[Pharmacoeconomic aspects of using cladribine (in tablets) for treatment of adult patients with remitting multiple sclerosis]. / Farmakoekonomicheskie aspekty primeneniya kladribina dlya lecheniya vzroslykh patsientov s vysokoaktivnym remittiruyushchim rasseyannym sklerozom.

OBJECTIVE: To conduct a pharmacoeconomic analysis of using cladribine (in tablets) as a second-line treatment option for adult patients with highly active remitting multiple sclerosis in Russia. MATERIAL AND METHODS: Current treatment practice of highly active multiple sclerosis (natalizumab, fingolimod, alemtuzumab, ocrelizumab) was considered as a comparator for cladribine (in tablets). Clinical and economic study was conducted using the «cost minimization¼ method. For budget impact analysis cost of using cladribine (in tablets) was compared to the cost of using current treatment practice. RESULTS: Cladribine in tablets is a cost-saving alternative for treatment of patients with highly active multiple sclerosis compared to the current treatment practice. Within a 4-year period direct medical costs reduction is 2 million RUB (50.1%) per person. CONCLUSION: In case of switching the patients, who are currently provided with other disease modifying drugs, to cladribine, in 4 years health budget will save up to 6284 million RUB (50.1%).

[Comparison of the clinical benefits of second-line drugs modifying the course of multiple sclerosis]. / Sravnenie klinicheskikh preimushchestv preparatov vtoroi linii, izmenyayushchikh techenie rasseyannogo skleroza.

This review aims at describing clinical benefits and characteristics of the main highly effective disease modifying drugs (DMD) for multiple sclerosis (MS): alemtuzumab, cladribine tablets, ocrelizumab, natalizumab, fingolimod based on the efficacy and safety. The authors highlight that all MS DMDs have certain benefits and features that shall be considered in prescribing pharmacotherapy. Cladribine in tablets are comparable by the efficacy to other modern highly effective second-line drugs, have a high level of evidence and a favorable safety profile, as well as the most preferred benefit/risk ratio among other MS DMDs indicated for the treatment of highly active MS, which offers an advantage to the drug. The use of cladribine in tablets will contribute to further study of the efficacy and safety of this highly efficient drug for MS treatment.

[Updated recommendations of the Council of Experts on the use and safety of alemtuzumab (Lemtrada)]. / Obnovlennye rekomendatsii soveta ekspertov po primeneniyu i obespecheniyu bezopasnosti terapii preparatom alemtuzumab (Lemtrada).

Alemtuzumab (Lemtrada) is a recombinant humanized IgG1 kappa monoclonal antibody to the surface cell glycoprotein, a CD52 differentiation cluster. The drug is approved for use in more than 65 countries, including the Russian Federation. The drug is one of the most effective methods of treating patients with aggressive multiple sclerosis, but the risk management plan should be followed. The safety profile of the drug includes infusion-associated reactions, thyroid dysfunction, immune cytopenia, acute cardiovascular events, infections, and other autoimmune diseases. This publication provides updated practical recommendations for the use of the drug and ensuring the safety of patients treated with alemtuzumab.

[The efficacy and safety of siponimod in the Russian population of patients with secondary progressive multiple sclerosis]. / Éffektivnost' i bezopasnost' siponimoda u patsientov s vtorichno-progressiruiushchim rasseiannym sklerozom v rossiiskoi populiatsii.

AIM: To study the efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis (SPMS) in the Russian population of the EXPAND study. MATERIAL AND METHODS: Ninety-four patients with SPMS from Russia were included in the analysis. Sixty-three patients received siponimod and 31 patients received placebo. The primary endpoint of the study was time to 3-month confirmed disability progression (3m-CDP) events, other clinical and radiological endpoints were also evaluated. RESULTS: The siponimod group showed a 54% reduction in the risk of 3m-CDP compared with the placebo group (p=0.0334). Secondary endpoints also showed the advantage of the drug over placebo. In the siponimod group, mild adverse events associated with impaired liver function, as well as arterial hypertension, were more common. No patient left the study due to an adverse event. CONCLUSION: The use of siponimod in patients with SPMS in the Russian population reduced the risk of disability progression. Siponimod showed a favorable safety profile.

[Clinical guidelines for the use of dimethyl fumarate in relapsing-remitting multiple sclerosis]. / Klinicheskie rekomendatsii po primeneniiu preparata dimetilfumarat pri remittiruiushche-retsidiviruiushchem rasseiannom skleroze.

Multiple sclerosis is a chronic demyelinating and neurodegenerative disease of the central nervous system, in which autoimmune inflammation and oxidative stress play essential pathogenetic roles. Activation and infiltration of immune cells in brain tissues, lipid peroxidation products, mitochondrial dysfunction, defective antioxidant protection, and many other pathological factors result in demyelination, axonal injury and death, and apoptosis of oligodendrocytes and neurons, all of which causes constant progression of the disease. The new oral agent for the treatment of relapsing-remitting multiple sclerosis (RRMS), dimethyl fumarate (DMF), helps change the pathogenetic mechanisms of the disease, thus decreasing the rate of exacerbations, slowing down disease progression, and reducing the risk of radiological progression of the disease.

[The search for optimal decision in the treatment of multiple sclerosis: to improve adherence not reducing the efficacy]. / Poisk optimal'noi patogeneticheskoi terapii rasseiannogo skleroza: vozmozhnost' povysit' priverzhennost' bol'nykh terapii, ne snizhaia ee éffektivnosti.

Long-term disease modifying therapy (DMD) therapy is the basis of modern MS treatment, effiecacy of which is modulated by the patient's adherence to therapy. One of the possible solutions of low adherence improvement is the use of innovative drugs and the development of more convenient regimens of injectable medications. This article gives a brief review of peg-interferon ß-1a clinical trials.

[The three-year follow-up study of retinal changes in patients with multiple sclerosis]. / Izmenenie setchatki u patsientov s rasseyannym sklerozom v techenie 3-letnego perioda.

AIM: To evaluate the ganglion cell complex (GCC) changes in projection to the state of the retinal nerve fiber layer (RNFL) in patients with multiple sclerosis (MS). MATERIAL AND METHODS: A total of 216 participants (370 eyes) were studied. Patients were divided into three groups: 1-st - 87 MS patients (121 eyes) with a history of optic neuritis (ON); 2-nd - 95 MS patients (186 eyes) without a history of ON; 3-rd - disease-free control 34 volunteers (63 eyes). Thirty-two MS patients (61 eyes) from the cross-sectional cohort were included for longitudinal analysis, follow-up period was 30 (9.5-36) months. Sixteen patients (21 eyes) had a history of optic neuritis. The study included anamnesis, refracted visual acuity and optical coherence tomography (OCT) performed with the use of RTVue-100 ОСТ system. RESULTS AND CONCLUSION: RNFL and GCC thickness was significantly decreased both in MS+ON and MS-ON groups compared to controls. No difference in the annual change of RNFL thickness and GCC parameters between patients with ON and patients who did not have any visual impairment in the anamnesis was found. Changes of GCC were detected only in patients with secondary progressive MS. The study of GCC and RNFL thickness can be used to describe and characterize the level of axonal damage in MS.

[Autoimmune encephalitis].

The authors consider the issues related to pathogenesis, clinical features, diagnosis and treatment of autoimmune encephalitis. It has been demonstrated that the development of autoimmune encephalitis can be associated with the oncologic process or be of idiopathic character. The pathogenesis of autoimmune encephalitis is caused by the production of antibodies that directly or indirectly (via T-cell mechanism) damage exo-and/or endocellular structures of the nerve cells. The presence of antobodies to endocellular structures of neurons in the cerebrospinal fluid of patients with autoimmune encephalitis in the vast majority of cases (> 95%) indicates the concomitant oncologic process, the presence of antibodies to membranes or neuronal synapses can be not associated with the oncologic process. Along with complex examination, including neuroimaging, EEG, cerebrospinal fluid and antibodies, the diagnostic algorithm in autoimmune encephalitis should include the search for the nidus of cancer. The treatment algorithm in autoimmune encephalitis included the combined immunosupressive therapy, plasmapheresis, immunoglobulines, cytostatics as well as treatment of the oncologic process.

[Experience of using interferon Β-1a biosimilans (cinnovex and genfaxon-44) in the Moscow Multiple Sclerosis Center]. / Opyt primeneniia bioanalogov Β-interferona-1a - sinnoveksa i genfaksona-44 v Moskovskom gorodskom tsentre rasseiannogo skleroza.

OBJECTIVE: To study the efficacy and tolerability of generics (interferon beta-1a biosimilans) cinnovex for intramascular introduction and genfaxon-44 for subcutaneous injections in multiple sclerosis (MS). MATERIAL AND METHODS: One hundred patients were treated with cinnovex and 104 patients were treated with genfaxon-44 during one year. Patient's status was assessed using clinical approach, psychometric scales and MRI. RESULTS AND CONCLUSION: The high percentage of withdrawal of treatment due to the lack of clinical effect and intolerance to the drugs was identified during the treatment. Positive effect with respect to stabilization of MS course was found only in patients who earlier did not receive disease-modifying drugs. Double-blind studies are needed to resolve the question of the adequacy of brand-name drugs and generics.

[Criteria of ineffectiveness of treatment with first-line therapy: how to use MRI results in decision making?]. / Kriterii neéffektivnosti terapii preparatami pervogo vybora: kak sleduet otnosit'sia k dannym MRT v priniatii resheniia? (Po povodu stat'i A.N. Boiko i soavt. "Vybor optimal'nogo preparata patogeneticheskogo lecheniia rasseiannogo skleroza: sovremennoe sostoianie problemy" #10(2), 2014).

The importance of MRI stuides in the control over treatment efficacy in multiple sclerosis and appropriate recommendations on drug substitution during treatment are discussed. We suggest low, middle or high risk in respect to the efficacy of current treatment. Accordingly, drug substitution can be related with the low level of fears for all three criteria or the moderate level for any two criteria or the high level for any one criterion. Since MRI criteria are important, this model appears to be the most rational because the physician can make a decision about treatment escalation if the patient has ≥3 new T2-lesions or ≥3 contrast-enhanced T1-lesions.