Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.

ABSTRACT:

Background

Infusion-related reactions (IRRs) are the most common adverse event (AE) associated with infusion of rituximab, an anti-CD20 monoclonal antibody.

Objective

Our objective was to evaluate the impact of dosing/infusion patterns and certain baseline characteristics on IRR occurrence during the first rituximab infusion administered as the biosimilar PF-05280586 (RTX-PF) or reference rituximab sourced from the EU (RTX-EU, MabThera^®) in patients with CD20+ low-tumor-burden follicular lymphoma.

Patients and methods

Rituximab (RTX-PF, n=196; RTX-EU, n=198) was administered (375 mg/m²) on days 1, 8, 15, and 22 (one cycle), with a follow-up period through 52 weeks. The relationships between infusion rate, drug exposure, and IRR incidence were ass

SUBMITTER: Courville J 

PROVIDER: S-EPMC8295162 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature