Long-term treatment with baricitinib – an analysis of the long-term safety and effectiveness

This study investigated the safety and effectiveness of long-term treatment with baricitinib (Olumiant) in rheumatoid arthritis (RA).  

They found that this drug was effective and well tolerated alone or in combination with methotrexate (MTX). 

Rheumatoid arthritis (RA) is a long-term condition caused by inflammation. Disease-modifying anti-rheumatic drugs (DMARDs) are used to lower RA disease activity. Methotrexate (MTX) is a DMARD that is prescribed in the early stages of RA. MTX blocks a number of inflammatory pathways. MTX is very effective at managing RA symptoms. Over time, MTX becomes less effective. At this stage, it can be used in combination with more selective DMARDs.

Baricitinib (BCB) is a drug that blocks enzymes called Janus kinases (JAK). BCB stops JAK1 and JAK2 from activating an inflammatory pathway. This stops the production of chemicals that promote inflammation by activating immune cells. BCB is effective alone or in combination with MTX. It is unclear if BCB is safe and effective in the long-term in patients with RA.

This study included 423 patients with active RA. This study was a long-term extension of another trial. Patients were initially treated with BCB alone, BCB + MTX or MTX alone. In this study, MTX treatment was stopped and patients switched to BCB only. Patients were allowed to restart MTX in combination with BCB if needed. The aim of the trial was to assess the long-term safety and effectiveness.

At 24 weeks, 47% of patients maintained low disease activity on BCB alone. 53% of patients required additional MTX to maintain low disease activity.

50% of patients reported side effects of treatment. They included infections, common cold, and urinary tract infections. The number of side effects that halted treatment was low (1.5-3.5%). 

The authors concluded that BCB was effective in the long-term and well tolerated alone or in combination with MTX.

This trial was funded by sponsored by Eli Lilly and Company and Incyte Corporation, the manufacturer of baricitinib.

If you have any concerns regarding RA please consult with your doctor.