In the REFLEX Trial, Rituxan + methotrexate was proven efficacious in patients with persistent, active disease despite TNFi therapy. [1,13]

REFLEX EFFICACY DATA

REFLEX Trial Design

The majority of patients in the REFLEX Trial had an inadequate response to one TNFi due to lack of efficacy. [1]

The 24-week pivotal REFLEX Study (Study 1) enrolled 520 patients (499 evaluable) with active rheumatoid arthritis (RA) who had an inadequate response to at least 1 TNFi therapy and active disease (≥8 swollen and ≥8 tender joints). Patients were randomized to receive 2 x 1000-mg Rituxan infusion + methotrexate (MTX) or placebo + MTX. The primary end point was ACR20 at 6 months. Patients who met certain criteria* were also eligible to participate in an open-label extension. The REFLEX Trial was open label after 6 months, and end points at Year 2 were exploratory. [1,13]

Study design of REFLEX Trial and subsequent open-label extension study[1,2,12]

DMARD, disease-modifying anti-rheumatic drug; IV, intravenous; MTX, methotrexate; PO, per os; SJC, swollen joint count; TJC, tender joint count; TNF, tumor necrosis factor; TNFi, tumor necrosis factor inhibitor.
TNF and/or DMARD withdrawal period.
In the REFLEX Trial, primary safety and efficacy were evaluated at 24 weeks. [1]
Patients initially randomized to placebo + MTX were eligible for rescue therapy with Rituxan at 16 weeks. [1]

REFLEX Trial: ACR Responses at 6 Months

The majority of patients in the REFLEX Trial had an inadequate response to one TNFi due to lack of efficacy. [1]

REFLEX Trial patient disposition:

  • 91% had failed a TNFi due to lack of efficacy [1]

  • 60% had been on 1 previous TNFi therapy [1]

  • 31% had been on 2 previous TNFi therapies [1]

  • 9% had been on 3 previous TNFi therapies [1]

  • Average disease duration of 12 years [1]

In the pivotal placebo-controlled trial, a significantly higher proportion of patients treated with one course of Rituxan + MTX achieved an ACR response vs placebo + MTX. [1]

TNFi inadequate responders at 6 months
after 1 course of Rituxan + MTX [1,13]

ACR, American College of Rheumatology; MTX, methotrexate; TNFi, tumor necrosis factor inhibitor.

Recommended Dosing Interval

The FDA-recommended dosing of Rituxan for patients with RA is every 6 months or based on clinical evaluation, but no sooner than every 4 months (16 weeks).[13] Learn more about Rituxan's dosing schedule.

Components of ACR Response at 6 months

At 6 months, one course (2 x 1000 mg) of Rituxan + MTX provided significant reductions in all ACR response criteria. [13]

Components of ACR response at 6 months—Percent change from Baseline in TNFi inadequate responders (modified ITT population) [9,13]

ACR, American College of Rheumatology; CRP, C-reactive protein; ITT, intent to treat; MTX, methotrexate; SJC, swollen joint count; TJC, tender joint count; TNFi, tumor necrosis factor inhibitor.
*Similar results were observed in 28-joint counts.
Visual analogue scale: 0=best, 100=worst.
Disability index of the Health Assessment Questionnaire (HAQ): 0=best, 3=worst.
§Represents mean change from Baseline.