Why carry out this study? |
Very brief background leading to the study. |
The NPF recommends evaluating patient response to treatment at week 12, with a target response of BSA ≤ 1% and an acceptable response of BSA ≤ 3% or a ≥ 75% improvement in BSA. |
Numbers of patients achieving NPF week 12 target and acceptable responses for ixekizumab (IXE) versus other biologics have not been demonstrated across clinical trials or real-world studies of plaque psoriasis. |
What did the study ask? |
This post hoc analysis aimed to compare the achievement of NPF target and acceptable responses at week 12 for IXE versus other biologics across four head-to-head clinical trials and the real-world PSoHO observational study. |
What was learned from the study? |
What were the study outcomes/conclusions? |
Greater proportions of patients with plaque psoriasis treated with IXE achieved NPF target and acceptable responses at week 12 compared with those treated with other biologics. |
What has been learned from the study? |
IXE demonstrated therapeutic benefit in providing patients with NPF-defined target or acceptable responses at week 12 across clinical trial and real-world settings and in both biologic (bio)-naïve and bio-experienced patients. |
Introduction
Methods
Study Design, Participants, and Treatment
UNCOVER-2–3
IXORA-R
IXORA-S
PSoHO
Ethics Statement
Outcome Measures
Statistical Analyses
Head-to-Head Clinical Trial Data
Real-World Data (PSoHO)
Results
Clinical Data from Head-to-Head Trials
Patients
UNCOVER-2 AND UNCOVER-3 | ||||||
---|---|---|---|---|---|---|
All enrolled patients | Patients with NPF target responses at week 12a | Patients with NPF acceptable responses at week 12b | ||||
IXE Q2W (N = 736) | ETN (N = 740) | IXE Q2W (N = 384) | ETN (N = 110) | IXE Q2W (N = 542) | ETN (N = 264) | |
Age, years | 45.1 (13.2) | 45.5 (13.3) | 44.7 (13.8) | 45.6 (14.7) | 44.9 (13.4) | 45.2 (14.3) |
Male, n (%) | 475 (64.5) | 505 (68.2) | 233 (60.7) | 69 (62.7) | 334 (61.6) | 177 (67.0) |
BMI | 30.1 (7.1) | 31.0 (7.4)* | 29.3 (6.8) | 28.2 (5.8) | 29.7 (6.9) | 29.3 (6.4) |
Duration since PsO symptom onset or diagnosis, years, median (min, max) | 16.2 (0.5, 63.0) | 16.4 (0.6, 56.9) | 16.9 (0.5, 61.4) | 18.1 (0.7, 51.6) | 15.3 (0.5, 63.0) | 17.3 (0.7, 51.6) |
Previous conventional therapy, n (%) | 386 (52.4) | 388 (52.4) | 198 (51.6) | 57 (51.8) | 276 (50.9) | 142 (53.8) |
Previous biologic therapy, n (%) | 142 (19.3) | 136 (18.4) | 87 (22.7) | 16 (14.5) | 119 (22.0) | 38 (14.4)* |
Used 1 therapy, n (%) | 94 (12.8) | 102 (13.8) | 59 (15.4) | 14 (12.7) | 80 (14.8) | 29 (11.0) |
Used 2 therapies, n (%) | 32 (4.3) | 22 (3.0) | 19 (4.9) | 0 (0) | 26 (4.8) | 5 (1.9) |
Used ≥ 3 therapies, n (%) | 16 (2.2) | 12 (1.6) | 9 (2.3) | 2 (1.8) | 13 (2.4) | 4 (1.5) |
PASI | 20.1 (7.8) | 19.9 (7.5) | 19.3 (7.2) | 17.8 (5.2)* | 19.9 (7.5) | 20.0 (7.1) |
BSA % involvement | 26.6 (16.7) | 26.8 (16.6) | 25.0 (15.7) | 22.1 (12.3) | 26.3 (16.2) | 27.8 (16.2) |
sPGA | 3.5 (0.6) | 3.5 (0.6) | 3.5 (0.6) | 3.3 (0.5)* | 3.5 (0.6) | 3.5 (0.6) |
Moderate, n (%) | 385 (52.3) | 376 (50.8) | 212 (55.2) | 74 (67.3) | 292 (53.9) | 144 (54.5) |
Severe, n (%) | 308 (41.8) | 330 (44.6) | 158 (41.1) | 35 (31.8) | 226 (41.7) | 110 (41.7) |
Very severe, n (%) | 43 (5.8) | 34 (4.6) | 14 (3.6) | 1 (0.9) | 24 (4.4) | 10 (3.8) |
IXORA-R | ||||||
---|---|---|---|---|---|---|
All enrolled patients | Patients with NPF target responses at week 12a | Patients with NPF acceptable responses at week 12b | ||||
IXEQ2W (N = 520) | GUS (N = 507) | IXEQ2W (N = 317) | GUS (N = 227) | IXEQ2W (N = 423) | GUS (N = 358) | |
Age, years | 49.0 (13.9) | 49.0 (14.9) | 48.4 (14.0) | 47.5 (15.1) | 48.6 (14.0) | 48.4 (15.2) |
Male, n (%) | 338 (65.0) | 314 (61.9) | 212 (66.9) | 134 (59.0) | 278 (65.7) | 217 (60.6) |
BMI | 32.9 (7.9) | 32.8 (8.0) | 32.0 (7.7) | 31.6 (7.1) | 32.7 (7.9) | 31.9 (7.4) |
Duration since PsO symptom onset or diagnosis, years, median (min, max) | 14.1 (0.5, 70.3) | 12.1 (0.5, 67.2) | 14.2 (0.5, 70.3) | 11.3 (0.5, 55.2)* | 14.2 (0.5, 70.3) | 12.1(0.5, 67.2) |
Previous conventional therapy, n (%) | 170 (32.7) | 141 (27.8) | 96 (30.3) | 75 (33.0) | 136 (32.2) | 106 (29.6) |
Previous biologic therapy, n (%) | 139 (26.7) | 134 (26.4) | 86 (27.1) | 57 (25.1) | 113 (26.7) | 93 (26.0) |
Used 1 therapy, n (%) | 97 (18.7) | 97 (19.1) | 68 (21.5) | 45 (19.8) | 81 (19.1) | 69 (19.3) |
Used 2 therapies, n (%) | 28 (5.4) | 27 (5.3) | 15 (4.7) | 11 (4.8) | 22 (5.2) | 19 (5.3) |
Used ≥ 3 therapies, n (%) | 14 (2.7) | 10 (2.0) | 3 (0.9) | 1 (0.4) | 10 (2.4) | 5 (1.4) |
PASI | 19.5 (7.9) | 19.3 (7.1) | 18.9 (7.9) | 19.3 (7.5) | 19.5 (8.1) | 19.6 (7.2) |
BSA % involvement | 24.1 (16.1) | 23.8 (15.4) | 22.4 (15.0) | 23.9 (16.2) | 23.9 (16.0) | 24.6 (15.7) |
sPGA | n/a | n/a | n/a | n/a | n/a | n/a |
Moderate, n (%) | 266 (51.3) | 252 (49.7) | 169 (53.3) | 123 (54.2) | 217 (51.3) | 179 (50.0) |
Severe, n (%) | 224 (43.2) | 232 (45.8) | 132 (41.6) | 100 (44.1) | 182 (43.0) | 166 (46.4) |
Very severe, n (%) | 29 (5.6) | 23 (4.5) | 16 (5.0) | 4 (1.8) | 24 (5.7) | 13 (3.6) |
IXORA-S | ||||||
---|---|---|---|---|---|---|
All enrolled patients | Patients with NPF target responses at week 12a | Patients with NPF acceptable responses at week 12b | ||||
IXEQ2W (N = 136) | UST (N = 166) | IXEQ2W (N = 40) | UST (N = 69) | IXEQ2W (N = 87) | UST (N = 111) | |
Age, years | 42.7 (12.7) | 44.0 (13.3) | 42.2 (12.1) | 43.0 (12.7) | 41.7 (11.9) | 42.6 (12.4) |
Male, n (%) | 90 (66.2) | 112 (67.5) | 15 (37.5) | 25 (36.2) | 35 (40.2) | 38 (34.2) |
BMI | 28.8 (5.6) | 29.7 (7.0) | 28.9 (6.6) | 28.4 (5.5) | 28.6 (6.2) | 28.7 (5.4) |
Duration since PsO symptom onset or diagnosis, years, median (min, max) | 16.0 (1, 50) | 16.5 (0, 59) | 14.5 (1.0, 52.0) | 16.0 (1.0, 43.0) | 15.0 (0, 52.0) | 15.0 (1.0, 43.0) |
Previous conventional therapy, n (%) | 74 (54.4) | 107 (64.5) | n/a | n/a | n/a | n/a |
Previous biologic therapy, n (%) | 18 (13.2) | 25 (15.1) | 6 (15.0) | 7 (10.1) | 12 (13.8) | 15 (13.5) |
1 therapy, n (%) | 12 (8.8) | 18 (10.8) | n/a | n/a | n/a | n/a |
2 therapies, n (%) | 5 (3.7) | 7 (4.2) | n/a | n/a | n/a | n/a |
≥ 3 therapies, n (%) | 1 (0.7) | 0 (0) | n/a | n/a | n/a | n/a |
PASI | 19.9 (8.2) | 19.8 (9.0) | 19.6 (9.5) | 19.2 (7.4) | 19.8 (8.9) | 20.0 (7.8) |
BSA % involvement | 26.7 (16.5) | 27.5 (16.7) | 29.1 (16.7) | 25.6 (15.9) | 29.1 (17.4) | 27.1 (16.7) |
sPGA | 3.6 (0.7) | 3.6 (0.6) | 3.5 (0.6) | 3.4 (0.6) | 3.5 (0.6) | 3.5 (0.6) |
Moderate, n (%) | 61 (44.9) | 71 (42.8) | n/a | n/a | n/a | n/a |
Severe, n (%) | 63 (46.3) | 83 (50.0) | n/a | n/a | n/a | n/a |
Very severe, n (%) | 10 (7.4) | 12 (7.2) | n/a | n/a | n/a | n/a |
Achievement of NPF Target Responses at Week 12
Achievement of NPF Acceptable Responses at Week 12
Real-World Data (PSoHO) Patients
Overall US OL (N = 1773) | Anti-IL-17A (N = 720) | Other biologics (N = 1053) | IXE (N = 501) | SEC (N = 219) | GUS (N = 272) | RIS (N = 230) | ADA (N = 225) | UST (N = 112) | TILD (N = 83) | BROD (N = 60) | |
---|---|---|---|---|---|---|---|---|---|---|---|
Age, years | 45.3 (13.6) | 46.8 (13.7)‡ | 44.3 (13.3) | 47.3 (14.0) | 45.6 (13.0) | 44.2 (12.9) | 44.0 (13.6) | 45.0 (12.7) | 46.1 (14.5) | 45.4 (13.1) | 44.4 (14.1) |
Male, n (%) | 1014 (57.2) | 407 (56.5) | 607 (57.6) | 290 (57.9) | 117 (53.4) | 158 (58.1) | 145 (63.0) | 131 (58.2) | 65 (58.0) | 49 (59.0) | 34 (56.7) |
BMI | 29.2 (6.8) | 29.4 (6.6) | 29.1 (6.9) | 29.5 (6.7) | 29.1 (6.5) | 29.2 (6.7) | 28.9 (7.1) | 29.7 (6.7) | 28.2 (5.6) | 29.6 (7.6) | 29.3 (7.6) |
Duration since onset of PsO, years, median (Q1, Q3) | 14.1 (7.1, 23.8) | 14.6 (6.5, 24.6) | 14.0 (7.4, 23.1) | 14.1 (6.6, 25.5) | 15.0 (6.3, 22.2) | 15.7 (8.2, 24.6) | 13.7 (8.0, 23.0) | 14.0 (6.5, 23.0) | 12.1 (6.3, 23.3) | 16.0 (8.1, 25.8) | 15.0 (7.7, 21.0) |
Previous conventional therapy, n (%) | 1400 (79.0) | 535 (74.4)‡ | 865 (82.1) | 374 (74.8) | 161 (73.5) | 200 (73.5) | 177 (77.0) | 211 (93.8) | 95 (84.8) | 73 (88.0) | 50 (83.3) |
Previous biologic therapy, n (%) | 645 (36.4) | 275 (38.2) | 370 (35.1) | 193 (38.6) | 82 (37.4) | 165 (60.7) | 97 (42.2) | 18 (8.0) | 31 (27.7) | 26 (31.3) | 22 (36.7) |
1 therapy, n (%) | 437 (24.7) | 190 (26.4) | 247 (23.5) | 130 (26.0) | 60 (27.4) | 100 (36.8) | 68 (29.6) | 12 (5.3) | 24 (21.4) | 20 (24.1) | 13 (21.7) |
2 therapies, n (%) | 105 (5.9) | 48 (6.7) | 57 (5.4) | 33 (6.6) | 15 (6.8) | 31 (11.4) | 14 (6.1) | 3 (1.3) | 5 (4.5) | 2 (2.4) | 1 (1.7) |
≥ 3 therapies, n (%) | 103 (5.8) | 37 (5.1) | 66 (6.3) | 30 (6.0) | 7 (3.2) | 34 (12.5) | 15 (6.5) | 3 (1.3) | 2 (1.8) | 4 (4.8) | 8 (13.3) |
PASI | 14.7 (8.7) | 14.6 (8.6) | 14.7 (8.8) | 14.4 (8.5) | 15.0 (8.9) | 14.9 (9.5) | 15.7 (10.1) | 13.5 (7.4) | 14.6 (8.1) | 14.2 (8.0) | 16.2 (8.6) |
BSA % involvement | 21.7 (17.9) | 21.4 (17.7) | 21.8 (18.1) | 20.8 (17.2) | 22.9 (18.6) | 22.2 (18.7) | 21.1 (19.0) | 20.9 (17.3) | 23.2 (18.1) | 19.9 (15.1) | 23.9 (18.5) |
sPGA | 3.2 (0.9) | 3.2 (0.9) | 3.2 (0.9) | 3.2 (0.9) | 3.3 (0.9) | 3.3 (0.8) | 3.3 (1.0) | 3.1 (0.8) | 3.1 (0.9) | 3.0 (1.0) | 3.2 (0.9) |
Moderate, n (%) | 885 (50.7) | 364 (51.2) | 521 (50.4) | 254 (51.1) | 110 (51.4) | 129 (48.0) | 87 (39.0) | 134 (60.1) | 62 (56.4) | 37 (45.1) | 35 (60.3) |
Severe, n (%) | 546 (31.3) | 220 (30.9) | 326 (31.6) | 163 (32.8) | 57 (26.6) | 91 (33.8) | 85 (38.1) | 57 (25.6) | 30 (27.3) | 24 (29.3) | 16 (27.6) |
Very severe, n (%) | 74 (4.2) | 33 (4.6) | 41 (4.0) | 16 (3.2) | 17 (7.9) | 14 (5.2) | 15 (6.7) | 5 (2.2) | 2 (1.8) | 2 (2.4) | 3 (5.2) |