Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial.
Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial.
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DOI：
10.1007/s40122-022-00424-7
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发表时间：
2022-12
期刊：
影响因子：
4
通讯作者：
Verburg, Kenneth M.
中科院分区：
文献类型：
--
作者：
Markman, John D.;Schnitzer, Thomas J.;Perrot, Serge;Beydoun, Said R.;Ohtori, Seiji;Viktrup, Lars;Yang, Ruoyong;Bramson, Candace;West, Christine R.;Verburg, Kenneth M.
最近的一项III期、随机、安慰剂和曲马多对照试验（56周治疗/24周安全性随访）证明了tanezumab 10 mg在慢性腰痛（CLBP）患者中的疗效，并且对标准治疗镇痛药反应不足。在这里，我们报告了本研究中治疗反应的临床意义，重点是疼痛的次要指标，对日常功能的干扰，整体疾病状态和对治疗的满意度。患者接受安慰剂（直至第16周; n = 406）、皮下（SC）tanezumab 5 mg（每8周一次; n = 407）、SC tanezumab 10 mg（每8周一次; n = 407）或口服曲马多缓释剂（100-300 mg/天; n = 605），持续56周。在第16周和第56周评估患者的腰痛总体评估（PGA-LBP）、简明疼痛量表-简表（BPI-sf）、药物治疗满意度问卷（TSQM）和改良的患者报告治疗影响（mPRTI）。在第16周，对于评估的PGA-LBP（10 mg）和大多数BPI-sf（两种剂量）、TSQM（两种剂量）和mPRTI（两种剂量）项目，他尼珠单抗明显优于安慰剂（p < 0.05）。第56周时，PGA-LBP和BPI-sf较基线持续改善。然而，第56周时的改善幅度略低于第16周。第16周时，与安慰剂相比，曲马多未改善PGA-LBP或BPI-sf评分。第56周时，tanezumab和曲马多之间的大多数差异未达到所有终点的统计学显著性水平。通过测量疼痛、日常功能干扰、患者疾病状态总体评估和治疗满意度获得的全部证据表明，与安慰剂相比，tanezumab对某些CLBP患者具有临床意义的获益。ClinicalTrials.gov：NCT02528253。在线版本包含补充材料，可通过10.1007/s40122-022-00424-7获得。
A recent phase 3, randomized, placebo- and tramadol-controlled trial (56-week treatment/24-week safety follow-up) demonstrated efficacy of tanezumab 10 mg in patients with chronic low back pain (CLBP) and a history of inadequate response to standard-of-care analgesics. Here, we report on the clinical meaningfulness of treatment response in this study, focused on secondary measures of pain, interference with daily functions, overall disease status, and satisfaction with treatment. Patients received placebo (up to week 16; n = 406), subcutaneously administered (SC) tanezumab 5 mg (every 8 weeks; n = 407), SC tanezumab 10 mg (every 8 weeks; n = 407), or orally administered tramadol prolonged-release (100–300 mg/day; n = 605) for 56 weeks. Patient’s global assessment of low back pain (PGA-LBP), Brief Pain Inventory-short form (BPI-sf), Treatment Satisfaction Questionnaire for Medication (TSQM), and modified Patient-Reported Treatment Impact (mPRTI) were assessed at weeks 16 and 56. At week 16, significant (p < 0.05) improvements over placebo were evident with tanezumab for the PGA-LBP (10 mg) and most BPI-sf (both doses), TSQM (both doses), and mPRTI (both doses) items assessed. Improvements over baseline persisted for the PGA-LBP and BPI-sf at week 56. However, the magnitude of improvements was modestly lower at week 56 relative to week 16. Tramadol did not improve PGA-LBP or BPI-sf scores versus placebo at week 16. Most differences between tanezumab and tramadol at week 56 did not reach the level of statistical significance for all endpoints. The totality of the evidence as captured by measures of pain, interference with daily function, patient overall assessment of disease status, and satisfaction with treatment demonstrates the clinically meaningful benefit of tanezumab for some patients with CLBP compared with placebo. ClinicalTrials.gov: NCT02528253. The online version contains supplementary material available at 10.1007/s40122-022-00424-7.
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影响因子：
39.2
作者：
Qaseem, Amir;Wilt, Timothy J.;Forciea, Mary Ann
通讯作者：
Forciea, Mary Ann
影响因子：
2.6
作者：
Grabovac, Igor;Dorner, Thomas Ernst
通讯作者：
Dorner, Thomas Ernst
影响因子：
5.7
作者：
Gilron, I;Tod, D;Orr, E
通讯作者：
Orr, E
影响因子：
--
作者：
Hoy, Damian;Bain, Christopher;Buchbinder, Rachelle
通讯作者：
Buchbinder, Rachelle
DOI：
10.1016/s1090-3801(02)00042-3
发表时间：
2002-01-01
期刊：
EUROPEAN JOURNAL OF PAIN-LONDON
影响因子：
--
作者：
McCracken, LM;Evon, D;Karapas, ET
通讯作者：
Karapas, ET