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.
Links and references:
[4] Annals of the Rheumatic Diseases, volume 76, supplement 2, year
2017, page 148 / Session: From classics to new: synthetic DMARDs in RA , (Oral
Presentations ) / DOI: 10.1136/annrheumdis-2017-eular.5428
[5] Annals of the Rheumatic Diseases, volume 76, supplement 2, year
2017, page 270 / Session: Rheumatoid arthritis - non biologic treatment ,
(Poster Presentations ) / DOI: 10.1136/annrheumdis-2017-eular.5814
[6] Annals of the Rheumatic Diseases, volume 76, supplement 2, year
2017, page 281 /
Session: Rheumatoid arthritis - non biologic treatment , (Poster
Presentations ) / DOI: 10.1136/annrheumdis-2017-eular.5799
[7] Annals of the Rheumatic Diseases, volume 76, supplement 2, year
2017, page 267 / Session: Rheumatoid arthritis - non biologic treatment ,
(Poster Presentations ) / DOI: 10.1136/annrheumdis-2017-eular.5460
.
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