Monday, June 17, 2013

Ixekizumab at the EULAR 2013

Ixekizumab targets the interleukin-17 (IL-17) and is also known as LY2439821. It has been introduced at the ACR 2011 in Chicago:
But after the introduction I couldn’t get any news at the 2012 meeting. So I’ve been very eager to see, if the drug is still being under scrutiny. There have been two studies.

L. Xie and colleagues presented a “small post-hoc analysis” [SAT0137]: “Early clinical improvements (week 4) predict subsequent clinical response with ixekizumab in rheumatoid arthritis patients with inadequate response to TNF inhibitors”. The authors concluded: “In this small post-hoc analysis of a Phase 2 trial of ixekizumab, TNF-IR patients achieving improvements in DAS28-ESR and DAS28-CRP < 0.7 at Week 4 had very low likelihood of achieving an ACR20 response at Week 12. In addition, patients achieving greater levels of improvement had a reasonable probability of achieving an ACR20 response at Week 12.”

This information doesn’t bring us much further in understanding how effective ixekizumab might be. I’ve learnt in this analysis that the best cut-off point of DAS28-ESR and DAS28-CRP is < 0.7, but I haven’t learnt anything about how many patients achieve DAS remission or ACR20, ACR50 or ACR70.

Let’s turn to the second study. M. Genovese and colleagues presented a study [SAT0107]: “Efficacy and safety after 64 weeks of ixekizumab treatment in a phase 2 open label extension study in patients with rheumatoid arthritis“. The authors concluded: “Clinical improvements observed with ixekizumab treatment in the double blind phase were maintained or improved in the pts that participated in the open label extension through Week 64. Ixekizumab was well tolerated, …”.

At least they published these two studies to keep a flickering light burning. I may close with the last word by Johann Wolfgang von Goethe: “More light”. I hope that the ACR 2013 will see more data, especially a phase 3 study.

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