RESEARCH - A randomized double-blind, placebo-controlled trial of MM-093 in patients with active RA

November 30, 2006

Ann Rheum Dis. 2006 Nov 17; [Epub ahead of print]

A Randomised double-blind, placebo-controlled trial of a recombinant version

of human alpha fetoprotein (MM-093) in patients with active rheumatoid

arthritis.

Pollard LC, Murray J, Moody MD, EJ, Choy EH.

King's College London, United Kingdom.

OBJECTIVE: RA tends to remit during pregnancy, with more patients achieving

remission in the third trimester, coinciding with an increase in levels of

alpha fetoprotein (AFP). In vitro and animal studies have shown that AFP has

immunomodulatory properties. MM- 093 is a non-glycosylated, recombinant

version of human AFP. METHODS: The safety, tolerability and clinical effects

of MM-093 were assessed in this 12-week, randomised, double-blind,

placebo-controlled study. Twelve patients with RA, who had active disease

and were on stable doses of methotrexate, received weekly subcutaneous

injections of placebo or 21mg of MM-093. Assessments were carried out at

baseline and weekly thereafter. RESULTS: Baseline characteristics were

similar in both groups. There was one dropout in the placebo group due to

flare of disease. Treatment with MM-093 was well tolerated. No serious

adverse event was observed. By day 85 MM-093 produced a statistically

significant mean improvement from baseline in DAS28 (0.913 vs 0.008,

p=0.033) and patient's global assessment (28.9% vs - 36.3%, p=0.02) compared

to placebo.

CONCLUSION: This is the first randomized, controlled trial of MM-093, a

recombinant version of human AFP, in patients with RA. MM-093 was well

tolerated. Evidence of efficacy was observed, suggesting that MM-093 may

have therapeutic potential in RA.

PMID: 17114190

7114190

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

s Hopkins Medicine

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