D. van der Heijde and colleagues published a study on baricitinib and radiographic progression at the EULAR 2016 Meeting. For all waiting for a protein kinase inhibitor to be approved in the EU this is good news. Baricitinib inhibits JAK1 and JAK2. Tofacitinib seems to have produced the lacking studies on radiographic progression, which stopped the approval by EMEA. As D. van der Heijde is one of the leading experts in measuring radiographic progression, baricitinib has made a grand leap forward to apply for EMEA’s approval. BTW Pfizer restarted the process to get approval for tofacitinib.
D. van der Heijde, M. Dougados, Y.-C. Chen, M. Greenwald, E. Drescher,
R. Klar, L. Xie, I. de la Torre, T.P. Rooney, S. Witt, D. Schlichting,
S. DeBono, P. Emery [THU0168] published: “Baricitinib inhibits radiographic Progression of Structural Joint Damage at 1 Year in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to csDMARDS”. The data has been collected in the RA-BUILD study and the RA-BEYOND extension study. Conclusions: “Once daily oral bari[citinib] inhibited radiographic progression of structural joint damage in pts [patients] with an IR [inadequate response] or intolerance to csDMARDs [conventional synthetic disease modifying anti rheumatic drugs] over 48 wks [weeks] of treatment. The most robust benefit across measures of radiographic progression was seen for the 4mg dose.”
As other studies, also presented at the EULAR 2016 Meeting, like RA-BEAM, RA-BEGIN or RA-Beacon already showed data on efficacy and safety of baricitinib, with the study on radiographic progression, baricitinib might get approval soon in the EU. Eli Lilly already seeks approval of the FDA in the U.S.
Let’s see, if tofacitinib or baricitinib will be available in Europe soon!