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Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation.
Int J Infect Dis. 2020 Aug 06; 100:421-424.IJ

Abstract

AIM

This study aimed to evaluate the safety and efficacy profile of low-dose tocilizumab (TCZ), to prevent disease progression, subcutaneously administered to patients with moderate COVID-19 pneumonia and hyperinflammation.

METHODS

Clinical characteristics and outcomes were retrospectively analysed of patients - with laboratory-confirmed bilateral COVID-19 pneumonia, hyperinflammation (C-reactive protein (CRP) ≥20 mg/dL), no hypoxaemia (oxygen saturation >90%), and no contraindications to TCZ - who were treated with subcutaneous TCZ (324 mg) administered within 48 h from hospitalization on top of standard of care (SOC). They were compared with matched controls treated with SOC only before TCZ was available at the institution. Clinical data were available for all patients until death or until day 35 for those discharged from hospital.

FINDINGS

Ten consecutive patients (six males, median age 55 years) treated with TCZ on top of SOC, and ten patients (six males, median age 56 years) treated with SOC only were included. TCZ was well-tolerated with no clinically relevant adverse events. TCZ was associated with a reduction in CRP at day 1 (-50%, IQR -28 to -80) and day 3 (-89%, IQR -79 to -96; p = 0.005 for within-group), whereas there was no significant change in CRP values in the SOC group (p < 0.001 for between-group comparisons at both time points). TCZ resulted in a parallel improvement in oxygenation, as assessed by the ratio of partial pressure of oxygen to fraction of inspired oxygen (P/F) ratio, which increased at day 1 (+11%, IQR +6 to +16; p = 0.005 for within-group and p = 0.006 for between-group comparisons), and day 3 (+23%, IQR +16 to +34; p = 0.005 for within-group and p = 0.003 for between-group comparisons). None of the TCZ-treated patients had disease progression, defined as requirement of oxygen therapy or mechanical ventilation, whereas progression occurred in five (50%) patients among the SOC group.

CONCLUSIONS

Low-dose subcutaneous TCZ may be a safe and promising therapeutic option administered on top of SOC to prevent disease progression in hospitalised patients with moderate COVID-19 and hyperinflammation.

Authors+Show Affiliations

Department of Medical, Oral and Biotechnological Sciences, 'G. D'Annunzio' University, Chieti, Italy; VCU Pauley Heart Center, Virginia Commonwealth University, Richmond VA, USA.Department of Medicine and Ageing Sciences, 'G. D'Annunzio' University, Chieti-Pescara, Italy; Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.Department of Medical, Oral and Biotechnological Sciences, 'G. D'Annunzio' University, Chieti, Italy.Department of Medical, Oral and Biotechnological Sciences, 'G. D'Annunzio' University, Chieti, Italy.Unit of Clinical Pathology, Pescara General Hospital, Pescara, Italy.Infectious Diseases Unit, Pescara General Hospital, Pescara, Italy.Respiratory Medicine Unit, Pescara General Hospital, Pescara, Italy.Respiratory Medicine Unit, Pescara General Hospital, Pescara, Italy.Hospital Pharmacy, Pescara General Hospital, Pescara, Italy.VCU Pauley Heart Center, Virginia Commonwealth University, Richmond VA, USA.Department of Medical, Oral and Biotechnological Sciences, 'G. D'Annunzio' University, Chieti, Italy.Infectious Diseases Unit, Pescara General Hospital, Pescara, Italy. Electronic address: parrutig@gmail.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32768701

Citation

Potere, Nicola, et al. "Low-dose Subcutaneous Tocilizumab to Prevent Disease Progression in Patients With Moderate COVID-19 Pneumonia and Hyperinflammation." International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, vol. 100, 2020, pp. 421-424.
Potere N, Di Nisio M, Rizzo G, et al. Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation. Int J Infect Dis. 2020;100:421-424.
Potere, N., Di Nisio, M., Rizzo, G., La Vella, M., Polilli, E., Agostinone, A., Spacone, A., Di Carlo, S., Costantini, A., Abbate, A., Porreca, E., & Parruti, G. (2020). Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation. International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, 100, 421-424. https://doi.org/10.1016/j.ijid.2020.07.078
Potere N, et al. Low-dose Subcutaneous Tocilizumab to Prevent Disease Progression in Patients With Moderate COVID-19 Pneumonia and Hyperinflammation. Int J Infect Dis. 2020 Aug 6;100:421-424. PubMed PMID: 32768701.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation. AU - Potere,Nicola, AU - Di Nisio,Marcello, AU - Rizzo,Giulia, AU - La Vella,Matteo, AU - Polilli,Ennio, AU - Agostinone,Adriana, AU - Spacone,Antonella, AU - Di Carlo,Silvio, AU - Costantini,Alberto, AU - Abbate,Antonio, AU - Porreca,Ettore, AU - Parruti,Giustino, Y1 - 2020/08/06/ PY - 2020/06/23/received PY - 2020/07/04/revised PY - 2020/07/23/accepted PY - 2020/8/10/pubmed PY - 2020/8/10/medline PY - 2020/8/10/entrez KW - COVID-19 KW - Cytokine release syndrome KW - IL-6 KW - Inflammation KW - SARS-CoV-2 KW - Tocilizumab SP - 421 EP - 424 JF - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JO - Int J Infect Dis VL - 100 N2 - AIM: This study aimed to evaluate the safety and efficacy profile of low-dose tocilizumab (TCZ), to prevent disease progression, subcutaneously administered to patients with moderate COVID-19 pneumonia and hyperinflammation. METHODS: Clinical characteristics and outcomes were retrospectively analysed of patients - with laboratory-confirmed bilateral COVID-19 pneumonia, hyperinflammation (C-reactive protein (CRP) ≥20 mg/dL), no hypoxaemia (oxygen saturation >90%), and no contraindications to TCZ - who were treated with subcutaneous TCZ (324 mg) administered within 48 h from hospitalization on top of standard of care (SOC). They were compared with matched controls treated with SOC only before TCZ was available at the institution. Clinical data were available for all patients until death or until day 35 for those discharged from hospital. FINDINGS: Ten consecutive patients (six males, median age 55 years) treated with TCZ on top of SOC, and ten patients (six males, median age 56 years) treated with SOC only were included. TCZ was well-tolerated with no clinically relevant adverse events. TCZ was associated with a reduction in CRP at day 1 (-50%, IQR -28 to -80) and day 3 (-89%, IQR -79 to -96; p = 0.005 for within-group), whereas there was no significant change in CRP values in the SOC group (p < 0.001 for between-group comparisons at both time points). TCZ resulted in a parallel improvement in oxygenation, as assessed by the ratio of partial pressure of oxygen to fraction of inspired oxygen (P/F) ratio, which increased at day 1 (+11%, IQR +6 to +16; p = 0.005 for within-group and p = 0.006 for between-group comparisons), and day 3 (+23%, IQR +16 to +34; p = 0.005 for within-group and p = 0.003 for between-group comparisons). None of the TCZ-treated patients had disease progression, defined as requirement of oxygen therapy or mechanical ventilation, whereas progression occurred in five (50%) patients among the SOC group. CONCLUSIONS: Low-dose subcutaneous TCZ may be a safe and promising therapeutic option administered on top of SOC to prevent disease progression in hospitalised patients with moderate COVID-19 and hyperinflammation. SN - 1878-3511 UR - https://www.unboundmedicine.com/medline/citation/32768701/Low_Dose_Subcutaneous_Tocilizumab_to_Prevent_Disease_Progression_in_Patients_with_Moderate_COVID_19_Pneumonia_and_Hyperinflammation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1201-9712(20)30616-0 DB - PRIME DP - Unbound Medicine ER -