Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation
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 analyse...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-11-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971220306160 |
| _version_ | 1818527499162746880 |
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| author | Nicola Potere Marcello Di Nisio Giulia Rizzo Matteo La Vella Ennio Polilli Adriana Agostinone Antonella Spacone Silvio Di Carlo Alberto Costantini Antonio Abbate Ettore Porreca Giustino Parruti |
| author_facet | Nicola Potere Marcello Di Nisio Giulia Rizzo Matteo La Vella Ennio Polilli Adriana Agostinone Antonella Spacone Silvio Di Carlo Alberto Costantini Antonio Abbate Ettore Porreca Giustino Parruti |
| author_sort | Nicola Potere |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T06:36:54Z |
| format | Article |
| id | doaj.art-956a61141e164ecd8a11698a9ffa3136 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-12-11T06:36:54Z |
| publishDate | 2020-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-956a61141e164ecd8a11698a9ffa31362022-12-22T01:17:20ZengElsevierInternational Journal of Infectious Diseases1201-97122020-11-01100421424Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammationNicola Potere0Marcello Di Nisio1Giulia Rizzo2Matteo La Vella3Ennio Polilli4Adriana Agostinone5Antonella Spacone6Silvio Di Carlo7Alberto Costantini8Antonio Abbate9Ettore Porreca10Giustino Parruti11Department of Medical, Oral and Biotechnological Sciences, ‘G. D’Annunzio’ University, Chieti, Italy; VCU Pauley Heart Center, Virginia Commonwealth University, Richmond VA, USADepartment of Medicine and Ageing Sciences, ‘G. D’Annunzio’ University, Chieti-Pescara, Italy; Department of Vascular Medicine, Academic Medical Center, Amsterdam, The NetherlandsDepartment of Medical, Oral and Biotechnological Sciences, ‘G. D’Annunzio’ University, Chieti, ItalyDepartment of Medical, Oral and Biotechnological Sciences, ‘G. D’Annunzio’ University, Chieti, ItalyUnit of Clinical Pathology, Pescara General Hospital, Pescara, ItalyInfectious Diseases Unit, Pescara General Hospital, Pescara, ItalyRespiratory Medicine Unit, Pescara General Hospital, Pescara, ItalyRespiratory Medicine Unit, Pescara General Hospital, Pescara, ItalyHospital Pharmacy, Pescara General Hospital, Pescara, ItalyVCU Pauley Heart Center, Virginia Commonwealth University, Richmond VA, USADepartment of Medical, Oral and Biotechnological Sciences, ‘G. D’Annunzio’ University, Chieti, ItalyInfectious Diseases Unit, Pescara General Hospital, Pescara, Italy; Corresponding author at: Infectious Diseases Unit, Pescara General Hospital, Via Fonte Romana 8, 65124, Pescara, Italy.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.http://www.sciencedirect.com/science/article/pii/S1201971220306160COVID-19SARS-CoV-2InflammationCytokine release syndromeIL-6Tocilizumab |
| spellingShingle | Nicola Potere Marcello Di Nisio Giulia Rizzo Matteo La Vella Ennio Polilli Adriana Agostinone Antonella Spacone Silvio Di Carlo Alberto Costantini Antonio Abbate Ettore Porreca Giustino Parruti Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation International Journal of Infectious Diseases COVID-19 SARS-CoV-2 Inflammation Cytokine release syndrome IL-6 Tocilizumab |
| title | Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation |
| title_full | Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation |
| title_fullStr | Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation |
| title_full_unstemmed | Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation |
| title_short | Low-dose subcutaneous tocilizumab to prevent disease progression in patients with moderate COVID-19 pneumonia and hyperinflammation |
| title_sort | low dose subcutaneous tocilizumab to prevent disease progression in patients with moderate covid 19 pneumonia and hyperinflammation |
| topic | COVID-19 SARS-CoV-2 Inflammation Cytokine release syndrome IL-6 Tocilizumab |
| url | http://www.sciencedirect.com/science/article/pii/S1201971220306160 |
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