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Randomized Controlled Trial
. 2018 Jan;77(1):111-118.
doi: 10.1136/annrheumdis-2017-211375. Epub 2017 Sep 28.

Clinical and radiological outcomes of 5-year drug-free remission-steered treatment in patients with early arthritis: IMPROVED study

Gülşah Akdemir  1 , Lotte Heimans  1 , Sytske Anne Bergstra  1 , Robbert J Goekoop  2 , Maikel van Oosterhout  3 , Johannes H L M van Groenendael  4 , André J Peeters  5 , Gerda M Steup-Beekman  6 , Leroy R Lard  7 , Peter B J de Sonnaville  8 , Bernard A M Grillet  9 , Tom W J Huizinga  1 , Cornelia F Allaart  1
Affiliations
Randomized Controlled Trial

Clinical and radiological outcomes of 5-year drug-free remission-steered treatment in patients with early arthritis: IMPROVED study

Gülşah Akdemir et al. Ann Rheum Dis. 2018 Jan.

Abstract

Objectives: To determine the 5-year outcomes of early remission induction therapy followed by targeted treatment aimed at drug-free remission (DFR) in patients with early arthritis.

Methods: In 12 hospitals, 610 patients with early (<2 years) rheumatoid arthritis (RA) or undifferentiated arthritis (UA) started on methotrexate (MTX) 25 mg/week and prednisone (60 mg/day tapered to 7.5 mg/day). Patients not in early remission (Disease Activity Score <1.6 after 4 months) were randomised (single blind) to arm 1, adding hydroxychloroquine 400 mg/day and sulfasalazine 2000 mg/day, or arm 2, switching to MTX plus adalimumab 40 mg/2 weeks. Treatment adjustments over time aimed at DFR. Outcomes were remission percentages, functional ability, toxicity and radiological damage progression after 5 years.

Results: After 4 months, 387 patients were in early remission, 83 were randomised to arm 1 and 78 to arm 2. After 5 years, 295/610 (48%) patients were in remission, 26% in sustained DFR (SDFR) (≥1 year) (220/387 (57%) remission and 135/387 (35%) SDFR in the early remission group, 50% remission, 11% SDFR in the randomisation arms without differences between the arms). More patients with UA (37% vs 23% RA, p=0.001) and more anticitrullinated protein antibody (ACPA)-negative patients (37% vs 18% ACPA-positive, p<0.001) achieved SDFR.Overall, mean Health Assessment Questionnaire was 0.6 (0.5), and median (IQR) damage progression was 0.5 (0-2.7) Sharp/van der Heijde points, with only five patients showing progression >25 points in 5 years.

Conclusions: Five years of DFR-steered treatment in patients with early RA resulted in almost normal functional ability without clinically relevant joint damage across treatment groups. Patients who achieved early remission had the best clinical outcomes. There were no differences between the randomisation arms. SDFR is a realistic treatment goal.

Keywords: DMARDs (biologic); DMARDs (synthetic); disease activity remission; early rheumatoid arthritis; treatment.

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Conflict of interest statement

Competing interests: TWJH reports grants from AbbVie during the conduct of the study and grants from UCB, Bristol Myers Squibb, Pfizer, Roche, Sanofi-Aventis and Boeringher from outside the submitted work. The other authors declare no competing interests.

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