Tuesday, June 18, 2013

NNC0109-0012 (anti-IL-20 MAB) at the EULAR 2013

I had written about the novel anti-IL-20 MAB (NNC0109-0012) coming from last year’s ACR in Washington. NNC0109-0012 is a novel human monoclonal IgG4 antibody which binds to IL-20. Here’s the old story: http://rheumatologe.blogspot.de/2012/12/nnc0109-0012-at-acr-2012-in-washington.html.

Let’s switch to the 2013 meeting of EULAR in Madrid. There have been two posters/abstracts.

A. L. Blasius and colleagues, all working for Nordisk, published a study [AB0036]: “IL-20 targets local tissue inflammation as opposed to systemic inflammation”. Conclusions: “Using a variety of methods, no evidence could be found in support of a role for IL-20 in systemic immune responses. This is consistent with the hypothesis that IL-20 acts predominantly at local sites of inflammation.”

L. Senolt and colleagues presented a study [SAT0112]: “Improvements in patient-reported physical function, pain and global disease activity in patients with rheumatoid arthritis after treatment with NNC0109-0012 (anti-IL-20 MAB) in a phase 2a trial”. Conclusions: “12-weeks treatment with 3 mg/kg NNC0109-0012 effectively improved physical function, pain and global disease activity in RF- and ACPA positive patients with RA on stable MTX. These improvements were clinically relevant and sustained when measured at the end of the 13 weeks follow-up.”
Let’s compare this study and the study presented at the ACR.
Methods (EULAR 2013): “67 patients with active RA and inadequate responses to MTX were randomised to 12 once-weekly doses of 3mg/kg NNC0109-0012 (n=45) or placebo (n=22) and stable background MTX, and then followed for an additional 13 weeks. Of the 67 randomised patients 43 were Rheumatoid Factor [RF]- and anti-citrullinated peptide antibody [ACPA]-positive.”
Methods (ACR 2012): “A total of 67 RA patients (51 females:16 males) with active disease (DAS28 (CRP) _4.5, _5 swollen and _5 tender joints) were randomized in a 2:1 ratio (45 NNC0109-0012: 22 placebo) in a multicenter, double-blind, placebo-controlled, parallel group trial.”

If we see the same study again next ACR in newer evaluation and wording, it should be clear that “something is rotten in the state of Denmark” – sorry Nordisk, I couldn’t resist!

I’m less optimistic about NNC0109-0012 than I had been post ACR 2012. And I repeat: Nordisk - how about naming the child? It would make discussions easier and show commitment.

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