Past Coverage of EULAR 2015Past Coverage of EULAR 2015 Return To RheumReports Home

 

Baricitinib in RA - Phase 3 Results are Encouraging!

Dr. Andy Thompson  Featured
June 12 2015 4:00 AM ET via RheumReports RheumReports

Baricitinib, Oral Janus Kinase Inhibitor in Patients with Active RA who have an Inadequate Response to TNF Inhibitors.

Baricitinib is an oral reversible inhibitor of JAK 1 and 2. Marc Genovese presented a trial designed to assess the safety and efficacy of baricitinib in patients who were failing DMARDs and had tried other DMARDs and TNF-inhibitors.

Patients were randomized to baricitinib 2 mg QD, 4 mg QD or placebo with a primary outcome measure of the ACR 20 at week 12. Patients were mostly females (80%), average age of 55, 75% were ACPA- or RF-positive and patients had about 18 swollen joints. The patients were allowed to receive non-biologic DMARDs throughout the study.

The study met its primary endpoint with an ACR 20 of 55% at week 12 and 46% at week 24. The most interesting thing was that the ACR 20 at week 12 was 64% if a patient had failed a single TNF inhibitor and 53% if a patient had failed 3 biologic DMARDs. Even more interesting, the delta versus placebo for those who failed a single biologic was 32% and 40% if a patient had failed 3 biologics. There was a dose-dependent improvement in both DAS and CDAI.

A higher rate of serious adverse events was seen in the 4 mg dose group. There was no increase in serious infections, however, there was an increase in Zoster that was dose-related. 

In conclusion, baricitinib appears to be an effective therapy with the benefits beginning as early as 1 week after treatment initiation. Significant improvements in signs and symptoms were sustained through 24 weeks of treatment. The safety and tolerability remained satisfactory. The greatest benefits were seen with a dose of 4 mg QD.


Share This Report


About the Author

Dr. Andy Thompson
Dr. Andy Thompson

Dr. Andy Thompson is an Associate Professor at Western University and founder of Rheuminfo.com, Rheumtalks.com, and RheumReports.com.

View Full Bio

Trending Reports From EULAR 2015