Email updates

Keep up to date with the latest news and content from BMC Musculoskeletal Disorders and BioMed Central.

Open Access Highly Accessed Research article

Safety of infusing rituximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study

Charles H Pritchard1*, Maria W Greenwald2, Joel M Kremer3, Norman B Gaylis4, William Rigby5, Steve Zlotnick6, Carol Chung6, Birgit Jaber7, William Reiss6 and the RATE-RA Study Group

Author Affiliations

1 Rheumatology Specialty Center, 2360 Maryland Road, Willow Grove, PA 19090, USA

2 Desert Medical Advances, Palm Desert, CA, USA

3 Albany Medical College and the Center of Rheumatology, Albany, NY, USA

4 Arthritis & Rheumatic Disease Specialties, Aventura, FL, USA

5 Geisel School of Medicine at Dartmouth, Hanover, NH, USA

6 Genentech, Inc., South San Francisco, CA, USA

7 F. Hoffmann-La Roche Ltd, Basel, Switzerland

For all author emails, please log on.

BMC Musculoskeletal Disorders 2014, 15:177  doi:10.1186/1471-2474-15-177

Published: 24 May 2014

Abstract

Background

As recommended in the current prescribing information, rituximab infusions in patients with rheumatoid arthritis (RA) take 4.25 hours for the first infusion and 3.25 hours for subsequent infusions, which is a burden on patients and the health care system. We therefore evaluated the safety of infusing rituximab at a faster rate for an infusion period of 2 hours in patients with RA.

Methods

Patients with an inadequate response to anti-TNF who were rituximab-naive or -experienced received 2 courses of rituximab: Infusion 1 (Day 1) was administered over the standard 4.25 hours, and Infusions 2 (Day 15), 3 (Day 168) and 4 (Day 182) were administered over a faster 2-hour period. The primary endpoint was incidence of infusion-related reactions (IRRs) associated with Infusion 2.

Results

Of the 351 patients enrolled, 87% and 13% were rituximab-naive and -experienced, respectively. The incidence (95% CI) of IRRs associated with Infusion 1 was 16.2% (12.5%, 20.5%) and consistent with weighted historical incidence of 20.7% (19.4%, 22.1%). The incidence (95% CI) of IRRs associated with Infusions 2, 3, and 4 compared with respective weighted historical incidences at the standard infusion rate was 6.5% (4.1%, 9.7%) vs 8.1% (7.2%, 9.1%); 5.9% (3.5%, 9.3%) vs 11.5% (10.3%, 12.8%); and 0.7 (0.1%, 2.6%) vs 5.0% (4.2%, 6.0%), respectively. All IRRs were grade 1 or 2, except for 3 grade 3 IRRs associated with Infusion 1 and 2 grade 3 IRRs associated with Infusion 2. Four patients experienced a total of 5 grade 3 IRRs; 3 of these patients continued on to received subsequent infusions at the faster rate. There were no serious IRRs.

Conclusion

This study demonstrated that rituximab can be administered at the faster infusion rate at the second and subsequent infusions without increasing the rate or severity of IRRs.

Keywords:
Rituximab; Rheumatoid arthritis; Infusion-related reactions; Adverse events