Animal study of the cardiovascular effects of tofacitinib: Hemodynamic, biochemical, vascular, and mortality outcomes

Q: What is the clinical evidence from this study?

Population: Healthy (preclinical cardiovascular safety) (n=40). Intervention: Tofacitinib vs. Distilled water. Primary outcome: Diastolic blood pressure at day 28 (high dose) (p=0.002).

Q: What does this research mean for the field?

Tofacitinib induces dose-dependent reductions in systolic and diastolic blood pressure over 28 days in mice, accompanied by increased isolated basilar artery tone and reduced serum creatine kinase. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

A Rangelov; Iva Parvova; E. Hristov; Георги Момеков; Boris Kadinov; Lyubomir Marinov

doi:10.3897/pharmacia.73.e206503

September 15, 2026PharmaciaOpen Access

Animal study of the cardiovascular effects of tofacitinib: Hemodynamic, biochemical, vascular, and mortality outcomes

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Key result

Tofacitinib dose-dependently lowers systolic and diastolic BP versus control.

P=0.002
n=40

Why the study?

Does tofacitinib affect cardiovascular hemodynamics, biomarkers, vascular tone, and mortality in a preclinical rodent model?

Key Points

To evaluate the preclinical cardiovascular, hemodynamic, biochemical, vascular, and mortality effects of 28-day tofacitinib treatment across three doses in a mouse model.
Administered three different doses of tofacitinib or control vehicle to mice over a 28-day period.
Evaluated body weight, systolic and diastolic blood pressure, heart rate, serum CPK, CPK-MB, and cardiac troponin I (cTnI).
Assessed ex vivo vascular tone in isolated rat basilar artery rings precontracted with 20 mM KCl-PSS and 100 µM serotonin exposed to increasing tofacitinib concentrations (10−10 to 10−7 mol/L).
On day 28, tofacitinib significantly reduced systolic blood pressure at the high dose (p = 0.036) and diastolic blood pressure across all doses (low dose, p = 0.003; medium dose, p = 0.013; high dose, p = 0.002).
Control mice gained weight from 33.00 g to 35.13 g (p = 0.02), whereas weight loss occurred in all tofacitinib groups, reaching statistical significance in the low-dose group (p = 0.028).
Cumulative mortality was 10% in the low-dose group (1 death on day 28), 20% in the medium-dose group (1 death on day 14, 1 on day 28), and 0% in the control and high-dose groups, with negative cTnI results in all animals.

Structured PICO

Does tofacitinib affect cardiovascular hemodynamics, biomarkers, vascular tone, and mortality in a preclinical rodent model?

P

Population

40 male mice and additional male rats were used to evaluate the preclinical cardiovascular effects of tofacitinib over 28 days.

I

Intervention

Tofacitinib administered once daily via oral gavage for 28 days at three different doses: low (2.04 mg/kg), medium (4.07 mg/kg), and high (8.14 mg/kg).

C

Comparator

Control group administered the same volume of distilled water via oral gavage.

O

Outcome

Hemodynamic (systolic and diastolic blood pressure, heart rate), biochemical (CPK, CPK-MB, cTnI), vascular (basilar artery tone), and mortality outcomes over 28 days.surrogate

Main Result

p-value: p=0.002

Tofacitinib produced measurable cardiovascular and systemic effects in a rodent model, including dose-dependent blood pressure reductions and increased vascular tone, highlighting the need for further mechanistic studies on its cardiovascular safety.

Limitations

Relatively small number of animals
Translation of nonclinical results to human safety predictions is uncertain
relatively small number of animals presents a limitation in interpreting these findings

Implication

Preclinical hemodynamic signals with tofacitinib merit no practice change; leaves open human safety translation and mechanistic studies.

Abstract

Tofacitinib has raised cardiovascular safety concerns despite its proven therapeutic value in inflammatory diseases. This study evaluated its preclinical cardiovascular effects in a mouse model after 28 days of treatment with three different doses. Tofacitinib induced dose-dependent reductions in systolic and diastolic blood pressure, with significant effects evident by day 14 and more pronounced by day 28. Heart rate showed only minor, non-significant fluctuations, while serum creatine kinase and creatine kinase-MB decreased. Body weight gain was inhibited in treated animals, and mortality occurred only in the low- and medium-dose groups. The cardiac troponin I assay showed negative results in the control and tofacitinib-treated groups, and an increase in isolated rat basilar artery tone was induced by tofacitinib. Overall, tofacitinib produced measurable cardiovascular and systemic effects, supporting the need for further mechanistic studies and careful cardiovascular risk assessment.

Discussion

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Cite This Study

Rangelov et al. (2026) studied Healthy (preclinical cardiovascular safety) (n=40). Tofacitinib vs. Distilled water was evaluated on Diastolic blood pressure at day 28 (high dose) (p=0.002). Tofacitinib induced dose-dependent reductions in systolic and diastolic blood pressure over 28 days, with significant decreases in diastolic pressure across all doses compared to control.

synapsesocial.com/papers/6aabb7975f706d05830e6b16 https://doi.org/10.3897/pharmacia.73.e206503

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Animal study of the cardiovascular effects of tofacitinib: Hemodynamic, biochemical, vascular, and mortality outcomes

Key Points

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Animal study of the cardiovascular effects of tofacitinib: Hemodynamic, biochemical, vascular, and mortality outcomes

Key Points

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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