In clinical trials, the incidence of serious acute infusion reactions were experienced by <1% of patients.[13]

INFUSION-RELATED REACTIONS

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 pooled, placebo-controlled studies, more patients experienced acute infusion-related reactions* during their first infusion than after their second infusion.[13]

Serious acute infusion reactions were experienced by <1% of patients in either treatment group.

Acute infusion reactions*: First and second infusions[13]

MTX=methotrexate.
*Acute infusion reactions experienced during or within 24 hours following the first infusion, manifested by fever, chills, rigors, pruritus, urticaria/rash, angioedema, sneezing, throat irritation, cough, and/or bronchospasm, with or without associated hypotension or hypertension.[13]

Incidence of Infusion-Related Reactions from the Follow-Up Analysis in the Prescribing Information

Infusion-related reactions were the most common adverse event. Most reactions were mild to moderate in severity; less than 1% were serious.[13,16]

  • The proportion of patients experiencing acute infusion reactions decreased with subsequent courses of Rituxan[13,16]
  • Patients received Rituxan + MTX or placebo + MTX in the original study, followed by Rituxan as a rescue therapy or as part of an open-label extension study[18]

Incidence of acute infusion reactions* over 5 courses of Rituxan[16]

MTX=methotrexate.
Adapted from van Vollenhoven 2010.
*Acute infusion reactions experienced during or within 24 hours following the first infusion, manifested by fever, chills, rigors, pruritus, urticaria/rash, angioedema, sneezing, throat irritation, cough, and/or bronchospasm, with or without associated hypotension or hypertension.

Incidence of Infusion-Related Reactions in an Additional Long-Term Follow-Up Analysis at 11 Years

Care should be exercised when interpreting open-label results, due to the inability to minimize bias.

Infusion-related reactions were the most common adverse event. Most reactions were mild-to-moderate in severity; less than 1% were serious.[18]

Proportion of patients (%) with infusion-related reactions through 10 courses of Rituxan[18]

INF=infusion.
Adapted from van Vollenhoven EULAR 2013 and J Rheumatol 2015.

Patients received Rituxan + MTX or placebo + MTX in the original study, followed by Rituxan as rescue therapy or as part of an open-label extension study.[18]