OLUMIANT

What it is

OLUMIANT is a film-coated tablet containing baricitinib 2 mg or 4 mg. This medicinal product is subject to additional monitoring in Australia.

Approved indications —

Moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately, or who are intolerant, to one or more DMARDs. — Moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. — Severe alopecia areata in adult patients in whom other treatments have failed or are not appropriate and no spontaneous improvement is observed.

Dosing overview

For rheumatoid arthritis, a dose of 2 mg once daily may be acceptable for patients with inadequate response to cDMARDs who have moderate disease severity, limited risk of progressive joint damage and moderate impairment of physical function. For atopic dermatitis, a dose of 4 mg once daily may be considered for patients who have not achieved sustained control of disease activity with 2 mg once daily. OLUMIANT is given orally with or without food.

Key safety warnings

OLUMIANT should only be used if no suitable treatment alternatives are available in patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors such as current or past long-time smokers, and in patients 65 years of age and older. Major adverse cardiovascular events (MACE) have been reported in patients receiving OLUMIANT, with a higher rate observed compared to patients treated with TNF inhibitors in a retrospective observational study of baricitinib in RA patients. Serious and sometimes fatal events of thrombosis, including deep vein thrombosis (DVT), arterial thrombosis and pulmonary embolism (PE), have been reported in patients receiving JAK inhibitors, including baricitinib. Venous thromboembolism risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder. Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma, and lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including baricitinib. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. OLUMIANT treatment is associated with an increased rate of infections such as upper respiratory tract infections. Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including OLUMIANT and other JAK inhibitors, with herpes zoster and cellulitis being the most common serious infections reported with OLUMIANT. Patients should be screened for tuberculosis before starting OLUMIANT therapy and should not be given OLUMIANT if they have active TB. Anti-TB therapy should be considered prior to initiation of OLUMIANT in patients with previously untreated latent TB. Cases of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources, with diverticulitis potentially causing gastrointestinal perforation.

Contraindications

OLUMIANT is contraindicated in patients with known hypersensitivity to baricitinib or any of the excipients in the product. OLUMIANT must not be used in combination with bDMARDs.

PBS listing

The 2 mg and 4 mg tablets are each listed on the PBS with 3 items, requiring authority required streamlined approval, at an ex-manufacturer price of A$934.00.

Regulatory history

OLUMIANT baricitinib 2 mg and 4 mg film-coated tablets were first listed on the ARTG on 23 January 2018. The approval date was 19 January 2018 for the indication of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately, or who are intolerant, to one or more DMARDs. PBAC recommended the product in November 2017 for rheumatoid arthritis in patients who had inadequate response or intolerance to at least one conventional synthetic disease-modifying anti-rheumatic drug. In March 2018, PBAC recommended listing on a cost-minimisation basis for severe active rheumatoid arthritis. In July 2021, PBAC did not recommend OLUMIANT for severe atopic dermatitis.