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A safety analysis of oral prednisone as a pretreatment for rituximab in rheumatoid arthritis

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Abstract

The administration of 100 mg of methylprednisolone intravenously (IV) 1/2 h prior to rituximab decreases the incidence of acute infusion reactions (AIRs). However, this pretreatment adds considerable time and conveys potential risk. We performed an open-label prospective assessment of oral prednisone as a pretreatment to rituximab. This was a 26-week open-label trial of 40 mg of oral prednisone given 1/2 h prior to rituximab as a prophylaxis against AIRs in patients with rheumatoid arthritis (RA). The primary endpoint was AIRs in the first 24 h after their initial infusion. Secondary endpoints include AIRs during the 24 h following their second infusion and any adverse events experienced during the 26-week study; efficacy measures were also followed as secondary endpoints. Sixty-four subjects were screened, and 50 subjects qualified. Fourteen out of the 50 (28 %) subjects had AIRs within 24 h of their first infusion. There were four AIRs (8.3 %) within 24 h of their second infusion. One of day 0 AIRs required drug discontinuation (wheezing/bronchospasm). Forty out of 50 (80 %) subjects experienced an adverse event during the 26 weeks. There were three SAEs deemed not to be study-drug related. The DAS28 and HAQ-DI all improved significantly at weeks 8, 16, and 26 compared to baseline. Historical controls demonstrate that 27 % 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.

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Authors and Affiliations

  1. Department of Internal Medicine, Division of Rheumatology, University of South Florida, Tampa, FL, USA

    J. D. Carter, S. A. Zarabadi, L. R. Ricca, J. Valeriano-Marcet & F. B. Vasey

  2. Arthritis Associates, Palm Harbor, FL, USA

    A. McNeil & A. I. Sebba

  3. Division of Rheumatology, University of South Florida, 12901 Bruce B. Downs Blvd; MDC 81, Tampa, FL, 33612, USA

    J. D. Carter

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  1. J. D. Carter
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  2. S. A. Zarabadi
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  3. L. R. Ricca
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  4. A. McNeil
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  5. J. Valeriano-Marcet
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  6. F. B. Vasey
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  7. A. I. Sebba
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Correspondence to J. D. Carter.

Additional information

This research study was funded by an investigator-initiated grant from Genentech and Biogen Idec, Inc.

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Carter, J.D., Zarabadi, S.A., Ricca, L.R. et al. A safety analysis of oral prednisone as a pretreatment for rituximab in rheumatoid arthritis. Clin Rheumatol 31, 1605–1610 (2012). https://doi.org/10.1007/s10067-012-2059-4

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  • DOI: https://doi.org/10.1007/s10067-012-2059-4

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