Background The outcome of etanercept plus methotrexate (ETN+MTX) combination therapy for early rheumatoid arthritis (RA) is often best when patients (pts) are treated early,1 but identification of those who would most benefit from early treatment is challenging.
Objectives To assess pts with moderate-to-severe RA, stratified by symptom duration for their ability to achieve low disease activity (LDA) or remission (REM).
Methods Phase 1 of the PRIZE study was a 52-wk open-label period in which MTX-naïve pts with symptoms <12 mo from enrolment were treated with ETN 50 mg+MTX 10-25 mg. Patients were stratified by symptom duration as a proxy of disease duration: 0–≤3 mo, >3–6 mo, and >6 mo. Outcomes included change from baseline through wk 39; achievement of a normal score on the Health Assessment Questionnaire disability index (HAQ-DI, ≤0.5); the assessment of LDA/REM based on the Clinical Disease Activity Index (CDAI ≤10/≤2.8); DAS28 criteria (≤3.2/<2.6); and the Simplified Disease Activity Index (SDAI ≤11.0/≤3.3). Kaplan-Meier (KM) estimates of time-to-response were performed through wk 39 due to censoring of patients who did not achieve LDA at wk 39. Difference in KM curves between disease duration subgroups was assessed by log-rank test. Wk 52 data were used as supportive analyses.
Results 306 pts (baseline symptom duration 0–≤3 mo, n=35; >3–6 mo, n=104; >6 mo, n=167) were included. Baseline age, gender, race, and BMI were similar across disease duration subgroups, as were clinical measures of disease activity (Table). Significant improvements from baseline were observed for DAS28, CDAI, and SDAI in all subgroups at wk 39; raw mean change and adjusted mean change from baseline were similar in all three groups. While KM rate estimates of DAS28/CDAI/SDAI REM at wk 39 appear numerically higher for the early disease duration subgroups (Table 1), KM time-to-event curves indicated no significant difference between disease duration subgroups on any of the 7 disease activity scales measured. Wk 52 results gave similar findings. Thus, the ability to achieve LDA/REM in response to open-label ETN+MTX treatment in early RA was unaffected by differences in symptom duration ≤1 year before treatment initiation. Improvements in clinical measures of disease activity and QoL were also similar between disease duration subgroups.
Conclusions The use of induction with ETN+MTX in early RA largely overcomes the poorer outcomes often associated with delayed treatment.
Moreland et al, Arthritis Rheum. 2012;64:2824-35
Acknowledgements The PRIZE study (ClinTrials.gov NCT00913458) was sponsored by Pfizer Inc. Editorial/medical writing support was provided by Samantha Forster of Engage Scientific and was funded by Pfizer Inc.
Disclosure of Interest P. Emery Consultant for: AbbVie, Bristol-Meyers Squibb (BMS), MSD, Novartis, Pfizer Inc, Roche, and UCB Pharma Ltd., J. Bukowski Employee of: Pfizer Inc., A. Szumski Employee of: InVentiv Health and a paid contractor to Pfizer Inc for providing statistical support for this study and the development of this abstract., L. Marshall Employee of: Pfizer Inc.