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Amgen Response to The New England Journal of Medicine Study

THOUSAND OAKS, Calif. (June 24, 2013) – In response to the recent publication of "Therapies for Active Rheumatoid Arthritis after Methotrexate Failure" by O'Dell et al in The New England Journal of Medicine on June 11, 2013, Amgen issued the following statement:

This study was not designed to show comparative efficacy of triple therapy* versus Enbrel® (etanercept) plus methotrexate (MTX), in patients with rheumatoid arthritis who had active disease despite prior MTX therapy.  The study's primary aim was to evaluate the impact of the sequence of the two treatment regimens after 48 weeks.

A key limitation of the study is that more than one quarter of patients in each arm (27 percent) was switched from one therapy to the other during the trial, thereby confounding the results of the primary end point at 48 weeks.

A more direct, and conventional, efficacy comparison between two treatments would be for patients to begin and exit the study on the same treatment.

At 24 weeks (before switching occurred), more patients who received ENBREL plus MTX achieved efficacy endpoints that are representative of greater disease control (ACR70, DAS28 <3.2, DAS28 <2.6),1-3 than patients who received triple therapy; these results were statistically significant. Additionally, there was a trend toward greater inhibition of radiographic progression in the ENBREL-treated group; these results were achieved even though the study was not designed to have adequate statistical power for the secondary end point.

The authors also noted that the study showed a clear trend favoring a more rapid response in the etanercept plus MTX group.

In rheumatoid arthritis, early diagnosis and treatment are important as irreversible joint damage can occur early in the course of the disease. An early diagnosis and appropriate treatment program may help to stop or slow progression of permanent joint damage.4-5

ENBREL is supported by nearly 20 years of clinical data evaluating the efficacy and safety of treatment alone and in combination with MTX. When ENBREL and other TNF inhibitors were first approved by the FDA, they advanced the treatment of this disease by significantly reducing disease activity and inhibiting joint damage.  Based on the safety and efficacy profile of ENBREL, we are confident that it will remain a key tool to treat moderately to severely active rheumatoid arthritis.  Ultimately all treatment decisions are, and should be, made between a doctor and patient.

*Triple therapy defined as MTX, sulfasalazine (SSZ), and hydroxychloroquine (HCQ).

Indication

ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

Important Safety Information

ENBREL has been shown to increase the risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens, and should be discontinued if a patient develops a serious infection or sepsis. Test for latent TB (if positive, start treatment for TB prior to starting ENBREL) and monitor for active TB during treatment. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, including ENBREL.


References

1. O'Dell J, Mikuls T, Taylor T, et al. Therapies for active rheumatoid arthritis after methotrexate failure. New England Journal of Medicine. 2013; published online.

2. Fransen J, Creemers MC, Van Riel PL. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS28) with the ARA preliminary remission criteria. Rheumatology (Oxford). 2004;43:1252-1255.

3. Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum. 2008;59:1371-1377.

4. Krueger GG. Clinical features of psoriatic arthritis. Am J Manag Care. 2002: S160-70

5. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the Management of Rheumatoid Arthritis, 2002 Update. Arthritis & Rheumatism. 2002:46: 328–346