Background
Methods
Patients
Study design
Outcomes
Statistical analysis
Results
Patients
Characteristic | Secukinumab 300 mg (N = 139) | Secukinumab 150 mg (N = 138) | Placebo (N = 137) |
---|---|---|---|
Age (years), mean (SD) | 49.3 (12.9) | 50.1 (11.7) | 50.1 (12.6) |
Male, n (%) | 67 (48.2) | 61 (44.2) | 59 (43.1) |
Race, n (%) | |||
White | 130 (93.5) | 129 (93.5) | 133 (97.1) |
American Indian or Alaska Native | 0 | 2 (1.4) | 0 |
Asian | 3 (2.2) | 2 (1.4) | 4 (2.9) |
Other | 6 (4.3) | 5 (3.6) | 0 |
Weight (kg), mean (SD) | 87.1 (19.4) | 87.1 (20.0) | 82.6 (18.5) |
Number of previous anti-TNF treatments for PsA, n (%) | |||
0 | 95 (68.3) | 94 (68.1) | 93 (67.9) |
1 | 19 (13.7) | 22 (15.9) | 20 (14.6) |
≥ 2 | 25 (18.0) | 22 (15.9) | 24 (17.5) |
Time since diagnosis of PsA (years), mean (SD) | 8.3 (9.2) | 7.7 (8.5) | 6.6 (6.9) |
MTX use at randomization, n (%) | 70 (50.4) | 59 (42.8) | 68 (49.6) |
Systemic glucocorticoid use at randomization, n (%) | 23 (16.5) | 24 (17.4) | 32 (23.4) |
Anti-TNF-naïve, n (%) | 95 (68.3) | 94 (68.1) | 93 (67.9) |
Patients with specific disease characteristics, n (%) | |||
Psoriasis ≥ 3% of BSA | 62 (44.6) | 68 (49.3) | 59 (43.1) |
Presence of dactylitis | 46 (33.1) | 36 (26.1) | 36 (26.3) |
Presence of enthesitis | 88 (63.3) | 95 (68.8) | 98 (71.5) |
Disease and quality-of-life scores, mean (SD) | |||
TJC (78 joints) | 19.7 (14.8) | 23.3 (18.1) | 21.9 (16.2) |
SJC (76 joints) | 8.9 (6.4) | 11.2 (9.2) | 10.3 (8.6) |
DAS28-CRP | 4.5 (1.0) | 4.6 (1.1) | 4.7 (1.1) |
PASIa | 10.1 (8.6) | 8.8 (6.4) | 10.4 (9.0) |
Physician’s global assessment (VAS) | 51.8 (19.7) | 55.2 (16.7) | 54.8 (18.1) |
HAQ-DI | 1.1 (0.7) | 1.2 (0.6) | 1.2 (0.6) |
PsA pain (VAS) | 54.8 (23.8) | 54.4 (21.4) | 53.3 (23.8) |
Patient’s global assessment (VAS) | 59.9 (20.8) | 59.8 (22.1) | 60.6 (20.9) |
SF-36 PCS | 39.2 (8.4) | 37.9 (7.6) | 37.4 (8.5) |
Efficacy
Endpoint | Week | Secukinumab 300 mg (N = 139) | Secukinumab 150 mg (N = 138) | Placebo (N = 137) |
---|---|---|---|---|
ACR20 response, n/N (%) | 24 | 67/139 (48.2)* | 58/138 (42.0)* | 22/137 (16.1) |
52 | 81/139 (58.3) | 65/138 (47.1) | – | |
ACR50 response, n/N (%) | 24 | 48/139 (34.5)* | 26/138 (18.8)‡ | 12/137 (8.8) |
52 | 46/139 (33.1) | 38/138 (27.5) | – | |
DAS28-CRP, mean change from baseline ± SE | 24 | −1.56 ± 0.09* | −1.24 ± 0.1‡ | −0.64 ± 0.13 |
52 | −1.61 ± 0.09 | −1.41 ± 0.10 | – | |
PASI 75 response, n/N (%)b | 24 | 29/62 (46.8)* | 34/68 (50.0)‡ | 6/59 (10.2) |
52 | 46/62 (74.2) | 41/68 (60.3) | – | |
SF-36 PCS, mean change from baseline ± SE | 24 | 6.46 ± 0.59§ | 3.42 ± 0.60 | 2.94 ± 0.83 |
52 | 6.43 ± 0.66 | 4.49 ± 0.68 | – | |
PASI 90 response, n/N (%)b | 24 | 21/62 (33.9)§ | 25/68 (36.8) | 4/59 (6.8) |
52 | 34/62 (54.8) | 28/68 (41.2) | – | |
HAQ-DI score, mean change from baseline ± SE | 24 | − 0.38 ± 0.04§ | − 0.27 ± 0.04 | −0.17 ± 0.06 |
52 | −0.43 ± 0.05 | −0.30 ± 0.05 | – | |
Patients with resolution of dactylitis, n/N (%)c | 24 | 22/46 (47.8)§ | 14/36 (38.9) | 5/36 (13.9) |
52 | 28/46 (60.9) | 19/36 (52.8) | – | |
Patients with resolution of enthesitis, n/N (%)c | 24 | 35/88 (39.8)§ | 35/95 (36.8) | 15/98 (15.3) |
52 | 47/88 (53.4) | 44/95 (46.3) | – | |
Patient’s assessment of PsA pain (VAS), mean change from baseline ± SE | 24 | −18.23 ± 1.97* | −12.46 ± 2.0‡ | −3.75 ± 2.81 |
52 | −20.3 ± 2.1 | −11.8 ± 2.2 | – | |
FACIT-Fatigue, mean change from baseline ± SE | 24 | 6.40 ± 0.78† | 2.73 ± 0.80 | 2.07 ± 1.05 |
52 | 6.72 ± 0.9 | 3.25 ± 0.9 | – |
Autoinjector usability and satisfaction assessment
Safety
Variable | Through week 16 (placebo-controlled period) | Entire safety-data period | ||||
---|---|---|---|---|---|---|
Secukinumab 300 mg (N = 139) | Secukinumab 150 mg (N = 138) | Placebo (N = 137) | Any secukinumab 300 mg (N = 204) | Any secukinumab 150 mg (N = 202) | Any secukinumab (N = 406) | |
Exposure to study treatment (days), mean ± SD | 403.8 ± 108.3 | 392.3 ± 115.8 | 398.1 ± 112.1 | |||
Any AE | 76 (54.7) | 80 (58.0) | 77 (56.2) | 164 (194.9) | 156 (192.5) | 320 (193.7) |
Any serious AE | 3 (2.2) | 5 (3.6) | 9 (6.6) | 19 (8.8) | 21 (10.2) | 40 (9.5) |
Discontinued due to AEsa | 3 (2.2) | 5 (3.6) | 5 (3.6) | 9 (4.4) | 13 (6.4) | 22 (5.4) |
Deathb | 0 | 0 | 0 | 0 | 2 (1.0) | 2 (0.5) |
Common AEsc | ||||||
Nasopharyngitis | 13 (9.4) | 11 (8.0) | 13 (9.5) | 47 (25.0) | 30 (15.5) | 77 (20.2) |
Upper respiratory tract infection | 7 (5.0) | 6 (4.3) | 5 (3.6) | 23 (10.9) | 19 (9.3) | 42 (10.1) |
Diarrhea | 4 (2.9) | 7 (5.1) | 2 (1.5) | 16 (7.5) | 15 (7.2) | 31 (7.4) |
Back pain | 5 (3.6) | 4 (2.9) | 1 (0.7) | 16 (7.5) | 12 (5.7) | 28 (6.6) |
Headache | 6 (4.3) | 9 (6.5) | 6 (4.4) | 11 (5.1) | 15 (7.3) | 26 (6.1) |
Arthralgia | 4 (2.9) | 1 (0.7) | 1 (0.7) | 12 (5.5) | 13 (6.3) | 25 (5.9) |
Bronchitis | 3 (2.2) | 2 (1.4) | 5 (3.6) | 15 (6.9) | 9 (4.3) | 24 (5.6) |
Fatigue | 5 (3.6) | 4 (2.9) | 2 (1.5) | 7 (3.2) | 15 (7.3) | 22 (5.2) |
Urinary tract infection | 6 (4.3) | 3 (2.2) | 2 (1.5) | 13 (6.0) | 9 (4.2) | 22 (5.1) |
AEs of special interest | ||||||
Myocardial infarction | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.2) |
Neutropenia | 0 | 0 | 0 | 1 (0.4) | 2 (0.9) | 3 (0.7) |
Candida infection | 0 | 2 (1.4) | 2 (1.5) | 6 (2.7) | 8 (3.8) | 14 (3.2) |
IBD | 0 | 0 | 1 (0.7) | 1 (0.4) | 0 | 1 (0.2) |