Table 2.
Clinical trials in psoriatic arthritis.
| Study | Comparison | Population | TNFi-IR (%) |
MTX Use (%) |
Primary Outcome | Primary Endpoint (Weeks) | ACR20 (%) |
|---|---|---|---|---|---|---|---|
| TNF-α inhibitors | |||||||
| Antoni et al. (IMPACT 2) (N = 200) [36] |
IFX vs. PBO | csDMARD-IR or NSAID-IR | 0 | 46 | ACR20 | 14 | 58 (IFX) vs. 11 (PBO) * |
| Mease et al. (N = 205) [35] |
ETN vs. PBO | NSAID-IR | 0 | 41 | ACR20 | 12 | 59 (ETN) vs. 15 (PBO) * |
| Mease et al. (ADEPT) (N = 313) [34] |
ADA vs. PBO | NSAID-IR | 0 | 50.5 | ACR20 | 12 | 58(ADA) vs. 14 (PBO) * |
| Kavanaugh et al. (GO-REVEAL) (N = 405) [37] |
GOL (50 mg, 100 mg) vs. PBO | NSAID-IR | 0 | 48 | ACR20 | 24 | 48 (combined) vs. 9 (PBO) * |
| Mease et al. (RAPID-PsA) (N = 409) [38] |
CTZ (200 mg Q2W, 400 mg Q4W) vs. PBO | csDMARD-IR | NR 38.9 prior TNFi | 64 | ACR20 | 12 | 58 (Q2W) 51.9 (Q4W) vs. 24.3 (PBO) * |
| IL-12, 23p40 inhibitor | |||||||
| McInnes et al. (PSUMMIT 1) (N = 615) [55] | UST (45 mg, 90 mg) vs. PBO | csDMARD-IR | 0 | 48 | ACR20 | 24 | 42.4 (45 mg) 49.5 (90 mg) 22.8 (PBO) * |
| Ritchlin et al. (PSUMMIT 2) (N = 312) [56] | UST (45 mg, 90 mg) vs. PBO | Mixed csDMARD-IR/TNFi-IR | 57.7 | 50 | ACR20 | 24 | 43.8 (combined) 20.2 (PBO) * |
| Il-23p19 inhibitors | |||||||
| Deodhar et al. (DISCOVER-1) (N = 381) [67] | GKM (Q4W, Q8W) vs. PBO | Mixed csDMARD-IR/Apremilast-IR/TNFi-IR | 12 | 55 | ACR20 | 24 | 59 (Q4W) 52 (Q8W) 22 (PBO) * |
| Mease et al. (DISCOVER-2) (N = 739) [68] | GKM (Q4W, Q8W) vs. PBO | csDMARD-IR | 0 | 60 | ACR20 | 24 | 64 (Q4W) 64 (Q8W) 33 (PBO) * |
| Coates et al. (COSMOS) (N = 285) [73] | GKM vs. PBO | TNFi-IR | 84 | 55 | ACR20 | 24 | 44.4 (GKM) vs. 19.8 (PBO) * |
| Kristensen et al. (KEEPsAKE-1) (N = 964) [141] |
RKM vs. PBO | csDMARD-IR | 0 | 65.2 | ACR20 | 24 | 57.3 (RKM) vs. 33.5 (PBO) * |
| Östör et al. (KEEPsAKE-2) (N = 443) [142] | RKM vs. PBO | Mixed csDMARD-IR/Bio-IR | 46 | 47.1 | ACR20 | 24 | 51.3 (RKM) vs. 26.5 (PBO) * |
| Il-17A inhibitors | |||||||
| Mease et al. (FUTURE 1) (N = 606) [88] | SEC (150 mg, 75 mg) vs. PBO | Mixed csDMARD-IR/TNFi-IR | 29.4 | 61 | ACR20 | 24 | 50 (150 mg) 50.5 (75 mg) 17.3 (PBO) |
| McInnes et al. (FUTURE 2) (N = 397) [89] |
SEC (300 mg, 150 mg, 75 mg) vs. PBO | Mixed csDMARD-IR/TNFi-IR | 35 | 47 | ACR20 | 24 | 54 (300 mg) 51 (150 mg) 29 (75 mg) 15 (PBO) * |
| McInnes et al. (EXCEED) (N = 853) [107] |
SEC vs. ADA | csDMARD-IR | 0 | 85 | ACR20 | 52 | 67 (SEC) 62 (ADA) |
| Mease et al. (SPIRIT-P1) (N = 417) [103] |
IXE (Q2W, Q4W) vs. PBO vs. ADA (reference arm) | csDMARD-IR | 0 | 54.2 | ACR20 | 24 | 62.1 (Q2W) 57.9 (Q4W) 30.2 (PBO) * 57.4 (ADA) |
| Nash et al. (SPIRIT-P2) (N = 363) [102] |
IXE (Q2W, Q4W) vs. PBO | TNFi-IR | 91 | 41 | ACR20 | 24 | 48 (Q2W) 53 (Q4W) 20 (PBO) * |
| IL-17RA inhibitor | |||||||
| Mease et al. (AMVISION-1 and AMVISION-2) (N = 962) [108] |
Brodalumab (140 mg, 210 mg) vs. PBO | Mixed csDMARD-IR/Bio-IR | NR | NR | ACR20 | 16 | 45.8 (140 mg) 47.9 (210 mg) 20.9 (PBO) * |
| IL-17A/F inhibitor | |||||||
| McInnes et al. (BE-OPTIMAL) (N = 852) [113] |
BKM vs. PBO vs. ADA (reference arm) | csDMARD-IR | 0 | 58 | ACR50 (44% BKZ vs. 10% PBO) * |
16 | 62.2 (BKZ) vs. 24 (PBO) * 68.6 (ADA) |
| Merola et al. (BE-COMPLETE) (N = 400) [114] | BKM vs. PBO | TNFi-IR | 88 | 43 | ACR50 (43% BKZ vs. 7% PBO) * |
16 | 67 (BKZ) vs. 15.8 (PBO) * |
| JAK inhibitors | |||||||
| Mease et al. (OPAL Broaden) (N = 422) [121] |
TOFA (5 mg BD, 10 mg BD) vs. PBO vs. ADA (reference arm) | csDMARD-IR | 0 | 84 | ACR20 | 12 | 50 (5 mg) vs. 61 (10 mg) vs. 33 (PBO) * 52% (ADA) |
| Gladman et al. (OPAL Beyond) (N = 394) [122] |
TOFA (5 mg BD, 10 mg BD) vs. PBO | TNFi-IR | 100 | 73 | ACR20 | 12 | 50 (5 mg) vs. 47 (10 mg) vs. 24 (PBO) * |
| McInnes et al. (SELECT-PsA 1) (N = 1704) [126] | UPA (15 mg, 30 mg) vs. PBO vs. ADA (reference arm) | csDMARD-IR | 0 | 84 | ACR20 | 12 | 70.6 (15 mg) vs. 78.5 (30 mg) vs. 36.2 (PBO) * 65 (ADA) |
| Mease et al. (SELECT-PSA 2) (N = 641) [127] |
UPA (15 mg, 30 mg) vs. PBO | Bio-IR | NR 92% Bio-IR |
37 | ACR20 | 12 | 56.9 (15 mg) vs. 63.8 (30 mg) vs. 24.1 (PBO) * |
| Mease et al. (EQUATOR) (N = 131) [128] |
Filgotinib vs. PBO | csDMARD-IR | 0 | 55 | ACR20 | 16 | 80 (filgotinib) vs. 33 (PBO) * |
| Other targets | |||||||
| Mease et al. (N = 203) [133] |
Deucravacitinib (6 mg, 12 mg) vs. PBO | Mixed csDMARD-IR/TNFi-IR | NR 15.8% prior TNFi | 54.7 | ACR20 | 16 | 52.9 (6 mg) vs. 62.7 (12 mg) vs. 31.8 (PBO) * |
| Mease et al. (ASTRAEA) (N = 424) [134] |
ABA vs. PBO | Mixed csDMARD-IR/TNFi-IR | 61 | 60 | ACR20 | 24 | 39.4 (ABA) vs. 22.3 (PBO) * |
* Statistically significant result; MTX, methotrexate; TNFi-IR, tumour necrosis factor inhibitor inadequate response; csDMARD-IR, conventional synthetic disease modifying anti-rheumatic drug inadequate response; Bio-IR, biologic inadequate response; NSAID-IR, non-steroidal anti-inflammatory drug inadequate response; IFX, infliximab; PBO, placebo; ETN, etanercept; ADA, adalimumab; GOL, golimumab; CTZ, certolizumab pegol; UST, ustekinumab; GKM, guselkumab; RKM, rizankisumab; SEC, secukinumab; IXE, ixekizumab; BKM, bimekizumab; TOFA, tofacitinib; UPA, upadacitinib; ABA, abatacept.