Second-line baricitinib associated with improvement for patients with RA in phase 3 trial
Baricitinib as a second-line therapy was associated with symptom relief in patients with rheumatoid arthritis, according to a results of a phase 3 trial.
In this 24-week phase 3 study, researchers assessed 684 patients with rheumatoid arthritis (RA) who previously failed therapy with conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Each day, patients received either placebo, 2 mg of baricitinib or 4 mg of baricitinib. The endpoints were ACR20 response, DAS28 and a Simplified Disease Activity Index (SDAI) score of no greater than 3.3.
Compared with placebo, more patients achieved ACR20 with 4 mg of baricitinib after 12 weeks (62% vs. 39%). There were also statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness. In addition, there was a reduction of radiographic progression of structural joint damage at week 24. Adverse events were the same between the 4-mg baricitinib and placebo groups (5% vs. 5%). Among patients who took baricitinib, one patient developed tuberculosis and another developed non-melanoma skin cancer. In patients who took placebo, two deaths and three major adverse cardiovascular events occurred. Furthermore, baricitinib was associated with a neutrophil decrease and a lipoprotein increase.
“These data suggest baricitinib is an effective disease-modifying agent for treating the signs and symptoms of RA, with 4 mg being the most effective dose,” the researchers wrote. – by Will Offit
Disclosures: Dougados reports he received grant and research support or consulting support from AbbVie, Bristol Myers-Squibb, Eli Lilly and Company, Novartis, Pfizer, Roche, Sanofi and UCB.