Friday, November 11, 2016

Baricitinib reaching out for the market

It seems that baricitinib gets ready to come to the market. The annual meetings this year have seen a plethora of studies on baricitinib both at the EULAR meeting in London and the ACR meeting in Washington.

Noteworthy: both meetings received different studies or better different aspects of studies. With other compounds abstracts didn’t differ at both congresses. Not so with baricitinib.

Interestingly the crucial study on radiographic progression only appeared at the EULAR meeting. The FDA approved tofacitinib, but EMEA didn’t a couple of years ago. I think this had an impact on baricitinib. If it had an impact on FDA, let’s wait to see if baricitinib is approved or not. Tofacitinb has applied for approval in Europe (March 2016), so Xeljanz should have an advantage of time.

The study by D. van der Heijde and colleagues showed a robust inhibition of radiographic progression for the 4 mg dose of baricitinib.

N.V. Zamora and colleagues came to the following conclusions: 1. baricitinib with or without MTX had better responses as compared to MTX at 12 and 24 weeks (baricitinib+MTX lower withdrawal rate than MTX alone), 2. baricitinib showed similar effects as adalimumab (with higher rates of SAEs). The authors consider baricitinib to be an additional therapeutic option to treat patients with moderate to severe rheumatoid arthritis, who have an inadequate response to other treatment agents.

There will be a study in a few days by Kevin L. Winthrop and colleagues at the ACR Annual Meeting in Washington: “Herpes Zoster in Patients with moderate to Severe Rheumatoid Arthritis Treated with Baricitinib” [Abstract Number: 3027] – which will have to be discussed at the meeting first.

What can we say today? Lilly is committed to bring baricitinib to the market. Let’s see how quickly. I expect approval or non-approval within half a year both for the US and the EU.

Radiographic progression – EULAR [THU0168] 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: Baricitinib Inhibits Radiographic Progression of Structural Joint Damage at 1 Year in Patients with Rheumatoid Arthritis (Ra) and an Inadequate Response to csDMARDS. DOI: 10.1136/annrheumdis-2016-eular.1611

Meta-Analysis - EULAR [SAT0177] N.V. Zamora , J. Tayar , M.A. Lopez-Olivo , R. Christensen , M.E. Suarez-Almazor: Baricitinib for  Rheumatoid Arthritis: A Systematic Review and Meta-Analysis. DOI: 10.1136/annrheumdis-2016-eular.4449

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