An International, Retrospective Study of Off-Label Biologic Use in the Treatment of Hypereosinophilic Syndromes.
An International, Retrospective Study of Off-Label Biologic Use in the Treatment of Hypereosinophilic Syndromes.
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DOI：
10.1016/j.jaip.2022.02.006
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发表时间：
2022-05
影响因子：
9.4
通讯作者：
Bochner, Bruce S.
中科院分区：
文献类型：
--
作者：
Chen, Michael M.;Roufosse, Florence;Wang, Sa A.;Verstovsek, Srdan;Durrani, Sandy R.;Rothenberg, Marc E.;Pongdee, Thanai;Butterfield, Joseph;Lax, Timothy;Wechsler, Michael E.;Stein, Miguel L.;Ogbogu, Princess U.;Kahwash, Basil M.;Mathur, Sameer K.;Simon, Dagmar;Akuthota, Praveen;Holland, Nicole;Wetzler, Lauren;Ware, JeanAnne M.;Guo, Canting;Fay, Michael P.;Khoury, Paneez;Klion, Amy D.;Bochner, Bruce S.
嗜酸性粒细胞增多症 (HES) 的治疗通常需要使用具有显着副作用的免疫调节剂。生物制剂的出现提供了一种替代治疗方式。检查现实世界的实践数据，以描述怀疑直接或间接影响嗜酸性粒细胞炎症的各种生物制剂治疗 HES 的安全性和后果。通过在线 REDCap 数据存储库收集了 13 个中心的回顾性数据。纳入标准包括 1) 外周嗜酸性粒细胞计数≥1500/mm3，无继发原因，2) 嗜酸性粒细胞增多引起的临床表现，以及 3) 已接受美泊利单抗（抗 IL-5）、贝那利珠单抗（无岩藻糖基化抗 IL-5 受体 α）、奥马珠单抗（抗 IgE）、阿仑单抗 （抗 CD52）、dupilumab（抗 IL-4 受体 α）或 reslizumab（抗 IL-5）在安慰剂对照临床试验之外。在为 121 名 HES 患者开具的 151 个生物制剂疗程中，59% 的 HES 症状得到改善，77% 的患者可以逐渐减少其他 HES 药物的用量。总体而言，105 名患者在开始生物制剂治疗时每天接受全身性糖皮质激素治疗，并且能够通过每天平均减少 10 毫克泼尼松当量来减少糖皮质激素剂量。除了阿仑单抗的输注反应外，生物制剂通常是安全的且耐受性良好。 24 名患者中有 13 名在更换生物制剂后出现临床改善，9 名患者在对较低剂量的美泊利单抗无反应后对增加美泊利单抗剂量有反应。尽管 HES 每种亚型的最佳剂量和选择仍有待确定，但生物制剂可能为 HES 现有疗法提供更安全的替代治疗方案。这项研究的局限性包括其回顾性以及数据收集和每种生物制剂的可用性的站点间差异。
Treatment of hypereosinophilic syndrome (HES) often requires the use of immunomodulators with substantial side effect profiles. The emergence of biologics offers an alternative treatment modality. To examine real world practice data to describe the safety and consequences of various biologics suspected to either directly or indirectly impact eosinophilic inflammation for the treatment of HES. Retrospective data from 13 centers were collected via an online REDCap data repository. Inclusion criteria included 1) peripheral eosinophil count ≥1500/mm3 without a secondary cause, 2) clinical manifestations attributable to the eosinophilia, and 3) having received mepolizumab (anti-IL-5), benralizumab (afucosylated anti-IL-5 receptor alpha), omalizumab (anti-IgE), alemtuzumab (anti-CD52), dupilumab (anti-IL-4 receptor alpha), or reslizumab (anti-IL-5) outside of a placebo-controlled clinical trial. Of the 151 courses of biologics prescribed for 121 patients with HES, 59% resulted in improved HES symptoms and 77% enabled tapering of other HES medications. Overall, 105 patients were on daily systemic glucocorticoids at the time of a biologic initiation and were able to reduce their glucocorticoid dose by a median reduction of 10 mg of daily prednisone equivalents. Biologics were generally safe and well tolerated other than infusion reactions with alemtuzumab. Thirteen out of 24 patients had clinical improvement after switching biologics, and 9 patients responded to increasing the dose of mepolizumab after lack of response to a lower dose. Biologics may offer a safer treatment alternative to existing therapies for HES, although the optimal dosing and choice for each subtype of HES remains to be determined. Limitations of this study include its retrospective nature and inter-site differences in data collection and availability of each biologic.
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影响因子：
14.2
作者：
Roufosse, Florence;Kahn, Jean-Emmanuel;Rothenberg, Marc E.;Wardlaw, Andrew J.;Klion, Amy D.;Kirby, Suyong Yun;Gilson, Martyn J.;Bentley, Jane H.;Bradford, Eric S.;Yancey, Steven W.;Steinfeld, Jonathan;Gleich, Gerald J.
通讯作者：
Gleich, Gerald J.
DOI：
10.1016/j.clml.2012.09.018
发表时间：
2013-06
期刊：
Clinical lymphoma, myeloma & leukemia
影响因子：
--
作者：
Strati P;Cortes J;Faderl S;Kantarjian H;Verstovsek S
通讯作者：
Verstovsek S
影响因子：
--
作者：
MASI, AT;HUNDER, GG;ZVAIFLER, NJ
通讯作者：
ZVAIFLER, NJ
DOI：
10.1016/j.jaip.2018.04.033
发表时间：
2018-09
期刊：
The journal of allergy and clinical immunology. In practice
影响因子：
--
作者：
Kuang FL;Fay MP;Ware J;Wetzler L;Holland-Thomas N;Brown T;Ortega H;Steinfeld J;Khoury P;Klion AD
通讯作者：
Klion AD
影响因子：
14.2
作者：
Ogbogu, Princess U.;Bochner, Bruce S.;Butterfield, Joseph H.;Gleich, Gerald J.;Huss-Marp, Johannes;Kahn, Jean Emmanuel;Leiferman, Kristin M.;Nutman, Thomas B.;Pfab, Florian;Ring, Johannes;Rothenberg, Marc E.;Roufosse, Florence;Sajous, Marie-Helene;Sheikh, Javed;Simon, Dagmar;Simon, Hans-Uwe;Stein, Miguel L.;Wardlaw, Andrew;Weller, Peter F.;Klion, Amy D.
通讯作者：
Klion, Amy D.