Experts concerned over exclusion of Itolizumab from FAQs issued by health ministry for management of COVID-19

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Public health experts have raised concern over the fact that Biocon’s drug Itolizumab, which has received emergency use approval for COVID-19, has not been mentioned in the FAQs issued by the Union health ministry for clinical management of COVID-19 patients in ICUs.

The ministry had issued FAQs on better clinical management of COVID-19 patients in ICUs, prepared by All India Institute of Medical Sciences (AIIMS), New Delhi.

Biocon Ltd on July 11, 2020 had received the Drugs Controller General of India’s (DCGI) approval for emergency use of Itolizumab (ALZUMAb) injection 25mg/5mL solution in India, for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19. Itolizumab is the first anti-CD6 novel biologic therapy to be approved for emergency use, anywhere in the world, for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.

The emergency use approval of Itolizumab from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi. The study focused on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19. The primary endpoints for reduction in one-month mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.

As per FAQs, hydroxychloroquine (HCQ) has been advised as a prophylaxis in healthcare workers (HCW) and high-risk contacts without contraindications. It can be used along with proper use of PPE and other infection control practices to protect from COVID 19.

Ivermectin has been found to be a potent inhibitor of SARS CoV2 replication in vitro, but the doses required to achieve this effect in vivo far exceeds the usual dose. It is currently not recommended in the national guidelines but can be used in patients in whom HCQ is contraindicated.

Methyl prednisolone vs dexamethasone corticosteroids are currently indicated in moderate to severe COVID-19 patients. Recovery trial has used dexamethasone. However, both IV dexamethasone or methyl prednisolone may be used based on the availability. Tocilizumab has been approved by DCGI on compassionate grounds in view of an ongoing pandemic. However, it is an experimental therapy, has a limited role, and should be used only in patients with cytokine syndrome after ruling out active infections.

Convalescent plasma collected from ABO matched donors with high neutralizing titers can be given to patients at risk of developing severe COVID in early stages of the disease. However, it should also be considered an experimental therapy and should be used with caution.
Studies have used favipiravir mainly in mild or asymptomatic COVID, claiming to prevent progression, whereas the majority of this cohort recover with just supportive care and monitoring and usually require no specific therapy. Evidence is weak for the use of favipiravir and is currently not recommended in national guidelines.

There is no evidence to support the use of antifibrotic agents like pirfenidone in preventing COVID related fibrosis and hence should not be used.

Remdesivir/TCZ are experimental therapies, approved by DCGI in view of the ongoing pandemic. Therefore, they should not be used as empirical therapy for suspected cases. You should use these agents only in proven COVID patients, where clinically indicated.

Talking about Itolizumab, Dr Suresh Kumar, medical director, Lok Nayak Hospital, Delhi said, “Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80% and would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged.”

Dr Mohan Joshi, Dean, BYL Nair Hospital, Mumbai said, “In our hospital, we have tried Itolizumab in many COVID-19 patients with moderate to severe ARDS and found significant improvement in clinical, radiological and inflammatory markers after administering Itolizumab. These outcomes were quite evident with one dose of Itolizumab when administered before the ‘cytokine storm’ set in. Most of the patients have well tolerated the drug. Given the growing surge of COVID-19 cases, I would recommend use of Itolizumab in moderate to severe complications in COVID-19.”

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