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June 2, 2021

Lilly’s Olumiant lowers pain in Phase III rheumatoid arthritis trial

According to trial data, Olumiant enhanced overall physical function at 12 weeks as compared to Humira and placebo.

Eli Lilly and Company has reported post-hoc analyses data from the Phase III RA-BEAM study that showed Olumiant 4mg (baricitinib) lowered pain and duration of morning joint stiffness in moderate to severe rheumatoid arthritis (RA) patients.

Discovered by Incyte and licenced to Lilly, Olumiant is an oral Janus kinase (JAK) inhibitor approved and available in 75 countries for treating moderately to severely active RA in adults.

For the post-hoc analysis of RA-BEAM, 1,305 subjects from the Phase III trial were randomised into one of three groups.

Subjects in the first group were given an oral, once-daily 4mg dose of Olumiant, while the other two groups received injectable Humira (adalimumab) 40mg on alternative weeks and placebo, respectively.

All subjects in these three groups were given background methotrexate.

Trial data showed that Olumiant also enhanced overall physical function at 12 weeks compared to adalimumab and placebo.

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The changes in pain relief were not affected by disease activity during treatment, Lilly noted.

Furthermore, subjects receiving Olumiant had higher improvements in fatigue versus placebo, and the improvements were comparable to Humira after 12 weeks.

The drug’s safety data was consistent with an already observed safety profile in RA patients.

Post-hoc analysis lead author and University of Oxford Musculoskeletal Sciences professor Peter Taylor said: “Despite available treatment options, patients with rheumatoid arthritis are still living with daily symptoms, including pain, that continue to limit their day-to-day activities.

“This analysis offers valuable insights to rheumatologists seeking to help their patients reduce disease activity and address the symptoms that are important to patients.”

Lilly noted that the company will present analyses from the prospective Swiss Clinical Quality Management observational cohort, a trial that assessed Olumiant’s effectiveness and persistence versus other biologics for RA treatment.

Last month, Lilly reported that the SURPASS-4 clinical trial of its investigational treatment, tirzepatide, in type 2 diabetes patients with greater cardiovascular risk met all the primary and key secondary endpoints.

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