Itolizumab: Emergency Covid-19 Drug

• 13 Jul 2020

Why in News

Recently, the Drugs Controller General of India (DCGI) has cleared Itolizumab for restricted emergency use in Covid-19 cases.

• Itolizumab is a drug used to treat severe chronic plaque psoriasis.
  
  • Plaque psoriasis is a chronic autoimmune condition in which skin cells build up and form scales and itchy, dry patches.

Key Points

• Itolizumab is for emergency use only in the treatment of Cytokine Storm Syndrome (CSS) in moderate to Severe Acute Respiratory Distress Syndrome (ARDS) patients due to Covid-19.
  
  • CSS is an uncontrolled attempt by the immune system to neutralise the virus that often ends up damaging the lungs and other organs and even death.
  • ARDS is a disease in which the lung loses its capacity to expand further.
• It will be manufactured and formulated as an intravenous (IV) injection at the bio-manufacturing facility in Bengaluru.
• Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications.
  
  • Itolizumab is a biologic/biologic drug given by injection (shot) or IV infusion.
  • A biologic is a protein-based drug derived from living cells cultured in a laboratory.
  • Biologics are different from traditional systemic drugs that impact the entire immune system.
  • Biologics only target specific parts of the immune system and biologics used to treat psoriatic disease block the action of a specific type of immune cell called a T-cell.

Reasons for its Approval

• DCGI’s approval for the repurposed drug comes after the successful conclusion of a randomised, controlled clinical trial at multiple hospitals.
  
  • The trial was designed employing a method called Simon’s Two-Stage Design, an approach in executing phase-2 clinical trials where the efficacy of a drug is tested.
• Other criteria such as improvement in oxygen levels and reduced inflammation were also convincing to several doctors who used the drug on their patients.
• The evaluation also rests on Itolizumab being added to the ‘best standard of care’ which slightly varied across hospitals.
  
  • In general, this consisted of hydroxychloroquine (HCQ), ritonavir (antivirals), oxygen therapy, antibiotics, heparin (to avoid clotting) and some got methylprednisolone (a corticosteroid).
• Its usage was justified because of its large trials and safety assessments are already done for psoriasis. Plus, it is hard to recruit a larger number of patients in critical care conditions so numbers had to be kept low.
  
  • There are no hard rules on a minimum number of recruits.
  • For an orphan drug (used to treat orphan or rare diseases), small numbers of recruits are approved.
• The available evidence for remdesivir suggests that it may decrease the time for clinical improvement when used in moderate to severe cases and has no benefits in terms of reduced mortality.
  
  • Remdesivir has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury.
• Another drug Tocilizumab has not shown any benefits in mortality reduction.
• Criticism:
  
  • Itolizumab appears to have been tested on too few patients to reliably conclude on its benefits and with such a small sample size it would be unwise to claim it as the final and fully successful drug.
  • 30 patients were recruited across four hospitals and 20 of them were given Itolizumab along with the ‘standard of care treatment’ and 10 were given only standard of care.
  • Nobody died from the set of 20 patients and 3 patients died from the set of 10 patients.

Drug Controller General of India

• It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
• It comes under the Ministry of Health and Family Welfare.

Source: TH