Summary of findings 4. Anakinra versus placebo for reducing inflammation in familial Mediterranean fever.
| Anakinra compared with placebo for familial Mediterranean fever | ||||||
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Patient or population: participants with familial Mediterranean fever Settings: outpatient (Israel) Intervention: anakinra Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Anakinra | |||||
|
Number of participants experiencing an attack1 Follow‐up: 4 months |
1000 per 1000 | 760 per 1000 (540 to 1000) | RR 0.76 (0.54 to 1.07) | 25 (1 study) | ⊕⊕⊕⊝ moderate2 | RR < 1 indicates an advantage to anakinra. Number of participants experiencing an attack at 1 and 2 months follow‐up were analysed; the difference between anakinra and placebo were not significant at either time‐point, RR 0.72 (95% CI 0.47 to 1.11) and RR 0.76 (95% CI 0.54 to 1.07), respectively. |
| Duration of attacks | Not reported. | NA | ||||
| Number of days between attacks | Not reported. | NA | ||||
| Prevention of AA amyloidosis | Not reported. | NA | ||||
| Adverse drug reactions | 308 per 1000 | 166 per 1000 (37 to 751) | RR 0.54 (0.12 to 2.44) | 25 (1 study) | ⊕⊕⊕⊝ moderate2 | Information from main text states: "The study reported that drug‐related adverse events were experienced by 16.7% of people in the anakinra group and 30.8% in the control group, including injection site reaction, headache, presyncope, dyspnea and itching" (Ben‐Zvi 2017). |
|
Acute phase response Follow‐up: 4 months |
The mean CRP was 19.9 mg/L in the placebo group. | The mean CRP was 3.9 mg/L in the anakinra group. | NA | 20 (1 study) | ⊕⊕⊕⊝ moderate2 | The P value was 0.006 for the CRP, significant difference, and 0.07 for the SAA, no significant difference. |
| The mean SAA was 110.3 mg/L in the placebo group. | The mean SAA was 11.1 mg/L in the anakinra group. | NA | ||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AA: amyloid A; CI: confidence interval; CRP: C‐reactive protein;NA: not applicable; RR: risk ratio; SAA: serum amyloid A. | ||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
- Attack definition: fever ≥38℃ lasting 6 hours to 7 days and accompanied by painful in either the abdomen, the chest, the joints, or the skin.
- Downgraded once for the small sample size.