Eli Lilly to present baricitinib’s results for juvenile idiopathic arthritis from its Phase III safety and efficacy study at EULAR 2022.

EULAR 2022: A look at Lilly’s Baricitinib Late Breaking (LBA) Abstract presentation

30 May, 2022 | DelveInsight

The EULAR (European Congress of Rheumatology) 2022 will be held virtually and onsite in Copenhagen, offering the first-ever hybrid congress experience. Among the plethora of presentations planned for EULAR 2022, we have chosen something of paramount importance.

Lilly’s Baricitinib Late Breaking (LBA) Abstract

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF blockers.

Lilly will present data from a Phase III efficacy and safety study of baricitinib for JIA treatment. It is a group of diseases characterized by immune-mediated chronic arthritis, which often requires treatment with conventional synthetic or biologic disease-modifying antirheumatic drugs. The main objective of this study was to investigate baricitinib’s efficacy and safety in pediatric patients with JIA and an inadequate response to conventional or biologic-DMARDs.

The Phase III, JUVE-BASIS trial, was carried out at multiple locations and got completed in January this year. This study aimed to evaluate the safety and efficacy of the oral dosage of baricitinib for the treatment of JIA patients, specifically targeting patients in the age group of 2–17.

According to the results presented in the abstract, a significant reduction in time and frequency of JIA flares was observed in patients with JIA compared to placebo. Also, improved JIA-ACR scores in most baricitinib-treated patients within 12 weeks were also seen. The safety profile of baricitinib was consistent with its known safety profile in adult rheumatoid arthritis indications.

A better understanding of the effects of baricitinib can be developed after the EULAR 2022 presentation, where the complete and detailed results for the Phase III trial will be presented.

Conclusion

NICE has already recommended JAK inhibitors for the treatment of JIA patients. At the same time, the US FDA has approved Pfizer’s Xeljanz (tofacitinib) for JIA treatment, making it the only approved JAK inhibitor for JIA patients. Getting the approval for the treatment of JIA patients with baricitinib will pose a competitive challenge to the already approved JAK inhibitor, tofacitinib, in the JIA space. As baricitinib will become the second JAK inhibitor to be recognized in the JIA treatment space with an acceptable safety profile, we expect it to give stiff competition to tofacitinib in the market.

Company

Title

Trial Acronym

Phase

Indication

Abstract number

Date/Time

Eli Lilly

Baricitinib in Juvenile: A Phase III, Double-Blind, Placebo-controlled, Withdrawal, Efficacy and Safety Study

NCT03773978

III

Juvenile Idiopathic Arthritis

LB0002

June 4, 2022

12:20–12:30 PM

For more detailed analysis, visit: Juveline Idiopathic Arthritis market

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