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    ICMR reviewing use of tocilizumab for treatment of coronavirus pandemic

    Synopsis

    Tocilizumab is a rheumatoid arthritis drug manufactured by Swiss pharmaceutical company Roche under the brand name Actemra. The medication is part of the health ministry’s clinical management protocol for Covid-19 under investigational therapies for patients with moderate symptoms of the illness.

    tocilimizabAgencies

    “While many experts believe that tocilizumab should be dropped from the treatment protocol, there are some who believe that the drug should be made available with caveats"

    NEW DELHI: The government is reconsidering the inclusion of tocilizumab in its treatment protocol for Covid-19 after new evidence emerged that it does not improve the condition of people with the disease.

    Tocilizumab is a rheumatoid arthritis drug manufactured by Swiss pharmaceutical company Roche under the brand name Actemra. The medication is part of the health ministry’s clinical management protocol for Covid-19 under investigational therapies for patients with moderate symptoms of the illness.

    But difference of opinion has emerged in the national task force of the Indian Council of Medical Research (ICMR) over its inclusion after Roche said in July that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe Covid-19 associated pneumonia.

    “While many experts believe that tocilizumab should be dropped from the treatment protocol, there are some who believe that the drug should be made available with caveats,” a member of the ICMR task force told ET on condition of anonymity. “Hence, the discussion has not concluded.” The meeting was held last week.

    Investigational therapies are those with limited available evidence for “off-label” use and included in the standard protocol after an expert committee approves it.

    “Many cited the literature which did not show any remarkable results, with many studies showing no benefit from the drug,” said another member, adding that some in the task force believe that the drug has the potential to benefit a certain subgroup of patients if given at the right time.

    “The studies cited by them suggest that the drug shortens the time of discharge without any increase in adverse effects. Hence, they suggested that tocilizumab should not be removed in haste,” the member said.

    The task force is yet to take a decision in this regard and may review the issue again.

    After the updated results of the phase 3 trials were released, senior executives of Roche had said they were disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four.

    According to doctors at Delhi's All India Institute of Medical Sciences (AIIMS), tocilizumab should be used only in patients with cytokine syndrome, after ruling out active infections. “It is an experimental therapy and has a limited role,” an advisory by AIIMS said.


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