The quality of evidence is downgraded by imprecise results (wide confidence intervals).
A Cochrane review included 1 study with 262 subjects. More participants in the pegloticase every 2 weeks (biweekly) group (table ) had complete resolution of one or more tophi compared with participants in the placebo group. The results for pegloticase monthly group are shown in table . Comparison of the two pegloticase groups found that more participants in the biweekly pegloticase arm had complete resolution of one or more tophi compared with participants in the monthly pegloticase group (RR 1.91, 95% CI 1.03 to 3.55). As pain, function, serum acid normalisation and quality of life data were only presented for the total population in the study, and not for the subgroup with tophi at baseline, these outcomes were not reported in the review.
| Outcome | Relative effect (95% CI) | NNTB/NNTH (95% CI) | Assumed risk - Placebo | Corresponding risk - Biweekly pegloticase (95% CI) | Participants (studies) |
|---|---|---|---|---|---|
| NA = not applicable | |||||
| Regression of tophi | RR 5.45 (1 to 22) | NNTB 3 (2 to 6) | 74 per 1000 | 404 per 1000 (104 to 1000) | 79 (1 study) |
| Withdrawals due to adverse events | RR 7.59 (1.04 to 55.55) | NNTH 7 (4 to 16) | 23 per 1000 | 177 per 1000 (24 to 1000) | 128 (1 study) |
| Total adverse events | RR 0.99 (0.91 to 1.07) | NA | 953 per 1000 | 941 per 1000 (851 to 1000) | 128 (1 study) |
Pegloticase administered biweekly and pegloticase administered monthly resulted in more withdrawals due to adverse events than placebo. A similar proportion of participants in the biweekly and monthly pegloticase arms withdrew due to adverse events (RR 0.93, 95% CI 0.49 to 1.75). Infusion reactions were the most common reason for study discontinuation with both biweekly and monthly pegloticase (22/85 with biweekly pegloticase versus 2/43 with placebo; RR 5.56, 95% CI 1.37 to 22.57; NNTH 2; 35/84 with monthly pegloticase group versus 2/43 with placebo; RR 8.96, 95% CI 2.26 to 35.49; NNTH 2). Pegloticase administered biweekly and pegloticase administered monthly resulted in similar numbers of participants with any adverse event to placebo. The top three most common adverse events were gout flares, infusion reactions and headaches; 80% of adverse events were due to flares of gout. This may explain the high rate of adverse events in the placebo groups that were essentially untreated.
| Outcome | Relative effect (95% CI) | NNTB/NNTH (95% CI) | Assumed risk - Placebo | Corresponding risk - Monthly pegloticase (95% CI) | Participants (studies) |
|---|---|---|---|---|---|
| NA = not applicable | |||||
| Regression of tophi | RR 2.86 (0.7 to 12) | NA | 74 per 1000 | 212 per 1000 (52 to 889) | 79 (1 study) |
| Withdrawals due to adverse events | RR 8.19 (1.12 to 59.71 | NNTH 6 (4 to 14) | 23 per 1000 | 190 per 1000 (166 to 1000) | 127 (1 study) |
| Total adverse events | RR 1.05 (0.98 to 1.14) | NA | 953 per 1000 | 1000 per 1000 (980 to 1000) | 127 (1 study) |
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