EULAR 2016 | Daily Highlights
FIFTY PERCENT OF PATIENTS WHO TAPERED TNF-BLOCKERS WHILE IN STABLE REMISSION ARE ABLE TO MAINTAIN A TAPERED REGIMEN AT 3 YEAR: LONG TERM FOLLOW-UP EXTENSION OF THE STRASS TRIAL.Abstract: FRI0155
Authors: J. Sigaux1,*, F. Bailly1, L. Gossec1, T. Alfaiate 1, F. Gandjbakhch 1, V. Foltz 1, J. Morel 1, E. Dernis 1, P. Gaudin 1, O. Brocq 1, J.-M. Berthelot1, J.-C. Balblanc 1, X. Mariette 1, F. Tubach 1, B. Fautrel 1
Co Authors: 1STRASS investigator group, Paris, France
Step-down strategy of spacing anti-tumor necrosis factor (TNF) agents in patients with rheumatoid arthritis (RA) in remission are feasible in the context of randomized clinical trials (RCTs). However, we lack information on the long-term sustainability of a DAS driven step down strategy in clinical practice.
This long-term extension study of a tapering RCT (STRASS trial(1)) aimed to assess the rate of patients who maintained the tapered regimen of etanercept (ETA) or adalimumab (ADA) in the in S-arm (progressive injection spacing) and M-arm (full regimen) and to evaluate the rate of treatment switch for inefficacy during the 3 years following the trial.
This observational 36 months follow-up considered all patients who completed the STRASS RCT (1). During the follow-up, the physicians were completely free of therapeutic decision making. Physicians were contacted between April and October 2015 and the data on the 36-month period after the end of trial retrospectively collected. The co-primary outcomes were the rate of patients who were taking their initial biologic at tapered regimen and the switch rate for loss of efficacy or safety. Percentage of full regimen anti-TNF intake was calculated over the 3 first years after trial end in both arms, using data from 12-monthly follow-up time points.
96 patients (70.1% of patients completing the RCT) had follow-up data available up to 3 years. At the end of the STRASS RCT (Table), 72 (75%) were in LDA or remission: 47 (48.9%) were taking ETA, 35 (36.5%), ADA, 2 (2.1%) another biologic and 12 (12.5%) no biologic because of remission. In addition, amongst patients still on their initial TNF blockers, 59/80 (74%) were treated at full regimen, 21/80 (26%) at tapered regimen. 3 years later, 65/96 (67.7%) were still on their initial anti-TNF: 73.1% vs 61.4% respectively in M and S-arm, p=0.23), either at full regimen 36/96(38%), tapered regimen 29/96 (30%, 32% vs 29%, p=0.75), or completely stopped (11.5%: 5.8% vs 18.2%, p=0.06). 28 patients (29.2%, 25% vs 34.1%, p=0.33) had switched for another biologic. The mean percentage of full regimen of antiTNF over 3 years was 70.1±30.4%: respectively 74.3±28.2% vs 64.6±32.9% (p=0.19). DAS28-VS was not different between M and S-arm (2.42 vs 2.01 (p=0.23)).
Table. Disease activity and treatment strategy
|Initial M-arm (n=52)||Initial S-arm (n=44)|
|RCT end||LDA or remission, n (%)||42 (80.8)||30 (68.2)|
|Treatment spaced or no biologic, n (%)||0 (0)||33 (75.0)|
|At 3 years||LDA or remission, n (%)||31 (72.1)||27 (73.0)|
|Full dose of initial antiTNF, n (%)||23 (44)||13 (30)|
|Spacing initial antiTNF without stop, n (%)||15 (29)||14 (32)|
|No biologic, n (%)||3 (6)||8 (18)|
|Switch rate over 3 years due to relapse, n (%)||12 (32)||10 (20)|
Maintenance of anti-TNF was high (68% at 3 years) in this cohort of patients with established RA treated according to the treat-to-target paradigm, with no difference between the 2 initial RCT arms. More than 1/3 of patients were received tapered anti-TNF regimen. References
(1) Fautrel B, ARD 2016;75(1):59-67
Disclosure of Interest
In recent years, several trials have explored the possibility of tapering or spacing biologic DMARDs, in particular anti-TNFs. The data suggest that in RA patients in clinical remission reducing the bDMARD dose may be feasible, however most of these trials had limited follow-up (typically 6 or 12 months) and the real clinical question is whether or not we take any long-term risk for our patients by tapering these medication. This long-term extension study is interesting because it answers some of these concerns: First of all it shows that over the years, patients initially randomized to the anti-TNF ‘spacing arm’ do not require more bDMARDs or higher dosages then patients who were kept on standard anti-TNF dosage. In fact, 3 and 4 years after randomization, the same proportion of patients was able to diminish their anti-TNF (approx. 1/3 of patients), without difference on clinical outcomes. These are very reassuring results, which may encourage us to try spacing our bDMARDs more often in patients who are in remission or at low disease activity.
Prof. Dr. Axel Finckh
Geneva University Hospital
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