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Submitted: 01 Sep 2025
Revision: 01 Dec 2025
Accepted: 02 Dec 2025
ePublished: 29 Mar 2026
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Pharm Sci. Inpress.
doi: 10.34172/PS.026.43120
  Abstract View: 85

Original Article

Evaluation of the Effects of Baricitinib in Patients with Acute Respiratory Distress Syndrome: A Pilot, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Mehdi Nurmohammad Ahari ORCID logo, Shadi Ziaie, Ata Mahmoodpoor, Hassan Soleimanpour, Hamed Valizadeh, Fariba Pourkarim, Saman Chaparzadeh, Hadi Hamishehkar* ORCID logo
*Corresponding Author: Email: [email protected]

Abstract

Background: Despite advances in supportive care, acute respiratory distress syndrome (ARDS) remains a major cause of mortality and morbidity in critically ill patients. The lack of effective pharmacological treatments underscores the necessity for novel, evidence-based therapies. Investigating baricitinib’s potential to improve outcomes could address unmet needs and transform management strategies in this serious condition.

Material and methods: This double-blind, placebo-controlled clinical trial enrolled 20 patients with ARDS at Imam Reza Hospital, Tabriz. Participants were randomly assigned to two groups and received either baricitinib or a placebo. All patients received standard supportive care throughout hospitalization. Demographic and clinical data were collected from medical records and bedside interviews. Outcomes were assessed over 28 and 60 days, with both clinical and laboratory markers.

Results: Intervention group showed a greater improvement in the arterial oxygenation (PaO₂/FiO₂ ratio) versus the placebo group but there was no significant difference between the two groups from the baseline through day 14 (P=0.37). Significant difference was observed in the reduced need for advanced respiratory support (P<0.05) for the intervention group compared to the placebo group. Although hospital stay was longer (P<0.05), intensive care unit (ICU) mortality was lower in the intervention group (P<0.05). Kaplan-Meier analysis revealed a higher survival probability with baricitinib, with mortality rates of 30% for baricitinib versus 50% in the control group.

Conclusion: The findings of this study demonstrate that baricitinib administration in patients with ARDS led to improvements in oxygenation, reduced need for advanced respiratory support, and lower ICU mortality compared to the control group, despite a longer hospital stay.


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