• Biogen Idec Inc., of Cambridge, Mass., reported results from its Phase IIa trial of baminercept (BG9924), a dual-mechanism lymphotoxin-beta and LIGHT pathway inhibitor, suggesting clinically meaningful improvements in American College of Rheumatology (ACR) scores and individual core set measurements in rheumatoid arthritis patients over placebo. Results showed that ACR score improvements persisted for up to eight weeks following the final study dose and were seen in patients given 1 mg/kg or 3 mg/kg once-weekly subcutaneously, the two highest doses, for four weeks. 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 to 4.6 percent and 6.7 percent with placebo, respectively. The most common adverse event was headache. No serious adverse events were reported.
• Bristol-Myers Squibb Co., of New York, reported cumulative five-year data from an extension of a Phase IIb trial showing that Orencia (abatacept) demonstrated long-term efficacy and safety in adult rheumatoid arthritis patients who had an inadequate response to methotrexate. A total of 219 patients entered the extension study to receive a fixed dose of Orencia approximating 10 mg/kg every four weeks, and 130 patients continued in the study for five years. At year five, improvements in ACR 20, 50 and 70 responses were 83 percent, 65 percent and 40 percent, respectively. More than one-third of those patients achieved an ACR 70 response at year five.
• Human Genome Sciences Inc., of Rockville, Md., presented Phase II results demonstrating that LymphoStat-B (belimumab) achieved a sustained improvement in disease activity across multiple clinical measures, decreased the frequency of disease flares over time and was well tolerated through 2.5 years on treatment in combination with standard of care in patients with active systemic lupus erythematosus. As reported in June, results from the 52-week study of 449 patients randomized to receive LymphoStat-B or placebo showed that the drug significantly reduced disease activity over placebo. Data from the trial's extension demonstrated an increase from 46 percent to 54 percent in the combined patient response rate, which was selected as the primary efficacy endpoint for the Phase III trials, and, among serologically active subjects who completed 128 weeks of treatment, 63 percent responded based on that measure of clinical effect.
• Trubion Pharmaceuticals Inc., of Seattle, reported positive Phase IIb data showing that its TRU-015 provided statistically significant efficacy in rheumatoid arthritis patients after a single infusion of 800 mg or 1,600 mg. At 24 weeks, ACR 20, 50 and 70 response rates in the 800 mg dose group were 65 percent, 26 percent and zero percent, respectively. In the 1,600 mg dose group, response rates were 61 percent, 13 percent and 4 percent, respectively. In comparison, ACR 20, 50 and 70 response rates in the placebo group were 33 percent, 9 percent and 2 percent, respectively. Administration with TRU-015 was well tolerated and resulted in a consistent pharmacokinetic and pharmacodynamic profile. Trubion is co-developing the product with Madison, N.J.-based Wyeth Pharmaceuticals.