Abstract
Objective: To explore the influence of early treatment response to etanercept-methotrexate therapy on sustained remission after tapering/withdrawal of etanercept in methotrexate/biologic-naïve patients with early rheumatoid arthritis in the PRIZE study (ClinicalTrials.gov: NCT00913458). Method: In the initial 52-week open-label phase, enrolled patients received once-weekly etanercept 50 mg plus methotrexate. Patients who achieved DAS28 ≤3.2 at week 39 and <2.6 at week 52 were randomized to etanercept 25 mg plus methotrexate, methotrexate monotherapy, or placebo once weekly for 39 weeks in the double-blind phase. The relationships between responses in the open-label phase and sustained remission (DAS28 <2.6 at weeks 76 and 91, without glucocorticoid rescue therapy from weeks 52 to 64) in the double-blind phase were analyzed. Results: In the open-label phase, 70% of patients achieved DAS28 remission at week 52. In the double-blind phase, 63%, 40%, and 23% of patients had sustained DAS28 remission in the reduced-dose combination-therapy, methotrexate-monotherapy, and placebo groups, respectively. In patients receiving reduced-dose combination therapy, sustained remission was more likely in those who achieved DAS28 remission (p = 0.005) or low disease activity (p=0.044) in a shorter time, and who had a lower DAS28 (p = 0.016) or achieved ACR/EULAR Boolean remission (p < 0.05) at the end of the open-label phase. In patients receiving methotrexate monotherapy, sustained remission was associated with a lower acute-phase response (C-reactive protein, p = 0.007; erythrocyte sedimentation rate, p = 0.016) at the end of the open-label phase. Conclusion: Fast response and suppression of inflammation with etanercept-methotrexate therapy may predict successful etanercept tapering/withdrawal in patients with early rheumatoid arthritis.
Highlights
Clinical remission and Low Disease Activity (LDA) are currently well-recognized treatment targets for patients with Rheumatoid Arthritis (RA), regardless of the level of their disease activity, because control of inflammation has been shown to reduce structural joint damage, quality-of-life impairment, and functional disability [1 - 3]
Of the 306 patients enrolled in the PRIZE study, 222 completed the 52-week open-label phase, and 198 achieved a treatment response with full-dose combination therapy (Supplemental Fig. S1) [11]
In the open-label phase, in which all patients received etanercept 50 mg plus methotrexate, 70%, 61%, 57%, and 51% of patients achieved remission according to the Disease Activity Score for 28-joint counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and ACR/EULAR Boolean criteria, respectively, at week 52 (Fig. 1A)
Summary
Clinical remission and Low Disease Activity (LDA) are currently well-recognized treatment targets for patients with Rheumatoid Arthritis (RA), regardless of the level of their disease activity, because control of inflammation has been shown to reduce structural joint damage, quality-of-life impairment, and functional disability [1 - 3]. During the open-label first phase of the PRIZE (Productivity and Remission in a randomIZed controlled trial of etanercept vs standard of care in Early rheumatoid arthritis) study, patients with early, active, moderate-to-severe RA showed significant and rapid improvement in disease activity and function with combined 50 mg etanercept once weekly (QW) with methotrexate therapy [11]. In this early RA population, induction therapy with the combination regimen was associated with remission or LDA in most of the treated patients. The design and patient populations of the PRIZE study provided the opportunity to examine factors that may have influenced the maintenance of remission in the double-blind phase after etanercept was tapered or withdrawn among patients who initially responded to induction therapy with the full-dose regimen
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