The results of the first phase of a clinical trial conducted worldwide reveal that the drug “Teriflunomide”, administered orally, is effective and safe in the treatment of pediatric multiple sclerosis.
This study, which assesses the efficacy and safety of the drug in the initial stage of the disease, began in 2016 and involves 166 children, recruited from 59 health institutions in 23 countries – Belgium, Bulgaria, Canada, China, Slovenia, Spain, Estonia, USA, France, Greece, Israel, Lebanon, Lithuania, North Macedonia, Morocco, Netherlands, Portugal, United Kingdom, Russia, Serbia, Tunisia, Turkey and Ukraine.
In Portugal, the clinical trial called “TERIKIDS” takes place at the Pediatric Hospital of the Centro Hospitalar e Universitário de Coimbra (CHUC) and is led by Filipe Palavra, a pediatric neurologist and professor at the Faculty of Medicine of the University of Coimbra (FMUC).
The results obtained so far reveal “a reduction of approximately 34% in the risk of clinical outbreak in patients treated with teriflunomide, compared to placebo, as well as a significant reduction (43%) in the time until a clinical outbreak is diagnosed or changes the therapeutic attitude due to the increase in the number of lesions identified by magnetic resonance imaging (MRI)”, reports Filipe Palavra.
It was also found that the drug reduced the number of new or enlarged lesions, detected by MRI, by about 55% and the number of enhanced lesions after gadolinium administration (active lesions) by about 75%. In addition, teriflunomide was well tolerated by the children and adolescents participating in the study.
In the meantime, the clinical trial continues to be carried out, in order to allow the accumulation of data that may “lead to the formal approval of the use of teriflunomide in the treatment of children and adolescents diagnosed with multiple sclerosis in the future. And this aspect has an impact on clinical practice, given that the therapeutic options available for this age group are scarce”, says the FMUC specialist.
Filipe Palavra also recognizes that “clinical research in complex diseases such as multiple sclerosis is a very big challenge, only feasible because there are patients and families available to participate in demanding programs, with very frequent clinical follow-up, and also teams of motivated professionals who, in addition to their assistance functions, they dedicate part of their time to scientific research.
Doctors, nurses, psychologists, pharmacists, laboratory and radiology technicians, clinical secretaries and operational assistants, all are essential for science to be done in our hospital”.
Multiple sclerosis is the best known of the demyelinating diseases of the central nervous system, characterized by the destruction of the myelin sheath that involves neurons in the brain, cerebellum, brain stem, spinal cord and optic nerve.
It is described as a pathology of an immune-mediated nature, because at the base of the myelin destruction process are autoimmune mechanisms, which means that, “for unknown reasons, the cells of the immune system, that is, of our defenses, are“ mistaken ” and “attack” the myelin sheath, leading to its destruction”, explains the FMUC professor.