- Roche's anti-inflammatory drug Actemra did not help patients hospitalized with severe COVID-19-associated pneumonia, according to Phase 3 results announced by the Swiss drugmaker Wednesday.
- Treatment with Actemra didn't improve patients' clinical status any more than placebo after four weeks, and patients given the biologic drug were no more likely to survive from the disease's damaging assault on the lungs.
- The trial result is a major blow to a hypothesis that drugs like Actemra, which block a protein called IL-6, could help mitigate the worst effects of COVID-19. Kevzara, a similar drug from Sanofi and Regeneron, also showed no benefit in placebo-controlled study of patients hospitalized with the disease. Still, Roche said its committed to other ongoing trials of Actemra in different COVID-19 settings and in tandem with antivirals.
In the early days of the pandemic, researchers in China and in France separately reported intriguing findings. Actemra — commonly used to treat rheumatoid arthritis — may have been helping keep hospitalized COVID-19 patients alive or off invasive breathing support.
The results were one of many tantalizing findings in a global rush to repurpose drugs for the emergent disease. While that hunt helped uncover the benefits to the steroid dexamethasone and Gilead's antiviral remdesivir, it also turned up false leads and disappointments.
Notably, both dexamethasone and remdesivir were proven beneficial in large, randomized and placebo-controlled studies. By contrast, the early results supporting Actemra, and drugs like hydroxychloroquine, came from flawed, smaller tests.
Even so, Roche, as well as Sanofi and partner Regeneron, quickly started trials to study their arthritis drugs in hopes of conclusively proving them in COVID-19.
Their hypothesis is now in some doubt. Since April, Sanofi and Regeneron have reported negative results from two trials of Kevzara, while a third is ongoing. Wednesday's results from Roche's trial, a 450-patient, Phase 3 study called COVACTA, further weaken the case for IL-6 inhibitors in COVID-19.
On the study's main goal, there was no difference between Actemra and placebo when assessing patients on a 7-point scale of their condition. A slightly greater percentage of Actemra-treated patients, 19.7%, died within four weeks compared to the 19.4% of placebo-treated patients who died.
Treatment with Actemra did seem to lead to earlier discharge from the hospital, and result in less use of ventilation support, but the difference versus placebo was not statistically significant in either case.
Roche plans to publish results from COVACTA in a peer-reviewed journal. And, despite the setback, the drugmaker still intends to study Actemra further.
Two other Phase 3 trials are still underway. One of them, REMDACTA, tests Actemra alongside remdesivir in hospitalized COVID-19 patients. A Phase 2 study, MARIPOSA, is evaluating the drug's use in moderate to severe patients.
In addition, RECOVERY, the British study that proved dexamethasone's benefit, will also continue to test Actemra in COVID-19 patients despite Wednesday's result, Reuters reported.