In RA pooled placebo-controlled studies, the incidence of serious infections was 2% for patients treated with Rituxan + MTX vs 1% for patients treated with placebo + MTX at 24 weeks.
INFECTIONS AND SERIOUS INFECTIONS
Rituxan Rheumatoid Arthritis (RA) Pooled, Placebo-Controlled Studies at 24 Weeks
These data are based on 938 patients treated during a 24-week period in Phase 2 and Phase 3 studies of Rituxan (2 x 1000 mg) or placebo administered in combination with methotrexate.
In the pooled, placebo-controlled studies, 39% of patients treated with Rituxan + MTX experienced an infection of any type compared to 34% of patients treated with placebo + MTX.
The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis.
Serious Infection Rates in Long-Term Data
In the experience with Rituxan in 2578 patients with RA, the rate of serious infections was 4.31 per 100 patient-years
The most common serious infections (≥5%) were pneumonia or lower respiratory tract infections, cellulitis, and urinary tract infections
Fatal serious infections included pneumonia, sepsis, and colitis
- Rates of SIE remained stable in patients receiving subsequent
Serious Infection Rates in Additional Long-Term Follow-Up Analysis
Care should be exercised when interpreting open-label results, due to the inability to minimize bias.
Serious infection events* per 100 patient-years over 11 years of follow-up[17,18]
Adapted from van Vollenhoven EULAR 2013 and J
PY, patient-years; SIE, serious infection event.
*Serious and/or those requiring IV antibiotics.
†All-Exposure rate calculation includes up to 11 years of follow-up.