250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

O’Connor, PW; Filippi, Massimo; Arnason, Barry G. W.; Comı, Gıancarlo; Cook, Stuart D.; Goodin, Douglas S.; Hartung, Hans Peter; Jeffery, Douglas; Kappos, Ludwig; Boateng, Francis; Filippov, V. L.; Groth, Maria; Knappertz, Volker; Kraus, Christian; Sandbrink, Rupert; Pohl, Christoph; Bogumil, Timon

doi:10.1016/s1474-4422(09)70226-1

Cited by 387 publications

(304 citation statements)

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“…No difference was observed between the groups in number of lesions or clinical relapses. The Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial randomized RRMS participants in a 2:2:1 fashion to IFNB-1b SC 250 μg QOD vs 500 μg vs GA SC 20 mg daily for three years [48]. Participants and treating physicians were unblinded to treatment assignment, but evaluating physicians remained blinded.…”

Section: Comparator Trialsmentioning

confidence: 99%

“…As described in previous sections, GA was compared to IFNB-1a SC (REGARD) and IFNB-1b SC (BECOME and BEYOND) [46][47][48] for the treatment of RRMS. Though each study under individual scrutiny had potential reasons for failing to demonstrate GA superiority, it has become accepted practice to consider GA and highdose interferons to have similar clinical efficacy.…”

Section: Comparator Trialsmentioning

confidence: 99%

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Interferon Beta and Glatiramer Acetate Therapy

McGraw

Lublin

2013

Neurotherapeutics

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Section: Comparator Trialsmentioning

confidence: 99%

Section: Comparator Trialsmentioning

confidence: 99%

Interferon Beta and Glatiramer Acetate Therapy

McGraw

Lublin

2013

Neurotherapeutics

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“…Importantly, there was no evidence that a switch of therapy was related to depressive symptoms; only injection issues or poor response was associated with a change in therapy. It is conceivable that patients discontinued therapy in a way that is related to depres- patients with MS (N = 2447) randomized to IFNβ-1b 500 µg, IFNβ-1b 250 µg, or GA. 21,22 In addition, longterm findings from the PRISMS (Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis) trial, which prospectively compared the efficacy and safety of two different doses of IFNβ-1a with placebo, found no significant differences in the incidence of depression or depression-related adverse events among patients with MS (N = 560) randomized to IFNβ-1a 22 µg, IFNβ-1a 44 µg, or placebo over time. 23 While BEYOND and PRISMS were not specifically designed to examine depression as an outcome, these results are supportive of the outcomes observed in the current study.…”

Section: Use Of Concomitant Antidepressant Medicationmentioning

confidence: 99%

“…1,11 This study as well as other comparison studies have not supported those earlier findings. [18][19][20][21][22][23] There is mounting clinical evidence that IFNβ therapy is not likely to induce depression in MS patients. 1 Treating depression pharmacologically or with cognitive-behavioral therapy is usually very effective in MS patients.…”

Section: Use Of Concomitant Antidepressant Medicationmentioning

confidence: 99%

Relationship Between Disease-Modifying Therapy and Depression in Multiple Sclerosis

Kirzinger¹,

Jones²,

Siegwald³

2013

International Journal of MS Care

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Many prescribers of disease-modifying therapies (DMTs) for multiple sclerosis (MS) believe that interferon beta (IFNβ) is more likely than glatiramer acetate (GA) to increase depression during the course of MS treatment. Therefore, newly diagnosed patients with a history of depression are often placed on GA therapy from the onset of MS treatment. The aim of this study was to examine the relationship between DMT type and depression among patients with relapsing-remitting MS (RRMS). Patients with RRMS who were examined from 2000 to 2007 and who remained on a single course of therapy (either an IFNβ or GA) were included in a retrospective review of medical records. Patients were asked to complete the Beck Depression Inventory (BDI) at treatment initiation and every 6 months thereafter for up to 4 years. Only patients who had completed a BDI within 6 weeks of starting their DMT were included in the analysis. No significant differences in mean change in BDI score were observed from baseline to 48 months between the IFNβ and GA subgroups. Additionally, no significant differences in mean BDI score change were observed between antidepressant-treated and non–antidepressant-treated patients within the IFNβ or GA subgroup. Neither IFNβ nor GA therapy appears to exacerbate depressive symptoms in patients with RRMS who remain on their initial therapy.

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“…The aim of this study was not to compare efficacy of the medications, because head-to-head studies have previously confirmed, only the negligible difference among the drugs used [15][16][17] .…”

Section: Discussionmentioning

confidence: 99%

Clinical predictors of response to immunomodulators for multiple sclerosis

Olival

Lima²,

Lima

et al. 2012

Arq. Neuro-Psiquiatr.

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Multiple sclerosis (MS) is an autoimmune disease characterized by demyelinating inflammatory activity of the central nervous system. It is most prevalent in young adults between 20 and 40 years of age and constitutes a frequent cause of neurological dysfunction in this age group 1 .Immunomodulatory therapy had been proven to be effective in modifying the natural course of the disease in patients with MS. Interferon beta (IFNb) and glatiramer acetate (GA) comprise the first line of therapy for MS and have seemed to reduce the rate of demyelination exacerbations compared to placebo in clinical trials 2-5 . However, not all patients are responsive to this treatment 6 . ABStrActObjectives: To determine, based on clinical criteria, the proportion of multiple sclerosis (MS) patients responsive to immunomodulators (RI) and nonresponsive to immunomodulators (NRI), and to ascertain whether clinical and epidemiological data differs between RI and NRI patient groups. Methods: Patients were assessed on rate of exarcerbations per year, for the period before and after commencement of treatment. The RI and NRI groups were compared for several clinical and epidemiological characteristics. Discussion and conclusion: A total of 31.4% of the patients were nonresponders to the immunomodulatory treatment. The main predictors of immunomodulatory response were early diagnostic and commencement of therapy and high rate of annual exacerbations prior to treatment. Given the arsenal of medication options available for MS management, screening potential candidates for different therapeutic approaches are critical to optimize evolution of patients with the disease.Key words: multiple sclerosis, immunomodulators, predictors. reSUMO Objetivos: Avaliar por meio de critérios clínicos, a proporção de pacientes com esclerose múltipla (EM) responsivos aos imunomoduladores (RI) e não responsivos aos imunomoduladores (NRI) e avaliar se dados clínicos e epidemiológicos são distintos nesses dois grupos. Méto-dos: Os pacientes foram avaliados quanto à taxa de surtos por ano no período antes e após o início do tratamento. Diversas características clínicas e epidemiológicas foram comparadas entre os pacientes RI e NRI. Discussão e conclusão: Em nossa população, 31,4% dos pacientes não responderam ao tratamento com os imunomoduladores. Os principais preditores de resposta aos imunomoduladores foram: diagnóstico e início precoce da terapia e elevada taxa de surtos anual antes do tratamento. Como existem várias opções medicamentosas disponíveis para o tratamento da EM, a identificação de candidatos potenciais para abordagens terapêuticas diferentes representa o ponto crucial para otimizar a evolução dos pacientes com essa doença.Palavras-Chave: esclerose múltipla, imunomoduladores, preditores.

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250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

Abstract: Bayer HealthCare Pharmaceuticals.

Cited by 387 publications

References 28 publications

Interferon Beta and Glatiramer Acetate Therapy

Interferon Beta and Glatiramer Acetate Therapy

Relationship Between Disease-Modifying Therapy and Depression in Multiple Sclerosis

Clinical predictors of response to immunomodulators for multiple sclerosis

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