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Biogen Idec's baminercept alfa shows promise in patients with rheumatoid arthritis
Date:6/12/2008

ata Results

The Phase IIa blinded, multicenter, placebo-controlled trial was designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of baminercept with methotrexate, a standard RA therapy, at different dose ranges. Patients (n=47) were randomized in a dose-escalating fashion to receive placebo or one of six doses of baminercept, ranging from 0.01 mg/kg to 3.0 mg/kg once weekly for four weeks, followed by eight weeks of observation. Patients had to have received methotrexate for at least three months prior to enrollment and continued to receive a stable dose of methotrexate throughout the study period.

Study results suggested improvement in the majority of ACR core set measurements (a series of standard measurement criteria for RA symptom and disease improvement) in patients given baminercept compared with placebo. At day 35, patients given baminercept showed an average 60 percent improvement from baseline in swollen joint count and 47 percent improvement in tender joint count, compared with 4.6 percent and 6.7 percent with placebo, respectively. Improvements in these ACR measures persisted for eight weeks after the final baminercept dose. Similar levels of improvements were observed at day 35 in several other standard markers of inflammation and disease progression. ACR scores and other measures improved in a dose dependent manner, with the greatest improvements reported in the groups receiving 1.0 mg/kg and 3.0 mg/kg.

The most common adverse event in patients receiving baminercept was headache. Transient mild-to-moderate flu-like symptoms were observed in 9 patients (25 percent) within 24 hours after the first dose of baminercept. However, these symptoms responded well to paracetamol (acetaminophen) and tended not to recur with subsequent doses. No serious, drug-related adverse events were reported in this study.

Based on the results of the Phase IIa study, Biogen Idec has initiated two Phase II
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Contact: Rachi Govil
rachi.govil@offspringpr.com
212-798-9827
Offspring PR
Source:Eurekalert

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