Table 2.
Primary and secondary outcomes in patients allocated to l-azathioprine (L-AZA)/ allopurinol (ALLO) versus AZA at week 52 (n = number of patients) in intention to treat analysis. The table shows the median (25th to 75th percentile) 6-thioguanine (TGN) and methylmercaptopurine (MeMP) levels (pmol/8 × 108 RBC) at week 6 and week 52, calprotectin (mg/kg) at week 52 and the two health-related quality of life scores at week 52 short inflammatory bowel disease questionnaire (SIBDQ) and short health scale (SHS).
| Outcomes | AZA/ALLO n = 47 | AZA n = 42 | P value | Odds Ratio | 95% CI |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Remission | 20 (43%) | 9 (21%) | 0·048 | 2.54 | 1.00–6.78 |
| Secondary outcomes | |||||
| Total Mayo score < 3 | 22 (47%) | 13 (31%) | 0·034 | 1.54 | 1.01–2.36 |
| Endoscopic Mayo 0 | 19 (41%) | 8 (19%) | 0·072 | 0.64 | 0.13–3.13 |
| Histological score 0 | 16 (34%) | 7 (17%) | 0·362 | 2.00 | 0.45–8.98 |
| 6TGN Week 6 | 454 (341‒568) | 330 (207‒412) | 0.001 | ||
| 6‒TGN Week 52 | 475 (356‒594) | 303 (199‒401) | 0.001 | ||
| MeMP Week 6 | 246 (156‒299) | 3134 (1836‒5987) | 0.001 | ||
| MeMP Week 52 | 113 (66‒267) | 3305 (1334‒6153) | 0·001 | ||
| Calprotectin | 121 (30‒1210) | 49 (30‒1800) | 0·757 | ||
| SIBDQ | 57 (36‒68) | 55 (47‒65) | 0·621 | ||
| SHS | 61 (14‒279) | 73 (27‒117) | 0·396 |