Impact of 5-year baricitinib treatment for active, rheumatoid arthritis in preventing radiographic progression of joint damage.

This study evaluated the effect of oral baricitinib (Olumiant) on the prevention of radiographic progression of joint damage over 5 years in patients with active rheumatoid arthritis (RA). The data showed that patients treated with oral baricitinib had less radiographic progression over 5 years, compared to those initially given a conventional synthetic disease-modifying antirheumatic drug (csDMARD) and placebo or methotrexate (MTX; Otrexup) alone.

RA is a chronic inflammatory disease that results in joint inflammation, swelling, and pain. Progressive joint damage seen on radiographs (X-rays) is associated with persistent joint inflammation. csDMARDs like MTX and biological DMARDs (bDMARDS) such as adalimumab (ADA; Humira) can reduce joint pain and swelling. Although they can provide protection against progressive structural damage, progression may still occur for some patients.

Baricitinib is a bDMARD that has shown to provide clinical and functional benefits to patients in previous studies, including low rates of radiographic progression. However, it remains unclear whether oral baricitinib is capable of sustained inhibition of radiographic progression in the long-term.

This study included 1837 patients with active RA. All patients received baricitinib 2mg or 4mg once daily. Before receiving baricitinib, 504 patients received a placebo. 779 patients received baricitinib as their first-line therapy. 132 patients previously received MTX alone and 148 received MTX + baricitinib, while 254 patients received ADA before baricitinib treatment. Patients were followed up with X-rays at 2, 3, 4, and 5 years of treatment. 

Patients initially on baricitinib, with or without MTX, had less progression after 2 to 5 years compared to those initially on MTX alone. A higher proportion of patients initially treated with baricitinib alone or combined with MTX had no progression at years 3 to 5 compared to those initially treated with MTX alone.

Compared to placebo, a higher proportion of patients initially on baricitinib plus ADA, with an inadequate response to MTX had no progression of disease.

The study showed that the use of oral baricitinib in patients with active RA had sustained, lower levels of radiographic progression, compared to initial csDMARD or placebo over 5 years.

The study did not include a true placebo and the use of background medication was not considered. The data analyzed came from different studies, with different protocols. The studies analyzed were funded by Eli Lilly and Company, the manufacturer of baricitinib.