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Olumiant for the treatment of adults with moderately-to-severely active rheumatoid arthritis. Approved by FDA


The U.S. Food and Drug Administration ( FDA ) has approved the 2-mg dose of Olumiant ( Baricitinib ), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis ( RA ) who have had an inadequate response to one or more tumor necrosis factor ( TNF ) inhibitor therapies.

Use of Olumiant in combination with other Janus kinase ( JAK ) inhibitors or biologic disease-modifying antirheumatic drugs ( bDMARDs ), or with potent immunosuppressants such as Azathioprine and Cyclosporine is not recommended.
Olumiant may be used as monotherapy or in combination with Methotrexate ( MTX ) or other non-biologic DMARDs.

The Olumiant clinical trial Program has included the RA-BEACON study, a randomized, double-blind, placebo-controlled study in which patients were randomly assigned to receive Baricitinib 2 mg, Baricitinib 4 mg or placebo, in addition to conventional DMARDs that they were currently using.
This study has included 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies.
Patients could have had prior therapy with other bDMARDs.

The study results have shown that significantly higher ACR20 response rates and improvement in all individual ACR20 component scores were observed at week 12 with Baricitinib.
The study found that patients treated with Baricitinib had significantly higher rates of ACR20 response versus placebo-treated patients at week 12 ( 49% of Baricitinib-treated patients versus 27% of placebo-treated patients ).
Baricitinib has also demonstrated early symptom relief, with ACR20 responses seen as early as week 1.
Patients treated with Baricitinib reported significant improvements in physical function based on the Health Assessment Questionnaire Disability Index ( HAQ-DI ) ( recording an average score of 1.71 before treatment and 1.31 at week 12 ) compared to placebo-treated patients ( who recorded an average score of 1.78 before treatment and 1.59 at week 12 ).

Olumiant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis.
Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Olumiant.
Lymphoma and other malignancies have been observed in patients treated with Olumiant as well.
Additionally, thrombosis, including deep venous thrombosis, pulmonary embolism and arterial thrombosis, some fatal, have occurred in patients treated with Olumiant.
Other warnings and precautions include gastrointestinal perforations, laboratory abnormalities ( including neutropenia, lymphopenia, anemia, liver enzyme elevations, and lipid elevations ) and a warning against the use of live vaccines with Olumiant.
The most common adverse events ( occurring in greater than or equal to 1% of Olumiant 2 mg- and Olumiant 4 mg-treated patients in placebo-controlled trials ) included upper respiratory tract infections, nausea, herpes simplex and herpes zoster.

Rheumatoid arthritis is a chronic, painful and progressive form of arthritis. It is estimated that about two-thirds of established patients with rheumatoid arthritis will not reach clinical remission with their first TNF inhibitor therapy, and a significant percentage will not maintain efficacy as time goes on. ( Xagena )

Source: Eli Lilly, 2018

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