FDA/CDC

FDA approves Olumiant for treatment of rheumatoid arthritis


 

The Food and Drug Administration has approved a 2-mg dose of Olumiant (baricitinib), an orally administered Janus kinase (JAK) inhibitor, to treat adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or poorly to methotrexate, its manufacturer, Eli Lilly, announced June 1. The regulators voted against approval of the 4-mg dose because of concerns about the safety profile.

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Olumiant was approved in large part because of results from the RA-BEACON study, a randomized, double-blind, placebo-controlled trial in which patients were randomly assigned to receive baricitinib at 2 or 4 mg or placebo, in addition to conventional disease-modifying antirheumatic drugs (DMARDs) that they were currently using. Investigators looked at 527 randomized patients who had failed treatment with a biologic DMARD. The study found that, after 12 weeks of Olumiant use, patients had much higher American College of Rheumatology 20 response rates and improvement in ACR20 component scores at week 12 (P less than .0001). In fact, 49% of patients treated with Olumiant responded to treatment, compared with 27% of placebo-treated patients. Patients treated with Olumiant also reported significant improvements on the Health Assessment Questionnaire Disability Index, with the average score of 1.71 at baseline dropping to 1.31 at week 12, compared with a decline from 1.78 with placebo at baseline to 1.59 at week 12.

Olumiant is accompanied by a boxed warning about the risk of serious infections, malignancies, and thrombosis. Patients taking Olumiant also have experienced tuberculosis and opportunistic viral, fungal, and bacterial infections. These infections have led to hospitalization or death.

As part of the approval, Lilly and the original developer of baricitinib, Incyte, have agreed to conduct further randomized and controlled clinical trials to evaluate the long-term safety of Olumiant.

Lilly said in its announcement that it expects to launch Olumiant in the United States by the end of the second quarter of 2018 at a targeted price that is 60% less than “the leading TNF inhibitor.” Additionally, Lilly will offer patient support in the form of a patient support program called Olumiant Together. More information for the program can be obtained by calling 844-OLUMIANT.

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