Baricitinib, the artist formerly known as LY3009104 / INCB028050 (a novel oral inhibitor of JAK1/2), made me very enthusiastic at the ACR 2012 Meeting. A year ago there had only been a study telling me not to worry about cholesterol in patients receiving baricitinib. What do we have now? A phase 2b study from Japan. And that's all, folks!
Y. Tanaka and colleagues [THU0149] presented the following study: "EFFICACY AND SAFETY OF BARICITINIB IN JAPANESE RHEUMATOID ARTHRITIS PATIENTS AT 12 WEEKS". Conclusions: "Clinical efficacy was demonstrated in this Phase 2b study of baricitinib in combination with background MTX in Japanese RA pts through 12 weeks. Safety signals observed through 12 weeks were consistent with a previous study of baricitinib in non-Japanese pts with RA." Nothing to say against this study. Everything is fine, but it only tells us little more than what we already know.
We are desperately waiting for a phase 3 study! I've talked to the Lilly people and they told me that phase 3 studies haven't completed recruiting. So we still have to wait for these important studies.
I had already thought that FDA and EMEA are getting stricter in applying drug efficiency and safety requirements as seen after last year's ruling of EMEA concerning tofacitinib; the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a negative opinion for Xeljanz® (tofacitinib). Maybe the current phase 3 studies need more time than expected to make them watertight. Despite my new worries and disappointments I hope that baricitinib will make it to the market.