Table 2.
Difference in endoscopic scores of activity, biomarkers, and drug levels between baseline and end of study visit
| Combination group (n=67)* | Infliximab withdrawal group (n=71)* | Immunosuppressant withdrawal group (n=69)* | p value (combination vs infliximab withdrawal) | p value (immunosuppressant withdrawal vs infliximab withdrawal) | ||
|---|---|---|---|---|---|---|
| hsCRP (mg/L) | .. | .. | .. | |||
| Baseline | 1·24 (0·51 to 2·8); n=65 | 1·19 (0·61 to 2·44); n=68 | 1·19 (0·52 to 2·61); n=66 | .. | .. | |
| End of study | 1·41 (0·70 to 4); n=52 | 1·74 (0·83 to 4); n=58 | 2 (0·87 to 5·56); n=56 | .. | .. | |
| Difference (End of study–baseline) | 0·05 (−0·48 to 1·61); n=51 | 0·54 (0·01 to 1·82); n=56 | 0·6 (−0·18 to 2·3); n=55 | 0·25 | 0·51 | |
| Faecal calprotectin (μg/g) | .. | .. | .. | |||
| Baseline | 78·2 (26·1 to 320·2); n=41 | 95 (22 to 289·4); n=47 | 61·4 (22 to 195·4); n=53 | .. | .. | |
| End of study | 50·7 (22 to 278·7); n=22 | 148·4 (27·9 to 492); n=30 | 130·9 (52·4 to 323·3); n=25 | .. | .. | |
| Difference (End of study–baseline) | 0 (−95·8 to 17·9); n=14 | 1 (−25·9 to 131); n=26 | 15·3 (−2·7 to 123·8); n=24 | 0·33 | 0·47 | |
| CDEIS | .. | .. | .. | |||
| Baseline | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0); n=68 | .. | .. | |
| End of study | 0 (0 to 1·9); n=46 | 0 (0 to 4·8); n=54 | 0 (0 to 0); n=49 | .. | .. | |
| Difference (End of study–baseline) | 0 (0 to 0·02); n=46 | 0 (0 to 3·5); n=54 | 0 (0 to 0); n=49 | 0·41 | 0·039 | |
| SES-CD | .. | .. | .. | |||
| Baseline | 0 (0 to 2) | 0 (0 to 0.5) | 0 (0 to 1) | .. | .. | |
| End of study | 0 (0 to 1); n=65 | 0 (0 to 4); n=69 | 0 (0 to 1); n=62 | .. | .. | |
| Difference (End of study–baseline) | 0 (0 to 1); n=65 | 0 (0 to 2); n=69 | 0 (0 to 0.8); n=62 | 0·15 | 0·29 | |
| Infliximab trough (μg/mL) | .. | .. | .. | |||
| Baseline | 3·55 (2·53 to 5·75); n=66 | 4·1 (2·5 to 6·3); n=69 | 4·1 (2·43 to 5·73); n=66 | .. | .. | |
| End of study | 3·54 (2·48 to 5·7); n=52 | 0·07 (0·04 to 3·55); n=54 | 3·4 (1·8 to 5·8); n=53 | .. | .. | |
| Difference (End of study–baseline) | 0·25 (−1·13 to 2·13); n=52 | −3·45 (−5·65 to −0·7); n=53 | −0·1 (−2·1 to 1·2); n=53 | <0·0001 | <0·0001 | |
| Anti-infliximab antibodies (μg/mL) | .. | .. | .. | |||
| Baseline | 0·4 (0·3 to 0·6); n=66 | 0·5 (0·3 to 0·7); n=69 | 0·5 (0·3 to 0·7); n=66 | .. | .. | |
| End of study | 0·4 (0·28 to 0·6); n=52 | 0·4 (0·2 to 0·68); n=54 | 0·5 (0·3 to 0·9); n=53 | .. | .. | |
| Difference (End of study–baseline) | −0·1 (−0·1 to 0·1); n=52 | −0·1 (−0·2 to 0); n=53 | 0 (−0·1 to 0·2); n=53 | 0·31 | 0·012 | |
Data are median (IQR); (n). CDEIS=Crohn's Disease Endoscopic score of Severity. SES-CD=Simplified Endoscopic Score for Crohn's Disease. hsCRP=high-sensitivity C-reactive protein.
*
Number of participants is indicated as “; n= ” when not corresponding to n=67 in the combination group, n=71 in the infliximab withdrawal group, and n=69 in the immunosuppressant withdrawal group.