The U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib) on June 1, 2018. Produced by a joint venture between Eli Lilly and Company and Incyte Corporation, Olumiant is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) in people who have not had an adequate response to one or more anti-TNF (tumor necrosis factor) therapies.1
Olumiant is a Janus kinase (JAK) inhibitor. JAK is a type of cytokine, or chemical messenger, that is believed to play a role in inflammation. In conditions like RA, the inflammatory response is overactive, and JAK inhibitors can reduce the inflammation and may stop joint damage that can be a long-term consequence of RA. Olumiant should not be used in combination with other JAK inhibitors or with biologic disease-modifying anti-rheumatic drugs (DMARDs).1
The FDA approval is based on data from clinical trials, in which Olumiant showed significant response rates compared to placebo. Olumiant also demonstrated a fast therapy benefit, with some patients experiencing relief in the first week of treatment.1
A new option for hard-to-treat patients
Olumiant offers a new treatment option for those who haven’t gotten relief from currently available therapies for RA, whose disease is referred to as “hard-to-treat.” RA is a varied disease, and not everyone benefits from each medication. There is a great need for a variety of medications to offer people living with RA multiple treatment options. For those who have tried all the existing treatments and not found relief, the approval of Olumiant is encouraging.1
Concerns over safety
Based on the clinical trial data, the FDA advisory committee was concerned about some of the safety data on Olumiant and only approved use of the lower, 2 mg dose. (In phase III clinical trial, both the 2-mg and 4-mg doses were evaluated.) They also limited the approval of Olumiant to treat only those who had tried and failed to see a benefit from TNF inhibitors, and the FDA required a black box warning on the drug — their strictest warning label.2
The lower dose won’t have as much effectiveness as the higher dose, but the lower dose also reduces the risk of side effects, some of which are serious. Lilly president of bio-medicines Christi Shaw said the company will continue to study the higher dose with hopes of providing it to patients in the future. Additional studies are currently underway, and the company intends to keep working with the FDA. Lilly is also planning a randomized clinical trial to assess long-term safety data.2,3
Possible side effects of Olumiant
In clinical trials, several potentially serious side effects were associated with the use of Olumiant, including serious infections, malignancies (lymphoma and other cancers), and blood clots (thrombosis). Serious infections may be viral, bacterial, or fungal, and may require hospitalization. Some infections may lead to death. Blood clots may also be fatal and include deep venous thrombosis (blood clot in a deep vein like the legs), pulmonary embolism (blood clot in the lungs), and arterial thrombosis (blood clot in an artery, which could cause a heart attack or stroke).4
The most common side effects experienced by patients in clinical trials receiving Olumiant were upper respiratory tract infections, nausea, herpes simplex and herpes zoster. Other side effects seen with Olumiant include gastrointestinal perforations and changes in blood work (white blood cell counts, red blood cell counts, blood lipids, and liver enzymes).4
While the exact price of Olumiant hasn’t been announced, the manufacturer Lilly said it will offer the medication at a 60% discount to the price of the leading TNF inhibitor.1
FDA Approves Olumiant (baricitinib) 2-mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis, press release. PR Newswire. Available at https://www.prnewswire.com/news-releases/fda-approves-olumiant-baricitinib-2-mg-tablets-for-the-treatment-of-adults-with-moderately-to-severely-active-rheumatoid-arthritis-300658215.html. Accessed 6/5/18.
Carroll J. UPDATED: FDA quashes blockbuster dreams at Eli Lilly and Incyte, offering a severely limited approval for Olumiant. Endpoints News. Available at https://endpts.com/fda-quashes-blockbuster-dreams-at-eli-lilly-and-incyte-offering-a-severely-limited-approval-for-olumiant/. Accessed 6/5/18.
Sagonowsky E. Saddled with a black box and low dose, Lilly, Incyte RA drug Olumiant faces uphill fight. Fierce Pharma. Available at https://www.fiercepharma.com/pharma/lilly-incyte-arthritis-drug-olumiant-nabs-fda-approval-but-only-at-low-dose. Accessed 6/5/18.
Olumiant prescribing information. Available at http://pi.lilly.com/us/olumiant-uspi.pdf. Accessed 6/5/18.