Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
A Preliminary Report of Remission Induction with Two Therapeutic Strategies with Infliximab or High Dose Intravenous Steroids for the Treatment of Rheumatoid Arthritis.
Nam1, Jackie L., Villeneuve2, Edith, Conaghan3, Philip G., Hensor4, Elizabeth, Keen5, Helen I., Amarasena6, Roshan, Gough7, Andrew K.
NIHR Leeds Musculoskeletal Biomedical Research Unit, LIMM, University of Leeds., Leeds, United Kingdom
University of Leeds, Leeds, United Kingdom
NIHR-Leeds Musculoskeletal Biomedical Unit, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, United Kingdom
NIHR-Leeds Biomedical Research Unit and Leeds Institute of Molecular Medicine, University of Leeds, Leeds, United Kingdom
NIHR-Leeds Musculoskeletal Biomedical Research Unit and Leeds Institute of Molecular Medicine, University of Leeds, Leeds, United Kingdom
UWA, Perth, Australia
Salford Royal Foundation trust, Manchester, United Kingdom
Harrogate District Hospital, Harrogate, United Kingdom
The York Hospital, York Teaching Hospital NHS Foundation Trust, York, United Kingdom
York Teaching Hospital NHS Foundation Trust, Harrogate, United Kingdom
Early intensive treatment strategies have demonstrated good clinical outcomes for patients with rheumatoid arthritis (RA). Infliximab (IFX) and the use of high dose steroids have shown to be effective for remission induction. Objectives: To compare the efficacy of methotrexate (MTX) + IFX vs. MTX + high dose intravenous (IV) steroid as induction therapy, together with dose and treatment modification according to predefined disease activity measures in patients with DMARD naïve RA.
The IDEA study is a 78 week multicentre randomised controlled study of 112 patients with early (symptom duration of >3 and <12 months) DMARD naïve RA (1987 ACR criteria, DAS>2.4). Patients were randomised to one of 2 groups IFX or steroid/placebo. Treatment was blinded until week 26 then pragmatically guided by disease activity scores according to a pre determined therapeutic regime. The IFX group received: IFX 3mg/kg (weeks 0, 2, 6, 14, 22) + MTX 10mg weekly increasing to 20mg by week 6 with IFX dose modification (increase or stopping) depending on DAS 44 from week 26. The steroid/placebo group received: IV methylprednisolone 250mg at week 0, placebo infusions at weeks 2, 6, 14, 22 + MTX 10mg weekly increasing to 20mg by week 6; from week 26 treatment was escalated stepwise as follows if DAS >2.4: add sulphasalazine (SSZ) and hydroxychloroquine (HCQ), then stop SSZ+ HCQ and add leflunomide (LEF), then one of the following combinations: MTX s/c +LEF or MTX + ciclosporin or MTX+ LEF + prednisolone 57.5mg daily. Additional IM methylprednisolone 120mg was administered if DAS >2.4 (weeks 6, 14, 22, 38, 50 and 62) for both groups. Other biologics were also allowed from week 26 according to NICE guidelines. Remission data are reported here.
Baseline characteristics were similar in the 2 patient groups. At week 2 remission (DAS <1.6) was achieved in 22.2% (12/54) in the IFX group and 8.9% (5/56) in steroid/placebo group (p=0.054). At week 26, 33.3% (18/54) and 44.6% (25/56) in the in the IFX and steroid/placebo groups respectively were in remission (p=0.224). At week 50, a greater percentage achieved remission in the IFX group (IFX 51.9% (28/54) vs. steroid/placebo 35.7% (20/56), p=0.088. By week 78, similar remission rates were seen in the two groups (IFX 48.1% (26/54) vs. steroid/ placebo 51.8% (29/56), p= 0.703).
Early and sustained remission rates were achieved using an intensive treatment strategy with IFX as induction therapy. Similar remission rates were achieved using with high dose IV steroids; although some reduction was seen at 50 weeks this was regained at week 78. Analysis of the radiographic data will be of interest in providing further information regarding the effects of the two therapeutic strategies on bone damage.
To cite this abstract, please use the following information:
Nam, Jackie L., Villeneuve, Edith, Conaghan, Philip G., Hensor, Elizabeth, Keen, Helen I., Amarasena, Roshan, et al; A Preliminary Report of Remission Induction with Two Therapeutic Strategies with Infliximab or High Dose Intravenous Steroids for the Treatment of Rheumatoid Arthritis. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :463