Low-Dose Mycophenolate Mofetil for Treatment of Neuromyelitis Optica Spectrum Disorders: A Prospective Multicenter Study in South China
To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs). This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase...
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Published in | Frontiers in immunology Vol. 9; p. 2066 |
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Abstract | To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs).
This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase and prospective data from the post-treatment phase. From September 2014 to February 2017, NMOSD patients seropositive for aquaporin 4-IgG (AQP4-IgG) were treated with low-dose MMF.
Ninety NMOSD patients were treated with MMF for a median duration of 18 months (range 6-40 months). The median annual recurrence rate (ARR) decreased from 1.02 before treatment to 0 (
< 0.0001) after treatment, and the Expanded Disability Status Scale (EDSS) score decreased from 4 to 3 (
< 0.0001). The EDSS score was significantly lower (
= 0.038) after the first 90 days of treatment. The serum AQP4-IgG titer decreased in 50 cases (63%). The median Simple McGill pain score (SF-MPQ) was reduced in 65 patients (88%) with myelitis from 17 (range 0-35) to 11 (range 0-34) after treatment (
< 0.0001). The median Hauser walking index (Hauser Walk Rating Scale) was reduced from 2 (range 1-9) before treatment to 1 (range 0-7) after treatment (
< 0.0001). Adverse events were documented in 43% of the patients, and eight patients discontinued MMF due to intolerable adverse events. Fourteen (16%) of the total patients discontinued MMF after our last follow-up for various reasons and switched to azathioprine or rituximab.
Low-dose MMF reduced clinical relapse and disability in NMOSD patients in South China. However, some patients still suffered from adverse events at this dosage.
www.ClinicalTrials.gov, identifier : NCT02809079. |
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AbstractList | Objective:
To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs).
Methods:
This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase and prospective data from the post-treatment phase. From September 2014 to February 2017, NMOSD patients seropositive for aquaporin 4-IgG (AQP4-IgG) were treated with low-dose MMF.
Results:
Ninety NMOSD patients were treated with MMF for a median duration of 18 months (range 6–40 months). The median annual recurrence rate (ARR) decreased from 1.02 before treatment to 0 (
P
< 0.0001) after treatment, and the Expanded Disability Status Scale (EDSS) score decreased from 4 to 3 (
P
< 0.0001). The EDSS score was significantly lower (
P
= 0.038) after the first 90 days of treatment. The serum AQP4-IgG titer decreased in 50 cases (63%). The median Simple McGill pain score (SF-MPQ) was reduced in 65 patients (88%) with myelitis from 17 (range 0–35) to 11 (range 0–34) after treatment (
P
< 0.0001). The median Hauser walking index (Hauser Walk Rating Scale) was reduced from 2 (range 1–9) before treatment to 1 (range 0–7) after treatment (
P
< 0.0001). Adverse events were documented in 43% of the patients, and eight patients discontinued MMF due to intolerable adverse events. Fourteen (16%) of the total patients discontinued MMF after our last follow-up for various reasons and switched to azathioprine or rituximab.
Conclusion:
Low-dose MMF reduced clinical relapse and disability in NMOSD patients in South China. However, some patients still suffered from adverse events at this dosage.
Clinical Trial Registration:
www.ClinicalTrials.gov
, identifier : NCT02809079. To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs). This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase and prospective data from the post-treatment phase. From September 2014 to February 2017, NMOSD patients seropositive for aquaporin 4-IgG (AQP4-IgG) were treated with low-dose MMF. Ninety NMOSD patients were treated with MMF for a median duration of 18 months (range 6-40 months). The median annual recurrence rate (ARR) decreased from 1.02 before treatment to 0 ( < 0.0001) after treatment, and the Expanded Disability Status Scale (EDSS) score decreased from 4 to 3 ( < 0.0001). The EDSS score was significantly lower ( = 0.038) after the first 90 days of treatment. The serum AQP4-IgG titer decreased in 50 cases (63%). The median Simple McGill pain score (SF-MPQ) was reduced in 65 patients (88%) with myelitis from 17 (range 0-35) to 11 (range 0-34) after treatment ( < 0.0001). The median Hauser walking index (Hauser Walk Rating Scale) was reduced from 2 (range 1-9) before treatment to 1 (range 0-7) after treatment ( < 0.0001). Adverse events were documented in 43% of the patients, and eight patients discontinued MMF due to intolerable adverse events. Fourteen (16%) of the total patients discontinued MMF after our last follow-up for various reasons and switched to azathioprine or rituximab. Low-dose MMF reduced clinical relapse and disability in NMOSD patients in South China. However, some patients still suffered from adverse events at this dosage. www.ClinicalTrials.gov, identifier : NCT02809079. Objective: To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs). Methods: This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase and prospective data from the post-treatment phase. From September 2014 to February 2017, NMOSD patients seropositive for aquaporin 4-IgG (AQP4-IgG) were treated with low-dose MMF. Results: Ninety NMOSD patients were treated with MMF for a median duration of 18 months (range 6-40 months). The median annual recurrence rate (ARR) decreased from 1.02 before treatment to 0 (P < 0.0001) after treatment, and the Expanded Disability Status Scale (EDSS) score decreased from 4 to 3 (P < 0.0001). The EDSS score was significantly lower (P = 0.038) after the first 90 days of treatment. The serum AQP4-IgG titer decreased in 50 cases (63%). The median Simple McGill pain score (SF-MPQ) was reduced in 65 patients (88%) with myelitis from 17 (range 0-35) to 11 (range 0-34) after treatment (P < 0.0001). The median Hauser walking index (Hauser Walk Rating Scale) was reduced from 2 (range 1-9) before treatment to 1 (range 0-7) after treatment (P < 0.0001). Adverse events were documented in 43% of the patients, and eight patients discontinued MMF due to intolerable adverse events. Fourteen (16%) of the total patients discontinued MMF after our last follow-up for various reasons and switched to azathioprine or rituximab. Conclusion: Low-dose MMF reduced clinical relapse and disability in NMOSD patients in South China. However, some patients still suffered from adverse events at this dosage.CLINICAL TRIAL REGISTRATIONwww.ClinicalTrials.gov, identifier : NCT02809079. Objective: To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs).Methods: This study was a multicenter, open, prospective, follow-up clinical trial. The data include retrospective clinical data from the pretreatment phase and prospective data from the post-treatment phase. From September 2014 to February 2017, NMOSD patients seropositive for aquaporin 4-IgG (AQP4-IgG) were treated with low-dose MMF.Results: Ninety NMOSD patients were treated with MMF for a median duration of 18 months (range 6–40 months). The median annual recurrence rate (ARR) decreased from 1.02 before treatment to 0 (P < 0.0001) after treatment, and the Expanded Disability Status Scale (EDSS) score decreased from 4 to 3 (P < 0.0001). The EDSS score was significantly lower (P = 0.038) after the first 90 days of treatment. The serum AQP4-IgG titer decreased in 50 cases (63%). The median Simple McGill pain score (SF-MPQ) was reduced in 65 patients (88%) with myelitis from 17 (range 0–35) to 11 (range 0–34) after treatment (P < 0.0001). The median Hauser walking index (Hauser Walk Rating Scale) was reduced from 2 (range 1–9) before treatment to 1 (range 0–7) after treatment (P < 0.0001). Adverse events were documented in 43% of the patients, and eight patients discontinued MMF due to intolerable adverse events. Fourteen (16%) of the total patients discontinued MMF after our last follow-up for various reasons and switched to azathioprine or rituximab.Conclusion: Low-dose MMF reduced clinical relapse and disability in NMOSD patients in South China. However, some patients still suffered from adverse events at this dosage.Clinical Trial Registration: www.ClinicalTrials.gov, identifier : NCT02809079. |
Author | Li, Caixia Lu, Zhengqi Yan, Zhenwen Wang, Zhanhang Zhou, Yifan Yang, Hui Feng, Huiyu Huang, Qiao Hu, Xueqiang Yin, Jia Qiu, Wei Long, Youming Wang, Jingqi |
AuthorAffiliation | 4 Department of Neurology, Guangdong 999 Brain Hospital , Guangzhou , China 5 Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University , Guangzhou , China 6 Department of Neurology, Second Affiliated Hospital of Guangzhou Medical University , Guangzhou , China 9 School of Mathematics, Sun Yat-sen University , Guangzhou , China 7 Department of Neurology, Nanfang Hospital , Guangzhou , China 3 Department of Neuro-Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University , Guangzhou , China 8 Department of Neurology, First Affiliated Hospital of Sun Yat-sen University , Guangzhou , China 2 Department of Neurology, Zhaoqing No. 2 People's Hospital , Zhaoqing , China 1 Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University , Guangzhou , China |
AuthorAffiliation_xml | – name: 5 Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University , Guangzhou , China – name: 6 Department of Neurology, Second Affiliated Hospital of Guangzhou Medical University , Guangzhou , China – name: 3 Department of Neuro-Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University , Guangzhou , China – name: 8 Department of Neurology, First Affiliated Hospital of Sun Yat-sen University , Guangzhou , China – name: 7 Department of Neurology, Nanfang Hospital , Guangzhou , China – name: 4 Department of Neurology, Guangdong 999 Brain Hospital , Guangzhou , China – name: 1 Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University , Guangzhou , China – name: 2 Department of Neurology, Zhaoqing No. 2 People's Hospital , Zhaoqing , China – name: 9 School of Mathematics, Sun Yat-sen University , Guangzhou , China |
Author_xml | – sequence: 1 givenname: Qiao surname: Huang fullname: Huang, Qiao organization: Department of Neurology, Zhaoqing No. 2 People's Hospital, Zhaoqing, China – sequence: 2 givenname: Jingqi surname: Wang fullname: Wang, Jingqi organization: Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China – sequence: 3 givenname: Yifan surname: Zhou fullname: Zhou, Yifan organization: Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China – sequence: 4 givenname: Hui surname: Yang fullname: Yang, Hui organization: Department of Neuro-Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China – sequence: 5 givenname: Zhanhang surname: Wang fullname: Wang, Zhanhang organization: Department of Neurology, Guangdong 999 Brain Hospital, Guangzhou, China – sequence: 6 givenname: Zhenwen surname: Yan fullname: Yan, Zhenwen organization: Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China – sequence: 7 givenname: Youming surname: Long fullname: Long, Youming organization: Department of Neurology, Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China – sequence: 8 givenname: Jia surname: Yin fullname: Yin, Jia organization: Department of Neurology, Nanfang Hospital, Guangzhou, China – sequence: 9 givenname: Huiyu surname: Feng fullname: Feng, Huiyu organization: Department of Neurology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China – sequence: 10 givenname: Caixia surname: Li fullname: Li, Caixia organization: School of Mathematics, Sun Yat-sen University, Guangzhou, China – sequence: 11 givenname: Zhengqi surname: Lu fullname: Lu, Zhengqi organization: Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China – sequence: 12 givenname: Xueqiang surname: Hu fullname: Hu, Xueqiang organization: Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China – sequence: 13 givenname: Wei surname: Qiu fullname: Qiu, Wei organization: Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30258442$$D View this record in MEDLINE/PubMed |
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ContentType | Journal Article |
Copyright | Copyright © 2018 Huang, Wang, Zhou, Yang, Wang, Yan, Long, Yin, Feng, Li, Lu, Hu and Qiu. 2018 Huang, Wang, Zhou, Yang, Wang, Yan, Long, Yin, Feng, Li, Lu, Hu and Qiu |
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Keywords | a prospective study mycophenolate mofetil South China therapy neuromyelitis optica spectrum disorders |
Language | English |
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Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Edited by: Fabienne Brilot, University of Sydney, Australia This article was submitted to Multiple Sclerosis and Neuroimmunology, a section of the journal Frontiers in Immunology Reviewed by: Romain Marignier, Hospices Civils de Lyon, France; Sudarshini Ramanathan, University of Sydney, Australia; Michael Levy, Johns Hopkins University, United States These authors have contributed equally to this work and share first authorship |
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Snippet | To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders (NMOSDs).
This... Objective: To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders... Objective: To evaluate the efficacy and safety of low-dose mycophenolate mofetil (MMF, 1,000 mg/day) treatment of neuromyelitis optica spectrum disorders... |
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Title | Low-Dose Mycophenolate Mofetil for Treatment of Neuromyelitis Optica Spectrum Disorders: A Prospective Multicenter Study in South China |
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