Summary of findings 4. Anakinra versus placebo for reducing inflammation in familial Mediterranean fever.
| Anakinra versus placebo for familial Mediterranean fever | ||||||
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Patient or population: people 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) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Anakinra | |||||
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Number of participants experiencing an attacka Follow‐up: 4 months |
1000 per 1000 | 760 per 1000 (540 to 1000) | RR 0.76 (0.54 to 1.07) | 25 (1 study) | ⊕⊕⊕⊝ Moderateb | RR < 1 indicates an advantage to anakinra. Number of participants experiencing an attack at 1 and 2 months' follow‐up were analyzed; there was no evidence of a difference between anakinra and placebo at either time point (1 month: RR 0.72, 95% CI 0.47 to 1.11; 2 months: RR 0.76, 95% CI 0.54 to 1.07). |
| Duration of attacks | Not reported. | |||||
| Time between attacks | Not reported. | |||||
| Prevention of AA amyloidosis | Not reported. | |||||
| Adverse drug reactions | 308 per 1000 | 166 per 1000 (37 to 751) | RR 0.54 (0.12 to 2.44) | 25 (1 study) | ⊕⊕⊕⊝ Moderateb | Information from main text stated, "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). |
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Acute‐phase response Follow‐up: 4 months |
The mean CRP was 19.9 mg/L in the placebo group. | Mean CRP was 16.0 mg/L lower in the anakinra group (27.38 lower to 4.62 lower). | — | 20 (1 study) | ⊕⊕⊕⊝ Moderateb | P = 0.006, favoring anakinra. |
| The mean SAA was 110.3 mg/L in the placebo group. | Mean SAA was 99.2 mg/L lower in the anakinra group (204.69 lower to 6.29 higher). | — | P = 0.07, no evidence of a difference. | |||
| *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;RR: risk ratio; SAA: serum amyloid A protein. | ||||||
| GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: 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 certainty: we are very uncertain about the estimate. | ||||||
aAttack definition: fever ≥ 38 °C or greater lasting six hours to seven days and accompanied by pain in the abdomen, chest, joints or skin. bDowngraded one level for the small sample size.