P < 0.05) at all time points starting from Week 1; the pain reduction was similar between opioid users and nonusers. Baricitinib 2 mg had greater pain reduction versus placebo in opioid users and nonusers starting at Week 4. A significant difference in pain reduction was not observed for adalimumab versus placebo in the opioid users but was observed in nonusers at all time points.
Pain reduction was observed and was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg but not adalimumab in this post hoc analysis.
在三项随机、双盲3期试验中，评估了在使用或未使用阿片类药物的类风湿性关节炎（RA）患者中，巴瑞替尼的止痛效果。
分析人群如下：i）将来自RA-BEAM（NCT01710358）的甲氨蝶呤反应不足（IR）患者、对传统改善病情抗风湿药物反应不足的RA-BUILD（NCT01721057）患者以及对至少一种肿瘤坏死因子抑制剂反应不足的RA-BEACON（NCT01721044）患者的每日一次4 mg巴瑞替尼组与安慰剂组进行整合；ii）来自RA-BUILD和RA-BEACON的2 mg巴瑞替尼组与安慰剂组；iii）来自RA-BEAM的每两周一次40 mg阿达木单抗组与安慰剂组。通过患者疼痛视觉模拟量表评估疼痛。协方差分析模型评估了直至第24周每个时间点治疗之间的止痛差异，并使用一个交互项来测试阿片类药物使用者和非使用者之间不同的治疗效果。
从第1周开始的所有时间点，4 mg巴瑞替尼在阿片类药物使用者和非使用者中均比安慰剂有更大程度的疼痛减轻（P < 0.05）；阿片类药物使用者和非使用者之间的疼痛减轻情况相似。从第4周开始，2 mg巴瑞替尼在阿片类药物使用者和非使用者中比安慰剂有更大程度的疼痛减轻。在阿片类药物使用者中，未观察到阿达木单抗与安慰剂在止痛方面有显著差异，但在非使用者的所有时间点均观察到有差异。
在这项事后分析中，观察到2 mg和4 mg巴瑞替尼在阿片类药物使用者和非使用者中均有疼痛减轻，且情况相似，但阿达木单抗并非如此。
