Updated: March 9, 2021 9:11:33 am
A phase 3 trial in India has found tocilizumab improves outcomes in severely ill Covid-19 patients, reviving the debate over the anti-inflammatory drug that is used primarily to treat rheumatoid arthritis. The study, conducted by researchers from Medanta Institute of Education and Research and the University of Bristol, has been published in The Lancet Respiratory Medicine. While suggesting that tocilizumab may help severely ill patients, the authors also noted that the study does not support the routine use of tocilizumab in adults with Covid-19.
On the one hand, the study adds to existing evidence about the drug’s utility in treatment of Covid-19. For instance, in January 7, researchers published on a pre-print server the results of a REMAP-CAP trial, which assessed 803 Covid-19 patients in ICU (353 given tocilizumab and 402 given standard treatment). While 64.2% ICU patients survived in the control arm, 72% survived when administered tocilizumab.
On the other hand, some studies have found tocilizumab less effective against Covid-19. The most crucial one came from tocilizumab manufacturer Roche in July 2020: it published phase 3 trial results that found tocilizumab did not meet the primary endpoint of clinical improvement or the secondary endpoint of reduction in mortality. And in October, The New England Journal of Medicine published a study on 243 patients that found tocilizumab was not effective in preventing death in moderately ill, hospitalised Covid-19 patients.
Called COVINTOC (Covid India Tocilizumab), the phase 3 trial reported in The Lancet was conducted in 12 public and private hospitals across India. Of 180 adult patients, 89 patients received standard care, and 91 received standard care plus tocilizumab. Patients were followed up over a 28-day period.
Analysis of the data revealed a subset of patients with severe disease in whom tocilizumab might have a reduced risk for progression to death if treated with tocilizumab in addition to standard care, the University of Bristol said in a media release.
Clinical parameters or biomarkers to reliably identify patients who might benefit from tocilizumab, and the optimal timing of treatment during Covid-19 progression, remain unknown, the University noted. The authors conclude that while the study does not support the routine use of tocilizumab in adults with Covid-19, it adds to the growing evidence suggesting it may help some severely ill patients.
“Our study suggests tocilizumab might still be effective in patients with severe Covid-19 and so should be investigated further in future studies. It adds to existing evidence from the RECOVERY and REMAP-CAP studies which demonstrate that tocilizumab does have a significant impact on reducing mortality in those with Covid-19 requiring oxygen or being ventilated,” the release quoted the trial’s lead co-author, Professor A V Ramanan from the University of Bristol’s Medical School, as saying.
The study was funded by Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.
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