RIO DE JANEIRO, BRAZIL – A study, conducted by researchers at the Hospital Israelita Albert Einstein in São Paulo, of a drug for rheumatoid arthritis from Pfizer pharmaceutical company, showed that the medication, able to modulate the immune system, reduced by 37% the risk of death or respiratory failure in patients with moderate symptoms hospitalized with Covid-associated pneumonia.
The findings were published on Wednesday, June 16, in The New England Journal of Medicine.
The study began in October last year and the medication used was Tofacitinib, sold under the trade name Xeljanz, which showed an impact on cytokine storm, an exacerbated immune system reaction that can affect the functioning of vital organs. This serious complication, which can afflict Covid-19 patients, worsens the patient’s health condition and may lead to death.
“Our assumption was: if I take a patient with a positive PCR and pneumonia in the first three days of hospitalization, administer tofacitinib and manage to prevent this patient from deteriorating, it is possible to reduce the risk of death or respiratory failure,” explains Otávio Berwanger, director of the Academic Research Organization at Einstein.
The Stop-Covid study, randomized and double-blind, analyzed 289 patients in 15 partner hospitals and showed a decrease in deterioration and risk of death compared to patients who took a placebo.
“In this study, all patients were given the standard treatment, the recommended supportive measures, but we randomized people and half were given placebo while the other half were given tofacitanib. We found that in this group of patients there was a 37% reduction in the risk of death or respiratory failure over 28 days. We confirmed the benefit of using tofacitinib to prevent a cytokine storm and the benefit of this medication to treat these patients.”
The fact that the drug worked in medicated patients – about 90% were being treated with corticosteroids, such as dexamethasone – is another positive aspect, according to Berwanger.
“An interesting point is that it worked with conventional treatments. Other studies have been conducted with immunomodulators. The difference with this one is that the benefit occurs in addition to the corticoid. The result is very encouraging and positive. And in this study, the medication was very safe. Serious adverse events were similar to the placebo group.”
While the result is encouraging, Berwanger points out that this does not mean that this is a new treatment to fight Covid-19 nor that any patient can take it. “The medication was used in patients with no contraindications, at the correct dose, with daily monitoring by researchers and in a controlled environment and in the hospital. The research results are coming out right now.”
Pfizer Brasil’s Medical Director Márjori Dulcine points out that the medication is not authorized to be used against the disease.
“It is very important to emphasize that the drug has not been approved or authorized for use by any regulatory agency in the world for the treatment of Covid-19, since the published study is the first randomized, multicenter study to assess its impact on the treatment of the disease. Its potential use in the anti-covid arsenal will depend on the extensive evaluation of these data by regulatory bodies and health authorities.”
According to Márjori, in Brazil it is prescribed for the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
In 2017, the high-cost drug was incorporated into Brazil’s National Health System’s (SUS) list of medications for patients with rheumatoid arthritis who have not had positive results with one or more treatments able to change the course of the disease.
Source: Estadão