The evolution of interferon therapy in multiple sclerosis
https://doi.org/10.14412/2074-2711-2023-1S-58-64
Abstract
The article reviews the evolution of interferon-β (IFN-β) in the treatment of multiple sclerosis (MS) from the first high-dose interferons to the most recent pegylated forms. The results of pivotal trials are presented and discussed. The main problems of the first IFN-β were: 1) moderate efficacy in the presence of neutralizing antibodies (NAB, in 20% of treated patients), leading to a decrease in efficacy, 2) poor tolerability due to frequent injections (every other day), 3) severe local reactions and flu-like syndrome. Pegillation made it possible to extend the duration of administration to one injection every 14 days and to reduce the probability of NAB to less than 1% of all treated patients. The first drug administered subcutaneously had a pronounced flu-like syndrome; the domestic drug SamPEG-IFN-β1a administered intramuscularly was better tolerated with similar efficacy.
Supporting agencies: This article has been supported by Biocad
About the Authors
O. V. Boyko
Federal Center for Brain and Neurotechnologies, Federal Medical and Biological Agency of Russia
Russian Federation
Russian Federation
1, Ostrovityanova St., Build. 10, Moscow 117997
N. F. Smirnova
Federal Center for Brain and Neurotechnologies, Federal Medical and Biological Agency of Russia; Department of Neurology, Neurosurgery, and Medical Genetics, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
1, Ostrovityanova St., Build. 10, Moscow 117997
21, Ostrovityanova St., Moscow 117997
A. N. Boyko
Federal Center for Brain and Neurotechnologies, Federal Medical and Biological Agency of Russia; Department of Neurology, Neurosurgery, and Medical Genetics, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia
Russian Federation
Russian Federation
Alexey Nikolaevich Boyko
1, Ostrovityanova St., Build. 10, Moscow 117997
21, Ostrovityanova St., Moscow 117997
References
1. Kappos L. Interferons in multiple sclerosis. Neurol Clin. 2005 Feb;23(1):189-214, vii-viii. doi: 10.1016/j.ncl.2004.10.004
2. Haji Abdolvahab M, Mofrad MR, Schellekens H. Interferon Beta: From Molecular Level to Therapeutic Effects. Int Rev Cell Mol Biol. 2016;326:343-72. doi: 10.1016/bs.ircmb.2016.06.001. Epub 2016 Jul 20.
3. Michalska A, Blaszczyk K, Wesoly J, Bluyssen HAR. A Positive Feedback Amplifier Circuit That Regulates Interferon (IFN)- Stimulated Gene Expression and Controls Type I and Type II IFN Responses. Front Immunol. 2018 May 28;9:1135. doi: 10.3389/fimmu.2018.01135
4. Dumitrescu L, Constantinescu CS, Tanasescu R. Recent developments in interferon-based therapies for multiple sclerosis. Expert Opin Biol Ther. 2018 Jun;18(6):665-80. doi: 10.1080/14712598.2018.1462793. Epub 2018 Apr 20.
5. De Weerd NA, Samarajiwa SA, Hertzog PJ. Type I interferon receptors: biochemistry and biological functions. J Biol Chem. 2007 Jul 13;282(28):20053-7. doi: 10.1074/jbc.R700006200. Epub 2007 May 14.
6. Maimaitijiang G, Watanabe M, Shinoda K, et al. Long-term use of interferon-β in multiple sclerosis increases Vδ1–Vδ2–Vγ9–γδ T cells that are associated with a better outcome. J Neuroinflammation. 2019 Sep 13;16(1):179. doi: 10.1186/s12974-019-1574-5
7. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol. 1996 Mar;39(3):285-94. doi: 10.1002/ana.410390304. Erratum in: Ann Neurol. 1996 Sep;40(3):480.
8. Paty DW, Boiko AN. Beta-interferons delay the switch from relapsing-remitting to secondary progressive multiple sclerosis. Neurology. 2000;54(Suppl. 3):A337. doi: 10.1212/wnl.54.3.337
9. Brown JWL, Coles A, Horakova D, et al.; MSBase Study Group. Association of Initial Disease-Modifying Therapy with Later Conversion to Secondary Progressive Multiple Sclerosis. JAMA. 2019 Jan 15;321(2):175-87. doi: 10.1001/jama.2018.20588
10. Bayas A, Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis. Drug Saf. 2000 Feb;22(2):149-59. doi: 10.2165/00002018-200022020-00006
11. Reder AT, Feng X. How type I interferons work in multiple sclerosis and other diseases: some unexpected mechanisms. J Interferon Cytokine Res. 2014 Aug;34(8):589-99. doi: 10.1089/jir.2013.0158
12. Newsome SD, Scott TF, Arnold DL, et al. Long-term outcomes of peginterferon beta-1a in multiple sclerosis: results from the ADVANCE extension study, ATTAIN. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418791143. doi: 10.1177/1756286418791143
13. Interferon beta-1b is effective in relapsingremitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group. Neurology. 1993 Apr;43(4):655-61. doi: 10.1212/wnl.43.4.655
14. Li DK, Paty DW. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis. Prevention of Relapses and Disability by Interferon-beta1a Subcutaneously in Multiple Sclerosis. Ann Neurol. 1999 Aug;46(2):197-206. doi: 10.1002/1531-8249(199908)46:2<197::aid-ana9>3.0.co;2-p
15. Molyneux PD, Kappos L, Polman C, et al. The effect of interferon beta-1b treatment on MRI measures of cerebral atrophy in secondary progressive multiple sclerosis. European Study Group on Interferon beta-1b in secondary progressive multiple sclerosis. Brain. 2000 Nov;123 (Pt 11):2256-63. doi: 10.1093/brain/123.11.2256
16. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504. Erratum in: Lancet. 1999 Feb 20;353(9153):678.
17. PRISMS Study Group and the University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferonbeta-1a in relapsing MS. Neurology. 2001 Jun 26;56(12):1628-36. doi: 10.1212/wnl.56.12.1628. Erratum in: Neurology. 2001 Sep 25;57(6):1146.
18. Gold R, Rieckmann P, Chang P, Abdalla J; PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005 Aug;12(8):649-56. doi: 10.1111/j.1468-1331.2005.01083.x
19. Cohen BA, Rivera VM. PRISMS: the story of a pivotal clinical trial series in multiple sclerosis. Curr Med Res Opin. 2010 Apr;26(4):827-38. doi: 10.1185/03007991003604018. Erratum in: Curr Med Res Opin. 2010 Aug;26(8):1826. Dosage error in article text.
20. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-Beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferonbeta-1a in secondary progressive MS: Clinical results. Neurology. 2001 Jun 12;56(11):1496-504. doi: 10.1212/wnl.56.11.1496
21. Bailon P, Won CY. PEG-modified biopharmaceuticals. Expert Opin Drug Deliv. 2009 Jan;6(1):1-16. doi: 10.1517/17425240802650568
22. Baker DP, Lin EY, Lin K, et al. N-terminally PEGylated human interferon-beta-1a with improved pharmacokinetic properties and in vivo efficacy in a melanoma angiogenesis model. Bioconjug Chem. 2006 Jan-Feb;17(1):179-88. doi: 10.1021/bc050237q
23. Kang JS, Deluca PP, Lee KC. Emerging PEGylated drugs. Expert Opin Emerg Drugs. 2009 Jun;14(2):363-80. doi: 10.1517/14728210902907847
24. Calabresi PA, Kieseier BC, Arnold DL, et al.; ADVANCE Study Investigators. Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.
25. Kieseier BC, Arnold DL, Balcer LJ, et al. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.
26. Boyko AN, Bakhtiiarova KZ, Dudin VA, et al. The new pegylated interferon beta-1a (sampeginterferon beta-1a, BCD-054) in the treatment of remitting multiple sclerosis. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2019;119(10-2):100-9. doi: 10.17116/jnevro201911910100 (In Russ.).
27. Boyko AN, Boyko OV, Bakhtiyarova KZ, et al. Efficacy and safety of sampeginterferon-β1a in the treatment of relapsing remitting multiple sclerosis: results of 52 weeks of therapy in a randomized, double-blind clinical trial. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2022;122(1):62-71. doi: 10.17116/jnevro202212201162 (In Russ.).
28. Boyko AN. Ways to improve adherence to longterm injection therapy in multiple sclerosis using the example of pegylated interferon-β1a (sampeginterferon-β1a) Nevrologiya, neyropsikhiatriya, psikhosomatika = Neurology Neuropsychiatry Psychosomatics. 2022;122(1):62-71. doi: 10.17116/jnevro202212201162 (In Russ.).
Review
For citations:
Boyko OV, Smirnova NF, Boyko AN. The evolution of interferon therapy in multiple sclerosis. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2023;15:58-64. (In Russ.) https://doi.org/10.14412/2074-2711-2023-1S-58-64
Views:
263
Email this article 