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

Saavedra, Danay; Añé-Kourí, Ana Laura; Sánchez, Naivy; Filgueira, Lázaro Manuel; Betancourt, Jaime; Herrera, Carlos; Manso, Leniel; Chávez, Elibet; Caballero, Armando; Hidalgo, Carlos; Lorenzo, Geydi; Cepeda, M. Soledad; Valenzuela, Carmen; Ramos, Mayra; León, Kalet; Mazorra, Zaima; Crombet, Tania

doi:10.1186/s12979-020-00207-8

Cited by 23 publications

(18 citation statements)

References 35 publications

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“…Itolizumab's intervention, thus, can be helpful before the patient progresses to severe ARDS requiring IMV. Median time to recovery with Itolizumab was 8 (7-10) days and it was 10 (9-11) days with Remdesivir in the ACTT-1 trial, 20 (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27) days with Tocilizumab in the COVACTA trial and 19 days with Tocilizumab in the RECOVERY trial. 24,25,32 Taken together, the mortality, recovery, and remission observations with Itolizumab suggest a survival as well as an early recovery benefit.…”

Section: Discussionmentioning

confidence: 99%

“…9 In the past 1 year, >27,000 hospitalized patients have been treated for COVID-19 with Itolizumab across India. [17][18][19][20][21][22][23] This post-marketing study in 300 patients, hospitalized in COVID-19-designated Indian tertiary care hospitals, was carried out to assess safety and survival and recovery benefits of Itolizumab treatment in COVID-19 patients requiring oxygen therapy and having a PaO 2 /FiO 2 ratio (PFR) ≤200. This study presents results of the primary and key secondary All rights reserved.…”

Section: Introductionmentioning

confidence: 99%

“…9 In the past 1 year, >27,000 hospitalized patients have been treated for COVID-19 with Itolizumab across India. 17-23…”

Section: Introductionmentioning

confidence: 99%

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REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

Raveendra

Rathod²,

Darnule³

et al. 2021

Preprint

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Objective: To evaluate safety and efficacy of Itolizumab in hospitalized COVID-19 patients with PaO2/FiO2 ratio (PFR) ≤200 requiring oxygen therapy. Design: A multicentre, single-arm, Phase-4 study with a treatment period of 30-Days and an extended follow-up period of 90-Days. Methods: Hospitalized adult patients (n=300) with SARS-CoV-2 infection, with PFR ≤200, oxygen saturation ≤94% and ≥1 elevated inflammatory markers were included from 17 COVID-19 specific tertiary hospitals in India. Patients received Itolizumab infusion 1.6 mg/kg and were assessed for 1-month and then followed up to Day-90. Results: Day-30 post-treatment safety/efficacy results and Day-90 mortality results are presented. Primary outcome measures: incidence of severe acute infusion-related reactions (IRRs) (≥Grade-3) was 1.3% and mortality rate at 1-month was 6.7% (n=20/300). Key secondary analyses: Mortality rate at Day-90 was 8.0% (24/300). 91.7% patients came off the oxygen therapy within Day-30 of treatment. By Day-7, most patients had stable/improved SpO2 without increasing FiO2. Mean PFR improved by 50% by Day-7 (p<0.001) and the trend remained consistent till Day-30. Median time of recovery was 8 days. Cumulatively, at Day-30, 260(86.7%), 256(85.3%), 132(44.0%), 113(37.6%) and 32(10.7%) patients showed >1-point, >2-point, >3-point, >4-point and 5-point improvement on the modified COVID-19 8-point ordinal scale and worsening of symptoms by >1 point, >2 points and 3-points was seen in 26(8.7%), 20(6.7%) and 6(2.0%) patients, respectively. CRP, D-dimer, LDH and serum ferritin levels significantly decreased (p≤0.01) compared with baseline. IL-6 and TNFα levels also decreased 48-hours post-infusion. Overall, 123 treatment-emergent adverse events (TEAEs) were reported in 63 patients, most being Grades 1-3. Most common TEAEs were IRRs and lymphopenia; most common serious TEAEs were septic shock, worsening of ARDS and respiratory failure. No deaths were attributable to Itolizumab. Conclusion: Itolizumab shows no new safety concerns and suggests a mortality and recovery benefit at 1-month in hospitalized COVID-19 patients requiring oxygen therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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REcovery and SURvival of patients with moderate to severe acute REspiratory distress syndrome (ARDS) due to COVID-19: a multicentre, single-arm, Phase IV Itolizumab Trial: RESURRECT

Raveendra

Rathod²,

Darnule³

et al. 2021

Preprint

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“… 188 Based on a study, itolizumab decreased the circulating level of IL‐6 in serious and critical COVID‐19 patients and maintained the circulating level of IL‐6 in patients with moderate conditions. 189 According to a study by Diaz et al, the use of itolizumab along with other antiviral and anticoagulant drugs is accompanied by a decrease in the worsening of COVID‐19 disease and the need for mechanical ventilation and oxygen therapy, as well as a decrease in fatality in older patients with mild COVID‐19. 190 …”

Section: Monoclonal Antibodies Targeting the Inflammatory Mediatorsmentioning

confidence: 99%

Recent advances in antibody‐based immunotherapy strategies for COVID‐19

Esmaeilzadeh

Rostami

Yeganeh

et al. 2021

J of Cellular Biochemistry

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The emergence of a new acute respiratory syndrome Coronavirus 2 (SARS‐CoV‐2), the cause of the 2019‐nCOV disease (COVID‐19), has caused a pandemic and a global health crisis. Rapid human‐to‐human transmission, even from asymptomatic individuals, has led to the quick spread of the virus worldwide, causing a wide range of clinical manifestations from cold‐like symptoms to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan injury, and even death. Therefore, using rapid and accurate diagnostic methods to identify the virus and subsequently select appropriate and effective treatments can help improvement of patients and control the pandemic. So far, various treatment regimens along with prophylactic vaccines have been developed to manage COVID‐19‐infected patients. Among these, antibody‐based therapies, including neutralizing antibodies (against different parts of the virus), polyclonal and monoclonal antibodies, plasma therapy, and high‐dose intravenous immunoglobulin (IVIG) have shown promising outcomes in accelerating and improving the treatment process of patients, avoiding the viral spreading widely, and managing the pandemic. In the current review paper, different types and applications of therapeutic antibodies in the COVID‐19 treatment are comprehensively discussed.

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“…However, severe cases of COVID-19 pneumonia despite oxygenation, ventilatory support and steroids [2] have poor outcome, which triggered various trials evaluating immunosuppressive drugs to improve prognosis by controlling the hyperinflammatory state. The evidence of use of these drugs is limited and based on available literature till date, the use of these drugs has been summarised in Table 1 [3][4][5][6][7][8][9] Although tocilizumab is an off-label drug described in Indian national guidelines, there are no official guidelines for the use of the other drugs in India leading to variability in usage. It is imperative to use these drugs under a trial mode to generate further evidence and regularise the usage.…”

Section: Covid-19 -Deliberating Beyond Steroids In 2021mentioning

confidence: 99%