OBJECTIVES: Coronavirus disease (COVID-19) is an infectious disease that leads to a hyperinflammatory state known as cytokine release syndrome. Itolizumab (ALZUMAb^TM, Biocon India) is a humanized recombinant anti-CD6 monoclonal antibody that reduces serum levels of Interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (INF-γ). This study aims to evaluate the efficacy and safety of itolizumab in COVID-19 patients.

METHODS: MEDLINE and EMBASE via OVID SP platform were searched through June, 2022 for studies assessing the efficacy and safety of Itolizumab in Covid-19 patients. No restriction regarding the year of publication was applied. Two reviewers independently searched for articles and extracted data, resolving differences through consensus.

RESULTS: Of 43 identified studies, five were included (one randomized controlled trial, three single-arm trials, and one observational study). Kumar et al. 2021 reported no deaths in best supportive care (BSC) plus itolizumab arm compared to BSC alone arm (p=0.0296; 95% CI = -0.3 [-0.61, -0.08]). Similarly, the combination therapy showed improvements in SpO2 (p=0.0296), PaO2 (p=0.0296) and decreased levels of IL-6 (43 vs 212 pg/ml; p=0.0296), TNF-α (9 vs 39 pg/ml; p=0.0253), when compared with BSC alone arm. Likewise, single-arm studies of itolizumab reported a reduction in IL-6: 28.3 pg/mL to 25.9 pg/mL (Diaz et al. 2020), 290.2 pg/mL to 183.1 pg/mL (Saavedra et al. 2020), and 116.3 and 78.8 (Caballero et al. 2020). Frequent serious adverse events associated with itolizumab were pericardial effusion, hypothyroidism, and airway hyper-reactivity. Gore et al. 2020 reported an improved SpO2 from 88% to 96%.

CONCLUSIONS: Itolizumab demonstrated promising therapeutic activity in reducing hyperinflammatory states in COVID-19 patients along with an acceptable safety profile. Further studies in larger populations are needed to ascertain the therapeutic benefit of itolizumab in COVID-19.