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!
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