Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS

Cohen, J. A.; Imrey, Peter B.; Calabresi, Peter A.; Edwards, Keith R.; Eickenhorst, T.; Felton, Warren L.; Fisher, Elizabeth; Fox, Robert J.; Goodman, Andrew; Hara-Cleaver, Claire; Hutton, George J.; Mandell, Brian F.; Scott, Thomas F.; Zhang, H.; Apperson-Hansen, Carolyn; Beck, Gerald J.; Houghtaling, Penny L.; Karafa, Matt; Stadtler, Maria

doi:10.1212/01.wnl.0000341934.12142.74

Cited by 83 publications

(31 citation statements)

References 21 publications

(22 reference statements)

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“…The primary endpoint of new or enlarged T2 lesions comparing baseline and 12 month MRI scan was not met for any group. Nonsignificant trends in secondary outcomes variably favored either MTX or IVMP [56].…”

Section: Combination Trialsmentioning

confidence: 97%

Interferon Beta and Glatiramer Acetate Therapy

McGraw

Lublin

2013

Neurotherapeutics

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Section: Combination Trialsmentioning

confidence: 97%

Interferon Beta and Glatiramer Acetate Therapy

McGraw

Lublin

2013

Neurotherapeutics

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“…However, because of slow patient recruitment, the study was redesigned with a smaller enrollment target and shorter duration of follow up. In the redesigned study, 313 eligible patients entered the study on stable doses of IM IFNb-1a (30 mg once weekly) and were randomized to a 12-month course of adjunctive therapy with placebo (group 1), oral methotrexate 20 mg once weekly (group 2), intravenous methylprednisolone 1000 mg/day for 3 consecutive days every other month (group 3), or oral methotrexate and intravenous methylprednisolone at the same doses as in groups 2 and 3 (group 4) [Cohen et al 2009]. The primary endpoint was new or enlarged T2-hyperintense lesions, and secondary endpoints were EDSS scores, Multiple Sclerosis Functional Composite (MSFC) scores, and relapses.…”

Section: Combination Therapy With Ifnbmentioning

confidence: 99%

The interferon beta therapies for treatment of relapsing–remitting multiple sclerosis: are they equally efficacious? A comparative review of open-label studies evaluating the efficacy, safety, or dosing of different interferon beta formulations alone or in combination

Limmroth¹,

Putzki

Kachuck

2011

Ther Adv Neurol Disord

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Interferon beta preparations are the most widely used initial therapies prescribed for patients with relapsingremitting multiple sclerosis. Phase III studies have demonstrated comparable efficacy on clinical measures of disease activity, variable benefits on radiological measures, and good overall tolerability. Subsequent clinical studies have attempted to compare directly the three available interferon beta preparations, reporting both safety and efficacy data. We review the literature on studies evaluating interferon beta therapy for patients with relapsingremitting multiple sclerosis, discuss reasons for discrepant findings, and assess the utility of interferon beta-based combination regimens as the focus of future studies in the increasingly complex multiple sclerosis therapy landscape.

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“…Such findings point to inconclusive evidence of efficacy in PRMS, and there are no sufficiently welldesigned trials to ascertain the effectiveness of methotrexate monotherapy in RRMS. More recently, the randomized Avonex Combination Trial (ACT), which included 313 patients with RRMS, found no significant benefit of adding low-dose methotrexate to treatment in patients with ongoing disease activity while receiving IFNb-1a monotherapy [Cohen et al 2009]. Taken together, these findings suggest that methotrexate is likely to have only a limited role in MS management and therefore should not be used as a substitute for currently approved therapies.…”

Section: Cyclophosphamidementioning

confidence: 99%

Chemotherapeutics in the treatment of multiple sclerosis

Kieseier

Jeffery

2010

Ther Adv Neurol Disord

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Abstract:The likely pathogenic mechanisms of multiple sclerosis (MS) provide a sound rationale for investigating the efficacy of drugs possessing immunosuppressive or immunomodulatory properties. With proven efficacy, safety and tolerability, interferon beta formulations and glatiramer acetate have become the mainstay of initial treatment for patients with relapsing forms of MS. More recently, natalizumab, a humanized monoclonal antibody (mAb) against the cellular adhesion molecule a4-integrin, has been employed for patients with an inadequate response or lack of tolerability to an alternate MS therapy, or as initial therapy for patients with severe disease. Various agents initially developed for oncological indications, either as chemotherapeutics or mAbs, may also have current or future uses in MS treatment. Mitoxantrone is currently the only chemotherapeutic agent approved for treatment of MS in the United States, while in parts of Europe azathioprine is approved and widely used for MS treatment. Other chemotherapeutics that have been tested in MS to date include cyclophosphamide, methotrexate, cladribine, and the mAbs alemtuzumab and rituximab. While there has been varying evidence of efficacy for these compounds, each appears to be associated with serious risks that require careful consideration and management. Given the risks that have been demonstrated for available chemotherapeutic agents and while long-term postmarketing safety data are still not available for those agents in development, it seems prudent to carefully assess the possible use of chemotherapeutics in the treatment of MS. A thorough riskbenefit analysis is becoming increasingly important in the assessment of therapeutic options for this disabling disease.

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Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS

Abstract: This trial did not demonstrate benefit of adding low-dose oral methotrexate or every other month IV methylprednisolone to interferon beta-1a in relapsing-remitting multiple sclerosis.

Cited by 83 publications

References 21 publications

Interferon Beta and Glatiramer Acetate Therapy

Interferon Beta and Glatiramer Acetate Therapy

The interferon beta therapies for treatment of relapsing–remitting multiple sclerosis: are they equally efficacious? A comparative review of open-label studies evaluating the efficacy, safety, or dosing of different interferon beta formulations alone or in combination

Chemotherapeutics in the treatment of multiple sclerosis

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