Biomarkers
Statistically significant reduction in DAS 28 vs placebo at 6 months
Lasting DAS 28 efficacy in patients who have persistent, active disease despite anti-TNF therapy
DAS 28 was a secondary end point of the REFLEX trial. Adapted from Cohen et al for the REFLEX Trial Group.1
- 65% of patients in the group receiving Rituxan achieved good or moderate EULAR response vs 22% in the placebo group (P<.0001)1,b
b Results are based on European League Against Rheumatism(EULAR) Response Categories. Moderate is defined as follows:
For a DAS 28 score ≤3.2, an improvement between 0.6 to 1.2.
For a DAS 28 score >3.2 and ≤5.1, an improvement of >0.6.
For a DAS 28 score >5.1, an improvement of >1.2.
Good is defined as a DAS 28 score of ≤3.2 and improvement of >1.2.
For the group receiving Rituxan in the REFLEX study, the mean DAS 28 score at Month 6 was 5.0 and the mean improvement from baseline was 1.9.
Rituxan slows joint damage in patients with a range of disease activity
Subgroup analysis from the REFLEX trial; DAS 28 was a secondary end point of the REFLEX trial. Groups 1,2,3, and 4 represent quartiles of baseline DAS 28 ranges. All groups had patients with high disease activity at baseline, including Group 1 (Group 1 DAS 28 range: 3-6; Group 2 DAS 28 range: 6-7; Group 3 DAS 28 range: 7-8; Group 4 DAS 28 range: 8-9). All patients eligible to enter the REFLEX trial had, moderate to severe active RA, defined as ≥8 swollen joints and ≥8 tender joints. Adapted from Cohen et al.15
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%).
