inspirator schreef op 17 juni 2017 10:50:
Friday, June 16, 2017
Filgotinib at the 2017 EULAR Annual Meeting in Madrid
Filgotinib (GLPG0634, GS-6034) is an oral, selective JAK1 inhibitor, which is studied in combination with methotrexate (MTX) or as monotherapy. I have already written about this protein kinase inhibitor several times [1,2,3].
At the 2017 EULAR Annual Meeting in Madrid we have seen seven studies being presented.
We have a post-hoc analysis from two phase 2b studies by R. Westhovens and colleagues [4]: Filgotinib once daily at 100mg and 200mg with or without MTX showed improved clinical outcomes compared to placebo, baseline CRP levels did not matter.
There were two studies on different mouse models concerning psoriatic arthritis.
One study looked at a multi-biomarker disease activity (MBDA) score, which measures 12 disease-related biomarkers of inflammation and joint injury in RA patient.
One study has been on the reduction in the levels of different “cytokines related to TH1, TH2, TH17 and potentially B cells, as well as innate immunity” [5].
One study looked at the “effect of filgotinib on a background of MTX treatment on markers of inflammation in RA patients”[6]. Conclusion: “Treatment with filgotinib decreased several factors that have key roles in RA for matrix degradation, cartilage destruction, angiogenesis, leukocyte adhesion and recruitment.”
R. Alten and colleagues looked at long term safety and efficacy of filgotinib 200mg daily in patients from the DARWIN 3 Phase 2 open-label extension study [7]. The authors concluded: “With 1314 patient-years of exposure, the safety profile of filgotinib appears consistent with that of previously reported double-blind studies and the clinical response appears durable.”
Filgotinib has been tested further, but no data on a phase three study. Post-hoc analysis of former studies and new mouse model studies keep the pot warm, but in my opinion not simmering. Maybe filgotinib will fare better in the treatment of M. Crohn [8]. As baricitinib and tofacitinib already have been approved by EMA and are available on the market for treatment, I wonder, what Galapagos is waiting for. Let’s see if filgotinib will be marketed for indications like rheumatoid arthritis or psoriatic arthritis in the future.