Friday, June 16, 2017

ABT-494 (Upadacitinib) at the 2017 EULAR Annual Meeting in Madrid

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:
[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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