Table 2.
Summary of efficacy results during the extension phasea
| Efficacy Endpoints | Secukinumab 150 mg (N = 236) | ||||
|---|---|---|---|---|---|
| Year 2b | Year 3b | Year 4b | Year 5c | ||
| ACR20 | 158/213 (74.2) | 168/229 (73.4) | 142/211 (67.3) | 137/193 (71.0) | |
| ACR50 | 99/213 (46.5) | 122/229 (53.3) | 103/211 (48.8) | 100/193 (51.8) | |
| ACR70 | 58/213 (27.2) | 71/229 (31.0) | 64/211 (30.3) | 70/193 (36.3) | |
| PASI 75d | 93/117 (79.5) | 95/127 (74.8) | 86/120 (71.7) | 83/103 (80.6) | |
| PASI 90d | 73/117 (62.4) | 72/127 (56.7) | 68/120 (56.7) | 69/103 (67.0) | |
| Resolution of dactylitise | 92/107 (86.0) | 106/121 (87.6) | 102/113 (90.3) | 93/99 (93.9) | |
| Resolution of enthesitisf | 96/130 (73.8) | 106/137 (77.4) | 94/123 (76.4) | 89/113 (78.8) | |
| DAS28‐CRP remission | 101/213 (47.4) | 116/229 (50.7) | 111/212 (52.4) | 118/194 (60.8) | |
| DAS28‐CRP LDA | 128/213 (60.1) | 149/229 (65.1) | 143/212 (67.5) | 147/194 (75.3) | |
| Minimal Disease Activity | 76/215 (35.3) | 79/232 (34.1) | 82/216 (38.0) | 77/195 (39.5) | |
| HAQ‐DI | BL (SD) |
1.12 (0.661) [n = 213] |
1.14 (0.671) [n = 229] |
1.13 (0.662) [n = 210] |
1.09 (0.650) [n = 193] |
| mean change from BL (SD) |
−0.40 (0.587) [n = 213] |
−0.39 (0.632) [n = 229] |
−0.37 (0.644) [n = 210] |
−0.39 (0.626) [n = 193] |
|
| SF‐36 PCS | BL (SD) |
38.39 (7.929) [n = 207] |
38.15 (7.80) [n = 230] |
38.19 (7.734) [n = 213] |
38.39 (7.811) [n = 192] |
| mean change from BL (SD) |
5.72 (7.893) [n = 207] |
5.43 (8.417) [n = 230] |
5.52 (8.350) [n = 213] |
6.04 (8.341) [n = 192] |
|
Abbreviation: ACR, American College of Rheumatology; BL, baseline; DAS28‐CRP, Disease Activity Score 28‐joint count C‐reactive protein; HAQ‐DI, Health Assessment Questionnaire Disability Index; LDA, low disease activity; M, The total number of patients evaluated in the treatment group; PASI90, 90% improvement in Psoriasis Area and Severity Index; SF‐36 PCS, Short Form‐36 Physical Component Summary.
Results are n/M (%) unless otherwise stated. Results are shown for patients who entered the extension phase in the secukinumab 150‐mg group, including patients who switched from placebo to secukinumab 150 mg at weeks 16/24.
All patients received secukinumab 150 mg.
Includes 83 patients who had dose escalation from 150 to 300 mg based on physician's judgement from week 156 onward.
Patients with psoriasis affecting ≥3% body surface area at baseline (n = 89 [150 mg] and 82 [75 mg]).
Patients (n = 83 [150 mg] and 77 [75 mg]) with dactylitis at baseline, as measured using the Leeds Dactylitis Index.
Patients (n = 99 [150 mg] and 91 [75 mg]) with enthesitis at baseline, as measured using the Leeds Enthesitis Index.