Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Frequency and Duration of Drug-Free Remission After One Year of Treatment with Etanercept Vs. Sulfasalazine in Early Axial Spondyloarthritis 2 Year Data of the ESTHER Trial.
Song1, In-Ho, Hermann2, Kay-Geert, Haibel1, Hildrun, Althoff2, Christian, Poddubnyy1, Denis, Listing3, Joachim, Weibeta3, Anja
Charité Medical University, Campus Benjamin Franklin, Berlin, Germany
Charite Medical School, Berlin, Germany
German Rheumatism Research Centre, Berlin, Germany
University of Pennsylvania, Philadelphia, PA
Ev. Krankenhaus Hagen-Haspe, Hagen, Germany
Background/Purpose:
In patients with early axial spondyloarthritis (SpA) with a disease duration of < 5 years and with active inflammation on magnetic resonance imaging (MRI) in the spine and/or sacroiliac joints (SIJ) on baseline who were treated with etanercept (ETA, n= 40) vs. sulfasalazine (SSZ, n= 36) for 48 weeks [1] to assess: a) the frequency and duration of drug-free remission and b) the efficacy of ETA after flare, and c) long-term response of ETA during year 2 in already ETA-treated patients (ETA treatment in year 1 and year 2).
Methods:
At week 48, patients who reached study remission (defined as reaching ASAS remission and being free of active inflammation on whole-body-MRI in the spine and sacroiliac joints) were followed every 6 weeks without active treatment. In case of a flare (defined as a BASDAI increase of 2 points compared to week 48) all patients were (re-)treated with ETA for another year up to week 108. Patients who were in study remission at week 48 and who did not flare were excluded from the study at the end of year 2 (permanent drug-free remission). All patients who were not in study remission at week 48 were treated with ETA in year 2.
Results:
Study remission at week 48 was reached significantly more often by ETA- compared to SSZ-treated patients (13/40= 33% vs. 4/36= 11%, p= 0.03). Among patients reaching study remission (n= 17) 70% belonged to the non-radiographic axial SpA group and 30% to the AS group. 23% (9/40) of the ETA-group flared after a mean of 24.4 weeks and 8% (3/36) of the SSZ-group flared after 39.6 weeks (no significant difference for time to flare between both groups).Thus, 8% (3/40) of ETA-treated patients vs. 3% (1/36) of SSZ-treated patients reached drug-free remission. After initiation of ETA during year 2, flare-patients (n= 9) showed a significant (p< 0.001) response to ETA-treatment (table 1): 56% of flare-patients reached ASAS remission and 44% study remission as well as ASDAS inactive disease at week 108.
Formerly ETA-treated patients (n= 22) who did not reach study remission at week 48 showed a good sustained clinical and MRI response at week 108 (50% ASAS remission; 5 additional patients reached ASAS remission at week 108 who were not in remission at week 48; table 1).
Table 1.
| Remission-Flare Group | Remission-Flare Group | Non-Remission-Group | Non-Remission-Group | ||
|---|---|---|---|---|---|
| Parameter (mean and standard deviation) | Study time point | ETA year 1- ETA year 2 (n= 9) | SSZ year 1- ETA year 2 (n= 3) | ETA year 1- ETA year 2 (n= 22) | SSZ year 1- ETA year 2 (n= 26) |
| BASDAI | Baseline | 5.7 (1.8) | 5.9 (1.6) | 5.4 (1.1) | 5.9 (1.2) |
| BASDAI | Week 48 | 1.1 (0.6) | 2.0 (1.0) | 2.6 (1.7) | 4.7 (2.3) |
| BASDAI | Flare time point | 5.0 (1.5) | 4.5 (0.4) | Not applicable | Not applicable |
| BASDAI | Week 108 | 1.5 (1.4) | 1.7 (1.6) | 2.7 (2.3) | 3.2 (2.6) |
| MRI SIJ | Baseline | 12.0 (6.4) | 3.2 (3.9) | 8.6 (7.3) | 6.5 (5.8) |
| MRI SIJ | Week 48 | 1.1 (1.4) | 0 (0) | 2.4 (3.3) | 2.7 (3.2) |
| MRI SIJ | Week 108 | 0.4 (0.5) | 0 (0) | 2.9 (3.7) | 1.6 (2.0) |
| MRI Spine | Baseline | 0.2 (0.7) | 0.7 (1.2) | 3.4 (5.6) | 1.3 (2.5) |
| MRI Spine | Week 48 | 0 (0) | 0 (0) | 1.3 (1.9) | 1.0 (1.9) |
| MRI Spine | Week 108 | 0 (0) | 0.3 (0.6) | 1.0 (1.7) | 0.7 (1.6) |
| ASAS remission, % (n) | Week 108 | 56% (5/9) | 67% (2/3) | 50% (11/22) | 23.1% (6/26) |
| MRI remission, % (n) | Week 108 | 56% (5/9) | 67% (2/3) | 13.6% (3/22) | 26.1% (6/23) |
| Study remission, % (n) | Week 108 | 44% (4/9) | 33% (1/3) | 14% (3/22) | 8% (2/26) |
| ASDAS inactive disease (<1.3) | Week 108 | 44% (4/9) | 66.7% (2/3) | 38.1% (8/21) | 28.0% (7/25) |
Conclusion:
After one year of treatment with ETA 33% of patients with early axial SpA reached study remission, however 23% flared within 24 weeks while only 8% stayed in drug-free remission. Patients treated with ETA for 2 years showed continuously low disease activity with further improvement in a subgroup of patients.
[1]Song, I.-H. et al. 2011. Ann Rheum Dis. 2011 Apr;70(4):590–6.
To cite this abstract, please use the following information:
Song, In-Ho, Hermann, Kay-Geert, Haibel, Hildrun, Althoff, Christian, Poddubnyy, Denis, Listing, Joachim, et al; Frequency and Duration of Drug-Free Remission After One Year of Treatment with Etanercept Vs. Sulfasalazine in Early Axial Spondyloarthritis 2 Year Data of the ESTHER Trial. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2534
DOI:
