Tocilizumab in Severe COVID-19: A Quasi-Randomized Study in a Real-World Setting

25 Pages Posted: 3 Oct 2022

See all articles by Leanna Wise

Leanna Wise

University of Southern California - Keck School of Medicine

Lauren Mathias

University of Southern California - Keck School of Medicine

Aarya Kafi

University of California, San Diego (UCSD)

Wendy J. Mack

University of Southern California - Department of Population and Public Health Sciences

Omkar Rao

University of California, San Diego (UCSD)

Yash Kothari

University of Southern California - Keck School of Medicine

William Stohl

University of Southern California - Keck School of Medicine

Abstract

Objective: Tocilizumab (TCZ) is a rheumatology-based medication which, based on mixed results from randomized clinical trials, is approved for the treatment of severe COVID-19. Due to widespread use of TCZ in COVID-19, rheumatic disease patients, who require TCZ for long-term control of their underlying disease, have been confronted with shortages of TCZ. Accordingly, we evaluated TCZ on COVID-19 outcomes in a unique quasi-randomized, “real-world” setting.

Methods: Retrospective matched cohort study; March 1 – August 31 2020; February 20 – April 20 2021. Adults with severe COVID-19 admitted to hospital A (at which TCZ was available) were matched on COVID-19 surge number, sex, age, and BMI with adults with severe COVID-19 admitted to hospital B (at which TCZ was not available). Patients were followed from admission to hospital discharge or death. The exposure was administration of intravenous TCZ. Primary outcome was clinical improvement or discharge at 28. Secondary endpoints were clinical improvement or discharge at day 14, survival at days 14 and 28, and overall survival.

Results: There were no differences in clinical improvement at days 14 and 28 or in survival at days 14 and 28 between the two cohorts (TCZ n = 40; non-TCZ n = 133).

Conclusion: In our quasi-randomized 'real-world' experience, there was no apparent overall clinical benefit to the addition of TCZ in severe COVID-19. Given that TCZ use for COVID-19 has resulted in shortages for rheumatic disease patients, discretion is warranted with TCZ use to ensure that rheumatic disease patient care is not compromised.

Note:
Funding Information: This work was supported in part by the Thomas D Beardmore, MD, Memorial Endowment and by a gift from Sandra Kanengiser in memory of her uncle, Jack Norberg, and in honor of Dr. Orrin Troum. Biostatistical support was funded by grants UL1TR001855 and UL1TR000130 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health.

Declaration of Interests: The authors declare no conflict of interest for this manuscript.

Ethics Approval Statement: Institutional review board approval was obtained for this study (HS-20-00391).

Suggested Citation

Wise, Leanna and Mathias, Lauren and Kafi, Aarya and Mack, Wendy J. and Rao, Omkar and Kothari, Yash and Stohl, William, Tocilizumab in Severe COVID-19: A Quasi-Randomized Study in a Real-World Setting. Available at SSRN: https://ssrn.com/abstract=4217428 or http://dx.doi.org/10.2139/ssrn.4217428

Leanna Wise (Contact Author)

University of Southern California - Keck School of Medicine ( email )

Lauren Mathias

University of Southern California - Keck School of Medicine ( email )

Aarya Kafi

University of California, San Diego (UCSD) ( email )

9500 Gilman Drive
La Jolla, CA 92093
United States

Wendy J. Mack

University of Southern California - Department of Population and Public Health Sciences ( email )

Omkar Rao

University of California, San Diego (UCSD) ( email )

9500 Gilman Drive
La Jolla, CA 92093
United States

Yash Kothari

University of Southern California - Keck School of Medicine ( email )

William Stohl

University of Southern California - Keck School of Medicine ( email )

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