Outcomes of pregnancy during interferon beta‐1a therapy in Japanese patients with multiple sclerosis: Interim results of a postmarketing surveillance study

Shimizu, Yuko; Makioka, Haruki; Harada, Norihiro; Nakabayashi, Shoko; Saida, Takahiko; Kira, Jun Ichi

doi:10.1111/cen3.12231

Cited by 5 publications

(5 citation statements)

References 21 publications

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“…This issue resulted in a serious risk of bias 144,147,151,155 or a moderate risk of bias 145,152 in this domain. For the five cohort studies that included only an exposed group, three were rated as moderate quality 146,148,160 and two as poor quality 156,157 according to the NIH Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group.…”

Section: Resultsmentioning

confidence: 99%

“…Several studies investigated the impact of exposure to interferon beta and/or glatiramer acetate, [144][145][146][147][148][149][150][151][152][153][154][155][156][157][158] while fewer and more recent ones explored the effect of natalizumab, [159][160][161] dimethyl fumarate, 162 teriflunomide 163 and fingolimod. 164 In most studies, women were classified as being exposed to a DMT, provided the last dose/injection of drug was administered after the last menstrual period before conception.…”

Section: Recommendationsmentioning

confidence: 99%

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ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

et al. 2018

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Background and scopeMultiple sclerosis (MS) is an inflammatory-demyelinating disease of the central nervous system (CNS) that is characterized by inflammation, demyelination and degenerative changes. MS usually begins around the age between 20 and 40 years and affects two to three times as many women as men; it also constitutes the most frequent cause of non-traumatic disability in the young adult population. 1 The incidence of MS varies across regions, with rates as high as 8 to 10 new cases per 100,000 in high latitudinal regions. 2,3 Current estimates suggest that over 700,000 people are affected in Europe, with over 2.5 million cases worldwide, 4 which represent a significant burden in terms of impact on quality of life, societal costs and personal expenses. 5,6 Most patients (85%-90%) have a relapsing course from onset that is characterized by relapses and remissions of neurological symptoms Methods: This guideline has been developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology and following the updated EAN recommendations. Clinical questions were formulated in Patients-Intervention-Comparator-Outcome (PICO) format and outcomes were prioritized. The quality of evidence was rated into four categories according to the risk of bias. The recommendations with assigned strength (strong and weak) were formulated based on the quality of evidence and the risk-benefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. Results: A total of 10 questions were agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency (EMA) at the time of publication. A total of 21 recommendations were agreed by the guideline working group after three rounds of consensus. Conclusion:The present guideline will enable homogeneity of treatment decisions across Europe. associated with areas of CNS inflammation, and over the course of two decades, more than half of untreated patients transition to a phase of gradual worsening independent of acute attacks. 7,8 Progressive forms of MS can be present as the initial disease course (primary-progressive MS) in approximately 10%-15% of patients. 9,10 There is no curative treatment available for MS, and the current therapeutic strategy is aimed at reducing the risk of relapses and potentially disability progression. The treatment era for MS began in 1993, when the first interferon became available, and recent years have seen a large expansion in the therapeutic options for MS, with 11 disease-modifying therapies (DMTs) approved by the European Medicine Agency (EMA) in both injectable and oral formulations by the beginning of 2017. 11 The growing armamentarium of therapies brings new opportunities for individualized therapy where patients and providers must balance considerations around efficacy,...

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Section: Resultsmentioning

confidence: 99%

Section: Recommendationsmentioning

confidence: 99%

ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

et al. 2018

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“…Further study characteristics are presented in Appendix S4, Table S41. Several studies investigated the impact of exposure to interferon beta and/or glatiramer acetate [144][145][146][147][148][149][150][151][152][153][154][155][156][157][158], whilst fewer and more recent ones explored the effect of natalizumab [159][160][161], dimethyl fumarate [162], teriflunomide [163] and fingolimod [164]. In most studies, women were classified as being exposed to a disease modifying treatment (DMT) provided the last dose/injection of drug was administered after the last menstrual period before conception.…”

Section: Quality Assessmentmentioning

confidence: 99%

“…This issue resulted in a serious risk of bias [144,147,151,155] or a moderate risk of bias [145,152] in this domain. For the five cohort studies that included only an exposed group, three were rated as moderate quality [146,148,160] and two as poor quality [156,157] according to the National Institutes of Health Quality Assessment Tool for BeforeÀAfter (PreÀPost) Studies with No Control Group.…”

Section: Quality Assessmentmentioning

confidence: 99%

ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis

Montalbán

Gold

Thompson

et al. 2018

Euro J of Neurology

280

279

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Background and purpose: Multiple sclerosis (MS) is a complex disease with new drugs becoming available in the past years. There is therefore a need for a reference tool compiling current data to aid professionals in treatment decisions. The objective was to develop an evidence-based clinical practice guideline for the pharmacological treatment of people with MS. Methods: This guideline has been developed using the GRADE methodology and following the updated EAN recommendations for guideline development. Clinical questions were formulated in PICO format (patient, intervention, comparator, outcome) and outcomes were prioritized according to their relevance to clinical practice. Literature searches up to December 2016 were performed and the evidence is presented narratively and, when possible, combined in a fax: +34 93 2746084; e-mail: xavier.montalban@cem-cat.org) and for EAN: R. Gold, Department of Neurology, Ruhr University, St Josef-Hospital, Gudrunstr. 56, 44791 Bochum, Germany (tel.: +49-234-509244; fax: +49-234-5092414; e-mail: ralf.gold@rub.de). This is a Continuing Medical Education article, and can be found with corresponding questions on the EAN website, LEARN section https://www.ean. org/CME.2714.0.html. Certificates for correctly answered questions will be issued by EAN directly, you simply have to be logged-in. With positive results, EAN recommends accreditation of 1 hour of CME, which may be claimed with the national body in charge of CME accreditation. This paper is being simultaneously published in European Journal of Neurology and Multiple Sclerosis Journal.[Correction added on 13 February 2018, after online and print publication: (a) The abstract has been updated and a conclusion section in now included; (b) Recommendation 4 and 7 has been amended, and an additional recommendation has been added after the latter]. meta-analysis. The quality of evidence was rated into four categories -very high, high, low and very low À according to the risk of bias. The recommendations with assigned strength (strong, weak) were formulated based on the quality of evidence and the riskÀbenefit balance. Consensus between the panelists was reached by use of the modified nominal group technique. Results: A total of 10 questions have been agreed, encompassing treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and treatment strategies in MS and pregnancy. The guideline takes into account all disease-modifying drugs approved by the European Medicine Agency at the time of publication. A total of 21 recommendations were agreed by the guideline working group members after three rounds of consensus. Conclusion: The present guideline, which includes descriptions of the evidence together with recommendations, will enable homogeneity of treatment decisions across Europe. © 2018 European Academy of Neurology and European Committee of Treatment of Research in Multiple SclerosisBackground and scope

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“…There were 19 reports (16 patients) of elevated creatinine kinase levels, and five of these reports (in seven patients) were considered to be treatment related. Pregnancy outcomes data determined during this PMS study have been published elsewhere …”

Section: Resultsmentioning

confidence: 99%

Safety and efficacy response to interferon beta‐1a therapy in Japanese patients with multiple sclerosis: Interim results of a postmarketing surveillance study

Saida¹,

Makioka

Kira

2016

Clinical & Exp Neuroim

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Objectives To evaluate safety and efficacy of intramuscular interferon beta‐1a (IFN beta‐1a) in Japanese patients with relapsing–remitting multiple sclerosis over the first 2 years of treatment. Methods Safety data were collected from patients registered in a postmarketing surveillance (PMS) study and combined with spontaneous safety reports from other Japanese patients receiving IFN beta‐1a. Efficacy, including annualized relapse rate (ARR), was assessed only in patients in the postmarketing surveillance study. Results Safety analyses were based on 2589 patients, and efficacy analyses included 1241 of the 1638 patients registered in the postmarketing surveillance study who had completed 2 years of treatment (mean treatment duration, 598 days). Safety findings were consistent with those seen in clinical trials; the most commonly reported adverse event was fever (9.8%). The ARR decreased by 71% (from 0.95 at baseline, before study enrolment, to 0.28 at the last on‐therapy assessment) overall, and by 89% (from 1.22 to 0.14) among the 374 IFN beta‐naive patients. Among the 653 patients with relapse data at baseline and at year 2, 401 (61.4%) were classified as responders to intramuscular IFN beta‐1a therapy (defined as those with lower ARR at both year 1 and year 2 than at baseline), with an 87% reduction in ARR (from 1.29 at year 1 to 0.17 at year 2). Conclusions The results of this interim analysis are consistent with those of previous studies carried out largely in Caucasian patients, and show the efficacy and safety of intramuscular IFN beta‐1a treatment for Japanese patients with multiple sclerosis in clinical practice.

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Outcomes of pregnancy during interferon beta‐1a therapy in Japanese patients with multiple sclerosis: Interim results of a postmarketing surveillance study

Cited by 5 publications

References 21 publications

ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis

ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis

Safety and efficacy response to interferon beta‐1a therapy in Japanese patients with multiple sclerosis: Interim results of a postmarketing surveillance study

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