ACR Efficacy
Rituxan delivers a lasting ACR 50 response through 6 months with one course of therapy
Lasting efficacy in patients who have persistent, active disease despite prior anti-TNF therapy
REFLEX study enrolled 517 patients with RA (499 evaluable) with long-standing disease (mean duration: 12 years), inadequate response to at least 1 anti-TNF therapy and current methotrexate therapy (40% of patients had been on >1 prior anti-TNF therapy), active disease with at least 8 swollen and 8 tender joints, and radiographic evidence of at least 1 joint with a definite erosion attributable to RA. Adapted from Cohen et al for the REFLEX Trial Group.1 MTX indicates methotrexate.
In the pivotal study, one course of 2 infusions of 1000 mg achieved significantly higher ACR responses vs placebo at 6 months1
aPrimary end point was ACR 20
The first and only biologic demonstrated in anti-TNF inadequate responders to slow progression of joint damage
Rituxan protects joints by slowing the progression of structural damage
Data from REFLEX trial; see above for REFLEX study description. Radiographs of the hands and feet were obtained at baseline and Month 13, and were assessed using the total Genant-modified Sharp score. Eligible patients could enter the Rituxan retreatment protocol at Month 6.3 Placebo patients were eligible for rescue therapy with active drug after 4 months.1 Data derived from Rituxan full prescribing information2 and Keystone et al.3 P value from data on file5
- 60% of patients had been on 1 prior anti-TNF therapy1
Important safety information
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML).
Significant results in patients with an inadequate response to 1 or more anti-TNF therapies
Significant ACR responses in patients with a range of prior anti-TNF usage
Post hoc analysis of a subset of patients from the REFLEX trial; see above for REFLEX study description. Data derived from Kremer et al4 and Data on file.5
- Baseline patient characteristics in both groups of prior anti-TNF usage were similar4
The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended.
Radiographic data in patients with an inadequate response to 1 or 2 or more anti-TNF therapies
Post hoc subgroup analysis of radiographic data in patients with prior anti-TNF usage
Subgroup analysis of a secondary end point from REFLEX trial; Data on file.5
- Care should be exercised in interpreting results from a post hoc sub group analysis of a secondary endpoint.
In RA clinical trials, the most common adverse events with greater incidence in the group receiving Rituxan (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%).
Many anti-TNF patients may be candidates for Rituxan
Rituxan is for patients who have had an inadequate response to prior anti-TNF therapy
These patients may have:
- Persistent swollen and/or tender joints
- A need to increase the dose of their current therapy
- Increased markers of inflammation
- A need to increase the frequency of administration of their current therapy
- A need to consider adjusting or adding other medications to their current therapy
- An inadequate response to anti-TNF therapy
- Had an initial response to their current therapy that was not sustained
- Poor tolerance of anti-TNF therapy
- Persistent pain, fatigue, and stiffness
Consider Rituxan: Proven to slow joint damage in patients with persistent, active disease after 1 or more anti-TNF therapies
Important safety information
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML).
