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Dose Ranging Study of VX-509, An Oral Selective JAK3 Inhibitor, As Monotherapy in Patients with Active Rheumatoid Arthritis (RA)

Results: 204 subjects were treated: 81% female; mean age 56.1; mean disease duration 7.8 years. Mean baseline characteristics were a TJC of 16.4/28, SJC of 12.9/28, HAQ score of 1.65, CRP of 2.4 mg/dl, and DAS28-CRP of 6.1. 83% of VX-509 subjects and 67% of placebo subjects completed 12 weeks of dosing. Statistically significant differences from placebo in ACR20 responses at week 12 were achieved in VX-509 dose groups 50 mg and higher (all P=0.007). Significant ACR50 and ACR70 responses were also seen in subjects treated with VX-509 100 and 150 mg BID. Changes from baseline in DAS28-CRP were significant in VX-509 dose groups 50 mg BID and greater compared to placebo (all P=0.001). DAS28-CRP remission was achieved in 35% and 37% of the VX-509 100 and 150 mg groups, respectively, compared to 7% for placebo (both P=0.003).

Adverse events (AE) led to discontinuation in 7.9% of VX-509 subjects and 4.8% of placebo subjects. Infections were the most common AE, occurring with similar frequency in placebo (17%) and VX-509 subjects (12-25%). Serious AEs occurred in 4.9% of VX-509 and 2.4% of placebo subjects, with serious infection in 3.1% of VX-509 subjects (100 mg, n=3; 150 mg, n=2, including 1 case of TB) and none in placebo. Two deaths occurred in the VX-509 group (100 mg): 1 subarachnoid hemorrhage, 1 pneumonia. AEs of transaminase elevations were seen in 5.5% of VX-509 subjects and 4.9% of placebo subjects. Most were grade 1. There were dose-related reductions in platelets (within normal ranges) and low level dose-related increases in LDL and HDL. There were no effects on hemoglobin, neutrophils or renal function.

http://acr.confex.com/acr/2011/webprogram/Paper24549.html