AB1352 Evaluation of mri ramris score and clinical response in patients with acpa positive undifferentiated arthritistreated with infliximab versus placebo. (12th June 2018)

• Record Type: Journal Article
• Authors: Kirchgesner, T.; Vande Berg, B.; Sokolova, T.; Meric de Bellefon, L.; Nzeusseu, A.; Stoenoiu, M.; Durez, P.
• Is Part Of: Annals of the rheumatic diseases. Volume 77(2018)Supplement 2
• Page Start: 1764
• Page End: 1764
• Publication Date: 2018-06-12
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2018-eular.3504
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Patients (Pts) with Undifferentiated Arthritis (UA), positive for ACPA antibodies are at high risk of progressing to Rheumatoid Arthritis (RA). TNF play a key role in the pathogenesis of RA. Very early treatment with the combination of Methotrexate and Infliximab (IFX) in a small cohort of UA showed a benefit in clinical symptoms and reduction of MRI evidence of synovitis and erosions. Objectives: To assess whether IFX as a monotherapy is more effective than placebo (Pbo) in UA pts positive for ACPA. Here we evaluate the clinical response, the MRI RAMRIS score MRI and the risk to develop RA. Methods: This was a randomised, double-blind, Pbo-controlled, two-arm parallel design study of 12 months to the primary endpoint (proportion of pts who developed RA by ARA 2007 criteria). Pts with UA and symptomatic clinical synovitis of ≥1 joints and ACPA positivity were randomised 1:1 to IFX (3 mg/kg) or Pbo at week 0, 2, 6, 14 and 22, after which treatment was terminated. NSAIDs/stable low-dose oral corticosteroid (≤5 mg/day prednisone or equivalent) were permitted but no DMARDs. Disease activity measures (DAS28-CRP) were evaluated at BL, Wks 2 and 4, and every 4 wks until Wk 52. OMERACT RAMRIS scores (components: erosion, osteitis, synovitis, tenosynovitis) and peritendinitis scores were evaluated at BL and Mth 4. Pts who developed RA at any time were discontinued and could receive standard of care. Results: 28 pts were randomised (mean age: 48±12 years; mean duration of arthritis: 0.34±0.53 year; mean CRP level: 1.67±2.23 mg/dL). By 1 year, 11/15 (73%) pts treated with IFX developed RA vs 10/15 (67%) Pbo-treated pts (Kaplan Meier, log rank p=0.868). At wk 14, ACR 20, 50, 70 responses were observed respectively in 71.4%, 42.9%, 28.6% pts treated with IFX vs 21.4%, 0%, 0% treated with Pbo. Remission DAS28CRP rate was observed in 50% in the IFX group vs 21.4% in the Pbo group. Pts in the IFX arm experienced significantly greater improvements in RAMRIS score versus pbo at wk 16 (see graph). No severe safety issues was observed except one case of severe hepatotoxicity induced by Isoniazid. Conclusions: In this small randomised cohort of UA ACPA positive pts, we noted a significant difference in the RAMRIS scoring after 4 months in the IFX group vs PBo. This is the first study to report a worsening of disease activity based on the RAMRIS scores in the PBo group but changes were minimal and not observed in all pts. IFX has higher efficacy but did not prevent the progression to definite RA. Further analyses are ongoing to determine MRI predictors for severity. Reference: [1] Quinn MA, et al. Arthritis Rheum2005; 52(1):27–35. Disclosure of Interest: None declared