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Abstract Number: L10

In Rheumatoid Arthritis Patients with Stable Low Disease Activity On Methotrexate Plus Etanercept, Continuation of Etanercept 50 Mg Weekly or 25 Mg Weekly Are Both Clinically Superior to Discontinuation: Results From a Randomized, 3-Armed, Double-Blind Clinical Trial

R.F. van Vollenhoven1, Mikkel Østergaard2, Marjatta Leirisalo-Repo3, Till Uhlig4, Marita Jansson5, Åsa Klackenberg5, Katherine Hutchinson6 and Karin Franck-Larsson5, 1Clinical Trials Unit Department of Rheumatology, The Karolinska Institute, Stockholm, Sweden, 2Copenhagen University Hospital Glostrup, Copenhagen, Denmark, 3Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital, Helsinki, Finland, 4Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, 5Speciality Care Nordic Medical Affairs, Pfizer Nordic, Sollentuna, Sweden, 6Quanticate, Hitchin, United Kingdom

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Biologic agents, etanercept and rheumatoid arthritis (RA)

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Session Information

Session Title: ACR Late-breaking Abstract Oral Session

Session Type: Late-Breaking Abstracts

Background/Purpose: The efficacy of etanercept (ETN) in combination with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) is well established, and long-term trials1 and observational data have shown continued treatment maintains clinical responses in most patients. However, it is not yet known whether ETN must be continued in order to maintain a state of low disease activity/ remission (LDA/REM), or if the continuation of MTX alone or MTX combined with a lower dose of ETN, might be equally effective. We undertook a clinical trial “DOSERA” to study this question.

Methods: RA patients on ETN 50 mg wkly plus MTX (stable dose 7.5-25 mg/wk) and documented LDA/REM (DAS28≤3.2, ESR method) for ≥11 mths based on retrospective data were included. Additional key inclusion criteria were: age ≥18 y, stable MTX, no prior non-anti-TNF therapy and no prior attempt to discontinue ETN due to stable disease. Patients were followed for 2 months without major changes in therapy to ensure stable LDA/REM, and stratified based on LDA/remission status and randomly assigned 1:1:1 to ETN50 mg/wk (ETN50), ETN 25 mg/wk (ETN25), or placebo (PBO) while continuing MTX. Failure was defined as DAS28≥3.2 and an increase in DAS28≥0.6 or disease progression as determined by investigator or patient. The primary outcome was the proportion of non-failures at 48 wks, for ETN50 vs. PBO. Secondary outcomes included comparisons of non-failure and DAS28 outcomes for all 3 groups, and time to failure. The primary outcome was analyzed using a Generalized Estimating Equation model and expressed as the odds ratio (OR; 95% CI) for achieving non-failure.

Results: 106 patients were screened, 91 enrolled and 73 randomized. The groups were well-balanced at baseline. 70% were female, the average age (SD) was 57 (11) y, disease duration 13.6 (8.8) y (range 2.8-41.5), and 81% had a baseline DAS28≤2.6. After 48 wks, the proportion of non-failures was 52% for ETN50 and 13% for PBO (OR 7.2 (1.7-29.8), p=0.007). For ETN25, the proportion of non-failures was 44% [OR 4.2 (1.0-17.0); p=0.044 vs. PBO; not sign. vs. ETN50].  Median time to failure was 6 wks from randomization in PBO and 48 and 36 weeks for ETN50 and ETN25, respectively. Adverse events were similar between the groups; no unexpected safety signals were noted.

Conclusion: For RA patients with stable LDA/REM on MTX+ETN 50 mg/wk, continued treatment with ETN at 50 mg/wk or 25 mg/wk provides a significantly higher likelihood of maintaining stable disease state over 48 wks than PBO. The relatively low non-failure rates could be due to the patient population and to allowing multiple reasons for indicating failure. Thus, discontinuing ETN while maintaining a stable disease state appears to be possible for only a small minority of patients. In contrast, the positive results with the reduced ETN dosage seen in this trial provide evidence for an “induction-maintenance” strategy being feasible even in established RA.   

References: 1. Moreland L et al. J Rheumatol. Mar 2006;33:854-61


Disclosure:

R. F. van Vollenhoven,

Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB,

2,

Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB,

5;

M. Østergaard,

Abbott, Pfizer, Centocor,

2,

Abbott, Pfizer, Merck, Roche, UCB,

5,

Abbott, Pfizer, Merck, BMS, UCB, Mundipharma,

8;

M. Leirisalo-Repo,

Pfizer, MSD, Roche, Bristol-Myers Squibb,

5;

T. Uhlig,

Pfizer Inc,

5,

Pfizer Inc,

8;

M. Jansson,

Pfizer,

3;

Klackenberg,

Pfizer,

3;

K. Hutchinson,

Quanticate,

3;

K. Franck-Larsson,

Pfizer,

3.

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