Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Two-Year Radiographic Results from the TEAR Trial.

Moreland7,  Larry W., O'Dell9,  James R., Paulus1,  Harold E., Curtis8,  Jeffrey R., Bathon3,  Joan M., Clair2,  E. William St, Bridges6,  S. Louis

Encino, CA
Duke University, Durham, NC
Johns Hopkins Univ Ste, Baltimore, MD
Leiden University Medical Center, Meerssen, The Netherlands
The University of Alabama at Birmingham
Univ of Alabama-Birmingham, Birmingham, AL
Univ of Pittsburgh Med Ctr, Pittsburgh, PA
University of Alabama-Birmingham, Birmingham, AL
University of Nebraska Medical Center, Omaha, NE

Statement of Purpose:

To describe radiographic results of the Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) Trial, two-year, longitudinal, multi-center, randomized clinical trial that enrolled 755 early rheumatoid arthritis (RA) participants, comparing immediate combination treatment groups versus step-up from methotrexate (MTX) alone.

Figure 1. TEAR Study Protocol

*For SE: ETN or ST: SSZ + HCQ added at week 24 if DAS >= 3.2.

**X-Rays of hands and feet at BL = Baseline, Weeks 48 and 102.

Methods:

Participants that were enrolled in TEAR from 2004–2007 with early RA (<=3 years). In addition to demographic and clinical measures, hand/foot radiographs were obtained at weeks 0, 48 and 102 and scored using the modified Sharp/van der Heijde scoring system.

Results:

A total of 755 participants were enrolled in TEAR with 476 (63%) completing 102 weeks. As of June 2010: 474 (99.6%) baseline films and 297 completed films sets have been scored (62% of all completers). At baseline, the mean radiographic score was 6.2±15.0 units (median 2, IQR 0.5–6.0) and 22.2% had no damage (p = 0.30 by treatment group); 25.7% had no erosions, 66.9% had no joint space narrowing (p = 0.15 by group). The 297 with week 0 and 102 scores had a mean baseline score 5.4±12.7 (median 2, IQR 0.5–6.0, similar to entire cohort, p = 0.11); 19.5% had no damage.

Table 1. Mean Radiographic Scores for Completers Cohort (N=297)

  Observed Mean ± SD (% without damage)Baseline Adjusted Change, Week 102-0
GroupNWeek 0Week 102Mean ± SD95% CIp-value
IE1057.2 ± 19.8 (21.9)7.9 ± 20.5 (11.5)0.6 ± 4.2-0.6, 1.70.6884
IT454.4 ± 5.5 (17.8)7.1 ± 14.8 (11.4)2.7 ± 12.60.9, 4.5 
SE1064.1 ± 5.8 (20.8)4.7 ± 6.1 (8.0)0.6 ± 2.1-0.8, 1.8 
ST415.3 ± 7.2 (12.2)7.4 ± 10.1 (4.0)2.1 ± 6.40.2, 4.0 
By Treatment Only
ETN + MTX2115.7 ± 14.5 (21.3)6.2 ± 15.2 (9.7)0.6 ± 3.3-0.2, 1.40.0180
TT864.9 ± 6.3 (15.1)7.3 ± 12.7 (7.7)2.4 ± 10.11.1, 3.7 
By Timing Only
Immediate1506.4 ± 16.8 (20.7)7.6 ± 19.0 (11.5)1.6 ± 7.70.6, 2.60.8059
Step-Up1474.5 ± 6.1 (18.4)5.4 ± 7.5 (6.7)1.4 ± 3.90.4, 2.5 
All2975.4 ± 12.7 (19.5)6.5 ± 14.5 (14.5)1.1 ± 6.10.4, 1.8NA

At week 102, the completers cohort had a mean score 6.5±14.5 (median 3, IQR 1.0–7.5), 9.1% had no damage; 10.8% with no erosions, 40.3% with no joint space narrowing. The mean increase from week 0 to 102 was 1.1±6.1 (median 0, IQR 0–1.0) and was not different across the four groups (p=0.69). When only treatment is considered, pooling the two etanercept (ETN) groups and the two triple therapy (TT) groups, to assess main effects, there was a significant difference between those receiving ETN + MTX and TT (increase of 0.6 vs 2.4, respectively; p=0.02). There was no difference by the timing of treatment (immediate versus step-up, p=0.81). The difference between ETN + MTX and TT was also observed in the subgroup of individuals with baseline radiographic damage score > 0 (increase of 0.6 vs 2.8, p=0.02). There was no change at week 102 among patients with no damage at week 0. In addition, 71.4% of participants achieved radiographic remission (change <= 0.5), which was not different by the timing or type of treatment. The remaining 38% of x-rays for trial completers are in the process of being scored.

Conclusions:

While prior TEAR results showed no significant differences in clinical findings as assessed by DAS28, this preliminary analysis showed that treatment with ETN + MTX resulted in statistically significant radiographic benefit over TT, regardless of timing of treatment. All results to be updated to the full 476 completion cohort.

To cite this abstract, please use the following information:
Moreland, Larry W., O'Dell, James R., Paulus, Harold E., Curtis, Jeffrey R., Bathon, Joan M., Clair, E. William St, et al; Two-Year Radiographic Results from the TEAR Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1368
DOI: 10.1002/art.29134

Abstract Supplement

Meeting Menu

2010 ACR/ARHP