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ACR ABSTRACT - Induction therapy with MTX and prednisone in RA or very early arthritis: IMPROVED

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[1396] - Induction Therapy with Methotrexate and Prednisone in

Rheumatoid or Very Early Arthritic Disease: IMPROVED Study.

K V C de Boer1,K Visser2,H K Ronday3,A A Schouffoer4,J H L M

Groenendael5,A J Peeters6,I Speyer7,G Collée8,P B J Sonnaville9,B A M

Grillet10,T. W J Huizinga2,C F Allaart, MD, PhD1. 1LUMC, Leiden,

Leiden,2LUMC, Leiden,3Haga Hospital, the Hague,4Groene Hart Hospital,

Gouda,5Franciscus Hospital, Roosendaal,6Reinier de Graaf Gasthuis,

Delft,7Bronovo Hospital, the Hague,8MCH, the Hague,9Oosterschelde

Hospital, Goes,10Zorgsaam, Terneuzen

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.

Abstract 1396

Tuesday, November 9, 2010, 3:30 pm

http://www.abstracts2view.com/acr/search.php?search=do & intMaxHits=10 & where= & ando\

rnot= & query=1396 & condition=PUBNUMBER

Not an MD

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