ECTRIMS eLearning

Evaluation of efficacy of glatiramer acetate treatment for multiple sclerosis in Japan
Author(s): ,
T. Okamoto
Affiliations:
Neurology, National Center Hospital, National Center of Neurology and Psychiatry; Multiple Sclerosis Center, National Center of Neurology and Psychiatry
,
Y. Lin
Affiliations:
Neurology, National Center Hospital, National Center of Neurology and Psychiatry; Multiple Sclerosis Center, National Center of Neurology and Psychiatry; Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan
,
M. Araki
Affiliations:
Neurology, National Center Hospital, National Center of Neurology and Psychiatry; Multiple Sclerosis Center, National Center of Neurology and Psychiatry; Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan
,
W. Sato
Affiliations:
Multiple Sclerosis Center, National Center of Neurology and Psychiatry; Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan
,
Y. Takahashi
Affiliations:
Neurology, National Center Hospital, National Center of Neurology and Psychiatry
T. Yamamura
Affiliations:
Multiple Sclerosis Center, National Center of Neurology and Psychiatry; Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan
ECTRIMS Learn. Okamoto T. 10/10/18; 229437; EP1600
Tomoko Okamoto
Tomoko Okamoto
Contributions
Abstract

Abstract: EP1600

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: Glatiramer acetate (GA) has been established as a first-line therapy in multiple sclerosis (MS) for more than 20 years in Western countries. In contrast, in Japan, interferon beta (IFN-β) has been the only disease-modifying drug (DMD) for MS for over 10 years. Later, fingolimod and natalizmab, second-line therapies, were introduced prior to GA. GA became available only 2 years ago. It is thus very important to evaluate the efficacy of GA as a therapeutic for MS patients in Japan.
Objective: To evaluate the effectiveness and usefulness of GA in MS patients in Japan.
Methods: We conducted a retrospective evaluation of the clinical background, clinical course, and side effect profile of GA in patients with MS. GA was administered between December 2015 and February 2018 in our hospital. We observed their clinical course until February 2018.
Results: One hundred and one patients with MS (35 men, 66 women) received GA treatment. Mean Expanded Disability Status Scale at the introduction of GA was 3.5, and the mean period from the onset of MS was 9.2 years. Other DMDs were used before the administration of GA in 57 cases, with 44 and 8 patients receiving one and two types of DMDs, respectively. Five patients received GA after receiving IFN-β, fingolimod, and natalizmab. GA treatment has been continued in 61% of the 101 patients and stopped in 39%. Although 91 (90%) of the 101 patients treated with GA had adverse events (AEs) upon administration of the drug, only 8 patients stopped GA treatment because of AEs. In 46 patients who continued GA for more than 1 year, the annualized relapse rate before GA administration was 0.76, and that after GA administration was 0.37, indicating that GA suppressed recurrence with a significance of p < 0.01. GA was effective in cases where patients were IFN-β-non-responders or in those where other DMDs were discontinued due to side effects. In addition, in certain cases, a stable clinical course was obtained after GA administration, even in those that failed to achieve a satisfactory outcome after treatment with IFN-β, fingolimod, and natalizmab.
Conclusion: GA is a promising treatment of choice for Japanese patients with MS.
Disclosure: T. Okamoto received funding for a clinical trial from Takeda Pharmaceutical Co., Ltd. Y. Lin received speaker honoraria from Asahi Kuraray Medical, Ltd. M. Araki received honoraria from Chugai Pharmaceutical Co., Ltd.; Novartis Pharmaceuticals; Biogen Japan; Bayer Holding Ltd; Takeda Pharmaceuti-cal Co., Ltd. W. Sato and Y. Takahashi report no disclosures. T. Yamamura served on the scientific advisory board for Biogen Japan, Chugai Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd and received travel funding and/or speaker honoraria from Mitsubishi Tanabe Pharma, Novartis, Nihon, Santen, Abbott Japan/Eisai, Biogen Japan, Dainippon Sumitomo, Bayer Holding, and Astellas Pharma Inc., and Takeda Pharmaceutical Co., Ltd., and received research support from Ono, Chugai, Teva, Mitsubishi Tanabe Pharma, Asahi Kuraray Medical, and the Ministry of Health, Labor, and Welfare of Japan.

Abstract: EP1600

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: Glatiramer acetate (GA) has been established as a first-line therapy in multiple sclerosis (MS) for more than 20 years in Western countries. In contrast, in Japan, interferon beta (IFN-β) has been the only disease-modifying drug (DMD) for MS for over 10 years. Later, fingolimod and natalizmab, second-line therapies, were introduced prior to GA. GA became available only 2 years ago. It is thus very important to evaluate the efficacy of GA as a therapeutic for MS patients in Japan.
Objective: To evaluate the effectiveness and usefulness of GA in MS patients in Japan.
Methods: We conducted a retrospective evaluation of the clinical background, clinical course, and side effect profile of GA in patients with MS. GA was administered between December 2015 and February 2018 in our hospital. We observed their clinical course until February 2018.
Results: One hundred and one patients with MS (35 men, 66 women) received GA treatment. Mean Expanded Disability Status Scale at the introduction of GA was 3.5, and the mean period from the onset of MS was 9.2 years. Other DMDs were used before the administration of GA in 57 cases, with 44 and 8 patients receiving one and two types of DMDs, respectively. Five patients received GA after receiving IFN-β, fingolimod, and natalizmab. GA treatment has been continued in 61% of the 101 patients and stopped in 39%. Although 91 (90%) of the 101 patients treated with GA had adverse events (AEs) upon administration of the drug, only 8 patients stopped GA treatment because of AEs. In 46 patients who continued GA for more than 1 year, the annualized relapse rate before GA administration was 0.76, and that after GA administration was 0.37, indicating that GA suppressed recurrence with a significance of p < 0.01. GA was effective in cases where patients were IFN-β-non-responders or in those where other DMDs were discontinued due to side effects. In addition, in certain cases, a stable clinical course was obtained after GA administration, even in those that failed to achieve a satisfactory outcome after treatment with IFN-β, fingolimod, and natalizmab.
Conclusion: GA is a promising treatment of choice for Japanese patients with MS.
Disclosure: T. Okamoto received funding for a clinical trial from Takeda Pharmaceutical Co., Ltd. Y. Lin received speaker honoraria from Asahi Kuraray Medical, Ltd. M. Araki received honoraria from Chugai Pharmaceutical Co., Ltd.; Novartis Pharmaceuticals; Biogen Japan; Bayer Holding Ltd; Takeda Pharmaceuti-cal Co., Ltd. W. Sato and Y. Takahashi report no disclosures. T. Yamamura served on the scientific advisory board for Biogen Japan, Chugai Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Co., Ltd and received travel funding and/or speaker honoraria from Mitsubishi Tanabe Pharma, Novartis, Nihon, Santen, Abbott Japan/Eisai, Biogen Japan, Dainippon Sumitomo, Bayer Holding, and Astellas Pharma Inc., and Takeda Pharmaceutical Co., Ltd., and received research support from Ono, Chugai, Teva, Mitsubishi Tanabe Pharma, Asahi Kuraray Medical, and the Ministry of Health, Labor, and Welfare of Japan.

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