Treatment of Active Idiopathic Inflammatory Myopathies by Low-Dose Interleukin-2: A Prospective Cohort Pilot Study.
Treatment of Active Idiopathic Inflammatory Myopathies by Low-Dose Interleukin-2: A Prospective Cohort Pilot Study.
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小剂量白介素2治疗活动性特发性炎症性肌病：一项前瞻性队列试验研究。
DOI：
10.1007/s40744-021-00301-3
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发表时间：
2021-06
影响因子：
3.8
通讯作者：
Li Z
中科院分区：
文献类型：
--
作者：
Miao M;Li Y;Huang B;Chen J;Jin Y;Shao M;Zhang X;Sun X;He J;Li Z
由于缺乏安全有效的药物，特发性炎性肌病（IIMs）的治疗具有挑战性。低剂量白细胞介素-2（IL-2）治疗是活动性IIM的一种新选择。本研究旨在探讨小剂量IL-2对活动性IIMs患者的临床和免疫学影响。入组了18例活动性IIM患者，在标准治疗的基础上每隔一天皮下注射1 × 106 IU IL-2，持续12周。试验的主要终点是第12周时调节性T（Treg）细胞占总CD 4 + T细胞百分比的变化。次要终点包括国际肌炎评估和临床研究（IMACS）改善定义（DOI）、2016年美国风湿病学会（ACR）/欧洲风湿病联盟（EULAR）肌炎反应标准、安全性和第12周和第24周的类固醇保留效果。在低剂量IL-2治疗下，77.78%（14/18）的患者在第12周达到IMACS DOI，83.33%（15/18）的患者符合2016年ACR/EULAR肌炎缓解标准。第12周时，包括PhGA、PGA和HAQ-DI、肌肉酶、MMT-8和肌外活动在内的所有个体核心集指标（CSM）均得到改善。皮肤皮肌炎疾病面积和严重程度指数活动评分（CDASI-a）从7分（4.5，13）下降到2分（0，7）（P < 0.001）。在第12周，低剂量IL-2治疗组Treg细胞比例显著增加（8.97% [5.77，9.89%] vs. 15.2% [10.4，17.3%]，P = 0.009）。未发生严重不良事件。低剂量IL-2对活动性IIM有效且耐受性良好。疾病活动的改善可能与TdR的促进有关。ClinicalTrials.gov标识符，NCT 04062019。在线版本包含补充材料，可通过10.1007/s40744-021-00301-3获得。
Treatment of idiopathic inflammatory myopathies (IIMs) is challenging due to a lack of safe and efficacious medication. Low-dose interleukin-2 (IL-2) treatment emerges as a new option in active IIMs. This study aims to explore the clinical and immunological effects of low-dose IL-2 in patients with active IIMs. Eighteen patients with active IIMs were enrolled and received 1 × 106 IU of IL-2 subcutaneously every other day for 12 weeks on top of standard care. The primary endpoint for the trial was change in percentage of regulatory T (Treg) cells in total CD4+ T cells at week 12. The secondary endpoints included the International Myositis Assessment and Clinical Studies (IMACS) definition of improvement (DOI), the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) myositis response criteria, safety, and steroid-sparing effect at weeks 12 and 24. With low-dose IL-2 treatment, 77.78% (14/18) patients achieved IMACS DOI and 83.33% (15/18) patients met the 2016 ACR/EULAR myositis response criteria at week 12. All individual core set measures (CSMs) including PhGA, PGA and HAQ-DI, muscle enzymes, MMT-8 and extramuscular activity were improved at week 12. The cutaneous dermatomyositis disease area and severity index activity score (CDASI-a) decreased significantly from 7 (4.5, 13) to 2 (0, 7) after IL-2 administration (P < 0.001). Proportion of Treg cells significantly increased with low-dose IL-2 treatment at week 12 (8.97% [5.77, 9.89%] vs. 15.2% [10.4, 17.3%], P = 0.009). There were no serious adverse events. Low-dose IL-2 was effective in active IIMs and well tolerated. The amelioration of disease activity may associate with promotion of Tregs. ClinicalTrials.gov identifier, NCT04062019. The online version contains supplementary material available at 10.1007/s40744-021-00301-3.
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影响因子：
4.9
作者：
Pandya JM;Loell I;Hossain MS;Zong M;Alexanderson H;Raghavan S;Lundberg IE;Malmström V
通讯作者：
Malmström V
影响因子：
15.8
作者：
Todd JA;Evangelou M;Cutler AJ;Pekalski ML;Walker NM;Stevens HE;Porter L;Smyth DJ;Rainbow DB;Ferreira RC;Esposito L;Hunter KM;Loudon K;Irons K;Yang JH;Bell CJ;Schuilenburg H;Heywood J;Challis B;Neupane S;Clarke P;Coleman G;Dawson S;Goymer D;Anselmiova K;Kennet J;Brown J;Caddy SL;Lu J;Greatorex J;Goodfellow I;Wallace C;Tree TI;Evans M;Mander AP;Bond S;Wicker LS;Waldron-Lynch F
通讯作者：
Waldron-Lynch F
影响因子：
27.4
作者：
Rosenzwajg, Michelle;Lorenzon, Roberta;Klatzmann, David
通讯作者：
Klatzmann, David
影响因子：
3.4
作者：
Miao, Miao;Li, Yuhui;Li, Zhanguo
通讯作者：
Li, Zhanguo
DOI：
10.1056/nejmoa1108188
发表时间：
2011-12-01
期刊：
The New England journal of medicine
影响因子：
--
作者：
Koreth J;Matsuoka K;Kim HT;McDonough SM;Bindra B;Alyea EP 3rd;Armand P;Cutler C;Ho VT;Treister NS;Bienfang DC;Prasad S;Tzachanis D;Joyce RM;Avigan DE;Antin JH;Ritz J;Soiffer RJ
通讯作者：
Soiffer RJ