The Drugs Controller General of India (DCGI) has recently given the green light for Itolizumab, a drug typically used to treat severe chronic plaque psoriasis, for restricted emergency use in Covid-19 cases. Psoriasis is a chronic autoimmune condition that results in the buildup of skin cells, leading to scales and itchy, dry patches. The press has been abuzz about this development due to its ramification on healthcare, especially concerning the ongoing pandemic.
Itolizumab’s Role
Itolizumab has been cleared for emergency use only, specifically for treating Cytokine Storm Syndrome (CSS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients afflicted by Covid-19. Patients experience CSS when the immune system, in an attempt to neutralise the virus, inadvertently damages the lungs and other organs, sometimes leading to death. ARDS is a disease where the lung’s capacity to expand is compromised.
This novel biologic therapy is set to be manufactured as an intravenous injection at a bio-manufacturing facility in Bengaluru. Interestingly, Itolizumab is the first biologic therapy of its kind to be approved anywhere globally for treating patients with moderate to severe Covid-19 complications.
About Biologic Drugs
Biologic drugs, like Itolizumab, are protein-based and derived from living cells cultured in a lab. Unlike traditional systemic drugs that impact the entire immune system, biologics only target specific parts of the immune system. In treatments of psoriatic disease, for instance, biologics work by blocking the action of a specific type of immune cell known as a T-cell.
The Approval Journey
DCGI’s approval stemmed from the success of a randomised, controlled clinical trial across multiple hospitals, designed using Simon’s Two-Stage Design. This methodology is commonly employed in phase-2 clinical trials to test a drug’s efficacy. Indicators such as improved oxygen levels and reduced inflammation convinced many doctors who utilised the drug on their patients.
Combination Approach
The evaluation of Itolizumab also factored in its addition to the ‘best standard of care’ which varied across hospitals but generally consisted of hydroxychloroquine (HCQ), ritonavir (antivirals), oxygen therapy, antibiotics, heparin (to avoid clotting) and some got methylprednisolone (a corticosteroid). This usage was reasoned due to the large trials and safety assessments performed for psoriasis care.
Existing Alternatives
One competing drug, remdesivir, has shown potential in decreasing time for clinical improvement in moderate to severe cases, but does not offer any benefits in terms of reducing mortality. Meanwhile, Tocilizumab hasn’t displayed any benefits in mortality reduction either.
Criticisms
Critics argue that Itolizumab was tested on too few patients to definitively determine its benefits. Only 30 patients were recruited across four hospitals in the study, with 20 given Itolizumab along with the ‘standard of care treatment’, and 10 receiving only standard care. While no deaths occurred in the first group, three patients died from the second group.
About Drug Controller General of India
The DCGI is responsible for the approval of licences for specific categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India, operating under the Ministry of Health and Family Welfare. With this recent approval of Itolizumab, they hope to provide a new tool in the global fight against Covid-19.
