Havana, Jun 11th. - After receiving, in September 2023, the medical record conditioned for the treatment of rheumatoid arthritis (AR), the Cuban drug Jusvinza is currently undergoing a Phase III clinical trial, which must be completed soon, and on whose results its final approval will depend in the therapy of this disease.
The doctor of Biological Sciences María del Carmen Domínguez Horta, leader of this research project at the Center for Genetic Engineering and Biotechnology (CIGB) over almost four years, told Granma that the main headquarters of the study is the Rheumatology service of the Hospital Clínico Surgical October 10, in Havana.
She explained that the trial is controlled with placebo and double blind, and includes patients with moderate RA, referred there after being evaluated by rheumatology specialists in the western provinces. The main objective is to corroborate the effectiveness of the drug, and the main clinical researcher is Dr. Dinorah Prada.
According to the initial results, Jusvinza maintains a good safety profile, and only light and reversible adverse events have been described, said Dr. Maria del Carmen.
Just with the granting of the conditioned registry, we did a study in the five eastern provinces and in Camaguey, which we call Mariana, and which involved 534 patients suffering from moderate and high RA, under the conduction of Dr. Osvaldo Calisté Manzano.
The effects observed consisted of a significant improvement in the clinical picture, while the excellent safety of the medicine was confirmed.
She emphasized that, from the treasured experience during his use against COVID-19, in which it was demonstrated that Jusvinza was effective in controlling hyperinflammation in serious and critical patients, in recent months two clinical trials in severe pneumonia acquired in the community and in acute respiratory distress syndrome are underway.
At present, we continue to deepen the study of Jusvinza's mechanism of action and its pharmacological properties, taking into account the potential spectrum of broad use of the drug, to treat acute and chronic inflammatory diseases.
The results have been published in high-impact scientific journals, and raise the prestige achieved by Cuban biotechnology, said Dr. Domínguez Orta.
Rheumatoid arthritis is an irreversible chronic, autoimmune, systemic and inflammatory disease, affecting about 135,000 people in Cuba and damages the joints of the whole body.
According to the World Health Organization (WHO), in 2019 around 18 million people were counted with the ailment throughout the world, of whom approximately 70 per cent are women, of whom 55 per cent are over 55 years of age.
It usually appears between the ages of 40 and 60, and usually attacks, more often, the joints of the hands, wrists, feet, ankles, knees, shoulders and elbows.
If not treated in time, AR in advanced stages can severely damage those structures and surrounding tissues, accentuating the body's physical ability to face daily work.
For Dr. María del Carmen Domínguez, having the drug Jusvinza puts the country in a position to benefit, in the not distant future, when it has the definitive record and produces in sufficient quantities, tens of thousands of patients who will be able to live with this chronic disease, without being forced to abandon the employment link and maintaining a full quality of life. (Text and photo: Granma Digital)