کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5913340 | 1570401 | 2016 | 7 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Development of anti-velaglucerase alfa antibodies in clinical trial-treated patients with Gaucher disease
ترجمه فارسی عنوان
توسعه آنتیبادیهای ضد ویگللوسروز آلفا در بیماران تحت درمان با بیمار مبتلا به بیماری گوچه
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کلمات کلیدی
CCL18radioimmunoprecipitationECLVelaglucerase alfachemokine (C-C motif) ligand 18seroconversionTEAE - teaerAnti-drug antibody - آنتی بادی ضد داروantibodies - آنتی بادی هاenzyme replacement therapy - آنزیم جایگزین درمانElectrochemiluminescence - الکتروکمی لومینسانسGaucher disease - بیماری گوچهELISA - تست الیزاEnzyme-linked immunosorbent assay - تست الیزاtreatment emergent adverse event - درمان عوارض جانبی ناگهانیadverse event - عارضه جانبی یا عوارض جانبیERT - هستندADA - وجود داردRIP - پاره کردن
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
زیست شناسی مولکولی
چکیده انگلیسی
Anti-drug antibodies may develop with biological therapies, possibly leading to a reduction of treatment efficacy and to allergic and other adverse reactions. Patients with Gaucher disease were tested for anti-drug antibodies every 6 or 12Â weeks in clinical studies of velaglucerase alfa enzyme replacement therapy, as part of a range of safety endpoints. In 10 studies between April 2004 and March 2015, 289 patients aged 2-84Â years (median 43Â years) were assessed for the development of anti-velaglucerase alfa antibodies. Sixty-four patients were treatment-naïve at baseline and 225 patients were switched to velaglucerase alfa from imiglucerase treatment. They received velaglucerase alfa treatment for a median of 36.4Â weeks (interquartile range 26.4-155.4Â weeks). Four patients (1.4%) became positive for anti-velaglucerase alfa IgG antibodies, two of whom had antibodies that were neutralizing in vitro, but there were no apparent changes in patients' platelet counts, hemoglobin levels or levels of CCL18 and chitotriosidase, suggestive of clinical deterioration after anti-velaglucerase alfa antibodies were detected, and no infusion-related adverse events were reported. Less than 2% of patients exposed to velaglucerase alfa tested positive for antibodies and there was no apparent correlation between anti-velaglucerase alfa antibodies and adverse events or pharmacodynamic or clinical responses.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Blood Cells, Molecules, and Diseases - Volume 59, July 2016, Pages 37-43
Journal: Blood Cells, Molecules, and Diseases - Volume 59, July 2016, Pages 37-43
نویسندگان
Gregory M. Pastores, Hadhami Ben Turkia, Derlis E. Gonzalez, Hiroyuki Ida, Azza A.G. Tantawy, Yulin Qin, Yongchang Qiu, Quinn Dinh, Ari Zimran,