Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Due to improved therapeutic management a steadily increasing number of rheumatoid arthritis (RA) patients reach stable remission of disease. Data on withdrawal of medication after sustained remission are limited, though it is important for economic and safety reasons. The RETRO study represents a real-life study addressing different strategies of reduction of DMARD therapy in RA patients in disease remission. The aim of the study was to evaluate the possibility of tapering and even discontinuation of DMARD therapy in RA patients in stable long-lasting remission and to determine predictors for recurrence of disease.
Methods: RETRO is a phase 3, multicenter, randomized, controlled, open, prospective, parallel-group trial (EudraCT Number: 2009-015740-42). Patients, fulfilling the ACR/EULAR2010 criteria for RA with disease history of ≥12 months, were enrolled into the study if they were in clinical remission (DAS28-ESR < 2.6) at stable dose of DMARDs for more than 6 months. Patients on ≥1 conventional and/or biological DMARDs were included and randomized into three trial arms: Arm 1 (control group) was continuing full-dose conventional and/or biological DMARD treatment for 12 months; arm 2 was reducing the dose of all conventional and/or biological DMARD treatment by 50% for 12 months and arm 3 was reducing the dose of all conventional and/or biological DMARD treatment by 50% for 6 months before entirely stopping DMARD. In case of recurrence of disease (DAS >2.6) the original therapy was restarted.
Results: 101 patients (61.4% females, 60% ACPA positive, 63% RF positive; 37.6% biologic therapy, 80.2% MTX, 7.9% other DMARDs) finished the one year endpoint: 38 patients in arm 1 (age 55.8±13.9y, disease duration 6.8±5.9y, remission 20.9±16.7mo), 36 patients in arm 2 (age 54.1±13.1y, disease duration 8.6±7.7y, remission 14.5±12.7mo) and 27 patients in arm 3 (age 54.8±12.3y, disease duration 5.6±7.0y, remission 17.6±19.5mo). Of 101 patients, 66.3% were still in remission at 12 mo. Trial arms 2 (38.9%, χ2(1)=5.0, p=0.036) and 3 (51.9%, χ2(1)=9.6, p=0.003) significantly differed from the control group (15.8% flare rate) with more patients flaring in reduction arms. However, there was no significant difference between the two reduction arms (χ2(1)=1.1, p=0.443). A multivariate logistic regression identified ACPA positivity (Wald χ2=4.5, p=0.03) and treatment reduction compared to the control group (arm2: Wald χ2=6.6, p=0.01, arm3: Wald χ2=8.8, p=0.003) as predictors for subsequent flares. Sex, disease duration, remission duration, age, RF, biologic DMARD and remission depth (defined by fulfilling Boolean remission criteria yes/no) failed to predict recurrence of disease in this study.
Conclusion: This study is a prospective real life treatment strategy study investigating the effect of reduction and discontinuation of DMARD therapy in RA patients in stable remission. Interestingly neither remission depth, nor disease duration at baseline or biological DMARD therapy predicted the recurrence of disease. Presence of ACPA but not RF was the only predictor for recurrence of disease. The data indicate that treatment reduction and even discontinuation is feasible in a subset of RA patients in stable remission.
Disclosure:
J. Haschka,
None;
J. Rech,
None;
M. Englbrecht,
None;
S. Finzel,
None;
M. Reiser,
None;
A. J. Hueber,
None;
A. Kleyer,
None;
H. P. Tony,
None;
M. Fleck,
None;
K. Manger,
None;
W. Ochs,
None;
J. Wendler,
None;
H. M. Lorenz,
None;
H. Nüßlein,
None;
R. Alten,
None;
W. Demary,
None;
G. Schett,
None.
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