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Long-term efficacy and safety of intramuscular interferon beta-1a: Randomized postmarketing trial of two dosing regimens in Japanese patients with relapsing-remitting multiple sclerosis.
Mult Scler Relat Disord. 2016 May; 7:102-8.MS

Abstract

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 30mcg once weekly (full-dose group, n=50) or 15mcg once weekly for 2 weeks then 30mcg 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.

Authors+Show Affiliations

Kansai Multiple Sclerosis Center and Department of Neurology, Kyoto Min-iren Central Hospital, Kyoto, Japan. Electronic address: Saida_takahiko@maia.eonet.ne.jp.Department of Neurology, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan. Electronic address: kira@neuro.med.kyushu-u.ac.jp.Biogen Japan Ltd, Tokyo, Japan. Electronic address: yasuhiro.ueno@biogen.com.Biogen Japan Ltd, Tokyo, Japan. Electronic address: nysharad@gmail.com.Biogen Japan Ltd, Tokyo, Japan. Electronic address: toshiyuki.hirakata@biogen.com.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27237769

Citation

Saida, Takahiko, et al. "Long-term Efficacy and Safety of Intramuscular Interferon Beta-1a: Randomized Postmarketing Trial of Two Dosing Regimens in Japanese Patients With Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis and Related Disorders, vol. 7, 2016, pp. 102-8.
Saida T, Kira J, Ueno Y, et al. Long-term efficacy and safety of intramuscular interferon beta-1a: Randomized postmarketing trial of two dosing regimens in Japanese patients with relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2016;7:102-8.
Saida, T., Kira, J., Ueno, Y., Harada, N., & Hirakata, T. (2016). Long-term efficacy and safety of intramuscular interferon beta-1a: Randomized postmarketing trial of two dosing regimens in Japanese patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis and Related Disorders, 7, 102-8. https://doi.org/10.1016/j.msard.2016.02.002
Saida T, et al. Long-term Efficacy and Safety of Intramuscular Interferon Beta-1a: Randomized Postmarketing Trial of Two Dosing Regimens in Japanese Patients With Relapsing-remitting Multiple Sclerosis. Mult Scler Relat Disord. 2016;7:102-8. PubMed PMID: 27237769.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of intramuscular interferon beta-1a: 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, Y1 - 2016/02/02/ PY - 2015/06/04/received PY - 2015/10/14/revised PY - 2016/02/01/accepted PY - 2016/5/31/entrez PY - 2016/5/31/pubmed PY - 2017/2/6/medline KW - Clinical trial KW - Interferon beta-1a KW - Japan KW - Multiple sclerosis KW - Phase IV SP - 102 EP - 8 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 7 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 30mcg once weekly (full-dose group, n=50) or 15mcg once weekly for 2 weeks then 30mcg 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. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/27237769/Long_term_efficacy_and_safety_of_intramuscular_interferon_beta_1a:_Randomized_postmarketing_trial_of_two_dosing_regimens_in_Japanese_patients_with_relapsing_remitting_multiple_sclerosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(16)30008-6 DB - PRIME DP - Unbound Medicine ER -