Last year I had stumbled upon ABT-494
[1]. An actual search at Clinical Trial lists 20 studies on Abt-494 [2]. The compound
already has entered phase 3.
ABT-494 has been named as upadacitinib, which
is a Janus kinase inhibitor against JAK1.
M.-E.F. Mohamed and colleagues presented a
study [3]: “ABT494 has no effect on the QT interval at the doses being evaluated
in rheumatoid arthritis phase 3 trials”. Did you read too quickly? You don’t
see data from a phase 3 study but from a phase 1 study in dosages being used in
phase 3 studies! The authors evaluated “abt-494 QT prolongation potential using
exposure-response analysis of data collected in early Phase 1 studies”. ABT-494
showed no potential for QT prolongation.
A study on pharmacokinetics also used data
acquired from healthy subjects, which mean phase 1 data.
M. Nurmohamed and colleagues studied [4]: “Changes
in c-reactive protein and lipid levels in patients with rheumatoid arthritis
treated with ABT-494, a selective JAK-1 inhibitor”. That’s a phase 2b study. Conclusions:
“Atherogenic burden did not increase in pts treated with ABT-494 for 12 wks. Compared
to non-responders, pts with a clinical response experienced a larger increase
in lipids and a larger decrease in hsCRP.”
There were two more studies. All in all phase
3 studies are under way, but so far no data available on these studies. I think
it’s very obnoxious to put catch words like phase 3 in the title of a
publication on data out of a phase 1 study. I’ll look very vigilantly on the
further development of upadacitinib.
Links and
References:
[2]
[3] Annals of the Rheumatic Diseases, volume
76, supplement 2, year 2017, page 1201 / Session: Rheumatoid arthritis - non
biologic treatment , (Abstracts Accepted for Publication ) / DOI:
10.1136/annrheumdis-2017-eular.3230
[4] Annals of the Rheumatic Diseases, volume
76, supplement 2, year 2017, page 280 / Session: Rheumatoid arthritis - non
biologic treatment , (Poster Presentations ) / DOI: 10.1136/annrheumdis-2017-eular.2807
.
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