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Baricitinib Shows Higher Efficacy Than Methotrexate in Patients With RA
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First-line baricitinib alone showed higher efficacy and similar safety compared with methotrexate for patients with rheumatoid arthritis, according to a recent phase 3 trial.
“The take-home points are: Baricitinib is as effective as monotherapy as it is in combination with [methotrexate] and that baricitinib monotherapy is more effective than [methotrexate] monotherapy in [methotrexate]-naive [rheumatoid arthritis],” Roy Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center, told Healio Rheumatology.
In patients with rheumatoid arthritis (RA) who had failed methotrexate, baricitinib (Eli Lilly/Incyte) has previously shown to be effective as a second-line therapy. In January, Eli Lilly and Co., along with Incyte Corp. sent a new drug application for baricitinib as an RA treatment to the FDA.
As part of the RA-BEGIN trial, researchers evaluated baricitinib — a Janus kinase inhibitor — in 588 patients, 91% of whom were naive to disease-modifying antirheumatic drugs, such as methotrexate. Patients were randomly assigned 4:3:4 to methotrexate, baricitinib or a combination of methotrexate and baricitinib for 52 weeks. Baricitinib was administered as 4 mg once per day. The primary endpoint was noninferiority of baricitinib to methotrexate, which was determined by an American College of Rheumatology response rate of 20% (ACR20) at week 24.
At week 24, the ACR20 was 77% for patients assigned baricitinib vs. 62% for methotrexate (P < .01). A similar increase occurred for combination therapy. In the baricitinib group, the researchers observed significant improvements in disease activity and physical function as early as week 1. In addition, radiographic progression was reduced in the baricitinib group, but only significantly in the baricitinib and methotrexate group. Rates of serious adverse events were similar between each group, whereas treatment-related infections were increased in the combination therapy group. Three deaths occurred in the methotrexate group, whereas none occurred in the other groups, according to the researchers. Further, one malignancy occurred in the methotrexate group, one occurred in the baricitinib group and four occurred in the combination therapy group.
The researchers concluded that baricitinib had superior efficacy and similar safety. – by Will Offit
Disclosure : The study was funded by Eli Lilly and Co. and Incyte Corp. Fleischmann reports receiving consultant fees from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly and Co., Janssen, Novartis, Roche, Sanofi-Aventis, Pfizer and UCB. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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