1. Adalimumab 40 mg every other week compared to placebo for fatigue in inflammatory bowel disease.
| Adalimumab 40 mg every other week compared to placebo for fatigue in inflammatory bowel disease | ||||||
| Patient or population: participants with moderately‐to‐severely active disease Setting: 92 centres in the United States, Europe, Canada, Australia and South Africa Intervention: adalimumab 40 mg every other week Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with adalimumab 40 mg every other week | |||||
| Fatigue assessed with: FACIT‐Fatigue follow‐up: 56 weeks | The mean fatigue score was 32.5 | MD 4.3 higher (1.75 higher to 6.85 higher) | ‐ | 337 (1 RCT) | ⊕⊕⊝⊝ LOW 1 | FACIT‐F scores ranged from 0 to 52, with higher scores indicating less fatigue. |
| Fatigue assessed with: SF‐36 Vitality follow‐up: 56 weeks | The mean fatigue score was 54.8 | MD 2.8 higher (5.1 lower to 10.7 higher) | ‐ | 143 (1 RCT) | ⊕⊕⊝⊝ LOW 2 | SF‐36 vitality subscale scores ranged from 0 to 100, with higher scores indicating greater vitality (less fatigue). |
| Quality of life assessed with: IBDQ follow‐up: 56 weeks | The mean quality of life score was 172.9 | MD 10.4 higher (0.53 lower to 21.33 higher) | ‐ | 145 (1 RCT) | ⊕⊕⊝⊝ LOW 2 | IBDQ scores ranged from 32 to 224, with higher scores indicating better quality of life. |
| Adverse events assessed with: MedDRA follow‐up: 56 weeks | 847 per 1,000 | 888 per 1,000 (826 to 930) | OR 1.44 (0.86 to 2.41) | 521 (1 RCT) | ⊕⊕⊕⊝ MODERATE 3 | |
| Serious adverse events assessed with: MedDRA follow‐up: 56 weeks | 153 per 1,000 | 92 per 1,000 (56 to 148) | OR 0.56 (0.33 to 0.96) | 521 (1 RCT) | ⊕⊕⊕⊝ MODERATE 3 | |
| Withdrawal due to adverse events assessed with: MedDRA follow‐up: 56 weeks | 134 per 1,000 | 69 per 1,000 (39 to 119) | OR 0.48 (0.26 to 0.87) | 521 (1 RCT) | ⊕⊕⊕⊝ MODERATE 3 | |
| *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 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 | ||||||
1 Downgraded two levels due to very serious imprecision as the confidence interval was wide and the fatigue data represented the last‐observation‐carried‐forward when a participant had missing value, dropped out or switched to open‐label therapy.
2 Downgraded two levels due to serious imprecision as the number of participants was small and confidence interval was wide.
3 Downgraded one level due to serious imprecision as the number of participants was small.