Table 1.
Intervention details of the RCTs
| Author | Study design (duration) | Number of patients by treatment group | Intervention and comparator | Primary endpoint |
|---|---|---|---|---|
| CAN (N = 3) | ||||
| Schlesinger et al., 2011a [20] | Adaptive single-dose, single-blind, active-controlled study (8 wk) |
CAN: n = 143 TA: n = 57 |
Intervention: One dose of CAN (10, 25, 50, 90, or 150 mg) and saline on day 1 Comparator: One dose of TA 40 mg and PBO on day 1 |
Pain (note: pain was the primary endpoint of the original study but is also reported in this study) |
| Schlesinger et al. 2011b [21] | Dose-ranging, multicentre, double-blind, double-dummy, active-controlled study (16 wk + 8-wk FU) |
CAN 25‒300 mg: n = 270 CAN q4wk: n = 53 CLC: n = 108 |
Intervention: One dose of CAN (25, 50, 100, 200 mg, 300 mg) or CAN q4wk Comparator: CLC 0.5 mg q.d |
CAN dose producing equivalent efficacy to CLC 0.5 mg (mean number of GFs PP) |
| Schlesinger et al., 2012 [19] | 2 multicentre, active-controlled, double-blind, parallel-group, double-dummy, phase 3 studies (12 wk + 12-wk ext) |
CAN: n = 225 TA: n = 229 |
Intervention: CAN 150 mg; PBO matching for each GF Comparator: TA 40 mg; PBO matching for each GF |
Pain intensity in the most affected joint at 72 h post-dose and time to first new GF |
| ANK (N = 2) | ||||
| Janssen et al., 2019 [16] | Randomised, double-blind, double-dummy, active comparator, PBO-controlled trial (5 d + 2-d safety FU) |
TaU: n = 45 ANK: n = 43 |
Intervention: 5-d treatment with ANK (100 mg q.d.) + PBO up to t.i.d. (CLC), b.i.d. (NAP) or q.d. (PRED) Comparator: TaU (0.5 mg up to t.i.d. for CLC; 500 mg up to b.i.d. for NAP; 35 mg q.d. for 5 d for PRED) + PBO q.d. for 5 d |
Mean change in pain in the most affected joint from BL to the average of pain scores at days 2‒4 with a prespecified non-inferiority margin of 0.4 |
| Saag et al., 2021 [18] | Randomised, double-blind, double-dummy, active-control, multicentre trial (15 d + 52-wk post-randomisation ext) |
TA: n = 55 ANK: n = 110 |
Intervention: ANK 100 mg q.d. for 5 d/ANK 200 mg q.d. for 5 d Comparator: TA 40 mg single injection on day 1 |
Change in pain intensity from BL to 24–72 h |
| RL (N = 5) | ||||
| Mitha et al., 2013 [17] | Randomised, double-blind, PBO-controlled, phase 3 study (16 wk + 5-wk safety FU) |
PBO: n = 82 RL: n = 166 |
Intervention: RL 80 mg/160 mg. q.w with loading doses of RL 160 mg (80-mg group) & 320 mg (160-mg group) on day 1, followed by 15 q.w. doses alongside AP 300 mg q.d Comparator: PBO q.w. Loading doses on treatment day 1 followed by 15 q.w. Patients also initiated on AP 300 mg q.d |
Mean number of GFs PP up to week 16 |
| Schumacher et al., 2012a [23] | Phase 2, randomised, double-blind, PBO-controlled trial (16-wk + 6-wk FU) |
PBO: n = 42 RL: n = 41 |
Intervention: RL 160 mg q.w. (loading dose: RL 320 mg) and AP 300 mg q.d Comparator: PBO q.w. and AP 300 mg q.d |
Number of GFs PP through week 12 |
| Schumacher et al., 2012b [22] | Phase 3, randomised, double-blind, PBO-controlled, confirmatory efficacy study (16-wk + 4-wk safety FU) |
PBO: n = 79 RL: n = 161 |
Intervention: RL 80 mg/160 mg q.w. Loading doses of RL 160 mg (80-mg group), 320 mg (160-mg group) on treatment day 1, alongside AP q.d Comparator: PBO q.w. Loading doses of PBO were administered on treatment day 1, alongside AP q.d |
Mean number of GFs PP through week 16 |
| Sundy et al., 2014 [24] | Phase 3, randomised, double-blind, PBO-controlled trial (16-wk + 4-wk safety FU) |
PBO: n = 330 RL: n = 985 |
Intervention: RL 160 mg q.w. Loading dose of RL 320 mg was administered in 2 equal volumes on day 1 Comparator: Loading dose of PBO was administered in 2 equal volumes on day 1, followed by 15 q.w. doses of PBO |
Safety (AE, SAE, and clinical laboratory variables) over 20 weeks |
| Terkeltaub et al., 2013 [25] | Phase 3, randomised, double blind, double-dummy, active- and PBO-controlled study (3‒9 d + safety FU on d 31) |
PBO + IND: n = 75 RL + IND: n = 74 RL + PBO: n = 73 |
Intervention: RL 320 mg at BL + IND (50 mg t.i.d. for 3 d [then 25 mg t.i.d. for up to 9 d]) or RL 320 mg at BL + PBO t.i.d. for 3 d (then PBO t.i.d. for up to 9 d) Comparator: PBO at BL + IND 50 mg t.i.d. for 3 d (then 25 mg t.i.d. for up to 9 d) |
Pain in the index joint at 24, 48 and 72 h |
AE adverse event, ANK anakinra, AP allopurinol, b.i.d twice daily, BL baseline, CAN canakinumab, CLC colchicine, d days(s), ext extension, FU follow-up, GF gout flare, h hour(s), IND indomethacin, n number of patients in group, N number of studies, NAP naproxen, PBO placebo, PP per patient, PRED prednisone, q.d once daily, q.w once weekly, q4wk every 4 weeks, RCT randomised controlled trial, RL rilonacept, SAE serious adverse event, t.i.d three times daily, TA triamcinolone acetonide, TaU treatment as usual, wk week(s)