Session Information
Date: Tuesday, November 10, 2015
Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster III
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: 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. 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).
Conclusion: 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.
|
Table. Efficacy outcomes at week 256 according to DAS28-CRP and SDAI treatment target status at week 24 |
|||
|
|
Treatment Target Status at Week 24 |
||
|
Outcome at week 256 |
DAS28-CRP <2.6
|
DAS28-CRP 2.6 to ≤3.2
|
DAS28-CRP >3.2
|
|
Pts |
115 |
59 |
253 |
|
HAQ |
0.35 ± 0.44 |
0.48 ± 0.60 |
0.90 ± 0.67* |
|
Change in vdH-S |
0.73 ± 3.49 |
0.11 ± 1.93 |
1.91 ± 6.34** |
|
SJC |
0.80 ± 1.60 |
1.53 ± 2.95 |
2.61 ± 4.60* |
|
TJC |
1.44 ± 3.68 |
2.79 ± 4.28** |
7.00 ± 10.09* |
|
CRP |
0.57 ± 0.65 |
0.60 ± 0.97 |
0.71 ± 0.90 |
|
Pain VAS |
1.20 ± 1.72 |
1.89 ± 2.08** |
3.00 ± 2.36* |
|
Pt Global Disease Assessment |
1.20 ± 1.58 |
1.79 ± 2.05** |
3.04 ± 2.37* |
|
Physician Global Disease Assessment |
0.55 ± 0.76 |
1.09 ± 1.40** |
1.64 ± 1.66* |
|
Data presented as mean ±SD. *p<0.0001 vs. pts with DAS28-CRP <2.6. **p<0.05 vs. pts with DAS28-CRP <2.6 |
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|
|
Treatment Target Status at Week 24 |
||
|
Outcome at week 256 |
SDAI ≤3.3
|
SDAI 3.3 to ≤11
|
SDAI >11
|
|
Pts, n |
56 |
130 |
241 |
|
HAQ |
0.24 ± 0.33 |
0.48 ± 0.57** |
0.92 ± 0.67* |
|
Change in vdH-S |
0.55 ± 3.22 |
0.67 ± 3.84 |
1.91 ± 6.24** |
|
SJC |
0.60 ± 1.47 |
1.34 ± 3.11 |
2.63 ± 4.46* |
|
TJC |
1.44 ± 3.60 |
2.24 ± 4.83** |
7.17 ± 10.10* |
|
CRP |
0.63 ± 0.75 |
0.63 ± 0.88 |
0.69 ± 0.86 |
|
Pain VAS |
0.73 ± 1.20 |
1.80 ± 2.11* |
3.04 ± 2.33* |
|
Pt Global Disease Assessment |
0.72 ± 0.96 |
1.77 ± 2.07* |
3.09 ± 2.34* |
|
Physician Global Disease Assessment |
0.50 ± 0.83 |
0.78 ± 1.12** |
1.72 ± 1.66* |
|
Data presented as mean ±SD. *p<0.0001 vs. pts with SDAI ≤3.3. **p<0.05 vs. pts with SDAI ≤3.3 |
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To cite this abstract in AMA style:
Emery P, Fleischmann R, Xu S, Hsia EC. Treatment Target Status at 6 Months and Long-Term Outcomes at 5 Years: Analysis of Methotrexate-Naïve Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/treatment-target-status-at-6-months-and-long-term-outcomes-at-5-years-analysis-of-methotrexate-naive-patients-with-rheumatoid-arthritis/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/treatment-target-status-at-6-months-and-long-term-outcomes-at-5-years-analysis-of-methotrexate-naive-patients-with-rheumatoid-arthritis/