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.[13]

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.[13]

The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis.[13]

Infections of any type at Week 24[13]

Serious infections at Week 24[13]

MTX=methotrexate.

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[13]

  • The most common serious infections (≥5%) were pneumonia or lower respiratory tract infections, cellulitis, and urinary tract infections[13]

  • Fatal serious infections included pneumonia, sepsis, and colitis[13]

  • Rates of SIE remained stable in patients receiving subsequent courses[13]

Serious infection events* per 100 patient-years over 7 years of follow-up[15]

Adapted from van Vollenhoven 2008.
PY, patient-years; SIE, serious infection event.
*Serious and/or those requiring IV antibiotics.

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 Rheumatol 2015.
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.