Session Information
Date: Sunday, October 21, 2018
Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
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. We 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 and the risk to develop RA.
Methods:
This was a randomized, 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 randomized 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 corticosteroids (≤5 mg/day)
were permitted but no DMARDs. Disease activity measures (DAS28CRP) 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 randomized (mean age: 48 +/- 12 yrs; mean UA duration: 0.34 +/- 0.53 yr; mean CRP: 1.67 +/- 2.23
mg/dL). By 1 yr, 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 (graph). Furthermore, the difference in the RAMRIS
score observed at Wk 14 was statistically different in the group of Pts who did not develop RA after 1 yr.
Conclusion:
In this small randomized 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.
Disclosure: T. Kirchgesner, None; B. Vande Berg, None; T. Sokolova, None; L. Meric de Bellefon, None; A. Nzeusseu Toukap, None; M. Stoenoiu, None; P. Durez, None.
To cite this abstract in AMA style:
Kirchgesner T, Vande Berg B, Sokolova T, Meric de Bellefon L, Nzeusseu Toukap A, Stoenoiu M, Durez P. Evaluation of MRI Ramris Score and Clinical Response in Patients with ACPA Positive Undifferentiated Arthritis Treated with Infliximab Versus Placebo [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/evaluation-of-mri-ramris-score-and-clinical-response-in-patients-with-acpa-positive-undifferentiated-arthritis-treated-with-infliximab-versus-placebo/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/evaluation-of-mri-ramris-score-and-clinical-response-in-patients-with-acpa-positive-undifferentiated-arthritis-treated-with-infliximab-versus-placebo/