Summary of findings for the main comparison. Ustekinumab compared to placebo for maintenance of remission in Crohn's disease.
| Ustekinumab compared to placebo for maintenance of remission in Crohn's disease | ||||||
| Patient or population: people with moderate to severe Crohn's disease in remission Setting: outpatient Intervention: ustekinumab Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with ustekinumab | |||||
|
Failure to maintain clinical remission Follow‐up: 22 weeks |
726 per 1000 | 581 per 1000 (457 to 741) | RR 0.80 (0.63 to 1.02) | 145 (1 RCT) | ⊕⊕⊕⊝ moderate1 | Clinical remission was defined as a CDAI < 150 points. |
|
Failure to maintain clinical response Follow‐up: 22 weeks |
575 per 1000 | 305 per 1000 (207 to 455) | RR 0.53 (0.36 to 0.79) | 145 (1 RCT) | ⊕⊕⊕⊝ moderate2 | Clinical response was defined as a ≥ 100‐point decrease from the baseline CDAI score. |
|
Failure to maintain clinical remission Follow‐up: 44 weeks |
641 per 1000 |
487 per 1000 (410 to 584) |
RR 0.76 (0.64 to 0.91) |
388 (1 RCT) |
⊕⊕⊕⊝ moderate3 | Clinical remission was defined as a CDAI < 150 points. |
|
Failure to maintain clinical response Follow‐up: 44 weeks |
557 per 1000 |
412 per 1000 (334 to 507) |
RR 0.74 (0.60 to 0.91) |
388 (1 RCT) |
⊕⊕⊕⊝ moderate4 | Clinical response was defined as a decrease from baseline in the CDAI score of ≥ 100 points or a CDAI score < 150. |
|
Adverse events Follow‐up: 44 weeks |
840 per 1000 |
789 per 1000 (731 to 865) |
RR 0.94 (0.87 to 1.03) |
541 (2 RCTs) |
⊕⊕⊕⊕ high | Commonly reported adverse events included worsening Crohn's disease, abdominal pain, nausea, arthralgia, and headache. |
|
Serious adverse events Follow‐up: 44 weeks |
155 per 1000 | 115 per 1000 (75 to 179) | RR 0.74 (0.48 to 1.15) | 541 (2 RCTs) | ⊕⊕⊕⊝ moderate5 | Commonly reported serious adverse events included malignant neoplasm, basal cell carcinoma, and injection site reactions. |
|
Withdrawal due to adverse events Follow‐up: 44 weeks |
14 per 1000 |
68 per 1000 (8 to 572) |
RR 4.93 (0.59 to 41.18) |
145 (1 RCT) |
⊕⊕⊝⊝ low6 | Adverse events leading to withdrawal included worsening Crohn's disease |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CDAI: Crohn's Disease Activity Index; CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded one level due to sparse data (95 events). 2Downgraded one level due to sparse data (64 events). 3Downgraded one level due to sparse data (210 events). 4Downgraded one level due to sparse data (179 events). 5Downgraded one level due to sparse data (70 events). 6Downgraded two levels due to very sparse data (6 events).