From: Interleukin-1β inhibitors for the management of acute gout flares: a systematic literature review
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 |