Amgen and Pfizer Announce Results From the Largest Completed Clinical Trial of a Biologic Therapy

The FINANCIAL — Amgen  and Pfizer Inc.  today announced results of the second and final period of the PRESERVE trial.

PRESERVE is a two-period multi-center trial in patients with moderately active rheumatoid arthritis  who achieved Disease Activity Score  28 low disease activity  or clinical remission on combination Enbrel  plus methotrexate  in Period one and were randomized to continue on ENBREL plus MTX or MTX alone in Period two. Results of Period two showed that the percentage of patients who maintained LDA or achieved clinical remission at week 88 was significantly higher in patients receiving ENBREL plus MTX than those on MTX alone. These results have been accepted in the late-breaker poster presentation at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago, from Nov. 5-9, 2011.

Patients with moderately active RA represent the largest RA population, yet they have not been widely studied as a distinct group in prospective clinical studies. The PRESERVE study is the largest completed clinical trial of a biologic therapy in adults with moderately active RA, despite MTX treatment.

The PRESERVE trial met both its primary and conditional primary endpoints by demonstrating a statistically superior response in moderately active RA patients taking ENBREL 50mg weekly plus MTX or ENBREL 25mg QW plus MTX compared with those taking MTX monotherapy at 88 weeks. Specifically, after achieving LDA  at 36 weeks on ENBREL 50mg QW plus MTX, the percentage of patients maintaining LDA at week 88 was significantly higher in the ENBREL 50mg QW and ENBREL 25mg QW  treatment groups than the MTX- alone group . The U.S. Food and Drug Administration – and the European Medicines Agency – recommended dose for ENBREL for the treatment of moderate to severe RA is 50mg QW.

Additionally, for DAS 28 clinical remission  Against Rheumatism  good response. There were no new safety signals, and the safety profile from PRESERVE was consistent with that seen in previous ENBREL studies. Thirty-five subjects reported at least one serious adverse event  during Period two. The proportion of subjects with at least one SAE was similar among treatment groups  in the  No specific SAE was observed in more than two subjects. Two deaths, which were considered to be unrelated to the study medication, occurred in the ENBREL 50mg QW plus MTX group.