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Compared With Adalimumab, Baricitinib Demonstrated Better Efficacy for RA
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In patients with rheumatoid arthritis who had an inadequate response to methotrexate, the oral Janus kinase inhibitor baricitinib demonstrated better efficacy through 52 weeks compared with adalimumab, according to recently published data.
“This is an exciting time for rheumatology, with potential new treatments for rheumatoid arthritis on the horizon,” Peter C. Taylor, MD, PhD, Norman Collisson Chair of Musculoskeletal Sciences in the Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, said in a press release. “The RA-BEAM study of baricitinib is the first phase 3 trial showing that a once-daily, oral treatment significantly improved clinical outcomes compared with a current standard of care, injectable adalimumab used with background methotrexate therapy.”
As a part of the RA-BEAM study, Taylor and colleagues conducted a 52-week, phase 3, double-blind placebo- and active-controlled trial of 1,307 patients with active rheumatoid arthritis who had an inadequate response to methotrexate. In a 3:3:2 ratio, patients received either placebo with a switch to baricitinib after 24 weeks; 4 mg of baricitinib once per day; or 40 mg of adalimumab every other week. At week 12, researchers measured ACR20 response as the primary endpoint and DAS28, the health assessment questionnaire-disability index and the Simplified disease activity index as secondary endpoints. At week 24, they also measured modified total Sharp score (mTSS) as a secondary endpoint.
After 12 weeks, researchers found more patients in the baricitinib group had an ACR20 response compared with the placebo group (70% vs. 40%). All secondary endpoints showed improved response compared with placebo, which included mTSS at week 24. In addition, a higher portion of patients in the baricitinib group met ACR20 vs. the adalimumab group (70% vs. 61%). After 52 weeks, a higher proportion of the baricitinib group achieved ACR50 and ACR70 compared with the adalimumab group from week 8 through week 52. At week 52, the baricitinib group had higher ACR50 and ACR70 response rates, although only ACR50 was significant, according to the release.
Adverse events — which included infections — were more common through 24 weeks with baricitinib and adalimumab compared with placebo. Therapy cessation through 24 weeks was 3% for placebo, 5% for baricitinib and 2% for adalimumab. Through 52 weeks, serious adverse events occurred in 8% of the baricitinib group and in 4% of the adalimumab group. Therapy cessation due to adverse events through 52 weeks was 7% for baricitinib and 4% for adalimumab.
Fewer than 1% of patients reported major adverse cardiovascular events for both baricitinib and adalimumab. Five patient deaths were reported, with two for baricitinib; one for placebo rescued to baricitinib; one for adalimumab; and one for placebo. Five patients reported cancer, with two patients in the baricitinib group and three in the placebo group. In addition, baricitinib was associated with a reduction in neutrophil count and increased creatinine and low-density lipoprotein cholesterol levels.
“These data demonstrate that baricitinib could provide another treatment option for people with rheumatoid arthritis,” Taylor said. – by Will Offit
Disclosures: Taylor reports personal fees from Eli Lilly and Company during the conduct of the study as well as grant support from Celgene and Galapagos, grant support and personal fees from UCB Pharma, and personal fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer and Takeda outside the submitted work. Please see the full study for a list of all other relevant financial disclosures.
References:
https://investor.lilly.com/releasedetail.cfm?ReleaseID=1012101
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