9. Ciprofloxacin (500 mg twice daily) with adalimumab compared to placebo with adalimumab for induction and maintenance of remission in Crohn's disease.
| Ciprofloxacin with adalimumab compared to placebo with adalimumab for induction and maintenance of remission in Crohn's disease | ||||||
| Patient or population: Participants with active CD Setting: Outpatient Intervention: Ciprofloxacin with adalimumab Comparison: Placebo with adalimumab | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo with adalimumab | Risk with Ciprofloxacin with adalimumab | |||||
| Failure to enter clinical remission Follow‐up: 12 weeks |
359 per 1,000 | 244 per 1,000 (118 to 492) | RR 0.68 (0.33 to 1.37) | 76 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | Clinical remission was defined as the closure of all fistulas All patients were treated with self‐administered adalimumab (patients were given induction dosing of 160 mg at day 0 and 80 mg at week 2, followed by maintenance of 40 mg every 4 weeks until week 24) |
| Failure to maintain clinical remission Follow‐up: 24 weeks |
See comments | Although the authors reported on this outcome, we did not include it as participants only received ciprofloxacin up to week 12. All participants received maintenance adalimumab after week 12 | ||||
| Failure to have clinical response | Not reported | This outcome was not reported | ||||
| Failure to maintain endoscopic remission | Not reported | This outcome was not reported | ||||
| Adverse Events Follow‐up: 12‐24 weeks |
872 per 1,000 | 837 per 1,000 (697 to 1,000) | RR 0.96 (0.80 to 1.16) | 76 (1 RCT) | ⊕⊕⊕⊝ MODERATE 3 | Adverse events included respiratory tract infection, fatigue and headache |
| Serious adverse events Follow‐up: 12‐24 weeks |
77 per 1,000 | 81 per 1,000 (18 to 377) | RR 1.05 (0.23 to 4.90) | 76 (1 RCT) | ⊕⊕⊝⊝ LOW 4 | Serious adverse events included sagittal sinus thrombosis, severe disease flares, herpes simplex infection and parastomal herniation |
| Withdrawal due to adverse events Follow‐up: 12‐24 weeks |
77 per 1,000 | 54 per 1,000 (9 to 305) | RR 0.70 (0.12 to 3.97) | 76 (1 RCT) | ⊕⊕⊝⊝ LOW 5 | Specific adverse events causing withdrawal were not reported |
| *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). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded two levels due to very sparse data (23 events)
2 Downgraded two levels due to very sparse data (29 events)
3 Downgraded one level due to sparse data (65 events)
4 Downgraded two levels due to very sparse data (6 events)
5 Downgraded two levels due to very sparse data (5 events)