Olumiant by Eli Lilly and Company

NOVEMBER 15, 2018
Monica Holmberg, PharmD, BCPS
The FDA has approved Olumiant (baricitinib; Eli Lilly and Company) to treat moderately to severely active rheumatoid arthritis.
The medication is indicated for adult patients who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonist therapies. The approval carries the limitation that the use of Olumiant in combination with biologic disease-modifying antirheumatic drugs (DMARDs), other Janus kinase (JAK) inhibitors, or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.1,2

Pharmacology and Pharmacokinetics
Olumiant is a JAK inhibitor. It reaches peak plasma concentrations about 1 hour after oral administration. Steady-state concentrations are obtained after 2 to 3 days of dosing. Olumiant is cleared renally and displays an elimination half-life of about 12 hours.1

Dose and Administration
Although other doses have been studied, the recommended dose of Olumiant is 2 mg orally once daily. It may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs. Olumiant should not be used in patients with an absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count <1000 cells/mm3, or a hemoglobin level <8 g/dL. Patients should be tested for tuberculosis before beginning treatment with Olumiant and, if positive, treated for tuberculosis before Olumiant therapy begins. Patients with active tuberculosis should not receive Olumiant. It may be taken without regard to food.1

Clinical Trials
The evaluation of Olumiant for efficacy and safety included the RA-BEACON study. This double-blind, placebo-controlled, randomized study consisted of 527 patients who had an inadequate response or an intolerance to 1 or more TNF inhibitor therapies. In addition to preexisting treatment with conventional DMARDs, study participants received 4 mg of baricitinib, 2 mg of Olumiant, or a placebo. The results of the study found the Olumiant group to have significantly higher response rates and improvement at week 12 than the placebo group. The Olumiant group also demonstrated earlier symptom relief than the placebo group, with some patients reporting relief as early as the first week and significant improvements in physical function compared with the placebo group.1,2

Contraindications, Warnings, and Precautions
Olumiant carries a boxed warning regarding the risk of malignancy, serious infections, and thrombosis. Lymphoma and other malignancies have occurred in patients using Olumiant. Patients using Olumiant are at risk for developing serious infections that may lead to hospitalization or death. If a serious infection occurs, treatment with Olumiant should be stopped until the infection is controlled. Reported infections include active tuberculosis, invasive fungal infections, and opportunistic pathogens. Arterial thrombosis, deep venous thrombosis, and pulmonary embolism have occurred in patients using Olumiant, and many of the conditions were serious, and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

The use of Olumiant should be avoided in patients with an active, serious infection, including localized infections. It should be used cautiously in patients at risk for gastrointestinal perforations or thrombosis. Laboratory monitoring is recommended during treatment with the medication because of potential changes in hemoglobin, lipids, liver enzymes, lymphocytes, and neutrophils. Patients using Olumiant should not receive live vaccines. Olumiant should not be used in patients taking strong organic anion transporter 3 inhibitors such as probenecid. Its use should be avoided in patients with severe hepatic impairment or moderate or severe renal impairment.

The most common adverse reactions (incidence ≥1%) include herpes simplex, herpes zoster, nausea, and upper respiratory tract infections.1
 
Monica Holmberg, PharmD, BCPS, earned her PharmD at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.

References
  1. Olumiant [prescribing information]. Indianapolis, IN: Lilly USA LLC; 2018. pi.lilly.com/us/olumiant-uspi. Accessed August 31, 2018.
  2. FDA approves Olumiant (baricitinib) 2-mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis [news release]. Indianapolis, IN: Eli Lilly and Co; June 1, 2018. . Accessed August 31, 2018.



 

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