Magnhild Hammersland Dagestad, Nils Vetti, Lars Christian Haugli Bråten, Elisabeth Gjefsen, Lars Grøvle, Kristina Gervin, Anne Julsrud Haugen, Gunnstein Bakland, Gunn Hege Marchand, Thomas Kadar, Kjersti Storheim, John-Anker Zwart, Jörg Assmus, Ansgar Espeland
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The effect on MC edema and in edema-defined subgroups is unknown.</p><p><strong>Methods: </strong>Patients with chronic LBP and type 1 MCs were randomized to receive four infliximab infusions or placebo over 98 days. MC edema was assessed using short tau inversion recovery imaging. Primary edema variables were maximum baseline edema volume (Volmax) ≥25% of vertebral body marrow (yes/no) and reduced edema at 6 months (yes/no). Maximum MC-related ADC value (0-100%) was measured at baseline. Outcomes at 5 months were the Oswestry Disability Index (ODI, 0-100, primary outcome) and LBP intensity (0-10). The analyses included logistic regression and linear mixed-effects models.</p><p><strong>Results: </strong>128 patients (mean age 43 years, 84 women) were included, of which78 were treated per protocol (PP). 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引用次数: 0
摘要
研究设计：随机试验。目的：评估英夫利昔单抗在减轻Modic change （MC）水肿方面是否优于安慰剂，以及MC水肿或MCs的表观扩散系数（ADC）值是否改变英夫利昔单抗对残疾或腰痛（LBP）的影响。背景数据总结：在目前的BackToBasic试验中，英夫利昔单抗在慢性腰痛和MC 1型患者的5个月随访中没有减少残疾或腰痛。对MC水肿和水肿定义亚组的影响尚不清楚。方法：慢性LBP和1型MCs患者随机接受4次英夫利昔单抗输注或安慰剂，持续98天。使用短tau反转恢复成像评估MC水肿。主要水肿变量为最大基线水肿体积(Volmax)≥25%的椎体骨髓（是/否）和6个月时水肿减少（是/否）。在基线时测量最大mc相关ADC值（0-100%）。5个月时的结局是Oswestry残疾指数（ODI, 0-100，主要结局）和腰痛强度（0-10）。分析包括逻辑回归和线性混合效应模型。结果：纳入128例患者（平均年龄43岁，84例女性），其中78例按方案治疗（PP）。英夫利昔单抗组与安慰剂组6个月时MC水肿减少的优势比为2.2(95%可信区间[CI] 0.8, 5.8；P=0.12)和2.1 (95% CI 1.02, 4.5；P=0.04)。MC水肿和ADC值均未改变英夫利昔单抗对ODI或LBP强度的影响。在5个月时，Volmax≥25%组的效果为-4.2 ODI点(95% CI -11.4, 3.1；初级PP分析)。结论：英夫利昔单抗无临床相关的减水肿作用。MC水肿并没有改变英夫利昔单抗对残疾或LBP的影响，MC相关的ADC值也没有改变。证据等级：二级。
Modic Change Edema in Chronic Low Back Pain Treated with Infliximab or Placebo: The BackToBasic Trial.
Study design: Randomized trial.
Objective: To assess whether infliximab is superior to placebo in reducing Modic change (MC) edema, and whether MC edema or apparent diffusion coefficient (ADC) values of MCs modify the effect of infliximab on disability or low back pain (LBP).
Summary of background data: In the present BackToBasic trial, infliximab did not reduce disability or LBP at 5-months follow-up in patients with chronic LBP and MC type 1. The effect on MC edema and in edema-defined subgroups is unknown.
Methods: Patients with chronic LBP and type 1 MCs were randomized to receive four infliximab infusions or placebo over 98 days. MC edema was assessed using short tau inversion recovery imaging. Primary edema variables were maximum baseline edema volume (Volmax) ≥25% of vertebral body marrow (yes/no) and reduced edema at 6 months (yes/no). Maximum MC-related ADC value (0-100%) was measured at baseline. Outcomes at 5 months were the Oswestry Disability Index (ODI, 0-100, primary outcome) and LBP intensity (0-10). The analyses included logistic regression and linear mixed-effects models.
Results: 128 patients (mean age 43 years, 84 women) were included, of which78 were treated per protocol (PP). The odds ratio for reduced MC edema at 6 months in the infliximab vs placebo group was 2.2 (95% confidence interval [CI] 0.8, 5.8; P=0.12) in the primary PP analysis and 2.1 (95% CI 1.02, 4.5; P=0.04) in the total sample. Neither MC edema nor ADC values modified the effect of infliximab on ODI or LBP intensity. At 5 months, the effect in the Volmax ≥25% group was -4.2 ODI points (95% CI -11.4, 3.1; primary PP analysis).
Conclusion: Infliximab had no clinically relevant edema reducing effect. MC edema did not modify the effect of infliximab on disability or LBP, nor did the MC-related ADC value.
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Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.
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