Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.


A Safety Analysis of Oral Prednisone As a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

Carter1,  John D., Albritton1,  Nancy, Zarabadi2,  S. Alireza, Ricca3,  Louis R., Valeriano-Marcet1,  Joanne, Vasey4,  Frank B., Sebba5,  Anthony

University of South Florida, Tampa, FL
Tampa Arthritis Center, Tampa, FL
University of South Florida College of Medicine, St Petersburg, FL
Wayne State Univ. Health Ctr., Detroit, MI
University of South Florida, Palm Harbor, FL

Background/Purpose:

The administration of 100mg of methylprednisolone intravenously (IV) ?hour prior to rituximab decreases the incidence and severity of acute infusion reactions (AIRs). However, the recommended pretreatment with IV methylprednisolone adds considerable time to the medication administration protocol; it also conveys potential risk. We present preliminary results of an assessment of oral prednisone as a pretreatment to rituximab.

Methods:

This is a 6-month open-label assessment of 40mg of oral prednisone given ?hour prior to rituximab as a prophylaxis against acute infusion reactions in patients with rheumatoid arthritis (RA). Subjects are ages 18–80 and either methotrexate (MTX) or TNF-antagonist inadequate responders and naïve to rituximab. All subjects have to be on concomitant methotrexate. Standard safety and laboratory exclusions applied. All subjects were treated with 40mg of oral prednisone ?hour prior to their rituximab infusions. Rituximab was administered as per the standard RA protocol; i.e. 1000mg IV twice at days #1 and #15. The primary endpoint is AIRs in the first 24 hours after the initiation of their day #1 infusion. The severity, timing, and treatment (including rituximab dose modifications) of any AIRs are also recorded. Secondary endpoints include AIRs during the 24 hours following the day #15 infusion and any adverse events experienced during the 6 month study; efficacy measures (DAS-28 and HAQ-DI) were also followed as secondary endpoints.

Results:

65 subjects were screened and 50 subjects qualified. Baseline demographics include 42 females and 8 males, with 39/50 (78%) Caucasians, 5 (10%) Hispanics, 3 African-Americans (6%), and 3 other. The subjects' mean age was 52.2 years (range 27–80) and disease duration was 11.2 years (range 1–49). The average MTX dose was 16.2mg weekly and 30/50 (60%) have failed previous anti-TNF therapy (average number of TNF-antagonists used was 1.5). 22/50 (44%) subjects were on glucocorticoids at baseline with an average dose of 7.1mg prednisone daily; 36/50 (72%) subjects were seropositive. The mean DAS28 at screening was 5.64 and their HAQ-DI was 1.39. Regarding the primary endpoint, 15/50 (30%) of the subjects had AIRs within 24 hours of their day #1 infusion; 13 were mild in severity and 2 were moderate. There were only 6 (12.2%) AIRs within 24 hours of their day #15 infusion; all were mild. One of the day #1 AIRs required drug discontinuation (wheezing). Of the 47 subjects who have completed the entire 6 months of the study, 37 (79%) experienced an AE at some point during the trial. There were 3 SAE's (a-fib, asthma, suicide attempt) deemed not to be study-drug related. The DAS28 and HAQ-DI all improved significantly at weeks 8, 16, and 26 compared to baseline.

Conclusion:

Historical controls demonstrate that 27–33% of RA subjects experience AIRs with their first rituximab infusion. Our data suggest a smaller dose of oral prednisone is an effective alternative to IV methylprednisolone as a pretreatment for rituximab in patients with RA.

To cite this abstract, please use the following information:
Carter, John D., Albritton, Nancy, Zarabadi, S. Alireza, Ricca, Louis R., Valeriano-Marcet, Joanne, Vasey, Frank B., et al; A Safety Analysis of Oral Prednisone As a Pre-Treatment for Rituximab in Rheumatoid Arthritis. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :2241
DOI:

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