title: Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study).
abstract: OBJECTIVE
  In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction.
  
  
  METHODS
  In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44<1.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50.
  
  
  RESULTS
  The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) -1.45 (-3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS<2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen.
  
  
  CONCLUSIONS
  In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.
authors.affiliation: Institute Rheumatic and Musculoskeletal Medicine, Leeds Institute of Molecular Medicine, University of Leeds, and NIHR Leeds Musculoskeletal Biomedical Research Unit, LTHT, , Leeds, UK.
authors.forename: J L
authors.initials: JL
authors.lastname: Nam
authors.forename: E
authors.initials: E
authors.lastname: Villeneuve
authors.forename: E M A
authors.initials: EM
authors.lastname: Hensor
authors.forename: P G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: H I
authors.initials: HI
authors.lastname: Keen
authors.forename: M H
authors.initials: MH
authors.lastname: Buch
authors.forename: A K
authors.initials: AK
authors.lastname: Gough
authors.forename: M J
authors.initials: MJ
authors.lastname: Green
authors.forename: P S
authors.initials: PS
authors.lastname: Helliwell
authors.forename: A M
authors.initials: AM
authors.lastname: Keenan
authors.forename: A W
authors.initials: AW
authors.lastname: Morgan
authors.forename: M
authors.initials: M
authors.lastname: Quinn
authors.forename: R
authors.initials: R
authors.lastname: Reece
authors.forename: D M
authors.initials: DM
authors.lastname: van der Heijde
authors.forename: R J
authors.initials: RJ
authors.lastname: Wakefield
authors.forename: P
authors.initials: P
authors.lastname: Emery
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013256:Steroids / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D013256:Steroids; D000069285:Infliximab