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An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients
Danay Saavedra1, Ana Laura Añé-Kourí2, Naivy Sánchez3
1Department of Clinical Immunology. Center of Molecular Immunology, 216 St, Corner 15, PO Box 16040, Havana, Atabey, Cuba. danays@cim.sld.cu.
Insights
Itolizumab treatment reduced interleukin-6 (IL-6) serum concentrations in critically and severely ill COVID-19 patients. This suggests itolizumab is a potential therapy to mitigate cytokine storm complications in severe COVID-19.
Area of Science:
- Immunology
- Virology
- Clinical Medicine
Background:
- COVID-19 presents a global healthcare challenge, particularly for elderly patients with comorbidities.
- Cytokine storm, driven by mediators like interleukin-6 (IL-6), contributes to severe COVID-19 progression.
- Itolizumab, an anti-CD6 monoclonal antibody, reduces key inflammatory cytokines including IL-6.
Purpose of the Study:
- To evaluate the effect of itolizumab on IL-6 serum concentrations in COVID-19 patients.
- To assess itolizumab's potential in managing cytokine storm in different COVID-19 severity groups.
Main Methods:
- An expanded access clinical trial was conducted for COVID-19 patients (critically, severely, and moderately ill).
- Serum IL-6 levels were monitored following a single dose of itolizumab in the first 24 patients.
- Patient cohort included elderly individuals with multiple comorbidities.
Main Results:
- A single dose of itolizumab led to decreased circulating IL-6 levels in critically and severely ill COVID-19 patients.
- In moderately ill patients, IL-6 levels remained low and did not increase after itolizumab administration.
- The study observed the IL-6 kinetic changes within the first 24 hours post-treatment.
Conclusions:
- Itolizumab demonstrates potential as a therapeutic agent to mitigate the adverse effects of cytokine storm in COVID-19.
- These findings support further investigation of itolizumab for managing severe COVID-19 outcomes.
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.
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