Is baricitinib a safe treatment for rheumatoid arthritis?

This study investigated the safety of baricitinib (Olumiant) for the treatment of rheumatoid arthritis (RA).

They found that baricitinib was well tolerated in patients with moderate-severe RA.

Rheumatoid arthritis (RA) is treated with medications to reduce inflammation. In RA, inflammation causes painful swelling and damage to the joints. This can lead to disability and a poor quality of life. Drugs used to treat RA are called anti-rheumatic disease-modifying drugs (DMARDs). Some patients do not respond well to DMARDs and continue to have active RA. Other patients respond well to DMARDs initially, but this wears off. This is particularly common with biological (b) DMARDs.

New medications are needed to address this. Janus kinase (JAK) inhibitors are a new type of drug to treat RA. These drugs prevent JAK enzymes from causing inflammation. Baricitinib (BCB) is a drug that blocks to JAK enzymes, JAK1 and JAK2. BCB can reduce disease activity in patients with RA. It is unclear if BCB is safe for long-term RA treatment.

This study included 3492 patients with moderate-severe RA. These patients were in 8 different clinical trials investigating BCB. The safety of BCB treatment was assessed over an average of 2 years. The number and nature of adverse events were analyzed.

The rates and nature of adverse events in BCB-treated patients was similar to other RA medications. The most common side effect reported in patients taking BCB was infections. Infections included herpes and tuberculosis. Infection rarely resulted in death in BCB – treated patients. The rate of malignancy (cancer) was similar in BCB and placebo (inactive drug) patients. Lymphoma rates were similar in patients taking BCB and other RA medications. Deep vein thrombosis (a blood clot forming in a deep vein, usually in the leg)/pulmonary embolism (a sudden blockage in a major blood vessel in the lugs) was observed in 5 patients in one clinical trial. 

The authors concluded that baricitinib was well tolerated on the long-term in patients with moderate-severe RA.

Approximately 80% of patients in this study were female. This study compared results from a number of trials with different protocols. This study was funded by Eli Lilly and Co., which manufactures baricitinib.

Baricitinib (Olumiant) was recently approved y the FDA for the treatment of moderately-to-severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.

If you have any concerns regarding RA treatment, please consult with your physician.