A phase II, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of MDX-1100, a fully human anti-CXCL10 monoclonal antibody, in combination with methotrexate in patients with rheumatoid arthritis.

Yellin M, Paliienko I, Balanescu A, Ter-Vartanian S, Tseluyko V, Xu LA, Tao X, Cardarelli PM, Leblanc H, Nichol G, Ancuta C, Chirieac R, Luo A.
Journal   Arthritis Rheum.
Analytes Measured  
Matrix Tested   Serum
Year   2011
Page Numbers  
Application   Immunogenicity
OBJECTIVE: CXCL10 (also known as interferon gamma inducible protein-10, IP-10) is a chemokine that potentially plays a role in the immunopathogenesis of RA. This phase II study evaluated the efficacy and safety of MDX-1100, a fully human, neutralizing anti-CXCL10 (anti-IP-10) monoclonal antibody, in patients with RA who had an inadequate response to methotrexate (MTX).

METHODS: Patients with active RA on stable doses of MTX (10 to 25 mg weekly) were randomized to receive intravenous doses of MDX-1100 at 10 mg/kg (n=35) or placebo (n=35) every other week. The primary endpoint was the ACR20 response rate at Day 85 and patients were followed for safety to Day 141.

RESULTS: The ACR20 response rate was significantly higher for MDX-1100 treated patients compared to placebo (54% versus 17%; p-value = 0.0024). Statistically significant difference in ACR20 response rate was observed between MDX-1100 and placebo treatment starting at Day 43 (p<0.05). The ACR50 and ACR70 response rates in the MDX-1100 treatment group at Day 85 were not significantly different from placebo. Overall, 51.4% of MDX-1100 treated patients and 30.3% of placebo treated patients experienced at least 1 adverse event. No drug related serious adverse events were reported.

CONCLUSIONS: MDX-1100 was well tolerated and demonstrated clinical activity in RA patients who had an inadequate response to MTX. This is the first study to demonstrate clinical activity of a chemokine inhibitor in RA and supports the potential role of IP-10 in the immunopathogenesis of RA.

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