Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex in relapsing remitting multiple sclerosis: A double blind randomized clinical trial

@article{Nafissi2012ComparingEA,
  title={Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex in relapsing remitting multiple sclerosis: A double blind randomized clinical trial},
  author={Shahriar Nafissi and Amirreza Azimi and A. Amini-Harandi and Shiva Salami and Mohammad Amir Shahkarami and Ramin Heshmat},
  journal={Clinical Neurology and Neurosurgery},
  year={2012},
  volume={114},
  pages={986-989}
}

Tables from this paper

A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran

TLDR
The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety.

A randomized double-blind trial of comparative efficacy and safety of Avonex and CinnoVex for treatment of relapsing-remitting multiple sclerosis

TLDR
Avonex and CinnoVex showed similar efficacy and safety outcome in patients with RRMS and there was no statistically significant difference in MRI activity and clinical activity between two groups.

Cost-utility analysis of interferon beta-1a (Avonex and Cinnovex) for relapsing remitting multiple sclerosis

TLDR
It is concluded that Cinnovex in patients with progressive relapsing MS is cost-effective associated with increased benefits compared with Avonex.

Quality of life in relapsing-remitting multiple sclerosis patients receiving CinnoVex compared with Avonex

TLDR
It was seen that there are no significant differences between QoL of Avonex and CinnoVex, but a limitation in this study the results may be different in other countries and even various areas in Iran.

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

TLDR
The main obstacles for the approval of biosimilar medications by international health agencies is their consistent inability to demonstrate therapeutic equivalence through physiochemistry, biology, immunogenicity aspects, molecular behavior and clinical studies.

Nocebo in Biosimilars and Generics in Neurology: A Systematic Review

TLDR
Despite its presence, the true burden of the nocebo response and effect cannot be accurately estimated in existing studies with generics and biosimilars in neurological diseases.

Pharmacotherapeuetic Options for the Treatment of Multiple Sclerosis

TLDR
The market landscape for MS drugs is in the midst of major change because the patent life of many of these medicines will soon expire, which will lead to the emergence of biosimilars.

Antidrug Antibodies Against Biological Treatments for Multiple Sclerosis

TLDR
It is now largely agreed that persistently high titers of NAbs indicate an abrogation of the biological response and, hence, an absence of therapeutic efficacy, and this observation should lead to a change of therapy.

Access and barriers to MS care in Latin America

  • V. RiveraM. Macías
  • Medicine
    Multiple sclerosis journal - experimental, translational and clinical
  • 2017
TLDR
Generic treatments, biosimilars, and follow-on complex non-biological drugs (CNBD) are commonly available in institutional formularies in LATAM despite their lack of supportive efficacy and safety data and reported molecular differences with the innovators.

Multiplexed Gene Expression as a Characterization of Bioactivity for Interferon Beta (IFN-β) Biosimilar Candidates: Impact of Innate Immune Response Modulating Impurities (IIRMIs)

TLDR
These studies indicate that determining the expression levels for an array of reporter genes that monitor different pathways can be informative as part of the demonstration of biosimilarity or comparability for complex immunomodulatory products such as IFN-β, but the sensitivity of each gene to potential impurities in the product should be examined to fully understand the results.

References

SHOWING 1-10 OF 27 REFERENCES

Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group.

  • Medicine, Psychology
    Neurology
  • 1995
TLDR
IFNB had a persistent beneficial effect on exacerbation rate and MRI burden of disease and was relatively free of long-term side effects.

Review of the clinical evidence for interferon β 1a (Rebif®) in the treatment of multiple sclerosis

TLDR
Pivotal trials, their cross-over extensions, and post-marketing studies consistently showed that INF β 1a 22 or 44 μg s.c.i.w. is safe and well tolerated, as adverse drug reactions are usually mild and manageable.

Magnetic resonance studies of intramuscular interferon beta-1a for relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group.

TLDR
Once weekly intramuscular IFNbeta-1a appears to impede the development of multiple sclerosis lesions at an early stage and has a favorable impact on the long-term sequelae of these inflammatory events as indicated by the slowed accumulation of T2 lesions.

Impact of interferon beta-1a on neurologic disability in relapsing multiple sclerosis

TLDR
It is demonstrated that IFNβ-1a treatment is associated with robust, clinically important beneficial effects on disability progression in relapsing MS patients and post hoc analyses related to disability outcomes using data collected during the double-blind, placebo-controlled phase III clinical trial.

Magnetic resonance studies of intramuscular interferon β–1a for relapsing multiple sclerosis

TLDR
Once weekly intramuscular IFNβ‐1a appears to impede the development of multiple sclerosis lesions at an early stage and has a favorable impact on the long‐term sequelae of these inflammatory events as indicated by the slowed accumulation of T2 lesions.

Magnetic resonance imaging changes with recombinant human interferon-beta-1a: a short term study in relapsing-remitting multiple sclerosis.

TLDR
Interferon-beta-1a seemed effective in reducing disease activity in relapsing-remitting multiple sclerosis at both the doses used.

Intramuscular interferon beta‐1a for disease progression in relapsing multiple sclerosis

TLDR
Interferon beta‐ la had a significant beneficial impact in relapsing multiple sclerosis patients by reducing the accumulation of permanent physical disability, exacerbation frequency, and disease activity measured by gadolinium‐enhanced lesions on brain magnetic resonance images.

Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.

TLDR
Starting treatment with interferon beta-1a at the time of a first demyelinating event is beneficial for patients with brain lesions on MRI that indicate a high risk of clinically definite multiple sclerosis.

Impact of neutralizing antibodies on the clinical efficacy of interferon beta in multiple sclerosis

TLDR
Clinicians should consider the possible development of NAbs when starting patients on treatment and in patients with disease progression while on IFN β treatment, suggesting that short-term clinical trials cannot adequately assess the efficacy of IFNβ products in MS.