Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
While synthetic or biologic disease-modifying antirheumatic drugs (DMARDs) are often effective, treatment with such agents does not adequately control disease activity in all patients. Early identification of those unlikely to achieve long-term therapeutic goals is a clinically relevant strategy that may allow for appropriate modification in patient management to achieve optimal outcomes. The objective of this subanalysis was to determine disease characteristics of patients with moderately active RA responsive (defined by achievement of DAS28<2.6) and non-responsive to treatment with etanercept (ETN) plus methotrexate (MTX) after 36 weeks in the PRESERVE study.
Methods
In the induction phase of PRESERVE, subjects with moderately active RA (DAS28 >3.2 and ≤5.1) despite stable doses of oral MTX received open-label ETN 50 mg QW plus MTX (titrated to ≤25 mg/week as needed through week 28) for 36 weeks. Baseline demographic and disease characteristics and treatment response (DAS28, CDAI, HAQ) were compared in responders (defined as patients with DAS28<2.6) and non-responders (DAS28 ≥2.6) at week 36. Analyses using observed cases (OC) were conducted in all patients who received ≥1 ETN/MTX dose (mITT population).
Results
Of 764 patients receiving ETN50/MTX, 515 (67.4%) were classified as responders and 249 (32.6%) as non-responders at week 36. At baseline, responders were significantly younger (46.9 vs 50.9 years, P<0.001) with a lower BMI (25.4 vs 26.4, P=0.008) compared with non-responders. Responders also had significantly lower ESR (21.2 vs 24.7, P<0.001), CRP (11.4 vs 14.4, P=0.02), DAS28 (4.3 vs 4.5, P<0.001), CDAI (17.5 vs 18.3, P<0.001) and HAQ (1.1 vs 1.3, P<0.001) values than non-responders at baseline. Among responders and non-responders, significant changes from baseline in DAS28, CDAI and HAQ were observed at Week 4 and at all time-points up to Week 36 (all P<0.0001). Reductions in DAS28, CDAI, and HAQ were significantly greater among responders than non-responders after 4 weeks and this difference between groups was maintained for all clinical outcomes for the duration of the study period (Table).
|
Table: Differences in disease characteristics at baseline (BL) and week 36 in responders and non-responders to ETN50/MTX at week 36 (OC) |
||||
|
Characteristic |
Mean (SD)/Adjusted Mean Change (SE) |
Mean Difference |
P Value |
|
|
Responders |
Non-Responder |
|||
|
DAS28 at BL |
4.3 (0.4) |
4.5 (0.4) |
|
<0.001 |
|
Week 36 |
1.9 (0.5)/-2.5 (0.03) |
3.4 (0.9)/-1.0 (0.04) |
-1.5 (-1.6, -1.4) |
<0.0001 |
|
CDAI at BL |
17.5 (4.8) |
18.3 (5.2) |
|
<0.001 |
|
Week 36 |
3.5 (2.6)/-14.2 (0.2) |
10.7 (7.5)/-7.2 (0.3) |
-7.0 (-7.7, -6.3) |
<0.0001 |
|
HAQ at BL |
1.1 (0.6) |
1.3 (0.6) |
|
<0.001 |
|
Week 36 |
0.4 (0.5)/-0.7 (0.02) |
0.9 (0.6)/-0.3 (0.03) |
-0.4 (-0.5, -0.4) |
<0.0001 |
Conclusion
In the PRESERVE trial, patients with moderately active RA who achieved DAS28<2.6 after treatment with ETN plus MTX showed lower disease activity and functional improvement at baseline than those patients who did not achieve treatment target. Understanding the difference between responders and non-responders may help guide treatment practices and provide the best therapeutic options to these different patient sub-types.
Disclosure:
J. Smolen,
Abbvie, BMS, Janssen, MSD, Pfizer, UCB,
2,
Abbvie, Amgen, Astra-Zeneca, Astro, BMS,Celgene, Glaxo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Samsung, UCB,
5;
D. Collier,
Amgen,
3,
Amgen,
1;
A. Szumski,
Pfizer Inc,
3;
H. Jones,
Pfizer Inc,
3;
L. Marshall,
Pfizer Inc,
1.
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