Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
| العنوان: | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
|---|---|
| المؤلفون: | Françoise Bouhour, Jérôme Franques, Etienne Godet, David H. Adams, Jean Pouget, Emilien Delmont, Odile Dubourg, Gilles Angibaud, Philippe Corcia, Chafké Belmokhtar, Pierre Lozeron, Arnaud Lacour, Mathieu Bataille |
| المصدر: | Neurology and Therapy Neurology and Therapy, Vol 8, Iss 1, Pp 69-78 (2019) |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | medicine.medical_specialty, Neurology, business.operation, Immunoglobulins, Chronic inflammatory demyelinating polyneuropathy, Octapharma, lcsh:RC346-429, 03 medical and health sciences, 0302 clinical medicine, Peripheral nervous system disease, Internal medicine, hemic and lymphatic diseases, Octagam®, Medicine, 030212 general & internal medicine, Adverse effect, Prospective cohort study, lcsh:Neurology. Diseases of the nervous system, Original Research, business.industry, Polyradiculoneuropathy, Retrospective cohort study, medicine.disease, Neurology (clinical), Immunotherapy, business, 030217 neurology & neurosurgery, Adverse drug reaction |
| الوصف: | Introduction Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a debilitating autoimmune neuropathy that is treated with intravenous immunoglobulin (IVIG). The aim of this retrospective study was to investigate the efficacy and safety of the sucrose-free IVIG Octagam® (Octapharma AG, Lachen, Switzerland) in patients with CIDP. Methods Data from 47 patients who received at least one dose of Octagam were collected from the records of 11 centres in France. Efficacy was assessed using Overall Neuropathy Limitation Scale (ONLS). Safety was evaluated using adverse event rates. Results Data from 24 patients who were IVIG naïve (n = 11) or had stopped IVIG ≥ 12 weeks before initiation of Octagam therapy (washout group; n = 13) were included in the efficacy analysis. At 4 months post-initiation of Octagam treatment, 41.7% of patients had improved their functional status (decrease of ≥ 1 ONLS score) with a significant change in the ONLS score from baseline (– 0.42; p = 0.04; signed test). Functional status was reduced in only two patients: one patient in the IVIG-naïve group and one patient in the IVIG-washout group. All 47 patients were included in the safety analysis, which showed that Octagam was well tolerated, with a frequency of 0.04 adverse events per Octagam course. The most common adverse drug reaction was headache. Conclusions These real-life results are consistent with the efficacy and safety of IVIG reported in randomised controlled studies. A long-term prospective study of Octagam in patients with CIDP is warranted. Funding Octapharma, France SAS. |
| تدمد: | 2193-8253 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::64ac12ea03ecb789a863e3ef334f017bTest https://pubmed.ncbi.nlm.nih.gov/30903535Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....64ac12ea03ecb789a863e3ef334f017b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 21938253 |
|---|