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Actemra found to cut need for assisted breathing in Covid patients

Study found that at day 28, incidence of infections was 10 per cent in Actemra arm, 11 per cent in placebo

In Summary

• The study enrolled 389 patients in Kenya, the United States, South Africa, Brazil, Mexico and Peru.

• Actemra has not been approved by any health authority for Covid-19-associated pneumonia.  

A medic holds a bottle labeled Vaccine COVID-19.
VACCINE TRIALS: A medic holds a bottle labeled Vaccine COVID-19.
Image: REUTERS

Empacta study has shown that Actemra can reduce the need for mechanical ventilation in patients with Covid-19 pneumonia, Roche Group member Genentech has said.

The study enrolled 389 patients in Kenya, the United States, South Africa, Brazil, Mexico and Peru.

In Kenya, the study saw patients enrolled into the clinical research unit at the Aga Khan University Hospital.

Both public and private sector patients were eligible to participate in the trial.

The trial that was led by the Kenya AIDs Vaccine Initiative Director Prof Omu Anzala attracted 200 Kenyans who registered to take part in the experiment.

Senators were also offered a chance to take part in the trial but they declined.

The trial enrolled hospitalised patients older than 18 with confirmed Covid-19 infection while on ambient air who did not require noninvasive or invasive mechanical ventilation.

The primary objective was to find out the cumulative proportion of participants dying or requiring mechanical ventilation by Day 28 of the study.

Empacta is global Phase III, randomised, multicentre study aimed at evaluating the efficacy and safety of Actemra used together with remdesivir; versus placebo plus remdesivir, in hospitalised patients with severe Covid-19-associated pneumonia receiving standard care.

The study has shown that patients who received Actemra (tocilizumab) plus standard care were 44 per cent less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard care.

The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2 per cent in the Actemra arm versus 19.3 per cent in the placebo arm.

“The trial demonstrated that Actemra can reduce the need for mechanical ventilation in patients with Covid-19 pneumonia, an important outcome in this serious disease,” chief medical officer and head of Global Product Development Levi Garraway said.

 “We plan to share this important data with the FDA and other health authorities around the world.”

The study is the first global, Phase III Covid-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by Covid-19.

The enrolment focus was largely underserved and minority patients with approximately 85 per cent of the 389 patients being from minority racial and ethnic groups.

“We have been striving to improve inclusion and diversity in our trials. During the pandemic, we saw how high the stakes were for many communities of colour and made diversity the centrepiece of this trial,” head of US Medical Affairs Jamie Freedman said.

The study found that at day 28, incidence of infections was 10 per cent and 11 per cent in the Actemra and placebo arms respectively, and the incidence of serious infections was five per cent and 6.3 per cent respectively.

In regard to adverse effects, 5.6 per cent of the patients who received Actremra reported constipation, while 5.2 per cent reported having anxiety while 3.2 per cent experienced headache.

Medical director at Roche Kenya Limited Beatrice Nyawira said disparities and lack of diversity in medical research holds the global community back.

“The Covid-19 pandemic continues to evolve rapidly in Kenya and around the world and Roche is doing everything we can to contribute. This is a watershed moment for Kenya and us at the Aga Khan University Hospital to participate in an international clinical trial that is testing the effectiveness of this novel drug on our patients here.” 

Actemra has not been approved by any health authority for Covid-19-associated pneumonia. 

Edited by R.Wamochie