Off-label Use of Itolizumab in Patients with COVID-19 ARDS: Our Clinical Experience in a Dedicated COVID Center
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Off-label Use of Itolizumab in Patients with COVID-19 ARDS: Our Clinical Experience in a Dedicated COVID Center. Indian J Crit Care Med 2021; 25 (4):467-469.
Severe acute respiratory syndrome coronavirus 2 has affected millions of people worldwide. This pandemic requires newer medical management strategies to control the morbidity and mortality associated with the disease. Several approaches, including global targeting of inflammation or neutralizing a single key inflammatory mediator, are being employed to cope with cytokine storms in coronavirus disease-2019 (COVID-19). The role of anti-inflammatory biologics, such as acalabrutinib, tocilizumab, anakinra, and itolizumab can become relevant. Itolizumab is a humanized recombinant immunoglobulin G1 monoclonal antibody. It targets the extracellular, scavenger receptor cysteine-rich (SRCR) distal domain 1 of CD6 and is responsible for priming, activation, and differentiation of T-cells. Itolizumab has been approved by the Drug Controller General of India for the treatment of COVID-19 in India. Here, we shared our clinical experience of 20 patients having moderate acute respiratory distress syndrome (ARDS) due to COVID-19 on treatment with itolizumab. We observed the mortality benefit with single-dose itolizumab (1.6 mg/kg) in patients having moderate COVID-19 ARDS.
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA 2020;323(11):1061–1069. DOI: 10.1001/jama.2020.1585.
Coperchini F, Chiovato L, Croce L, Magri F, Rotondi M. The cytokine storm in COVID-19: An overview of the involvement of the chemokine/chemokine-receptor system. Cytokine Growth Factor Rev 2020;53:25–32. DOI: 10.1016/j.cytogfr.2020.05.003.
Roschewski M, Lionakis MS, Sharman JP, Roswarski J, Goy A, Monticelli MA, et al. Inhibition of Bruton tyrosine kinase in patients with severe COVID-19. Sci Immunol 2020;5(48):eabd0110. DOI: 10.1126/sciimmunol.abd0110.
Alijotas-Reig J, Esteve-Valverde E, Belizna C, Selva-O’Callaghan A, Pardos-Gea J, Quintana A, et al. Immunomodulatory therapy for the management of severe COVID-19. Beyond the anti-viral therapy: a comprehensive review. Autoimmun Rev 2020;19(7):102569. DOI: 10.1016/j.autrev.2020.102569.
Marovich M, Mascola JR, Cohen MS. Monoclonal antibodies for prevention and treatment of COVID-19. JAMA 2020;324(2):131–132. DOI: 10.1001/jama.2020.10245.
Bughani U, Saha A, Kuriakose A, Nair R, Sadashivarao RB, Venkataraman R, et al. T cell activation and differentiation is modulated by a CD6 domain 1 antibody Itolizumab. PLoS One 2017;12(7):e0180088. DOI: 10.1371/journal.pone.0180088.
Guaraldi G, Meschiari M, Cozzi-Lepri A, Milic J, Tonelli R, Menozzi M, et al. Tocilizumab in patients with severe COVID-19: a retrospective cohort study. Lancet Rheumatol 2020;2(8):e474–e484. DOI: 10.1016/S2665-9913(20)30173-9.
Cavalli G, De Luca G, Campochiaro C, Della-Torre E, Ripa M, Canetti D, et al. Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respira- tory distress syndrome, and hyperinflammation: a retrospective cohort study. Lancet Rheumatol 2020;2(6):e325–e331. DOI: 10.1016/S2665-9913(20)30127-2.
Nair P, Melarkode R, Rajkumar D, Montero E. CD6 synergistic co-stimulation promoting proinflammatory response is modulated without interfering with the activated leucocyte cell adhesion molecule interaction. Clin Exp Immunol 2010;162(1):116–130. DOI: 10.1111/j.1365-2249.2010.04235.x.
Gupta A, Sharma YK, Deo K, Kothari P. Severe recalcitrant psoriasis treated with itolizumab, a novel anti-CD6 monoclonal antibody. Indian J Dermatol Venereol Leprol 2016;82(4):459–461. DOI: 10.4103/0378-6323.181466.
Anand A, Assudani D, Nair P, Krishnamurthy S, Deodhar S, Arumugam M, et al. Safety, efficacy and pharmacokinetics of T1h, a humanized anti-CD6 monoclonal antibody, in moderate to severe chronic plaque psoriasis – results from a randomized phase II trial. (96.13). J Immunol 2010 Apr 1;184(1 Supplement) 96.13 [Phase 2 trial of Itolizumab in moderate to severe chronic plaque psoriasis].
Treatment of patients with severe SARS-CoV-2 pneumonia with the anti-CD6 monoclonal antibody itolizumab-full text-WHO-ICTRP [Internet] [Cited 2020 Jul 16]. Available from: https://apps.who.int/trialsearch/Trial2.aspx?TrialID=RPCEC00000311.
Xu X, Han M, Li T, Sun W, Wang D, Fu B, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A. 2020;117(20):10970–10975. DOI: 10.1073/pnas.2005615117.
Albertini L, Soletchnik M, Razurel A, Cohen J, Bidegain F, Fauvelle F, et al. Observational study on off-label use of tocilizumab in patients with severe COVID-19. Eur J Hosp Pharm 2020;0:1–7. DOI: 10.1136/ejhpharm-2020-002414.
Fewer COVID-19 deaths in ICU suggest hospital care improving: study; 2020 [Accessed: September 20, 2020]. Available from: https://www.ndtv.com/world-news/coronavirus-fewer-covid-19-deaths-in-icu-suggest-hospital-care-improving-study-2264244.
