Table 1.
Characteristics of included induction trials
| Study | Country (number of centres) | Years of recruitment | Number of Patients (ITT) | Interventions (Number of patients in each arm, ITT) | Formulation | Age of Participants (mean*) | Definition of Active Disease | Definition of Remission | Duration of Therapy | Disease Duration (mean*) |
|---|---|---|---|---|---|---|---|---|---|---|
| Bar-Meir 1998 (35) | Israel (14) | Not reported | 201 | Budesonide 3 mg tid (n=100) Prednisone 40 mg od for two weeks, then tapered (n=101) |
pH-dependent | Adults (both arms: 33 y†) | CDAI 150–350 | CDAI ≤ 150 | 8 weeks | Both arms: 5 y† |
| Campieri 1997 (36) | Europe, New Zealand, Australia (26) | Not reported | 178‡ | Budesonide 9 mg od§ (n=58) Budesonide 4.5 mg bid§ (n=61) Prednisolone 40 mg od for two weeks, then tapered (n=58) |
CIR | Adults (37 y) | CDAI ≥200 | CDAI ≤ 150 | 12 weeks¶ | 7 y |
| Escher 2004 (37) | Europe (36) | 1998–2000 | 48 | Budesonide 9 mg daily§ (n=22) Prednisolone 1 mg/kg daily for four weeks, then tapered (n=26) |
CIR | Pediatric (13 y) | CDAI ≥200 | CDAI ≤ 150 | 12 weeks¶ | 0.7 y |
| Greenberg 1994 (38) | Canada (27) | 1991–1992 | 258 | Budesonide 3 mg daily (n=67) Budesonide 9 mg daily (n=61) Budesonide 15 mg daily (n=64) Placebo (n=66) |
CIR | Adults (32 y) | CDAI >200 | CDAI ≤ 150 | 8 weeks | 6 y |
| Gross 1996 (39) | Europe (16) | Not reported | 67 | Budesonide 3 mg tid (n=34) Methylprednisolone 48 mg for 1 week, then tapered (n=33) |
pH-dependent | Adults (31 y) | CDAI >150 | CDAI ≤ 150 or decrease ≥60 if baseline CDAI > 200 | 8 weeks | 68 months (6 y) |
| Levine 2003 (19) | Israel (13) | Not reported | 35 | Budesonide 3 mg tid (n=20) Prednisone 40 mg daily, then tapered (n=15) |
pH-dependent | Pediatric (14 y) | PCDAI 12.5–40 | PCDAI ≤ 10 | 10 weeks¶ | Not reported |
| Rutgeerts 1994 (40) | Europe (11) | Not reported | 176 | Budesonide 9 mg daily§ (n=88) Prednisolone 40 mg daily for two weeks, then tapered (n=88) |
CIR | Adults (34 y) | CDAI >200 | CDAI ≤ 150 or decrease in CDAI > 100 | 10 weeks¶ | 7 y |
| Suzuki 2013 (41) | Japan (21) | 2006–2008 | 77 | Budesonide 9 mg daily§ (n=26) Budesonide 15 mg daily§ (n=25) Placebo (n=26) |
CIR | Adults (37 y) | CDAI > 200 | CDAI ≤ 150 | 10 weeks¶ | <10 y: 63/77 (82%) ≥10 y: 14/77 (18%) |
| Thomsen 1998 (28) | Europe, South Africa, Australia (25) | 1994–1996 | 182 | Budesonide 9 mg daily (n=93) Mesalamine 2 mg bid (n=89) |
CIR | Adults (Budesonide: 34 y‖; Mesalamine: 31 y‖) | CDAI 200–400 | CDAI ≤ 150 | 16 weeks‡ | Budesonide: 6 y‖; Mesalamine: 5 y‖ |
| Tremaine 2002 (42) | USA (24) | 1995–1997 | 200 | Budesonide 9 mg od (n=80) Budesonide 4.5 mg bid (n=79) Placebo (n=41) |
CIR | Adults (39 y) | CDAI 200–400 | CDAI ≤ 150 | 10 weeks‡ | 11 y |
| Tromm 2011 (29) | Europe and Israel (46) | 2004–2008 | 311 | Budesonide 9 mg od (n=81) Budesonide 3 mg tid (n=77) Mesalamine 4.5 mg daily (n=153) |
pH-dependent | Adults (37 y) | CDAI 200–400 | CDAI ≤ 150 | 8 weeks | 6 y |
| Tursi 2006 (20) | Italy (multicentre; number of centres not reported) | 2004 | 30 | Budesonide 9 mg od (n=15) Beclomethasone dipropionate 10 mg daily (n=15) |
CIR | Adults (36 y) | CDAI 150–250 | CDAI ≤ 150 | 8 weeks | Not reported |
| Van Ierssel 1995 (21) | Netherlands (1) | Not reported | 18 | Budesonide 9 mg od§ (n=9) Prednisolone 40 mg daily for two weeks, then tapered (n=9) |
CIR | Adults (35 y**) | CDAI ≥200 | CDAI ≤ 150 | 10 weeks¶ | Not reported |
ABBREVIATIONS: od, once daily; bid, twice daily; tid, three times daily; CIR, controlled ileal release; CDAI, Crohn’s Disease Activity Index; y, years.
*Weighted average of all study arms.
†Unclear if study reported mean or median age and disease duration of trial participants.
‡Campieri 1997 did not provide intention-to-treat numbers for each treatment arm. One patient was randomized but did not receive treatment, but it is not known which treatment arm this patient was randomized to.
§Dose of budesonide was tapered after eight weeks.
¶When trials followed patients beyond the primary endpoint of eight weeks, only remission data at eight weeks were pooled.
‖Median.
**Average age for the full cohort was reported in the study.