Treatment of Multiple Sclerosis - Essay Example

Introduction

Contemporarily, therapeutic options are diverse for MS with the modifying properties of the disease. The therapy known as immune-modulatory with the interferon beta-1b or 1a, natalizumab, and glatiramer provides the same efficacy. In intolerant or resistant patients, the approved therapeutic option is mitoxantrone (Gärtner et al., 2017). IFN beta-1b in the patients who have MS binds to some interferon beta receptors which are specific on the immune cells surface, resulting in a change of several gene's expression and causing a reduction in the quantity of the adhesion molecules associated with the cell, major histocompatibility inhibition of the complex expression of class II (human leukocyte antigen genotype) and inflammatory cells migration reduction into the central nervous system (Rio et al., 2018).

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After getting treatment for two years, the development risk of the clinically defined MS is reduced with IFN beta-1b to 28% (with IFN beta-1b) from 45% (with placebo). Relapses are also reduced by IFN beta-1b for 34% and resulting in 31% of relapse-free patients (Gärtner et al., 2017). The secondary progressive disease's annual progression rate with IFN beta-1b is 3% lower (Zettl et al., 2016). And the frequent adverse effects caused by IFN beta-1b in the doses that are recommended include; insomnia, asthenia, reactions at the injection site (pain, non-specific reactions, discoloration, necrosis, inflammation, and redness), depression, headache, influenza-like syndrome, chills, myalgia, nausea, hypoesthesia, myasthenia and parenthesis (Kotterba et al., 2018).

Drug Class

The Interferon beta-1b in the interferon class is a cytokine used to treat secondary progressive and relapsing-remitting forms of multiple sclerosis (MS). Its use is recommended after the first occurrence of multiple sclerosis. Another closely related to interferon beta-1b is beta 1a, which is also indicated for multiple sclerosis using a similar drug profile (Zettl et al., 2016). EXTAVIA, commonly known as Interferon beta-1b, is a lyophilized, sterile, and purified protein produced by DNA recombinant techniques.

The manufacturing of Interferon beta-1b is through the fermentation involving bacteria of Escherichia coli's strain giving birth to the plasmid that is genetically engineered encompassing the human interferon Betaseron (Betaseron is a trading name of interferon beta-1b) gene (Kotterba et al., 2018). The gene was acquired from the human's fibroblast and is changed to replaces serine for the residue of cysteine available at position 17. The total number of amino acids available in Interferon beta-1b and the molecular weight is approximately 18,500 daltons. (Rio et al., 2018). It excludes the side chains of carbohydrates available in the natural material

The basic activity of EXTAVIA is approximately 32 million international units (IU) per mg interferon beta-1b. Every vial consists of interferon beta-1b at a quantity of 0.3 mg (Zettl et al., 2016). The unit for measurement is obtained by comparing the product's antiviral activity to the World Health Organization (WHO) standard of reference used to recombinant the interferon-beta in humans. Albumin (Human), USP of 15mg each per vial, and Mannitol are added to act as stabilizers. EXTAVIA (interferon beta -1b) is preservative-free and sterile for injection, white lyophilized powder for the subcutaneous injection after combining with the 0.54% solution of sodium chloride (diluent supplied) (Zettl et al., 2016).

Disease is Treating

Multiple sclerosis (MS) is a demyelinating and chronic inflammatory disease that encompasses a relapsing-remitting course of 85% to 90% and a progressive course of 10% to 15%. MS's pathological hallmarks are the lesions of both grey and white matter found in the central nervous system (Zettl et al., 2016). The disease onset normally occurs at the age of 39 years. An acute dysfunction with no focal neurologic features is experienced by the patient and is accompanied by complete or partial recovery. Episodes that are acute of the neurologic dysfunction and with diverse symptoms and signs will recur throughout the patient's life, with the complete or partial periods of clinical and remission stability (Rio et al., 2018).

The Trial

However, much of Extavia resembles Betaferon; no additional studies were needed to be conducted. A study by the IFNB study group of 1993 indicated first the efficiency of Betafero. The trial was made on the two doses: Placebo or Betaferon with individuals who exhibited the disease's signs and symptoms by replacing remitting multiple sclerosis. More doses of Betaferon lowered the relapse rate by almost 30% over the years of study compared with placebo (Kotterba et al., 2018). Another study was done on interferon's beta-1b long term effectiveness and also Copaxone. The study aimed to evaluate the long-term advantages of interferon beta-1b and glatiramer acetate (Copaxone). Many individuals taking interferon beta-1b or Copaxone were recruited at the centers of study around the United Kingdom. The level of disabilities they have was monitored for almost ten years (Zettl et al., 2016). The study found that interferon beta-1b delayed the walking stick's use at the end of four years compared to the group that was not treated (Gärtner et al., 2017).

The Pharmacokinetics

After the vigorous administration, IFN beta-1b is irregularly and slowly absorbed with the bioavailability of exactly 5% (Gärtner et al., 2017). Its distribution is made on the extracellular compartments and is ate degraded in the liver by the reticular-endothelial system. The total clearance of IFN beta-1b is almost 30 mL•min-1•kg-1, and the half-life of serum is around 5 hours (Gärtner et al., 2017). The IFN beta-1b in MS patients binds to the interferon beta receptors specific to the cell's surface in the immune system and leads to many genes' transition.

Mechanism of Action

The Interferon beta-1b results in the balance of anti- and pro-inflammatory agents found in the brain and reduces the number of inflammatory cells crossing the blood-brain barrier (Kotterba et al., 2018). In general, therapy with the IFN beta-1b results in neuron inflammation decrease. However, it is also known to raise the nerve growth factor production and improve neuronal survival (Kotterba et al., 2018).

The inhibition of the synthesis of pro-inflammatory cytokines occurs, and the production of immuno-suppressive cytokines is triggered. Finally, IFN beta-1b inhibits the T cells attacking the neural structures (Rio et al., 2018). Interferons play an essential role against infections as the first-line defense. They form part of the immune system that is non-specific.

Development of the Drug

There is medication effectiveness at lowering the attacks quantity in the relapsing-remitting multiple sclerosis (RRMS) and is resulting in a decrease in brain lesions accumulation. Interferon beta-1b causes a reduction in the relapses by almost 30%, and as a result, they turn to be at the forefront of treatment because of such a safe profile (Rio et al., 2018). The efficacy of the IFN beta-1b is greater than the one of IFN beta-1a and that of glatiramer acetate in the relapsing-remitting MS. The facts above make IFN beta-1b an essential drug in the immunological therapy’s spectrum for such debilitating diseases (Rio et al., 2018).

Therapeutic Implications of Drug

The IFN beta-1b is only available in injection forms, which results in the reactions of the skin at the injection site that may involve cutaneous necrosis. The skin reactions vary greatly in the clinical presentations they possess, normally appearing within the initial month of treatment, albeit their diminishing importance and frequency after the six months of getting treatments. Such reactions of the skin are more in women than in men. The mild skin reaction does not normally impede treatment, but necroses' appearance results in the therapy discontinuation. A visible dent may develop over time at the site of injection because of the destruction of the fat tissue (Zettl et al., 2016).

The Interferons, a subclass of cytokines, are normally produced during illnesses in the body to help fight the infection, taking responsibility for many influence infections like fatigue, fever, headaches, and muscle aches. Most patients report such symptoms some hours after getting an injection of interferon beta-1b and disappear typically within 24 hours because of the symptoms related to the increase of cytokines, which is temporary (Gärtner et al., 2017).

Another common effect with the interferon beta-1b is the functional deterioration of symptoms that are already existing. The deterioration is normally the same as the MS patient produces due to stress, fever, or heat. The drug can also decrease the number of neutrophils, lymphocytes, and leukocytes and affect the liver's function. On many occasions, the effects above are reversible and are not dangerous after the treatment's cessation(Zettl et al., 2016). Thus, it is advisable that all the patient needs to be checked regularly through blood analyses in the laboratory, including function tests of the liver, to make sure that interferons are used safely.

Conclusion

The interferon beta-1b covers a better segment in treating MS and the drug market because of its great efficacy. Therefore, when considering high reaction incidence to IFN beta-1b at the injection site, the future target should be the IFN beta-1b preparation development with the local tolerability, which is improved and the maintenance of systemic efficacy. The first injection of interferon beta-1b should be done under the healthcare provider's supervision, qualified by embracing pharmacokinetics. Competencies should be demonstrated in all the interferon beta-1b injection aspects by the user before independent use. Patients who have worse neurological deficits should never administer the injection by themselves without trained caregiver assistance.

References

Gärtner, J., Brück, W., Weddige, A., Hummel, H., Norenberg, C., Bugge, J. P., & BETAPAEDIC Study Group. (2017). Interferon beta-1b in treatment-naïve paediatric patients with relapsing–remitting multiple sclerosis: Two-year results from the BETAPAEDIC study. Multiple Sclerosis Journal–Experimental, Translational and Clinical, 3(4), 2055217317747623.
https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753955/&ved=2ahUKEwiP_JOSsqXtAhX3aRUIHcxqDUIQFjAAegQIAxAC&usg=AOvVaw3r9VW7PYrsU6XUDuCwzU0A

Kotterba, S., Neusser, T., Norenberg, C., Bussfeld, P., Glaser, T., Dörner, M., & Schürks, M. (2018). Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study. BMC neurology, 18(1), 123.
https://link.springer.com/article/10.1186/s12883-018-1113-5

Río, J., Rovira, À., Tintoré, M., Otero-Romero, S., Comabella, M., Vidal-Jordana, Á., ... & Tur, C. (2018). Disability progression markers over 6–12 years in interferon-β-treated multiple sclerosis patients. Multiple Sclerosis Journal, 24(3), 322-330.
https://www.google.com/url?sa=t&source=web&rct=j&url=https://pubmed.ncbi.nlm.nih.gov/28287331/&ved=2ahUKEwjjr-XRs6XtAhVipHEKHZkwAeUQFjAAegQIARAB&usg=AOvVaw3YerDLGXklTqX4IfG7xe26.