THOUSAND OAKS, Calif., and COLLEGEVILLE, Pa., June 19, 2003 - Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that patients receiving ENBREL(R) (etanercept) 50 mg once weekly for the treatment of active rheumatoid arthritis (RA) in a new clinical study experienced significant improvements in function and pain that were comparable to those receiving the currently approved dose (25 mg twice weekly), and significantly better than those receiving placebo. The data were presented at the European League Against Rheumatism (EULAR) Annual Congress of Rheumatology in Lisbon, Portugal.
The multi-center, double-blind, placebo-controlled study randomized 434 patients based on a 4:3:1 allocation to receive either ENBREL 50 mg (2 x 25 mg doses) once weekly, ENBREL 25 mg twice weekly, or placebo for eight weeks. The primary endpoint, a 20 percent improvement in signs and symptoms of RA (known as an ACR 20 response) after eight weeks, was achieved by 50 percent of patients treated once weekly with ENBREL, 49 percent of patients treated twice weekly with ENBREL and 19 percent of patients in the placebo group. Patients' functional status was assessed using the Health Assessment Questionnaire (HAQ). In addition, patient-reported measures assessing global status and pain were evaluated.
At week eight, improvement in HAQ was comparable for patients receiving either ENBREL dose, and significantly better than patients receiving placebo.
The average improvement from baseline in pain as reported by patients with ENBREL once weekly (33.4%) and ENBREL twice weekly (27.0%) was comparable, and higher than placebo (-19.3%). Average improvement from baseline in patient global scores showed similar results with ENBREL once weekly (26.8%), ENBREL twice weekly (26.7%) versus placebo (0.2%).
Adverse events, such as injection site reactions, infections, and headache, were similar to those reported in previous clinical trPage: 1 2 3 4 Related biology news :1
Contact: Rebecca Hamm, Amgen
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