Table 8

Trials of oral corticosteroids where data provided separately for isolated colonic CD

Author/refN (isolated colonic CD)Budesonide/comparatorPrimary end pointBudesonide remission rateComparator remission ratep ValueSteroid-related adverse eventsConclusions
Tromm et al15550 (distal colon excluding rectum) of 307 in trialBudesonide 9 mg once daily vs 3 mg three times daily vs mesalamine 1.5 g three times dailyWeek 8 remission, CDAI ≤15023/30 (76.7%)10/20 (50%)0.051Only 1 budesonide patient with acne, no other steroid-related eventsBudesonide borderline significance better than mesalamine
Bar-Meir et al15627 of 201 in trialBudesonide 9 mg once daily vs prednisone 40 mg once daily 2 weeks then taperWeek 8 remission, CDAI ≤1502/10 (20%)10/17 (58.8%)0.167% Prednisone vs 44% budesonideTrend towards better efficacy in colonic disease with prednisone, similar efficacy if small bowel involved
(a) Controlled trials of pH-modified release oral budesonide
Author/refN (isolated colonic CD) Prednisone/comparatorPrimary end pointPrednis(ol)one remission rate Comparator remission rate p Value Conclusions
Summers et al14334 of 295 in trial (Pt 1)Prednisone up to 60 mg/day (n=8) vs azathioprine 2.5 mg/kg (n=9) vs
Sulfasalazine 1 g/15 kg (n=8) vs
placebo (n=9)
Week 17 remissionData presented as rank outcomeData presented as rank outcome0.465Prednisone not effective in colon only disease (but only n=8 treated)
Malchow et al14449 of 215 in trial (induction data from table 11)Sulfasalazine or combination of sulfasalazine and 6-methyl prednisoloneRemission by week 186/8 (75%)Placebo 2/14 (14%)
Sulfasalazine 4/13 (31%)
Combination 13/14 (93%)
<0.01 for Sulfasalazine and 6-methylprednisolone and <0.001 for combinationAll active treatments better than placebo but combination superior to either agent alone
(b) Controlled trials of oral prednis(ol)one
  • CD, Crohn's disease; Pt 1, Part 1.