Randomised placebo-controlled trial of rituximab (anti- XXXX ) in active @entity31 .

@entity1 @entity500 @entity2225 @entity228 @entity31 @entity5837 @entity4446 @entity1151 @entity134 @entity230 @entity1499
OBJECTIVE: To assess the safety and efficacy of the B lymphocyte (anti- @entity2225 ) antibody, rituximab, in the treatment of @entity134 -resistant moderately active @entity31 ( @entity31 ). METHODS: A double-blinded, randomised controlled trial with a 2:1 ratio of treatment:placebo (phase II) was carried out in the setting of a University teaching hospital. The subjects comprised 24 @entity1 with moderately active @entity31 who have either failed to respond to conventional corticosteroid therapy or who have relapsed during @entity228 withdrawal. Five of 8 placebo-treated @entity1 and 12 of 16 rituximab-treated @entity1 were receiving @entity500 , @entity4446 or @entity1499 . Two infusions of rituximab 1 g in 500 ml of 0.9% saline intravenously over 4 h (n=16) or saline placebo (n=8) were given at 0 and 2 weeks. @entity1 still receiving corticosteroids on entry (placebo group 7/8; rituximab group 14/16) continued a standard @entity134 tapering regimen. The primary end point was remission (Mayo score  <= 2) at 4 weeks. Secondary end points included response (Mayo score reduced >=  3) at 4 and 12 weeks. RESULTS: Mayo score at entry was higher in rituximab-treated @entity1 (mean 9.19; 95% CI 8.31 to 10.06) than for placebo @entity1 (7.63; 6.63 to 8.62, p=0.03). At week 4 only 1/8 placebo-treated @entity1 and 3/16 rituximab-treated @entity1 were in remission (p=1.0), but 8/16 rituximab-treated @entity1 had responded compared with 2/8 placebo-treated @entity1 , with a median reduction in Mayo score of 2.5 (rituximab) compared with 0 (placebo; p=0.07). This response was only maintained to week 12 in 4/16. Mucosal healing was seen at week 4 in 5/16 rituximab-treated @entity1 and 2/8 placebo-treated @entity1 (non-significant). Rituximab was well tolerated, with one @entity5837 , three mild infusion reactions plus one case of (probably unrelated) non-fatal @entity1151 . CONCLUSIONS Rituximab has no significant effect on inducing remission in moderately active @entity31 not responding to oral @entity230 . There was a possible short-term response that was not sustained. Rituximab is well tolerated in @entity31 . CLINICAL TRIAL NUMBER: NCT00261118.
