Baseline characteristics of the patients1-150
| Variable | Mesalamine group (n=10) | Sulphasalazine group (n=12) | Balsalazide group (n=12) |
| Sex (M/F) | 4/6 | 7/5 | 6/6 |
| Age at entry (y) (mean (SD)) | 39.7 (9.7) | 36.8 (7.8) | 38.3 (10.7) |
| Weight (kg) (mean (SD)) | 66.1 (14.9) | 76.9 (16.5) | 84.7 (26.0) |
| AZA No | 7 | 9 | 8 |
| Dose (mg/kg) (mean (SD)) | 2.0 (0.7) | 2.0 (0.5) | 2.1 (0.6) |
| 6-MP No | 3 | 3 | 4 |
| Dose (mg/kg) (mean (SD)) | 1.2 (0.3) | 1.1 (0.2) | 1.1 (0.3) |
| TPMT activity (U/ml RBCs) | |||
| Overall mean | 16.1 | 17.0 | 18.0 |
| Overall SD | 4.2 | 5.6 | 4.1 |
| Overall median | 16.9 | 16.0 | 18.8 |
| Overall range | 8.6–21.2 | 9.2–28.9 | 8.3–23.1 |
| No low | 0 | 0 | 0 |
| No intermediate | 2A | 2B | 2C |
| No normal | 8 | 10 | 10 |
| Inflammatory bowel disease questionnaire (mean (SD)) | 186 (21) | 196 (18) | 178 (24) |
↵1-150 34 patients were screened, enrolled, and received at least one dose of study medication, and were included in the safety analysis. Elsewhere in the manuscript, results presented are for the intention to treat population (31 patients).
AZA, azathioprine; 6-MP, 6-mercaptopurine; TPMT, thiopurine methyltransferase; RBCs, red blood cells.
For patients with the intermediate TPMT phenotype, TPMT activities in the three treatment groups were: Amesalamine group 8.6 and 9.3 U/ml RBCs; Bsulphasalazine group 9.2 and 9.6 U/ml RBCs; and Cbalsalazide group 8.3 and 13.6 U/ml RBCs.