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
On behalf of the Society for Rheumatology Research Utrecht (SRU)
Background/Purpose: To investigate the frequency of long-term adverse events (AEs) in early rheumatoid arthritis (RA) patients treated additionally with prednisone 10 mg/day.
Methods: In the Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA) II trial patients initiated treatment with methotrexate (MTX) with 10 mg/d prednisone or placebo for 2 years; the trial was tight-controlled aiming for remission. Thereafter, patients were followed according to a protocol in clinical care. The occurrence of adverse events (AEs) with onset after the 2 year trial period as well as the use of prednisone after the end of the 2 year trial period, when it was the strategy to taper and stop the prednisone, was collected retrospectively from the patient medical charts. For the patients in the former prednisone strategy (pred), the proportion of patients who discontinued prednisone and time until discontinuation of prednisone was described. The frequency of long-term AEs in the pred group versus the former placebo strategy (plac) was analyzed using Fisher’s Exact tests.
Results:
Of the 236 patients included in the CAMERA-II trial, follow-up data was available of 118 patients (4 of 7 participating centers; data of the other patients are being collected): pred N=57, plac N=61; no longer followed according to protocol N=17. The median (IQR) follow-up time after the end of the 2-year trial period was 83 (61-100) and 79 (65-95) months, respectively. 49 (86%) patients treated with prednisone discontinued prednisone after median (IQR) 12 (3-88) months after the trial period. The other patients could not discontinue prednisone due to an increase in RA disease activity when tapering prednisone. The number (%) of AEs are described in Table 1. No statistically significant difference between the two groups was found for any of the AEs, except for cardiovascular diseases; there was a trend toward increased mortality.
|
Table 1. Frequency of adverse events in the pred vs plac groups |
|||
|
Adverse event (AE) |
pred N=57 |
plac N=61 |
p-value |
|
≥ 1 AE, n (%) |
23 (40.4) |
22 (36.1) |
0.71 |
|
Hypertension, n (%) |
2 (3.5) |
7 (11.5) |
0.17 |
|
Diabetes mellitus II, n (%) |
1 (1.8) |
1 (1.6) |
1.00 |
|
Gastrointestinal, n (%) |
1 (1.8) |
0 (0.0) |
0.48 |
|
Cataract, n (%) |
5 (8.8) |
7 (11.5) |
0.76 |
|
Glaucoma, n (%) |
0 (0.0) |
0 (0.0) |
– |
|
Fracture, n (%) |
7 (12.3) |
8 (13.1) |
1.00 |
|
Cardiovascular, n (%) |
10 (17.5) |
3 (4.9) |
0.04 |
|
Mortality, n (%) |
6 (10.5) |
1 (1.6) |
0.06 |
Conclusion: Overall, a low occurrence of AEs was found in this preliminary study, but we found an increased cardiovascular risk for the early RA patients treated at least during 2 years with 10mg/d prednisone.
To cite this abstract in AMA style:
de Hair M, IJff N, Jacobs J, van Laar J. Long-Term Adverse Events after Daily Concomitant Treatment with 10mg Prednisone in the 2-Year Computer Assisted Management in Early Rheumatoid Arthritis Trial-II [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/long-term-adverse-events-after-daily-concomitant-treatment-with-10mg-prednisone-in-the-2-year-computer-assisted-management-in-early-rheumatoid-arthritis-trial-ii/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-adverse-events-after-daily-concomitant-treatment-with-10mg-prednisone-in-the-2-year-computer-assisted-management-in-early-rheumatoid-arthritis-trial-ii/