The Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease (IMPROVED)-study is a multicentre two-step randomized single-blinded clinical trial in 610 early... Show moreThe Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic Disease (IMPROVED)-study is a multicentre two-step randomized single-blinded clinical trial in 610 early rheumatoid arthritis (RA) and undifferentiated arthritis (UA) patients. Intensive induction therapy (methotrexate (MTX) and a tapered high dose of prednisone) was started in the first 4 months. Treatment adjustments aimed at clinical remission (Disease Activity Score (DAS)<1.6): if DAS<1.6, medication was tapered and stopped, if DAS≥1.6, medication was intensified or restarted. Patients not in DAS-remission after 4 months were randomized to triple therapy (MTX, hydroxychloroquine and sulfasalazine) with prednisone (arm 1) or MTX+adalimumab (arm 2).After 4 months 61% was in DAS-remission (early DAS-remission group). After 5 years, 48% were in DAS-remission and 22% in drug-free remission (DFR). Patients in early DAS-remission group had better functional ability and more often achieved DAS-remission and DFR than patients that were randomized, without differences between the arms. UA patients had lower DAS and less autoantibody positivity at baseline compared to the RA patients. DAS-remission percentages were comparable between RA and UA patients, but more UA patients did achieve DFR (33% vs 19%). Autoantibody (rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA)) negative patients more often achieved DFR. Show less
