[Review of diagnostic criteria for multiple sclerosis].

Multiple sclerosis (MS) is a chronic, autoimmune disease of the central nervous system, leading to inflammatory demyelination and damage to neurons and their axons. The essence of MS is the occurrence of neurological symptoms associated with the occurance of demyelinating lesions disseminated in time (DIT) and space (DIS) (i.e. occurring within various CNS structures, in particular: pyramidal and cerebellar pathways). The aim of the article was to present the evolution of diagnostic criteria of multiple sclerosis in the years 1965-2017. Analysis of the changing criteria reveal that over the last several years, the time necessary to diagnose the disease, previously associated with the anticipation of subsequent symptoms of MS, now is definitely shorter, and the diagnosis can be made before the next relapse of MS, including cerebrospinal fluid examination.

Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study.

Cladribine is currently registered as a 10-milligram tablet formulation with a fixed cumulative dosage of 3.5 mg/kg over 2 years. It is important to investigate if an increased dosage may lead to further clinical stability with preserved safety. This study used an off-label subcutaneous (s.c.) formulation of cladribine and compared outcomes (Expanded Disability Status Scale (EDSS) scores and disease progression) between 52 relapsing multiple sclerosis (RMS) patients receiving different s.c. dosing regimens with up to 20 years of follow-up. The study group received induction therapy with s.c. cladribine (1.8 mg/kg cumulative dose; consistent with 3.5 mg/kg of cladribine tablets). Patients were subsequently offered maintenance therapy (repeated courses of 0.3 mg/kg s.c. cladribine during 5-20-year follow-up). Forty-one patients received an increased cumulative dose (higher than the induction dose of 1.8 mg/kg); 11 received the standard induction dose. Risk of progression on the EDSS correlated with lower cumulative dose (p < 0.05) and more advanced disability at treatment initiation (p < 0.05) as assessed by EDSS change between year 1 and years 5 and 10 as the last follow-up. Maintenance treatment was safe and well-tolerated, based on limited source data. Subcutaneous cladribine with increased cumulative maintenance dosage was associated with disease stability and favorable safety over a prolonged period of follow-up (up to 20 years) in RMS patients.