Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19
MD, MPH Shruti Gupta, PhD Wei Wang, MD Salim S Hayek, MD Lili Chan, MSCR Kusum S Mathews, MD, MPH, MSCR Michal L Melamed, MD, MHS Samantha K Brenner, MD, MPH Amanda Leonberg-Yoo, MS Edward J Schenck, MD, MS Jared Radbel, MD Jochen Reiser, PhD Anip Bansal, MD Anand Srivastava, MD, MPH Yan Zhou, MD Diana Finkel, DO Adam Green, MD, MBA Mary Mallappallil, MD Anthony J Faugno, MD Jingjing Zhang, Juan Carlos Q Velez, MD, MPH Shahzad Shaefi, MD Chirag R Parikh, PhD; David M Charytan, MD, MSc Ambarish M Athavale, MD Allon N Friedman, MD Roberta E Redfern, PhD Samuel A P Short, BA Simon Correa, MD, MMSc Kapil K Pokharel, MBBS Andrew J Admon, MD, MPH, MSc; John P Donnelly, PhD Hayley B Gershengorn, MD David J Douin, MD Matthew W Semler, MD Miguel A Hernán, MD, DrPH David E Leaf, Carl P Walther, Samaya J Anumudu, Justin Arunthamakun, Kathleen F Kopecky, Gregory P Milligan, Peter A Mccullough, Thuy-Duyen Nguyen, MD, MPH Shahzad Shaefi, Megan L Krajewski, Sidharth Shankar, Ameeka Pannu, Juan D Valencia, Sushrut S Waikar, Zoe A Kibbelaar, MD, MSc Ambarish M Athavale, Peter Hart, Shristi Upadhyay, Ishaan Vohra, Ajiboye Oyintayo, DO Adam Green, Jean-Sebastien Rachoin, Christa A Schorr, Lisa Shea, Daniel L Edmonston, Christopher L Mosher, Alexandre M Shehata, Zaza Cohen, Valerie Allusson, Gabriela Bambrick-Santoyo, Noor Ul Aain Bhatti, Bijal Mehta, Aquino Williams, MD, MHS Samantha K Brenner, Patricia Walters, Ronaldo C Go, Keith M Rose, MD Miguel A Hernán, Rebecca Lisk, Amy M Zhou, Ethan C Kim, MD Lili Chan, MSCR Kusum S Mathews, Steven G Coca, Deena R Altman, Aparna Saha, Howard Soh, Huei Hsun Wen, Sonali Bose, Emily A Leven, Jing G Wang, Gohar Mosoyan, Girish N Nadkarni, Pattharawin Pattharanitima, Emily J Gallagher, MD Allon N Friedman, John Guirguis, Rajat Kapoor, Christopher Meshberger, Katherine J Kelly, MD Chirag R Parikh, Brian T Garibaldi, Celia P Corona-Villalobos, Yumeng Wen, Steven Menez, Rubab F Malik, Carmen Elena Cervantes, Samir C Gautam, MD, MBA Mary C Mallappallil, Jie Ouyang, Sabu John, Ernie Yap, Yohannes Melaku, Ibrahim Mohamed, Siddhartha Bajracharya, Isha Puri, Mariah Thaxton, Jyotsna Bhattacharya, John Wagner, Leon Boudourakis, H Bryant Nguyen, Afshin Ahoubim, Kianoush Kashani, Shahrzad Tehranian, Leslie F Thomas, Dheeraj Reddy Sirganagari, Pramod K Guru, MD, MPH Yan Zhou, Paul A Bergl, Jesus Rodriguez, Jatan A Shah, Mrigank S Gupta, Princy N Kumar, Deepa G Lazarous, Seble G Kassaye, MD, MPH, MSCR Michal L Melamed, Tanya S Johns, Ryan Mocerino, Kalyan Prudhvi, Denzel Zhu, Rebecca V Levy, Yorg Azzi, Molly Fisher, Milagros Yunes, Kaltrina Sedaliu, Ladan Golestaneh, Maureen Brogan, Neelja Kumar, Michael Chang, Jyotsana Thakkar, Ritesh Raichoudhury, Akshay Athreya, Mohamed Farag, MS Edward J Schenck, Soo Jung Cho, Maria Plataki, Sergio L Alvarez-Mulett, Luis G Gomez-Escobar, Di Pan, Stefi Lee, Jamuna Krishnan, William Whalen, PhD; David M Charytan, Ashley Macina, Sobaata Chaudhry, Benjamin Wu, Frank Modersitzki, MD Anand Srivastava, Alexander S Leidner, Carlos Martinez, Jacqueline M Kruser, Richard G Wunderink, Alexander J Hodakowski, Juan Carlos Q Velez, Eboni G Price-Haywood, Luis A Matute-Trochez, Anna E Hasty, Muner Mb. Mohamed, Rupali S Avasare, David Zonies, MD, DrPH David E Leaf, MD, MPH Shruti Gupta, Meghan E Sise, Erik T Newman, Samah Abu Omar, MD, MMSc Kapil K Pokharel, Shreyak Sharma, Harkarandeep Singh, BA Simon Correa, Tanveer Shaukat, Omer Kamal, PhD Wei Wang, Heather Yang, Jeffery O Boateng, Meghan Lee, Ian A Strohbehn, Jiahua Li, Ariel L Mueller, MD Roberta E Redfern, Nicholas S Cairl, Gabriel Naimy, Abeer Abu-Saif, Danyell Hall, Laura Bickley, Chris Rowan, Farah Madhani-Lovely, Vasil Peev, MD Jochen Reiser, John J Byun, Andrew Vissing, Esha M Kapania, Zoe Post, Nilam P Patel, Joy-Marie Hermes, Anne K Sutherland, Amee Patrawalla, MD Diana G Finkel, Barbara A Danek, Sowminya Arikapudi, Jeffrey M Paer, Peter Cangialosi, Mark Liotta, MD, MS Jared Radbel, Sonika Puri, Jag Sunderram, Matthew T Scharf, Ayesha Ahmed, Ilya Berim, Jayanth S Vatson, Shuchi Anand, Joseph E Levitt, Pablo Garcia, Suzanne M Boyle, Rui Song, Ali Arif, MD Jingjing Zhang, Sang Hoon Woo, Xiaoying Deng, Goni Katz-Greenberg, Katharine Senter, Moh’d A Sharshir, Vadym V Rusnak, Muhammad Imran Ali, Terri Peters, Kathy Hughes, PhD Anip Bansal, Amber S Podoll, Michel Chonchol, Sunita Sharma, Ellen L Burnham, MD David J Douin, Arash Rashidi, Rana Hejal, Eric Judd, Laura Latta
JAMA Internal Medicine, doi:10.1001/jamainternmed.2020.6252
IMPORTANCE Therapies that improve survival in critically ill patients with coronavirus disease 2019 (COVID-19) are needed. Tocilizumab, a monoclonal antibody against the interleukin 6 receptor, may counteract the inflammatory cytokine release syndrome in patients with severe COVID-19 illness. OBJECTIVE To test whether tocilizumab decreases mortality in this population.
DESIGN, SETTING, AND PARTICIPANTS The data for this study were derived from a multicenter cohort study of 4485 adults with COVID-19 admitted to participating intensive care units (ICUs) at 68 hospitals across the US from March 4 to May 10, 2020. Critically ill adults with COVID-19 were categorized according to whether they received or did not receive tocilizumab in the first 2 days of admission to the ICU. Data were collected retrospectively until June 12, 2020. A Cox regression model with inverse probability weighting was used to adjust for confounding. EXPOSURES Treatment with tocilizumab in the first 2 days of ICU admission. MAIN OUTCOMES AND MEASURES Time to death, compared via hazard ratios (HRs), and 30-day mortality, compared via risk differences. RESULTS Among the 3924 patients included in the analysis (2464 male [62.8%]; median age, 62 [interquartile range {IQR}, 52-71] years), 433 (11.0%) received tocilizumab in the first 2 days of ICU admission. Patients treated with tocilizumab were younger (median age, 58 [IQR, 48-65] vs 63 [IQR, 52-72] years) and had a higher prevalence of hypoxemia on ICU admission (205 of 433 [47.3%] vs 1322 of 3491 [37.9%] with mechanical ventilation and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of <200 mm Hg) than patients not treated with tocilizumab. After applying inverse probability weighting, baseline and severity-of-illness characteristics were well balanced between groups. A total of 1544 patients (39.3%) died, including 125 (28.9%) treated with tocilizumab and 1419 (40.6%) not treated with tocilizumab. In the primary analysis, during a median follow-up of 27 (IQR, 14-37) days, patients treated with tocilizumab had a lower risk of death compared with those not treated with tocilizumab (HR, 0.71; 95% CI, 0.56-0.92). The estimated 30-day mortality was 27.5% (95% CI, 21.2%-33.8%) in the tocilizumab-treated patients and 37.1% (95% CI, 35.5%-38.7%) in the non-tocilizumab-treated patients (risk difference, 9.6%; 95% CI, 3.1%-16.0%). CONCLUSIONS AND RELEVANCE Among critically ill patients with COVID-19 in this cohort study, the risk of in-hospital mortality in this study was lower in patients treated with tocilizumab in the first 2 days of ICU admission compared with patients whose treatment did not include early use of tocilizumab. However, the findings may be susceptible to unmeasured confounding, and further research from randomized clinical trials is needed.
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