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New hopes in the medical fight against the coronavirus. An observational study with 778 covid-19 patients from 60 Spanish hospitals has concluded that the drug tocilizumab, used against rheumatoid arthritis, reduces the risk of death and the need for mechanical ventilation. Patients who took the drug – given with some frequency during the pandemic in hospitals – are three times less likely to die than the rest, according to the analysis. Until now, only low-dose dexamethasone had proven effective against the pathogen.
“We began to see that tocilizumab was effective against lung inflammation – which causes death in covid-19 – and now it should be studied in randomized trials in patients with that clinical profile. And in patients who cannot be included in trials, it could be considered as a treatment option ”, advances Jesús Rodríguez Baño, head of the Infectious Diseases service at the Virgen de Macarena Hospital in Seville and coordinator of the study. The research is observational, collects information to analyze it, it is not a clinical trial – more rigorous and with more evidence – and has indicated the efficacy of tocilizumab with patients admitted with hyperinflammation, between 40% and 60% of those hospitalized for covid -19, a high percentage, the researchers emphasize.
“It is very important because it confirms that the people who opted for tocilizumab are on the right track. It says go on, go on, go on, it decreases mortality. And it is also very important because the clinical trials will take time to arrive and the covid is in a hurry ”, sums up Juan Pablo Horcajada, head of the Infectious Diseases service and general covid coordinator at the Hospital del Mar in Barcelona. “Doctors who have lived with covid from the beginning think that in the face of so much inflammation [pulmonar] you had to give it [el tocilizumab]. It is not coffee for everyone, it is for a specific type of patient and it is not without adverse effects ”, says Horcajada.
The drug’s manufacturing laboratory, Roche, developed a clinical trial – not yet published – and advanced that tocilizumab did not offer efficacy against the coronavirus, which disappointed many of the specialists who were fighting in ICUs. “Roche’s report made a dent and lowered expectations, but not to withdraw it, since it only published a press release and we do not know well what type of patient it was given,” explains Horcajada. “We want to refute it and we believe that it was negative because it has not been tested in patients with inflammation,” adds Rodríguez Baño. The question is whether Roche will now invest funds to develop a clinical trial – always expensive and lasting at least six months – with patients with inflammation biomarkers, which could corroborate the Spanish research.
“Our study suggests that tocilizumab could be effective, it does not prove,” explains José Ramón Arribas, head of Infectious Diseases at the Madrid hospital in La Paz. A recent study carried out in the United States with the same drug published similar results indicating its benefits in fighting the coronavirus.
The 778 patients infected by COVID-19 and chosen for the study must have suffered a fever that was maintained over time or needed more oxygen therapy, in addition to suffering a worsening in their laboratory parameters indicative of systemic inflammation.
The work, published in the magazine Clinical Microbiology and Infection, It has been funded by the Carlos III Health Institute ―with a budget of 8,000 euros― and prepared under the auspices of the Spanish Network for Research in Infectious Pathology (REIPI) and the SEIMC-GeSIDA Foundation, in hospitals such as Virgen de Macarena, Gregorio Marañón, La Paz or Bellvitge.
11% of treated patients died
The study investigators, including infectious disease specialists, internists, and pulmonologists, used advanced statistical techniques to compare the risk of dying or requiring mechanical ventilation. 20% of the untreated patients died or required mechanical ventilation, compared to 11% of those treated with the drug or 15% of those treated with high-dose corticosteroids. This last treatment showed “less consistent” results, says Rodríguez Baño.
Apart from dexamethasone and now tocilizumab, hydroxychloroquine initially seemed to show efficacy against COVID-19, but an investigation with 96,000 patients in 671 hospitals showed that it increases the risk of death in hospitalized infected patients.
Despite this, the Spanish Agency for Medicines and Health Products (AEMPS) considered that the study published in The Lancet By researchers, it did not provide conclusions “strong enough” to stop using it or stop ongoing research in hospitals.
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