IN TNF-IR PATIENTS, RITUXAN + MTX SLOWED PROGRESSION OF STRUCTURAL DAMAGE

REFLEX Trial Design—

2-Year Radiographic Data

  • In the 2-year open-label extension, intent-to-treat patients with one post-Baseline radiograph (281 Rituxan patients and 187 placebo patients) received background MTX and had been randomized to Rituxan (2 x 1000-mg infusions, 2 weeks apart) or placebo; patients were eligible for Rituxan retreatment every 6 months[2]
  • Radiographs were taken at Baseline and at Weeks 24, 56, and 104. Radiographic changes were determined during discrete time intervals of Baseline to 24 weeks, 24-56 weeks, and 56-104 weeks. Two analyses were conducted, and results are described in the Prescribing Information[12,13]
  • End points at Year 2 were exploratory

MTX, methotrexate; TNF-IR, tumor necrosis factor inhibitor inadequate responder

 

Radiographic changes during 1 year: REFLEX Trial[2,13]

JSN, joint-space narrowing; mTSS, modified total Sharp score; MTX, methotrexate.
*The radiographic end points at 2 years were exploratory.
57% of total patients had no radiographic progression at 2 years.[2]

Sustained treatment effects were seen in the trial and are documented in the PI

  • 60 %
    At Year 1, 
    (n=168/278) of patients treated with Rituxan + MTX had no radiographic progression[13]
87 %
 (n=146/168) of Rituxan‑treated patients who had no progression the first year also had no progression in the second year[2,8]*

Modified Total Sharp Score[2,13]

Erosion Score[2,13]

Joint-Space Narrowing Score[2,13]