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.


Induction Therapy with Methotrexate and Prednisone in Rheumatoid or Very Early Arthritic Disease: IMPROVED Study.

de Boer5,  K. V. C., Visser6,  K., Ronday4,  H. K., Schouffoer3,  A. A., Groenendael2,  J. H. L. M., Peeters9,  A. J., Speyer1,  I.

Bronovo Hospital, The Hague
Zorgsaam, Terneuzen
Franciscus Hospital, Roosendaal
Groene Hart Hospital, Gouda
Haga Hospital, The Hague
LUMC, Leiden, The Netherlands
LUMC, Leiden
MCH, the Hague
Oosterschelde Hospital, Goes
Reinier de Graaf Gasthuis, Delft

Aim:

To assess the rate of remission after 4 months of treatment with methotrexate (MTX) and a tapered high dose prednisone in patients with recent onset rheumatoid or undifferentiated arthritis (RA and UA), in relation to clinical and demographic baseline criteria.

Methods:

IMPROVED is a multicenter single blind clinical study in patients with recent onset RA and UA, with an open label induction phase with MTX 25 mg/wk and prednisone 60 mg/day tapered to 7.5 mg/day in 7 weeks, aimed at achieving DAS < 1.6, which will be followed by tapering to drug free if remission persists, or randomization to multi-DMARD or MTX + adalimumab if DAS >= 1.6 after 4 months. To date, 161 patients with UA (arthritis > 1 joint, at risk for developing RA by estimation of a rheumatologist) and 261 patients with recent onset RA (ACR 1987 criteria, symptom duration < two years) were included. Clinical outcomes (% remission DAS <1.6) and functional ability measured with the Dutch Health Assessment Questionnaire (HAQ) after 4 months of treatment were compared between RA and UA patients. Independent predictors at baseline for achieving remission after 4 months were established by univariable followed by multivariable regression analysis.

Results:

At baseline, UA patients were younger, less often RF positive and had lower DAS, HAQ and ESR values, than RA patients (Table 1). After four months of treatment, clinical remission was achieved in 107/161 UA patients (66.5%) and in 153/261 RA (58.6%) (P = 0.12). Improvement in mean DAS was 1.32 (0.95) in the UA patients and 1.90 (1.05) in the RA patients (P < 0.001), improvement in mean HAQ was 0.57 (0.65) and 0.81 (0.65), respectively (P < 0.001) (table 1). Low baseline DAS was predictive for achieving remission after 4 months in both UA and RA (OR 0.36, 95% CI 0.18–0.67). In UA patients, but not in RA patients, other predictors for achieving clinical remission were male sex (OR 2.76, 95% CI 1.13–6.73) and ACPA-positivity (OR 2.83, 95% CI 1.07–7.51)

Conclusion:

After 4 months of treatment with MTX and a tapered high dose of prednisone in patients with recent onset RA or UA, clinical remission (DAS < 1.6) was achieved in 63% of all patients, with similar outcomes for mean DAS and HAQ. Only in UA patients, ACPA positivity is an independent predictor for achieving remission. This suggests that ACPA negative UA patients, who did not benefit from treatment with MTX monotherapy in the PROMPT study, also benefit less from prednisone. ACPA negative UA may be a different disease that requires different therapy than ACPA positive UA.

Table 1. Baseline characteristics, and clinical outcomes after 4 months of treatment of patients with UA or recent onset RA.

BaselineUA N = 161RA N = 261P-value
Age, years (mean, SD)48.3 (13.3)53.5 (14.2)<0.001
% Female64.666.30.72
Symptom duration, months (median, IQR)4.0 (2.0–7.0)4.0 (2.0–7.0)0.57
% RF positive33.161.1<0.001
% ACPA positive48.459.70.47
ESR mm/hr (median, IQR)17.0 (8.0–30.0)29.0 (13.0–42.5)<0.001
CRP mg/l (median, IQR)7.0 (3.0–19.0)12.5 (6.0–34.0)<0.001
DAS (mean, SD)2.74 (0.74)3.44 (0.91)<0.001
HAQ (mean, SD)0.96 (0.62)1.24 (0.64)<0.001
Follow up (4 months)   
DAS (mean, SD)1.43 (0.90)1.54 (0.88)0.57
HAQ (mean, SD)0.40 (0.49)0.43 (0.52)0.13
Improvement DAS (mean, SD)1.32 (0.95)1.90 (1.05)<0.001
Improvement HAQ (mean, SD)0.57 (0.65)0.81 (0.65)<0.001
% Remission66.558.60.12

To cite this abstract, please use the following information:
de Boer, K. V. C., Visser, K., Ronday, H. K., Schouffoer, A. A., Groenendael, J. H. L. M., Peeters, A. J., et al; Induction Therapy with Methotrexate and Prednisone in Rheumatoid or Very Early Arthritic Disease: IMPROVED Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1396
DOI: 10.1002/art.29162

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