Tocilizumab in Severe COVID-19: A Quasi-Randomized Study in a Real-World Setting
25 Pages Posted: 3 Oct 2022
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).
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