Trials of oral corticosteroids where data provided separately for isolated colonic CD
| Author/ref | N (isolated colonic CD) | Budesonide/comparator | Primary end point | Budesonide remission rate | Comparator remission rate | p Value | Steroid-related adverse events | Conclusions |
|---|---|---|---|---|---|---|---|---|
| Tromm et al155 | 50 (distal colon excluding rectum) of 307 in trial | Budesonide 9 mg once daily vs 3 mg three times daily vs mesalamine 1.5 g three times daily | Week 8 remission, CDAI ≤150 | 23/30 (76.7%) | 10/20 (50%) | 0.051 | Only 1 budesonide patient with acne, no other steroid-related events | Budesonide borderline significance better than mesalamine |
| Bar-Meir et al156 | 27 of 201 in trial | Budesonide 9 mg once daily vs prednisone 40 mg once daily 2 weeks then taper | Week 8 remission, CDAI ≤150 | 2/10 (20%) | 10/17 (58.8%) | 0.1 | 67% Prednisone vs 44% budesonide | Trend towards better efficacy in colonic disease with prednisone, similar efficacy if small bowel involved |
| (a) Controlled trials of pH-modified release oral budesonide | ||||||||
| Author/ref | N (isolated colonic CD) | Prednisone/comparator | Primary end point | Prednis(ol)one remission rate | Comparator remission rate | p Value | Conclusions | |
| Summers et al143 | 34 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 remission | Data presented as rank outcome | Data presented as rank outcome | 0.465 | Prednisone not effective in colon only disease (but only n=8 treated) | |
| Malchow et al144 | 49 of 215 in trial (induction data from table 11) | Sulfasalazine or combination of sulfasalazine and 6-methyl prednisolone | Remission by week 18 | 6/8 (75%) | Placebo 2/14 (14%) Sulfasalazine 4/13 (31%) Combination 13/14 (93%) | <0.01 for Sulfasalazine and 6-methylprednisolone and <0.001 for combination | All 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.