TY - JOUR
T1 - Long-term efficacy and safety of intramuscular interferon beta-1a
T2 - Randomized postmarketing trial of two dosing regimens in Japanese patients with relapsing-remitting multiple sclerosis
AU - Saida, Takahiko
AU - Kira, Jun Ichi
AU - Ueno, Yasuhiro
AU - Harada, Naozumi
AU - Hirakata, Toshiyuki
N1 - Funding Information:
This study was sponsored by Biogen Japan Ltd. The authors gratefully acknowledge the study investigators for their contributions. Biogen provided funding for editorial support in the development of this manuscript; Mary Goodsell of Infusion Communications and Rebecca Lew, PhD, CMPP and Rose Boutros, PhD of ProScribe – part of the Envision Pharma Group, wrote the first draft of this manuscript based on input from the authors. Biogen reviewed and provided feedback on the manuscript to the authors. The authors had full editorial control of the manuscript and provided their final approval of all content.
Funding Information:
Dr Saida has received funding from, held board membership with, spoken at scientific meetings for, prepared manuscripts for, and/or had consulting agreements with Astellas Pharma, Bayer Schering Pharma, Biogen, Daiichi Sankyo, Eisai, Kaketsuken, Merck Serono, Mitsubishi Tanabe Pharma, Nihon Pharmaceutical, Novartis, Ono Pharmaceutical, Sanofi, TDS Japan, Teijin Pharmaceutical. Dr Kira has received payment for lectures or funding from Astellas Pharma Inc., Eisai Co. Ltd, GlaxoSmithKline, Nichii Gakkan Co., Medical Review Co. Ltd, Alexion Pharmaceuticals, Bayer Yakuhin Ltd, Janssen Pharmaceutical K.K., Santen Pharmaceutical Co. Ltd, Ono Pharmaceutical, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma Co. Ltd, Sanofi, Novartis Pharma K.K., Takeda Pharmaceutical Ltd, Pfizer Japan Inc., Mitsubishi-Tanabe Pharmaceutical, Biogen Japan, Daiichi-Sankyo, Boehringer Ingelheim, and Japan Blood Products Organization. Mr Ueno, Mr Harada, and Mr Hirakata are current or former employees of and have equity interests in Biogen Japan.
Publisher Copyright:
© 2016 Published by Elsevier B.V.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - Objectives To evaluate the efficacy and safety of 2 years of treatment with intramuscular interferon beta-1a (IM IFN beta-1a) in Japanese patients with relapsing-remitting multiple sclerosis, with an exploratory analysis of the impact of initial dose titration on tolerability. Methods Japanese patients with relapsing-remitting multiple sclerosis were randomized to receive IM IFN beta-1a at dosages of either 30 mcg once weekly (full-dose group, n=50) or 15 mcg once weekly for 2 weeks then 30 mcg once weekly thereafter (titration group, n=50). Key outcomes included annualized relapse rate (ARR) at 2 years (primary endpoint), change in disability measured using the Expanded Disability Status Scale (EDSS), safety, and tolerability. Results The ARR (95% CI) decreased from 1.540 (1.381-1.718) at baseline to 0.371 (0.240-0.571) at Year 1 and 0.351 (0.244-0.503) at Year 2. EDSS improvements were apparent from Week 24; the mean change from baseline EDSS score (2.1) at Year 2 was -0.34 (P=0.004). The most frequently reported adverse events were influenza-like illness (92%), nasopharyngitis (57%), relapse of multiple sclerosis (51%), and injection-site reaction (30%). The overall incidence and severity of influenza-like symptoms were similar in the full-dose group and titration group; only 1 participant, in the full-dose group (2%), experienced severe influenza-like symptoms. However, the incidence of influenza-like symptoms was slightly reduced at earlier timepoints in the titration group. Conclusions The results of this 2-year study demonstrate that IM IFN beta-1a can be used effectively and safely in Japanese patients with relapsing-remitting multiple sclerosis for an extended period of time.
AB - Objectives To evaluate the efficacy and safety of 2 years of treatment with intramuscular interferon beta-1a (IM IFN beta-1a) in Japanese patients with relapsing-remitting multiple sclerosis, with an exploratory analysis of the impact of initial dose titration on tolerability. Methods Japanese patients with relapsing-remitting multiple sclerosis were randomized to receive IM IFN beta-1a at dosages of either 30 mcg once weekly (full-dose group, n=50) or 15 mcg once weekly for 2 weeks then 30 mcg once weekly thereafter (titration group, n=50). Key outcomes included annualized relapse rate (ARR) at 2 years (primary endpoint), change in disability measured using the Expanded Disability Status Scale (EDSS), safety, and tolerability. Results The ARR (95% CI) decreased from 1.540 (1.381-1.718) at baseline to 0.371 (0.240-0.571) at Year 1 and 0.351 (0.244-0.503) at Year 2. EDSS improvements were apparent from Week 24; the mean change from baseline EDSS score (2.1) at Year 2 was -0.34 (P=0.004). The most frequently reported adverse events were influenza-like illness (92%), nasopharyngitis (57%), relapse of multiple sclerosis (51%), and injection-site reaction (30%). The overall incidence and severity of influenza-like symptoms were similar in the full-dose group and titration group; only 1 participant, in the full-dose group (2%), experienced severe influenza-like symptoms. However, the incidence of influenza-like symptoms was slightly reduced at earlier timepoints in the titration group. Conclusions The results of this 2-year study demonstrate that IM IFN beta-1a can be used effectively and safely in Japanese patients with relapsing-remitting multiple sclerosis for an extended period of time.
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U2 - 10.1016/j.msard.2016.02.002
DO - 10.1016/j.msard.2016.02.002
M3 - Article
C2 - 27237769
AN - SCOPUS:84963677253
VL - 7
SP - 102
EP - 108
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
SN - 2211-0348
ER -