Baricitinib Gains FDA Approval for Moderate-to-Severe Rheumatoid Arthritis

The FDA on Friday announced the approval of baricitinib (Olumiant), a 2-mg dose, once-daily oral drug for adults with moderately-to-severely active rheumatoid arthritis (RA) who had an inadequate response to 1 or more tumor necrosis factor (TNF) inhibitor therapies.

Baricitinib is indicated for use as a monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Baricitinib is not recommended for use in combination with other Janus kinase (JAK) inhibitors or biologic DMARDs, or with immunosuppressants such as azathioprine and cyclosporine, according to a press release.

“We are pleased to provide RA patients in the US an effective treatment option with Olumiant, as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult to treat RA patients,” Christi Shaw, president, Lilly Bio-Medicines, said in a press release.

The efficacy of baricitinib was shown in the RA-BEACON study, a randomized, double-blind, placebo-controlled trial in which patients were randomized to receive baricitinib 2 mg, baricitinib 4 mg, or placebo, plus conventional DMARDs they were currently using. RA-BEACON included 527 patients who had an inadequate response or were intolerant to 1 or more TNF inhibitors. Patients could also have been previously treated with other biologic DMARDs, according to the release.

At 12 weeks, the researchers found 49% of patients treated with baricitinib achieved ACR20 response rates and improvement in all individual ACR20 component scores compared with 27% of patients in the placebo group, according to the release. Patients in the baricitinib group showed significant improvements in physical function based on the Health Assessment Questionnaire Disability Index with an average score of 1.71 prior to treatment and 1.31 at week 12 compared with patients in the placebo group, who had an average score of 1.78 prior to treatment and 1.59 at week 12.

“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,” Seth Ginsberg, co-founder and president of Creaky Joints and the Global Healthy Living Foundation, said in the press release. “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.”

Baricitinib was approved with a Boxed Warning for the risk of serious infections, malignancies, and thrombosis, Eli Lilly stated. The manufacturer said serious infections that lead to hospitalization or death were reported in some patients administered baricitinib, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, according to the press release. Additionally, lymphoma and other malignancies, and thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis—some fatal—occurred in some patients treated with baricitinib.

The most common adverse events reported in greater than or equal to 1% of patients in placebo-controlled trials of 2 mg- and 4 mg- baricitinib treated patients included upper respiratory tract infections, nausea, herpes simplex, and herpes zoster, according to the release. Lilly plans to launch baricitinib in the United States by the end of the second quarter of 2018 at a cost that is 60% less than the leading TNF inhibitor, according to the release.

“RA patients continue to experience unique challenges accessing the treatments prescribed by their health care providers,” Shaw said. “Therefore, we are determined to continue our work with stakeholders to demonstrate value across the health care system so providers have greater choice in prescribing treatments to fit individual patient needs.”