TDM-MS

Treatment tested

• Measurement of concentrations of orally-used DMDs
• Genetic testing
• Parameters for routine use of DMDs
• Side effects of orally used DMDs
• Teriflunomide

  Dihydroorotate dehydrogenase inhibitor

• Cladribine

  DNA inhibitor

• Dimethyl fumarate

  Kelch-like ECH-associated protein 1 inhibitor

• Fingolimod

Other measures (3)

Inclusion Criteria: * patients diagnosed with MS of all forms using any of the oral "DMDs" * men and women older than 18 years * signature of the Informed Consent to Participate in the Study Exclusion Criteria: * minor patients (below 18 years of age) * refusal to sign the Informed Consent to Participate in the Study * refusal of blood samples taken beyond standard examinations Criteria for exclusion from the study * non-compliance with the treatment regimen according to the decision of the attending physician * non-participation in blood samples taken as part of standard examinations

The main goal of multiple sclerosis (MS) treatment is to prevent further relapses of the disease and the progression of neurological deficit. Although MS cannot yet be cured, early control of symptoms and reduction of disease progression is associated with a longer time to disability and improve long-term treatment outcomes. Currently, MS is treated using a multidisciplinary approach, which consists of treatment with so-called "disease-modifying drugs" ("DMDs"), symptomatic therapy of individual symptoms, lifestyle adjustments, psychological support, and rehabilitation interventions. According to the latest results, treatment with "DMDs" can reduce the annual incidence of relapses by 29-68% compared to placebo or an active comparator. Thus, as can be seen, even this group of modern drugs does not completely compensate for MS in many patients. For this reason, there is a need to use certain parameters to best assess the effectiveness of individual treatments in specific patients with MS in routine clinical practice. Therapeutic drug monitoring (TDM) is a specific method of clinical pharmacology that has long been used to monitor therapy for a variety of diseases by measuring drug concentrations in body fluids (plasma, serum, whole blood, cerebrospinal fluid, breast milk) with subsequent interpretation by clinical pharmacologist and acceptance by the clinician. The groups of drugs for which TDM is routinely performed include selected groups of antibiotics (aminoglycosides, vancomycin, beta-lactams), immunosuppressants, digoxin, and especially drugs used in neurology and psychiatry (antiepileptics and psychotropic drugs). As far as "DMDs" is concerned, the first data on the possibility of using TDM in the therapy of MS have already appeared in the professional literature, but these are so far rare and completely insufficient. In addition, individual drugs differ not only in efficacy but also in dose, dosing schedule, and safety profile. The development of new analytical methods to determine serum or whole blood "DMDs" concentrations, together with the objectification of the relationship between measured concentrations to the patient's clinical condition and the possibility of objectifying patient adherence to treatment, could therefore significantly help individualize the dosage of "DMDs" in each individual patient.