Session Information
Date: Sunday, November 8, 2015
Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy Poster I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Tumor necrosis factor inhibitors (TNFi) have helped patients achieve remarkable outcomes as in improving synovitis and halting structural damages in severe cases of rheumatoid arthritis (RA). Nowadays academic interests lie towards strategies of ‘tapering’ or ‘discontinuing’ biological therapy, especially in cases where patients are being maintained in clinical remission for an adequate period. However, not many studies have traced the outcomes after discontinuing TNFi.
Methods: The ‘Investigation of outcomes after Golimumab discontinuation’ or GOLD study, is an observational study participated by 10 centers nationwide, following up clinical data of Korean RA patients who were enrolled in the 5-year extension study of GO-BEFORE and GO-FORWARD. Medical records of the 2-year post-golimumab period were reviewed and pertinent clinical data including DAS scores, prescriptions, comorbidities, laboratory findings, as well as radiographic images were analyzed.
Results: The 60 RA patients (male 5, female 55) had the following mean values at discontinuation (baseline); age of 51.0 years, disease duration of 16.5 years, and a DAS28-CRP score of 2.71. At the 2-year time point, 9/60 (15%) patients had restarted biologics. The mean period restarting biologics was 18.7 months (range 4~28) after discontinuation. Baseline characteristics of the ‘biologic restarters’ and ‘non-biologic users’ are depicted in the table. New joint damage was discovered only in non-biologic users (4/51 patients) at 2 years.
Conclusion: The GOLD study based on ‘deliberate’ discontinuation of TNFi in RA patients with low disease activity shows that patients with higher swollen joint counts, physician’s global assessment score at the time point of discontinuation tend to restart biologics in the near future. New joint damage ensued only in those off biologics.
Table. Baseline characteristics between the 2 groups at discontinuation*
|
Biologic Restarters (n= 9) |
Non-biologic Users (n= 51) |
P value |
Age, years |
49.9 |
51.2 |
0.73 |
ACR20, % |
66 |
82 |
0.27 |
ACR50, % |
44 |
55 |
0.56 |
ACR70, % |
44 |
31 |
0.44 |
DAS remission, % |
33 |
53 |
0.27 |
Rheumatoid factor, % |
89 (8/9) |
47 (24/51) |
0.16 |
Anti-CCP, % |
100 |
100 |
– |
Swollen joint count, n |
10.1 |
1.7 |
< 0.01 |
Tender joint count, n |
10.7 |
3.8 |
0.28 |
Patient’s global assessment (0-10) |
4.25 |
3.27 |
0.29 |
Physician’s global assessment (0-10) |
3.21 |
1.69 |
0.05 |
HAQ |
1.291 |
0.666 |
0.15 |
C-reactive protein, mg/dL |
0.34 |
0.52 |
0.07 |
Erythrocyte sedimentation rate, mm/hr |
41.5 |
32.2 |
0.42 |
DAS28-CRP |
3.18 |
2.65 |
0.29 |
DAS28-ESR |
4.18 |
3.27 |
0.17 |
Patient’s with bone erosion, % |
88 (7/8) |
49 (25/51) |
0.12 |
Patient’s with joint space narrowing, % |
75 (6/8) |
47 (24/51) |
0.44 |
Mean values are presented.
*Based on whether biologic had been restarted within 2 years after golimumab discontinuation
To cite this abstract in AMA style:
Shin K, Kwon HM, Kang SW, Park W, Park SH, Suh CH, Kim HA, Lee SG, Lee CK, Bae SC, Lee SK, Song YW. Outcomes after Discontinuing Tumor Necrosis Factor Inhibitor in Rheumatoid Arthritis: 2 Years of ‘post-Golimumab’ after Completion of the 5-Year Extension Study in Korea [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/outcomes-after-discontinuing-tumor-necrosis-factor-inhibitor-in-rheumatoid-arthritis-2-years-of-post-golimumab-after-completion-of-the-5-year-extension-study-in-korea/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/outcomes-after-discontinuing-tumor-necrosis-factor-inhibitor-in-rheumatoid-arthritis-2-years-of-post-golimumab-after-completion-of-the-5-year-extension-study-in-korea/