Интерферон бета 1а: Қолданылуы, әсері және көп склерозпен күрес

Cytokine in the interferon family

Interferon beta 1a (also interferon beta 1 alpha) is a cytokine in the interferon family used to treat multiple sclerosis (MS). It is produced by mammalian cells, while interferon beta 1b is produced in modified E. coli. Some research indicates that interferon injections may result in an 18–38% reduction in the rate of MS relapses. Interferon beta has not been shown to slow the advance of disability. Interferons are not a cure for MS (there is no known cure); the claim is that interferons may slow the progress of the disease if started early and continued for the duration of the disease. Treatment with interferons after an initial attack decreases the risk of developing clinical definite MS.

Interferon beta 1a is available only in injectable forms, and can cause skin reactions at the injection site that may include cutaneous necrosis. Skin reactions with interferon beta are more common with subcutaneous administration and vary greatly in their clinical presentation. Interferons, a subclass of cytokines, are produced in the body during illnesses such as influenza in order to help fight the infection. They are responsible for many of the symptoms of influenza infections, including fever, muscle aches, fatigue, and headaches. Many patients report influenza like symptoms hours after taking interferon beta that usually improve within 24 hours, being such symptoms related to the temporary increase of cytokines. This reaction tends to disappear after 3 months of treatment and its symptoms can be treated with over the counter nonsteroidal anti inflammatory drugs, such as ibuprofen, that reduce fever and pain. Overall, therapy with interferon beta leads to a reduction of neuron inflammation.

Avonex was approved in the US in 1996, and in the European Union in 1997, and is registered in more than 80 countries worldwide. It is the leading MS therapy in the US, with around 40% of the overall market, and in the European Union, with around 30% of the overall market. It is produced by the Biogen biotechnology company, originally under competition protection in the US under the Orphan Drug Act. Avonex is sold in three formulations, a lyophilized powder requiring reconstitution, a pre mixed liquid syringe kit, and a pen; it is administered via intramuscular injection.

Rebif is a disease modifying drug (DMD) used to treat multiple sclerosis in cases of clinically isolated syndromes as well as relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. It is co marketed by Merck Serono and Pfizer in the US under an exception to the Orphan Drug Act. It was approved in the European Union in 1998, and in the US in 2002; it has since been approved in more than 90 countries worldwide including Canada and Australia. EMD Serono has had sole rights to Rebif in the US since January 2016. Rebif is administered via subcutaneous injection.

Cinnovex is the brand name of recombinant Interferon beta 1a, which is manufactured as biosimilar/biogeneric in Iran. It is produced in a lyophilized form and sold with distilled water for injection. Cinnovex was developed at the Fraunhofer Society in collaboration with CinnaGen, and is the first therapeutic protein from a Fraunhofer laboratory to be approved as biogeneric / biosimilar medicine. There are several clinical studies to prove the similarity of CinnoVex and Avonex. A more water soluble variant is currently being investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany.

Plegridy is a brand name of a pegylated form of Interferon beta 1a. Plegridy's advantage is it only needs injecting once every two weeks.

Closely related to interferon beta 1a is interferon beta 1b, which is also indicated for MS, but is formulated with a different dose and administered with a different frequency. Each drug has a different safety/efficacy profile. Interferon beta 1b is marketed only by Bayer in the US as Betaseron, and outside the US as Betaferon.

In the United States, as of 2015, the cost is between US$1,284 and US$1,386 per 30 mcg vial. As of 2020, the National Average Drug Acquisition Cost (NADAC) in the United States for Avonex was $6,872.94 for a 30 mcg kit. Avonex and Rebif are on the top ten best selling multiple sclerosis drugs of 2013. It is an example of a specialty drug that would only be available through a specialty pharmacy. This is because it requires a refrigerated chain of distribution and costs $17,000 a year. No. 2013 Global Sales INN Brand names Companies 1 $4.33 billion Glatiramer acetate Copaxone Teva 2 $3.00 billion Interferon beta 1a Avonex Biogen Idec 3 $2.51 billion Interferon beta 1a Rebif Merck KGaA 4 $1.93 billion Fingolimod Gilenya Novartis 5 $1.41 billion Natalizumab Tysabri Biogen Idec 6 $1.38 billion Interferon beta 1b Betaseron/Betaferon Bayer HealthCare 7 $876 million Dimethyl fumarate Tecfidera Biogen Idec 8 $303 million 4 Aminopyridine Ampyra Acorda Therapeutics 9 $250 million Adrenocorticotropic hormone H. P. Acthar Gel Questcor Pharmaceuticals 10 $221 million Teriflunomide Aubagio Sanofi

Interferon beta 1a administered subcutaneously or intravenously was investigated since March 2020 as a potential treatment in patients hospitalized with COVID 19 in a multinational Solidarity trial (initially in combination with lopinavir) but it did not reduce in hospital mortality compared to local standard of care. SNG001, an inhalation formulation of interferon beta 1a, is being developed as a treatment for COVID 19 by Synairgen. A pilot trial in hospitalized patients showed higher odds of clinical improvement with SNG001 compared to placebo and in January 2021 a phase 3 trial in this population started.