The following data were presented at the 11th Congress of the European League Against Rheumatism in Rome.

• Alder Biopharmaceuticals Inc., of Bothell, Wash., and Bristol-Myers Squibb Co., of New York, said data from a dose-ranging Phase IIa trial support further development of BMS-945429/ALD518, an investigational monoclonal antibody directed interleukin-16, in rheumatoid arthritis. All three treatment groups in the 16-week study met the primary endpoint of statistically significant improvements in the ACR20 score over placebo at week 12. At week 16, ACR20 responses were observed in 75 percent to 82 percent of subjects receiving 80-mg, 160-mg and 320-mg doses vs. 36 percent in the placebo arm. ACR50 responses were achieved in 41 percent to 50 percent of patients receiving BMS-945429/ALD518 vs. 15 percent in the placebo group, and ACR70 responses were noted in 22 percent to 43 percent of the treatment group and 6 percent of the placebo group.

• Horizon Pharma Inc., of Northbrook, Ill., presented Phase III data showing that Lodotra, a circadian cytokine modulator and modified-release, low-dose prednisone tablet, statistically significantly improved American College of Rheumatology response criteria in patients with rheumatoid arthritis. Among the data were results from the 350-patient CAPRA-2 (Circadian Administration of Prednisone in Rheumatoid Arthritis) showing that ACR20 responses were statistically significant for patients treated with Lodotra (48.5 percent) compared to placebo (28.6 percent), for a "p" value of 0.0002. ACR50 response also was statistically significant, with 22.7 percent in the Lodotra arm compared to 9.2 percent in the placebo arm, and a "p" value of 0.0027. A new drug application is expected later this year.

• UCB SA, of Brussels, Belgium, and Immunomedics Inc., of Morris Plains, N.J., reported a Phase IIb study showing that epratuzumab provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus. Data from the EMBLEM study showed combined responder index rates that were numerically superior in all epratuzumab groups compared to placebo, reaching statistical significance in the 600-mg weekly group, with a "p" value of 0.0265, and the combined group of all 74 patients who received a cumulative dose of 2,400 mg, with a "p" value of 0.0239. In separate news, UCB also reported Cimzia (certolizumab pegol) data demonstrating rapid and sustained improvements in managing moderate to severe rheumatoid arthritis symptoms and pain for patients. Among those data, were results showing rapid improvements in ACR20 physical function, pain and fatigue as early as week 1 following Cimzia treatment in combination with methotrexate, and those improvements were sustained up to 48 weeks.