Tocilizumab in patients with severe COVID-19: a retrospective cohort study
No therapy is approved for COVID-19 pneumonia. The aim of this study was to assess the role of tocilizumab in reducing the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia who received standard of care treatment. This retrospective, observational cohort st...
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| Veröffentlicht in: | The Lancet. Rheumatology 2020-08, Vol.2 (8), p.e474-e484 |
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| creator | Guaraldi, Giovanni Meschiari, Marianna Cozzi-Lepri, Alessandro Milic, Jovana Tonelli, Roberto Menozzi, Marianna Franceschini, Erica Cuomo, Gianluca Orlando, Gabriella Borghi, Vanni Santoro, Antonella Di Gaetano, Margherita Puzzolante, Cinzia Carli, Federica Bedini, Andrea Corradi, Luca Fantini, Riccardo Castaniere, Ivana Tabbì, Luca Girardis, Massimo Tedeschi, Sara Giannella, Maddalena Bartoletti, Michele Pascale, Renato Dolci, Giovanni Brugioni, Lucio Pietrangelo, Antonello Cossarizza, Andrea Pea, Federico Clini, Enrico Salvarani, Carlo Massari, Marco Viale, Pier Luigi Mussini, Cristina |
| description | No therapy is approved for COVID-19 pneumonia. The aim of this study was to assess the role of tocilizumab in reducing the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia who received standard of care treatment.
This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centres in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care centre in Modena, Italy, between Feb 21 and April 30, 2020. All patients were treated with the standard of care (ie, supplemental oxygen, hydroxychloroquine, azithromycin, antiretrovirals, and low molecular weight heparin), and a non-randomly selected subset of patients also received tocilizumab. Tocilizumab was given either intravenously at 8 mg/kg bodyweight (up to a maximum of 800 mg) in two infusions, 12 h apart, or subcutaneously at 162 mg administered in two simultaneous doses, one in each thigh (ie, 324 mg in total), when the intravenous formulation was unavailable. The primary endpoint was a composite of invasive mechanical ventilation or death. Treatment groups were compared using Kaplan-Meier curves and Cox regression analysis after adjusting for sex, age, recruiting centre, duration of symptoms, and baseline Sequential Organ Failure Assessment (SOFA) score.
Of 1351 patients admitted, 544 (40%) had severe COVID-19 pneumonia and were included in the study. 57 (16%) of 365 patients in the standard care group needed mechanical ventilation, compared with 33 (18%) of 179 patients treated with tocilizumab (p=0·41; 16 [18%] of 88 patients treated intravenously and 17 [19%] of 91 patients treated subcutaneously). 73 (20%) patients in the standard care group died, compared with 13 (7%; p |
| doi_str_mv | 10.1016/S2665-9913(20)30173-9 |
| format | Article |
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This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centres in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care centre in Modena, Italy, between Feb 21 and April 30, 2020. All patients were treated with the standard of care (ie, supplemental oxygen, hydroxychloroquine, azithromycin, antiretrovirals, and low molecular weight heparin), and a non-randomly selected subset of patients also received tocilizumab. Tocilizumab was given either intravenously at 8 mg/kg bodyweight (up to a maximum of 800 mg) in two infusions, 12 h apart, or subcutaneously at 162 mg administered in two simultaneous doses, one in each thigh (ie, 324 mg in total), when the intravenous formulation was unavailable. The primary endpoint was a composite of invasive mechanical ventilation or death. Treatment groups were compared using Kaplan-Meier curves and Cox regression analysis after adjusting for sex, age, recruiting centre, duration of symptoms, and baseline Sequential Organ Failure Assessment (SOFA) score.
Of 1351 patients admitted, 544 (40%) had severe COVID-19 pneumonia and were included in the study. 57 (16%) of 365 patients in the standard care group needed mechanical ventilation, compared with 33 (18%) of 179 patients treated with tocilizumab (p=0·41; 16 [18%] of 88 patients treated intravenously and 17 [19%] of 91 patients treated subcutaneously). 73 (20%) patients in the standard care group died, compared with 13 (7%; p<0·0001) patients treated with tocilizumab (six [7%] treated intravenously and seven [8%] treated subcutaneously). After adjustment for sex, age, recruiting centre, duration of symptoms, and SOFA score, tocilizumab treatment was associated with a reduced risk of invasive mechanical ventilation or death (adjusted hazard ratio 0·61, 95% CI 0·40–0·92; p=0·020). 24 (13%) of 179 patients treated with tocilizumab were diagnosed with new infections, versus 14 (4%) of 365 patients treated with standard of care alone (p<0·0001).
Treatment with tocilizumab, whether administered intravenously or subcutaneously, might reduce the risk of invasive mechanical ventilation or death in patients with severe COVID-19 pneumonia.
None.</description><identifier>ISSN: 2665-9913</identifier><identifier>EISSN: 2665-9913</identifier><identifier>DOI: 10.1016/S2665-9913(20)30173-9</identifier><identifier>PMID: 32835257</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><ispartof>The Lancet. Rheumatology, 2020-08, Vol.2 (8), p.e474-e484</ispartof><rights>2020 Elsevier Ltd</rights><rights>2020 Elsevier Ltd. All rights reserved.</rights><rights>2020 Elsevier Ltd. All rights reserved. 2020 Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-9e5b71079caec8753d22a8346850e221276c475fe5f3c21aa4df4a9b1beba1c3</citedby><cites>FETCH-LOGICAL-c467t-9e5b71079caec8753d22a8346850e221276c475fe5f3c21aa4df4a9b1beba1c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32835257$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Guaraldi, Giovanni</creatorcontrib><creatorcontrib>Meschiari, Marianna</creatorcontrib><creatorcontrib>Cozzi-Lepri, Alessandro</creatorcontrib><creatorcontrib>Milic, Jovana</creatorcontrib><creatorcontrib>Tonelli, Roberto</creatorcontrib><creatorcontrib>Menozzi, Marianna</creatorcontrib><creatorcontrib>Franceschini, Erica</creatorcontrib><creatorcontrib>Cuomo, Gianluca</creatorcontrib><creatorcontrib>Orlando, Gabriella</creatorcontrib><creatorcontrib>Borghi, Vanni</creatorcontrib><creatorcontrib>Santoro, Antonella</creatorcontrib><creatorcontrib>Di Gaetano, Margherita</creatorcontrib><creatorcontrib>Puzzolante, Cinzia</creatorcontrib><creatorcontrib>Carli, Federica</creatorcontrib><creatorcontrib>Bedini, Andrea</creatorcontrib><creatorcontrib>Corradi, Luca</creatorcontrib><creatorcontrib>Fantini, Riccardo</creatorcontrib><creatorcontrib>Castaniere, Ivana</creatorcontrib><creatorcontrib>Tabbì, Luca</creatorcontrib><creatorcontrib>Girardis, Massimo</creatorcontrib><creatorcontrib>Tedeschi, Sara</creatorcontrib><creatorcontrib>Giannella, Maddalena</creatorcontrib><creatorcontrib>Bartoletti, Michele</creatorcontrib><creatorcontrib>Pascale, Renato</creatorcontrib><creatorcontrib>Dolci, Giovanni</creatorcontrib><creatorcontrib>Brugioni, Lucio</creatorcontrib><creatorcontrib>Pietrangelo, Antonello</creatorcontrib><creatorcontrib>Cossarizza, Andrea</creatorcontrib><creatorcontrib>Pea, Federico</creatorcontrib><creatorcontrib>Clini, Enrico</creatorcontrib><creatorcontrib>Salvarani, Carlo</creatorcontrib><creatorcontrib>Massari, Marco</creatorcontrib><creatorcontrib>Viale, Pier Luigi</creatorcontrib><creatorcontrib>Mussini, Cristina</creatorcontrib><title>Tocilizumab in patients with severe COVID-19: a retrospective cohort study</title><title>The Lancet. Rheumatology</title><addtitle>Lancet Rheumatol</addtitle><description>No therapy is approved for COVID-19 pneumonia. The aim of this study was to assess the role of tocilizumab in reducing the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia who received standard of care treatment.
This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centres in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care centre in Modena, Italy, between Feb 21 and April 30, 2020. All patients were treated with the standard of care (ie, supplemental oxygen, hydroxychloroquine, azithromycin, antiretrovirals, and low molecular weight heparin), and a non-randomly selected subset of patients also received tocilizumab. Tocilizumab was given either intravenously at 8 mg/kg bodyweight (up to a maximum of 800 mg) in two infusions, 12 h apart, or subcutaneously at 162 mg administered in two simultaneous doses, one in each thigh (ie, 324 mg in total), when the intravenous formulation was unavailable. The primary endpoint was a composite of invasive mechanical ventilation or death. Treatment groups were compared using Kaplan-Meier curves and Cox regression analysis after adjusting for sex, age, recruiting centre, duration of symptoms, and baseline Sequential Organ Failure Assessment (SOFA) score.
Of 1351 patients admitted, 544 (40%) had severe COVID-19 pneumonia and were included in the study. 57 (16%) of 365 patients in the standard care group needed mechanical ventilation, compared with 33 (18%) of 179 patients treated with tocilizumab (p=0·41; 16 [18%] of 88 patients treated intravenously and 17 [19%] of 91 patients treated subcutaneously). 73 (20%) patients in the standard care group died, compared with 13 (7%; p<0·0001) patients treated with tocilizumab (six [7%] treated intravenously and seven [8%] treated subcutaneously). After adjustment for sex, age, recruiting centre, duration of symptoms, and SOFA score, tocilizumab treatment was associated with a reduced risk of invasive mechanical ventilation or death (adjusted hazard ratio 0·61, 95% CI 0·40–0·92; p=0·020). 24 (13%) of 179 patients treated with tocilizumab were diagnosed with new infections, versus 14 (4%) of 365 patients treated with standard of care alone (p<0·0001).
Treatment with tocilizumab, whether administered intravenously or subcutaneously, might reduce the risk of invasive mechanical ventilation or death in patients with severe COVID-19 pneumonia.
None.</description><issn>2665-9913</issn><issn>2665-9913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNqFkU9vEzEQxS1ERavSjwDysRwWPP6zjjmAqkBLUaUeiLhaXu8sMdrEwfYGtZ--blOicurFtuw3b8a_R8gbYO-BQfvhB29b1RgD4pSzd4KBFo15QY721y-fnA_JSc6_GWNcAYARr8ih4DOhuNJH5Psi-jCG22nlOhrWdONKwHXJ9G8oS5pxiwnp_Prn5ZcGzEfqaMKSYt6gL2GL1MdlTIXmMvU3r8nB4MaMJ4_7MVmcf13MvzVX1xeX87OrxstWl8ag6jQwbbxDP9NK9Jy7mZDtTDHkHLhuvdRqQDUIz8E52Q_SmQ467Bx4cUw-7Ww3U7fC3tdpkxvtJoWVSzc2umD_f1mHpf0Vt1YLkFK11eD00SDFPxPmYlchexxHt8Y4Zcul0FAXqatU7aS-_jknHPZtgNn7JOxDEvYes-XMPiRhTa17-3TGfdU_7lXweSfACmobMNnsK3ePfUgVre1jeKbFHaG5mPE</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Guaraldi, Giovanni</creator><creator>Meschiari, Marianna</creator><creator>Cozzi-Lepri, Alessandro</creator><creator>Milic, Jovana</creator><creator>Tonelli, Roberto</creator><creator>Menozzi, Marianna</creator><creator>Franceschini, Erica</creator><creator>Cuomo, Gianluca</creator><creator>Orlando, Gabriella</creator><creator>Borghi, Vanni</creator><creator>Santoro, Antonella</creator><creator>Di Gaetano, Margherita</creator><creator>Puzzolante, Cinzia</creator><creator>Carli, Federica</creator><creator>Bedini, Andrea</creator><creator>Corradi, Luca</creator><creator>Fantini, Riccardo</creator><creator>Castaniere, Ivana</creator><creator>Tabbì, Luca</creator><creator>Girardis, Massimo</creator><creator>Tedeschi, Sara</creator><creator>Giannella, Maddalena</creator><creator>Bartoletti, Michele</creator><creator>Pascale, Renato</creator><creator>Dolci, Giovanni</creator><creator>Brugioni, Lucio</creator><creator>Pietrangelo, Antonello</creator><creator>Cossarizza, Andrea</creator><creator>Pea, Federico</creator><creator>Clini, Enrico</creator><creator>Salvarani, Carlo</creator><creator>Massari, Marco</creator><creator>Viale, Pier Luigi</creator><creator>Mussini, Cristina</creator><general>Elsevier Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200801</creationdate><title>Tocilizumab in patients with severe COVID-19: a retrospective cohort study</title><author>Guaraldi, Giovanni ; 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Rheumatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Guaraldi, Giovanni</au><au>Meschiari, Marianna</au><au>Cozzi-Lepri, Alessandro</au><au>Milic, Jovana</au><au>Tonelli, Roberto</au><au>Menozzi, Marianna</au><au>Franceschini, Erica</au><au>Cuomo, Gianluca</au><au>Orlando, Gabriella</au><au>Borghi, Vanni</au><au>Santoro, Antonella</au><au>Di Gaetano, Margherita</au><au>Puzzolante, Cinzia</au><au>Carli, Federica</au><au>Bedini, Andrea</au><au>Corradi, Luca</au><au>Fantini, Riccardo</au><au>Castaniere, Ivana</au><au>Tabbì, Luca</au><au>Girardis, Massimo</au><au>Tedeschi, Sara</au><au>Giannella, Maddalena</au><au>Bartoletti, Michele</au><au>Pascale, Renato</au><au>Dolci, Giovanni</au><au>Brugioni, Lucio</au><au>Pietrangelo, Antonello</au><au>Cossarizza, Andrea</au><au>Pea, Federico</au><au>Clini, Enrico</au><au>Salvarani, Carlo</au><au>Massari, Marco</au><au>Viale, Pier Luigi</au><au>Mussini, Cristina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tocilizumab in patients with severe COVID-19: a retrospective cohort study</atitle><jtitle>The Lancet. Rheumatology</jtitle><addtitle>Lancet Rheumatol</addtitle><date>2020-08-01</date><risdate>2020</risdate><volume>2</volume><issue>8</issue><spage>e474</spage><epage>e484</epage><pages>e474-e484</pages><issn>2665-9913</issn><eissn>2665-9913</eissn><abstract>No therapy is approved for COVID-19 pneumonia. The aim of this study was to assess the role of tocilizumab in reducing the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia who received standard of care treatment.
This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centres in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care centre in Modena, Italy, between Feb 21 and April 30, 2020. All patients were treated with the standard of care (ie, supplemental oxygen, hydroxychloroquine, azithromycin, antiretrovirals, and low molecular weight heparin), and a non-randomly selected subset of patients also received tocilizumab. Tocilizumab was given either intravenously at 8 mg/kg bodyweight (up to a maximum of 800 mg) in two infusions, 12 h apart, or subcutaneously at 162 mg administered in two simultaneous doses, one in each thigh (ie, 324 mg in total), when the intravenous formulation was unavailable. The primary endpoint was a composite of invasive mechanical ventilation or death. Treatment groups were compared using Kaplan-Meier curves and Cox regression analysis after adjusting for sex, age, recruiting centre, duration of symptoms, and baseline Sequential Organ Failure Assessment (SOFA) score.
Of 1351 patients admitted, 544 (40%) had severe COVID-19 pneumonia and were included in the study. 57 (16%) of 365 patients in the standard care group needed mechanical ventilation, compared with 33 (18%) of 179 patients treated with tocilizumab (p=0·41; 16 [18%] of 88 patients treated intravenously and 17 [19%] of 91 patients treated subcutaneously). 73 (20%) patients in the standard care group died, compared with 13 (7%; p<0·0001) patients treated with tocilizumab (six [7%] treated intravenously and seven [8%] treated subcutaneously). After adjustment for sex, age, recruiting centre, duration of symptoms, and SOFA score, tocilizumab treatment was associated with a reduced risk of invasive mechanical ventilation or death (adjusted hazard ratio 0·61, 95% CI 0·40–0·92; p=0·020). 24 (13%) of 179 patients treated with tocilizumab were diagnosed with new infections, versus 14 (4%) of 365 patients treated with standard of care alone (p<0·0001).
Treatment with tocilizumab, whether administered intravenously or subcutaneously, might reduce the risk of invasive mechanical ventilation or death in patients with severe COVID-19 pneumonia.
None.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>32835257</pmid><doi>10.1016/S2665-9913(20)30173-9</doi><oa>free_for_read</oa></addata></record> |
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| source | Alma/SFX Local Collection |
| title | Tocilizumab in patients with severe COVID-19: a retrospective cohort study |
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