An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients

  • Immun Ageing. 2020 Nov 14;17(1):34. doi: 10.1186/s12979-020-00207-8.
Danay Saavedra  1 ,  Ana Laura Añé-Kourí  2 ,  Naivy Sánchez  3 ,  Lázaro Manuel Filgueira  4 ,  Julio Betancourt  4 ,  Carlos Herrera  4 ,  Leniel Manso  4 ,  Elibet Chávez  5 ,  Armando Caballero  4 ,  Carlos Hidalgo  3 ,  Geydi Lorenzo  6 ,  Meylan Cepeda  6 ,  Carmen Valenzuela  6 ,  Mayra Ramos  6 ,  Kalet León  6 ,  Zaima Mazorra  6 ,  Tania Crombet  6
Affiliations
  • 1. Department of Clinical Immunology. Center of Molecular Immunology, 216 St, Corner 15, PO Box 16040, Havana, Atabey, Cuba. [email protected].
  • 2. Biochemical Department. ICBP "Victoria de Girón", Calle 146 # 3102, La Habana, Playa, Cuba.
  • 3. Manuel Piti Fajardo Universitary Hospital. Ciudad Escolar Abel Santamaría, U/M 9958, Santa Clara, Villa Clara, Cuba.
  • 4. Arnaldo Milian Castro Universitary Hospital, Arnaldo Milián Castro St, Santa Clara, Villa Clara, Cuba.
  • 5. Cardiocentro "Ernesto Che Guevara", Cuba St N° 610, Santa Clara, Villa Clara, Cuba.
  • 6. Department of Clinical Immunology. Center of Molecular Immunology, 216 St, Corner 15, PO Box 16040, Havana, Atabey, Cuba.
PMID: 33292350 DOI: 10.1186/s12979-020-00207-8
Abstract

Background: Since the COVID-19 outbreak an unprecedented challenge for healthcare systems around the world has been placed. In Cuba, the first case of COVID-19 was reported on March 11. Elderly with multiple comorbidities have been the most risky population. Although most patients present a mild to moderate disease, some have developed severe symptoms. One of the possible mechanisms underlying rapid disease progression is a cytokine storm, in which interleukin (IL) -6 seems to be a major mediator. Itolizumab is a humanized recombinant anti-CD6 monoclonal antibody (MAb), with the ability of reducing serum interferon gamma (INF-γ), tumour necrosis factor alpha (TNFα) and IL-6. Based on these previous results in patients with psoriasis and rheumatoid arthritis, an expanded access clinical trial was approved by the Cuban regulatory agency for COVID-19 critically, severely and moderately ill patients.

Results: We show here a short kinetic of IL-6 serum concentration in the first 24 COVID-19 patients treated with itolizumab. Most of patients were elderly with multiple comorbidities. We found that with one itolizumab dose, the circulating IL-6 decreased in critically and severely ill patients, whereas in moderately ill patients the values didn't rise as compared to their low baseline levels.

Conclusion: These findings suggest that itolizumab could be an attractive therapeutic option to decrease the negative outcome of the cytokine storm in COVID-19 patients.

Trial registration: CECMED IIC RD-EC 179, RPCEC00000311. Registered 4 May 2020 - Retrospectively registered, http://rpcec.sld.cu/ensayos/RPCEC00000311-Sp or http://rpcec.sld.cu/trials/RPCEC00000311-En.

Keywords
COVID-19; Cytokine release syndrome; IL-6; Itolizumab.
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