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SAT0162 Treatment Target Status at 6 Months and Long-Term Outcomes at 5 Years: Analysis of Methotrexate-Naïve Patients with Rheumatoid Arthritis in the GO-BEFORE Trial
  1. P. Emery1,2,
  2. R. Fleischmann3,
  3. S. Xu4,
  4. E.C. Hsia4,5
  1. 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, Univ of Leeds
  2. 2NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
  3. 3Metroplex Clinical Research Center, Univ of Texas Southwestern Medical Center, Dallas
  4. 4Janssen R&D, LLC., Spring House
  5. 5Univ of Pennsylvania, Philadelphia, United States

Abstract

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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