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Abstract Number: 2743

Treatment Target Status at 6 Months and Long-Term Outcomes at 5 Years: Analysis of Methotrexate-Naïve Patients with Rheumatoid Arthritis

Paul Emery1, Roy Fleischmann2, Stephen Xu3 and Elizabeth C. Hsia3,4, 1Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds Institute of Molecular Medicine and LMBRU, Leeds, United Kingdom, 2Rheumatology, Metroplex Clinical Research Center, Dallas, TX, 3Janssen Research & Development, LLC, Spring House, PA, 4University of Pennsylvania, Philadelphia, PA

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: rheumatoid arthritis (RA) and treatment

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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

 

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


Disclosure: P. Emery, Janssen R & D, LLC, 2; R. Fleischmann, Janssen R & D, LLC, 2; S. Xu, Janssen R & D, LLC, 3; E. C. Hsia, Janssen R & D, LLC, 3.

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 .
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