The approval is based on phase 3 clinical data that demonstrated efficacy for difficult to treat rheumatoid arthritis.
The FDA has approved the 2-mg dose of baricitinib (Olumiant®), 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, announced Eli Lilly and Company and Incyte Corporation in a press release. Use of baricitinib 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. Baricitinib may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.
The baricitinib clinical trial program 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 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 showed 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 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 with 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 baricitinib 4 mg-treated patients in placebo-controlled trials) included upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
As part of the approval, the companies have agreed to conduct a randomized controlled clinical trial to evaluate the long-term safety of baricitinib in patients with rheumatoid arthritis.
“Despite the advancements we’ve seen in the RA treatment landscape over the past several decades, many patients are still failing to achieve their disease management goals," said Seth Ginsberg, co-founder and president of CreakyJoints and the Global Healthy Living Foundation. “As it’s important for RA patients to have multiple treatment options available to best suit their disease characteristics and experiences, the approval of Olumiant is very encouraging for our community.”
Indications and usage: Olumiant® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of use: Use of Olumiant in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
FDA approves OLUMIANT® (baricitinib) 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis [press release]. Indianapolis, IN: PRNewswire; June 1, 2018.