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

BMC Musculoskeletal Disorders

William Reiss¹  Birgit Jaber⁶  Carol Chung¹  Steve Zlotnick¹  William Rigby³  Norman B Gaylis⁵  Joel M Kremer⁷  Maria W Greenwald⁴  Charles H Pritchard² 

[1] Genentech, Inc., South San Francisco, CA, USA;Rheumatology Specialty Center, 2360 Maryland Road, Willow Grove, PA 19090, USA;Geisel School of Medicine at Dartmouth, Hanover, NH, USA;Desert Medical Advances, Palm Desert, CA, USA;Arthritis & Rheumatic Disease Specialties, Aventura, FL, USA;F. Hoffmann-La Roche Ltd, Basel, Switzerland;Albany Medical College and the Center of Rheumatology, Albany, NY, USA

关键词: Adverse events;    Infusion-related reactions;    Rheumatoid arthritis;    Rituximab;   

Others  :  1125666
DOI  :  10.1186/1471-2474-15-177

 received in 2014-01-29, accepted in 2014-05-16,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Pritchard et al.; licensee BioMed Central Ltd.

【 图 表 】

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