Efficacy and tolerability of intramuscular interferon beta-1a compared with subcutaneous interferon beta-1a in relapsing MS: results from PROOF

Minagar, Alireza; Murray, Thomas J.

doi:10.1185/030079908x280545

Cited by 24 publications

(25 citation statements)

References 18 publications

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“…Escherichia coli-derived, unglycosylated interferon b-1b is more immunogenic than mammalian cell-derived, fully glycosylated interferon b-1a (Perini et al 2001). In general, more patients receiving subcutaneous (SC) interferon b-1a drug (Rebif 1 ) or SC interferon b1b develop neutralizing ADA compared with those receiving an intravenous (IV) interferon b-1a drug (Avonex 1 ), while patients receiving intramuscular interferon b-1a seldom develop neutralizing ADA (Farrell and Giovannoni 2007;Minagara and Murray 2008). To the contrary, repeated-dose rat and monkey studies have shown that intramuscular dosing with interferon b-1a (Rebif 1 ) was associated with higher ADA titers compared with IV dosing (Ponce et al 2009).…”

Section: Ada In Humans Administered Therapeutic Proteinsmentioning

confidence: 99%

Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes

et al. 2014

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Vascular inflammation, infusion reactions, glomerulopathies, and other potentially adverse effects may be observed in laboratory animals, including monkeys, on toxicity studies of therapeutic monoclonal antibodies and recombinant human protein drugs. Histopathologic and immunohistochemical (IHC) evaluation suggests these effects may be mediated by deposition of immune complexes (ICs) containing the drug, endogenous immunoglobulin, and/or complement components in the affected tissues. ICs may be observed in glomerulus, blood vessels, synovium, lung, liver, skin, eye, choroid plexus, or other tissues or bound to neutrophils, monocytes/macrophages, or platelets. IC deposition may activate complement, kinin, and/or coagulation/fibrinolytic pathways and result in a systemic proinflammatory response. IC clearance is biphasic in humans and monkeys (first from plasma to liver and/or spleen, second from liver or spleen). IC deposition/clearance is affected by IC composition, immunomodulation, and/or complement activation. Case studies are presented from toxicity study monkeys or rats and indicate IHC-IC deposition patterns similar to those predicted by experimental studies of IC-mediated reactions to heterologous protein administration to monkeys and other species. The IHC-staining patterns are consistent with findings associated with generalized and localized IC-associated pathology in humans. However, manifestations of immunogenicity in preclinical species are generally not considered predictive to humans.

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Section: Ada In Humans Administered Therapeutic Proteinsmentioning

confidence: 99%

Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes

et al. 2014

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“…Of patients receiving IM IFNb-1a, 60.5% remained relapse free, compared with 33% of patients receiving SC IFNb-1b and 54.5% of patients receiving SC IFNb-1a. Despite differences in relapse rates among the [Minagar and Murray, 2008]. PROOF was intended to collect up to 5 years of comparative efficacy and tolerability data using combined chart review and prospective observational data.…”

Section: Therapeutic Advances In Neurological Disorders 4 (5)mentioning

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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“…Moreover, the results of this trial which was carried out under normal clinical practice conditions, demonstrated that both IFN's studied herein (Axuareb -Biosimilar and AvonexOriginal) are comparable safe and reliable treatment options. Both products showed similarly significant beneficial impacts on disease activity [14][15][16][17].…”

Section: Discussionmentioning

confidence: 99%

A Therapeutic Trial of Bioequivalence Between Two Interferons Beta ?1a for Treating Relapsing ? Remitting Multiple Sclerosis

Perusquia¹

2015

J Mult Scler (Foster City)

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JMSO, an open access journal Perusquía-Ortega et al., J Mult Scler (Foster City) 2015, 2:3 http://dx.doi.org/10.4172/2376 Research Article Open Access Journal of Multiple Sclerosis AbstractIn order to appropriately support the equivalence between a biosimilar and the referenced biopharmaceutical it is essential to carry out equivalence or non-inferiority clinical studies. The objective of this paper was to study the therapeutic bioequivalence of IFN β-1A biosimilar vs. IFN β-1A innovator. The efficacy and safety of these drugs was assessed in Mexican patients under treatment for relapsing-remitting multiple sclerosis (RRMS). A parallel, multicenter, prospective and comparative study was carried out. Fifty patients with confirmed RRMS were studied. The following parameters were considered for the diagnosis of confirmed RRMS: Magnetic Resonance Imaging (MRI) demonstrating demyelinating lesions; expanded disability status scale (EDSS) scores between 0 -5.5; and McDonald's criteria compatible with MS. Patients were randomly divided into 2 groups of 25 patients each. Patients from the first group were treated with Avonex ®, 30 mg-per-week. Patients from the second group were treated with Axuareb® at the same dose. All patients were followed for a period of 24 months. Forty-five patients (90%) out of the initially recruited 50 patients completed the follow-up period. Annual relapse rates were 11% and 8% for Avonex and Axuareb, respectively. The proportions of relapse-free, improvement and detriment showed non-significant differences (p>0.05) between groups. The incidence of side effects showed a non-significant difference (p>0.05) between groups. SF-36 data of physical and mental status demonstrated non-significant differences between groups after the follow-up period. Although, MRI findings demonstrated a significant increase (p<0.05) in the number of demyelinating lesions after the follow-up period in both groups of patients, the group of patients treated with Axuareb demonstrated a significantly reduced mean number of lesions after the follow-up period. In conclusion, both drugs showed similar effectiveness and safety. Thus, from the results of this clinical trial, it seems that Axuareb, a biosimilar IFN is a safe and reliable alternative for treating patients with MS.

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Efficacy and tolerability of intramuscular interferon beta-1a compared with subcutaneous interferon beta-1a in relapsing MS: results from PROOF

Cited by 24 publications

References 18 publications

Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes

Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes

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

A Therapeutic Trial of Bioequivalence Between Two Interferons Beta ?1a for Treating Relapsing ? Remitting Multiple Sclerosis

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