Session Information
Date: Sunday, November 13, 2016
Title: Rheumatoid Arthritis – Clinical Aspects - Poster I: Clinical Characteristics/Presentation/Prognosis
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: The commonly used version of the 28-joint disease activity score based on C-reactive protein (DAS28-CRP4) includes swollen and tender joint counts (S/TJC), CRP and the patient global assesment of disease activity (PGA), while the 3-component version (DAS28-CRP3) does not include PGA. We examined whether these two instruments can be used interchangeably, and if assessment of disease activity status and treatment response to a tumor necrosis factor inhibitor (TNFi), such as originator adalimumab (ADA) in patients (pts) with rheumatoid arthritis (RA), differs.
Methods: This post hoc analysis used data from five randomized controlled trials: PREMIER, OPTIMA and CONCERTO enrolled pts with early RA who were MTX- and TNFi-naïve; DE019 and MUSICA enrolled pts with established RA and an inadequate response to MTX. The correlation between the two versions was calculated by Pearson correlation coefficients. The change from baseline in DAS28-CRP3 and DAS28-CRP4, and the number of patients reaching low disease activity (LDA, DAS28-CRP ≤3.2) or DAS28-CRP <2.6, was assessed at Weeks 12 and 24/26. Data from pts with non-missing DAS28-CRP-3 and -4 is included, pooled across trials by randomized treatment into ADA+ MTX, or placebo (PBO)+MTX.
Results: The DAS28-CRP3 and -4 versions showed a strong correlation (0.98, p<0 .001) for pts receiving MTX or ADA+MTX across all 5 trials, at both Week 12 and 24/26. Overall, in both treatment groups, most pts who achieved DAS28-CRP3 <2.6 (or LDA), also achieved DAS28-CRP4 <2.6 (or LDA) at both Week 12 and 24/26 (Table 1). Both versions were comparably responsive, with similar changes from baseline for pts in either treatment group, similar treatment differences, and response rate differences between pts receiving ADA+MTX and pts on PBO+MTX at Weeks 12 (Table 2) and 24 (not shown).
Conclusion: While the patient perspective is important, when PGA is not available, the DAS28-CRP3 score is able to provide an assessment of disease activity which correlates highly with the DAS28-CRP4 version.
| Table 1. Patients who achieved DAS28-CRP <2.6 or LDA by the 3-component or 4-component versions at Weeks 12 and 24 | ||||
|
Week 12 |
Week 24 |
|||
|
Patients with DAS3 <2.6 |
Patients with DAS3<2.6 but not DAS4 <2.6 |
Patients with DAS3 <2.6 |
Patients with DAS3<2.6 but not DAS4 <2.6 |
|
| PBO + MTX |
69 |
8/69 (11.6) |
127 |
4/127 (3.1) |
| ADA 40 mg + MTX |
193 |
14/193 (7.3) |
248 |
10/248 (4.0) |
|
|
||||
|
Patients with DAS3 LDA |
Patients in DAS3 but not DAS4 LDA |
Patients with DAS3 LDA |
Patients in DAS3 but not DAS4 LDA |
|
| PBO + MTX |
148 |
13/148 (8.8) |
213 |
14/213 (6.6) |
| ADA 40 mg + MTX |
346 |
19/346 (5.5) |
424 |
16/424 (3.8) |
| Table 2. Change from Baseline measured by the 3-component (ΔDAS3) or 4-component (ΔDAS4) versions of the score at Week 12 | ||||
|
ΔDAS3 |
treatment difference |
ΔDAS4 |
treatment difference |
|
| PBO + MTX |
-1.4 |
-0.7**** |
-1.6 |
-0.8**** |
| ADA 40 mg + MTX |
-2.1 |
|
-2.4 |
|
| LDA response rate measured by the 3-component (DAS3) or 4-component (DAS4) versions at Week 12 | ||||
|
DAS3 |
response rate difference |
DAS4 |
response rate difference |
|
| PBO + MTX |
15.3 |
19.7**** |
16.4 |
19.8**** |
| ADA 40 mg + MTX |
34.9 |
|
36.3 |
|
| DAS28-CRP <2.6 response rate measured by the 3-component (DAS3) or 4-component (DAS4) versions at Week 12 | ||||
|
DAS3 |
response rate difference |
DAS4 |
response rate difference |
|
| PBO + MTX |
7.1 |
12.4**** |
7.8 |
14.1**** |
| ADA 40 mg + MTX |
19.5 |
|
21.9 |
|
| **** p<0.001 | ||||
To cite this abstract in AMA style:
Breedveld F, Wang X, Cardoso A, Keystone E. The Relative Performance of 28-Joint Disease Activity Score Based on C-Reactive Protein with Three Versus Four Components in Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/the-relative-performance-of-28-joint-disease-activity-score-based-on-c-reactive-protein-with-three-versus-four-components-in-patients-with-rheumatoid-arthritis/. Accessed .ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-relative-performance-of-28-joint-disease-activity-score-based-on-c-reactive-protein-with-three-versus-four-components-in-patients-with-rheumatoid-arthritis/