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

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.