A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.
A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.
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DOI：
10.1016/j.semarthrit.2017.10.010
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发表时间：
2018-06
影响因子：
5
通讯作者：
Gourley M
中科院分区：
文献类型：
--
作者：
Schiffenbauer A;Garg M;Castro C;Pokrovnichka A;Joe G;Shrader J;Cabalar IV;Faghihi-Kashani S;Harris-Love MO;Plotz PH;Miller FW;Gourley M
在一项先导性研究中探讨英夫利西单抗治疗难治性皮肌炎（DM）和多发性肌炎（PM）患者的安全性和有效性。受试者在0、2、6和14周以盲态方式接受安慰剂或英夫利西单抗5 mg/kg输注。主要结果是与第0周相比，第16周时手动肌肉力量（MMT）改善>15%。次要结局指标为国际肌炎评估和临床研究组（IMACS）标准定义的改善。在第16周，每组中的应答者可以选择继续相同的治疗或改变为该研究组的非应答者治疗。在5 mg/kg英夫利西单抗组中的非应答者在第22、30、38周增加至英夫利西单抗7.5 mg/kg。安慰剂组第16周的无应答者在第16、18、22、30、38周接受英夫利西单抗5 mg/kg。在第40周重新评估结局。12例受试者完成研究至第16周。12例受试者中有6例接受了5 mg/kg剂量的英夫利西单抗治疗，仅1例受试者在该剂量下符合应答者标准。在接受英夫利西单抗治疗的其余5例受试者中，3例交叉至英夫利西单抗7.5 mg/kg剂量组。这三个人中的一个回答。安慰剂组的所有6例患者在第16周后交叉至5 mg/kg给药方案，其中2例对英夫利西单抗有应答。英夫利西单抗治疗难治性PM和DM患者耐受性良好，可能使一部分患者获益。
To investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM). Participants received infusions of either placebo or infliximab 5 mg/kg at 0, 2, 6 and 14 weeks in blinded manner. The primary outcome was a >15% Manual Muscle Strength (MMT) improvement at Week 16 compared to Week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At Week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5 mg/kg infliximab arm were increased to infliximab 7.5 mg/kg for week 22, 30, 38. Non-responders in the placebo arm at week 16 received infliximab 5 mg/kg at weeks 16, 18, 22, 30, 38. Outcomes were reassessed at Week 40. Twelve subjects completed the study to week 16. Six of the twelve subjects received infliximab treatment at the dose of 5 mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5 mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5 mg/kg dosing regimen after Week 16, and two of those responded to infliximab. Infliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients.
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影响因子：
12.7
作者：
Kuru, S;Inukai, A;Sobue, G
通讯作者：
Sobue, G
影响因子：
12.7
作者：
Kuru, S;Inukai, A;Sobue, G
通讯作者：
Sobue, G
影响因子：
27.4
作者：
Efthimiou, P.;Schwartzman, S.;Kagen, L. J.
通讯作者：
Kagen, L. J.
影响因子：
3.3
作者：
Lundberg, I;Brengman, JM;Engel, AG
通讯作者：
Engel, AG
影响因子：
5.5
作者：
Harris-Love, M. O.;Shrader, J. A.;Koziol, D.;Pahlajani, N.;Jain, M.;Smith, M.;Cintas, H. L.;McGarvey, C. L.;James-Newton, L.;Pokrovnichka, A.;Moini, B.;Cabalar, I.;Lovell, D. J.;Wesley, R.;Plotz, P. H.;Miller, F. W.;Hicks, J. E.;Rider, L. G.
通讯作者：
Rider, L. G.