Tuesday, August 20, 2013

Tabalumab in Rheumatoid Arthritis – new developments?

Today I received the September issue of the Annals of the Rheumatic Diseases. I was quite surprised looking at two articles on tabalumab in rheumatoid arthritis.

Mark C Genovese and colleagues: “Extended report: A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate” (Ann Rheum Dis 2013;72:9 1453-1460 Published Online First: 18 April 2013 doi:10.1136/annrheumdis-2012-202864).

Mark C Genovese and colleagues: “Extended report: Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors” (Ann Rheum Dis 2013;72:9 1461-1468 Published Online First: 25 December 2012 doi:10.1136/annrheumdis-2012-202775).

The first study showed “significantly higher ACR50 and ACR20 response rates versus placebo (p smaller than 0.05)” in the 120 mg dose group. After the completion of this study phase 3 were undertaken, but recently discontinued, because the expected efficacy wasn’t met. Link: http://newsroom.lilly.com/releasedetail.cfm?ReleaseID=738769.

In the second study we look at the following conclusion: “At week 16, the primary end point was not achieved, but an indication of efficacy was observed at earlier time points.” As this study already had been accepted in December 2012, Lilly’s discontinuation of the Phase 3 rheumatoid arthritis (RA) program for tabalumab could not be included.

So, all in all the published data rounds up the picture I already had (Link: http://rheumatologe.blogspot.de/2013/06/tabalumab-at-eular-2013-meeting.html - maybe I should have consulted Lilly’s announcement earlier!). Tabalumab isn’t a drug, which could be used for the benefit of patient with rheumatoid arthritis. Let’s wish tabalumab all the best concerning Lupus.

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