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

Q: How can I download an article?

To download an article from SID, first log in to the site, search for the article title, and click on the 'Download Article' option.

Q: How can I download an ISI article?

To download an ISI article on SID, enter the keyword or article title in the search bar, view the relevant results, click on the desired article, and select the 'Download Article' option.

Q: How can I access the SID database?

To access the SID database, visit SID.ir, create an account, and log in to access scientific resources.

Q: Is downloading articles from SID free?

Some articles on SID are available for free, while others require payment. Details are specified on the article's page.

NABAVI SEYED MASSOOD; ABOLFAZLI ROYA; Etemadrezaei Ali; HOSSEINI HAMED; MORADI NAHID; Shahriari Sanaz; Mehdipour Baharak; SHEKARCHI BABAK; SOLTANZADEH AKBAR

مرکز اطلاعات علمی Scientific Information Database (SID) - Trusted Source for Research and Academic Resources

Journal Paper

Paper Information

Journal: Iranian Journal of Pharmaceutical Research Year:2019 | Volume:18 | Issue:3 Page(s): 1632-1638

Download Full-Text

View:

169

Download:

173

Cites:

Information Journal Paper

Title

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

Author(s)

Keywords

Relapsing remitting multiple sclerosis

Beta interferon-1a

Biosimilar

Multiple sclerosis

Pharmacologic therapy

Abstract

We compared the efficacy and safety of a Biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of Multiple sclerosis/fa?page=1&sort=1&ftyp=all&fgrp=all&fyrs=all" target="_blank">Relapsing remitting Multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the Biosimilar medication and the reference treatment (30 μ g intramuscular, weekly for one year). We investigated changes in EDSS, relapse rate and MRI changes within one year. In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32. 4 ± 8. 8 and 31. 5 ± 8 for the Biosimilar medication and the reference arm respectively. One-year follow-up revealed a mean difference of 0. 084 in EDSS (95% CI: 0. 069-0. 237) between the two groups in favor of the Biosimilar medication. This value did not exceed the predefined non-inferiority margin of 0. 1. There were no statistically significant differences in relapse rate and systemic and local adverse events of the two groups. 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. In conclusion the Biosimilar interferon 1-a can be considered as an effective and safe alternative to the reference product due to lower cost and more availability.

Cites

No record.

References

No record.

Cite

APA: Copy

NABAVI, SEYED MASSOOD, ABOLFAZLI, ROYA, Etemadrezaei, Ali, HOSSEINI, HAMED, MORADI, NAHID, Shahriari, Sanaz, Mehdipour, Baharak, SHEKARCHI, BABAK, & SOLTANZADEH, AKBAR. (2019). A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Β eta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 18(3), 1632-1638. SID. https://sid.ir/paper/289165/en

Vancouver: Copy

NABAVI SEYED MASSOOD, ABOLFAZLI ROYA, Etemadrezaei Ali, HOSSEINI HAMED, MORADI NAHID, Shahriari Sanaz, Mehdipour Baharak, SHEKARCHI BABAK, SOLTANZADEH AKBAR. A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Β eta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2019;18(3):1632-1638. Available from: https://sid.ir/paper/289165/en

IEEE: Copy

SEYED MASSOOD NABAVI, ROYA ABOLFAZLI, Ali Etemadrezaei, HAMED HOSSEINI, NAHID MORADI, Sanaz Shahriari, Baharak Mehdipour, BABAK SHEKARCHI, and AKBAR SOLTANZADEH, “A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Β eta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 18, no. 3, pp. 1632–1638, 2019, [Online]. Available: https://sid.ir/paper/289165/en

Related Journal Papers

No record.

Related Seminar Papers

No record.

Related Plans

No record.

Recommended Workshops