Live Discussion on Itolizumab and Coronavirus – COVID-19 Treatment | COVID-19 India
There was big news out of India when the Drug Controller General of India (DCGI), approved the drug Itolizumab for emergency use for the treatment of cytokine release syndrome or the cytokine storms in patients with moderate to severe ARDS due to COVID-19.
Itolizumab is an anti CD6 monoclonal antibody that was approved by the DCGI for the treatment of moderate-to-severe chronic plaque psoriasis in 2013.
And according to Biocon’s chief medical officer, Dr. Sandeep Athalye,
itolizumab demonstrated a statistically significant advantage over the control arm, in one-month mortality rate. Key efficacy parameters such as PaO2 and SpO2 (oxygen saturation) improvement without increasing FiO2 (oxygen flow) also showed a statistically significant advantage for Itolizumab arm over the control arm. All the patients on Itolizumab arm were weaned off oxygen by day-30, and none needed ventilator support, unlike the control arm. Key secondary endpoints of clinical markers of inflammation such as IL-6, TNF-α, serum ferritin, d-dimer, LDH and CRP showed clinically significant suppression post-dose and correlated well with clinical improvement in symptoms and chest x-ray images. Itolizumab was overall well tolerated and was found to be safe. Itolizumab when administered to patients with moderate to severe ARDS due to Covid-19, prevents morbidity and mortality due to cytokine storm.
– Dr. Yo
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