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.
Treating to Target with TNFi in Active Established Rheumatoid Arthritis Results in Longer Drug Survival Than Routine Care with TNFi: Results from the Optimization of Humira RCT.
Pope4, Janet E., Thorne3, J. Carter, Haraoui2, Boulos, Sampalis1, John
This randomized trial in active RA receiving adalimumab was done to determine if targeted outcomes yielded better results than routine care in established RA and to determine if treating to no swollen joints (0SJC) would be more effective than treating to a DAS<3.2. Drug survival was studied, as the withdrawal rate for TNFi in RA is 20 to 30% annually for the first two years; then decreases thereafter.
The Optimization of Humira trial was a real-life 18 months RCT in patients with established active RA.; with randomization to: routine care (RC), or treating to clinical target (low DAS28<3.2 or 0/28 SJC). The primary outcome measure was the change in DAS28 at 12 months. Sample size was calculated to show a difference between RC and more intensive (targeted) care, allowing 20% to be previously TNFi experienced.
309 patients were enrolled. Mean age was 54 years, 80% were female, mean baseline DAS28 was 5.9 and the mean number of previous DMARDs used was 2.7. There were no between groups differences at baseline except for past number of DMARDS used (RC=2.6, DAS=2.9, 0SJC=2.5, p=0.02) and 0SJC was younger (51.5). More medication changes for RA (#/100 pt-months) occurred in 0SJC group: 3.3 in RC, 5.1 in DAS and 6.2 in 0SJC, P<0.035). 91% of completers were satisfied with treatment at 12 months. Targeted treatment resulted in faster improvement, but RC eventually caught up. At 6 months the change in DAS was -1.9 in RC, =2.4 in DAS and -2.0 in 0 SJC. At 12 months it was -2.4, -2.7 and -2.2 and 18 months: -2.5, -2.7. -2.1. The drop out was 52% in routine care, 27% in the DAS and 22% in the 0 SJC (p=0.001). Drop out due to adverse events was 8% in RC, 12% in DAS and 4% in 0SJC (p=0.018). The median time to DAS<3.2 was 368 in RC, 189 days in DAS and 371 days in 0SJC. Median time to good/moderate EULAR response was 185 days for RC, 76 days for DAS and 93 days for 0SJC (p=0.0002). More in intensive care achieved DAS<2.6 (p=NS). The figure shows time to DAS<3.2. The table demonstrates the markedly different drop outs between routine care and intensive care.
Treating to target with the same TNFi therapy in established RA may not alter the outcomes vs. routine care for DAS<3.2 by 18 months for those continuing treatment but the drop out rate with treating to a target is very low. A, low disease state occurs earlier in targeted care. The target of 0SJC may be feasible in established RA starting antiTNF treatment but does not look superior to DAS target.
|# of patients at baseline||109||100||99|
|Total # of patients discontinued||57 (52.3)||27 (27)||22 (22.2)|
|# of patients discontinued according to visit: n (%)||Visit 2||1 (0.9)||4 (4.0)||0 (0.0)||Overall: P<0.001 RC vs. DAS: P<0.001 RC vs. 0 SJC: P<0.001 DAS vs. 0 SJC: P=0.434|
|Visit 4||9 (8.3)||3 (3.0)||2 (2.0)|
|Visit 6||10 (9.2)||11 (11.0)||6 (6.1)|
|Visit 9||7 (6.4)||1 (1.0)||7 (7.1)|
|Visit 12||20 (18.3)||8 (8.0)||7 (7.1)|
|Unknown||10 (9.2)||0 (0.0)||0 (0.0)|
|# of patients discontinued according to visit: n (%)||Lost to Follow-up||19 (17.4)||3 (3.0)||5 (5.1)||Overall: P=0.018 RC vs. DAS: P=0.014 RC vs. 0 SJC: P=0.130 DAS vs. 0 SJC: P=0.177|
|Withdrawal of Consent||6 (5.5)||5 (5.0)||6 (6.1)|
|Adverse Event||9 (8.3)||12 (12.0)||4 (4.0)|
|Protocol Violation||1 (0.9)||0 (0.0)||2 (2.0)|
|Other||22 (20.2)||7 (7.0)||5 (5.1)|
To cite this abstract, please use the following information:
Pope, Janet E., Thorne, J. Carter, Haraoui, Boulos, Sampalis, John; Treating to Target with TNFi in Active Established Rheumatoid Arthritis Results in Longer Drug Survival Than Routine Care with TNFi: Results from the Optimization of Humira RCT. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :344