BEAM Study: Baricitinib Beats Placebo and Adalimumab in Rheumatoid Arthritis Save

Baricitinib is a novel inhibitor of Janus kinases JAK1 and JAK2 that has been extensively studied in rheumatoid arthritis (RA).  Baricitinib (AKA Oluminant) was recently approved by the EMA for use in Europe at a once daily dose of 4 mg per day.  Regulatory approval in the USA is pending with the FDA.

Mutiple trials have been done in RA subsets defined by their prior drug exposure including those who are DMARD/MTX naive, those who have failed either MTX or DMARDs and those with an inadequate response to TNF inhibitiors (TNFi).

The NEJM has published the results of one of those subsets in the BEAM trial, a 52-week, double-blind, placebo- and active-controlled trial wherein 1307 active RA patients with an inadequte response to methotrexate (MTX) were randomized (3:3:2) to either placebo (PBO) baricitinib 4 mg qd or adalimumab 40 mg every other week. The primary end-point was the ACR20 response

At week 12, ACR20/50/70 responses where significantly higher in BAR  than PBO or ADA. All major secondary objectives were met, including inhibition of radiographic progression of joint damage, according to the modified total Sharp scores at week 24 (mean change from baseline, PBO 0.41 vs. BAR 0.90; P<0.001).

There were no significant differences with serious infectious events, tuberculosis, or deaths. Baricitinib was associated with reductions in neutrophil counts and increases in levels of creatinine and low-density lipoprotein cholesterol.

These trial results will be integral in the FDA regulatory decisions regarding baricitinb.  But for those RA patients with an inadequate response to MTX, baricitinib is an effective treatment option.