Background Management guidelines recommend patients (pts) with RA should be treated with the intent of reaching a clinical target of low disease activity or remission at 6 months.
Objectives To compare long-term efficacy outcomes for MTX-naïve RA pts in the GO-BEFORE trial grouped by their treatment target status at week 24 using DAS28-CRP score (<2.6, 2.6 to ≤3.2, >3.2) and SDAI (≤3.3, >3.3 to ≤11, >11).
Methods In GO-BEFORE, 637 MTX-naïve pts with active RA were randomized to placebo (PBO)+MTX, golimumab (GLM)100mg +PBO, GLM 50mg+MTX, or GLM 100mg+MTX. Most PBO+MTX pts crossed over to GLM 50mg+MTX at wk52. In this analysis, pts were grouped by their treatment target status at wk24 using DAS28-CRP score (<2.6, 2.6 to ≤3.2, >3.2) and SDAI (≤3.3, >3.3 to ≤11, >11). Efficacy outcomes at 5 years (wk256) were evaluated for these mutually exclusive groups using observed data,
Results At wk24, 150 pts had DAS28-CRP <2.6, 85 had DAS28-CRP 2.6 to ≤3.2, and 368 had DAS28-CRP >3.2. Of these, 23%, 31%, and 31%, respectively, discontinued treatment before wk256; 3%, 2%, and 3%, respectively, were due to lack of efficacy. Greater proportions of patients treated with GLM+MTX than patients treated with PBO+MTX improved from having DAS28-CRP >3.2 at wk24 to DAS28-CRP <2.6 at wk 52. Among pts achieving treatment targets at wk24, the majority either maintained a DAS28-CRP <2.6 (80%) or improved to DAS28-CRP<2.6 (72%) at week 256. Over 50% of pts with DAS28-CRP >3.2 at wk24 achieved treatment targets at wk256. Pts with DAS28-CRP≤3.2 at wk 24 had less progression in vdH-S scores and lower HAQ, SJC, TJC, pain, and pt/physician global assessment of disease (GAD) scores at wk 256 vs. patients with DAS28-CRP >3.2 at wk 24 (Table). Also, pts with DAS28-CRP 2.6 to ≤3.2 at wk24 had higher TJC (but not SJC), pain, and pt/physician GAD scores at wk256 than pts with DAS28-CRP <2.6 at wk 24. HAQ and change in vdH-S at wk256 were not significantly different between pts who achieved either DAS28-CRP <2.6 or DAS28-CRP 2.6 to ≤3.2 at wk 24. Of note, CRP levels at wk256 were similar among the three groups. Similar results were observed using SDAI scores (Table).
Conclusions In GO-BEFORE, the majority of patients who achieved DAS28-CRP or SDAI score treatment targets at wk24 maintained or had improvement in clinical response at 5 years. At wk 256, efficacy outcomes, including clinical, functional, and radiographic scores, but not CRP level, at wk256 were significantly better among pts who had achieved DAS28-CRP <2.6 at wk24 vs pts with DAS28-CRP >3.2 at wk24. More subjective outcomes (TJC, pain, and pt/physician GAD) were also better at wk 256 for pts with DAS28-CRP <2.6 at wk 24 vs pts with DAS28-CRP 2.6 to ≤3.2 at wk24.
Disclosure of Interest P. Emery Grant/research support from: Janssen R&D, LLC., Consultant for: Janssen R&D, LLC., R. Fleischmann Grant/research support from: Janssen R&D, LLC., Consultant for: Janssen R&D, LLC., S. Xu Employee of: Janssen R&D, LLC., E. Hsia Employee of: Janssen R&D, LLC.
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