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Randomized Controlled Trial
. 2024 Nov 4:22:eAO0821.
doi: 10.31744/einstein_journal/2024AO0821. eCollection 2024.

Laboratory profiles of patients hospitalized with COVID-19 pneumonia treated with tofacitinib or placebo: a post hoc analysis from the STOP-COVID trial

Patrícia Oliveira Guimarães  1 , Lucas Petri Damiani  1 , Caio de Assis Moura Tavares  1 , Ari Stiel Radu Halpern  1 , J Jasper Deuring  2 , Luiz Vicente Rizzo  1 , Otavio Berwanger  3   4
Affiliations
Randomized Controlled Trial

Laboratory profiles of patients hospitalized with COVID-19 pneumonia treated with tofacitinib or placebo: a post hoc analysis from the STOP-COVID trial

Patrícia Oliveira Guimarães et al. Einstein (Sao Paulo). .

Abstract

Objective: Tofacitinib, an oral Janus kinase inhibitor, has been tested against a placebo in 289 patients with COVID-19 pneumonia. We analyzed the data from the tofacitinib- and placebo-treated patient cohorts to evaluate the laboratory profiles between baseline and day 7.

Methods: We performed post hoc analyses on the following laboratory tests over time during the first 7 days after randomization: hemoglobin, leukocytes, neutrophils, lymphocytes, platelets, alanine aminotransferase, and aspartate aminotransferase.

Results: Through the first 7 days after randomization, the levels of hemoglobin, white blood cells, neutrophils, and platelet counts were not significantly different between patients treated with tofacitinib or a placebo (all p>0.05). Non-significant differences were observed in aspartate aminotransferase levels over time between treatment groups, whereas alanine aminotransferase levels (U/L) were higher among tofacitinib-treated patients compared to placebo-treated patients (mean ratio, 1.30 [95% confidence interval (95%CI) = 1.14-1.48; p<0.01)].

Conclusion: In patients with COVID-19 pneumonia, the use of tofacitinib compared to placebo did not result in clinically meaningful changes in blood counts or liver enzymes over the first 7 days after randomization.

Registry of clinical trials: NCT04469114.

Plain language summary

In a post hoc analysis of the study of tofacitinib in hospitalized patients with COVID-19 pneumonia (STOP-COVID) trial, Guimaraes et al. evaluated the laboratory safety profile of tofacitinib use during the first 7 days of treatment in patients hospitalized with COVID-19 pneumonia compared with placebo. No clinically meaningful changes were observed in the value of white blood cells, lymphocytes, neutrophils, platelets, hemoglobin, or liver enzymes.

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Conflict of interest statement

Conflict of interest: Otavio Berwanger: reports receiving consultancy fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Novartis Pharma, and Pfizer; J. Jasper Deuring is an employee of and owns stocks and shares in Pfizer, Inc; and Caio de Assis Moura Tavares reports receiving speaker fees from Novo Nordisk outside the submitted work. The other authors declare no conflicts of interest.

Figures

None
Graphical abstract
Figure 1
Figure 1. Daily values from baseline through day 7: A) hemoglobin (mg/dL), B) white blood cell count (103 cells/mm3), C) neutrophils (103 cells/mm3), D) lymphocytes (103 cells/mm3), E) creatinine (mg/dL), and F) platelets (103 cells/mm3). In each panel, the numbers in blue and yellow refer to the number of patients with results available for each day in the Tofacitinib and Placebo Groups, respectively
See this image and copyright information in PMC

References

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