title: A safety analysis of oral prednisone as a pretreatment for rituximab in rheumatoid arthritis.
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.
authors.affiliation: Department of Internal Medicine, Division of Rheumatology, University of South Florida, Tampa, FL, USA. jocarter@health.usf.edu
authors.forename: J D
authors.initials: JD
authors.lastname: Carter
authors.forename: S A
authors.initials: SA
authors.lastname: Zarabadi
authors.forename: L R
authors.initials: LR
authors.lastname: Ricca
authors.forename: A
authors.initials: A
authors.lastname: McNeil
authors.forename: J
authors.initials: J
authors.lastname: Valeriano-Marcet
authors.forename: F B
authors.initials: FB
authors.lastname: Vasey
authors.forename: A I
authors.initials: AI
authors.lastname: Sebba
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011241:Prednisone / Q000008:administration & dosage*; D011446:Prospective Studies; D000069283:Rituximab; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab; D011241:Prednisone