Efficacy of secukinumab at weeks 24 and 52.
| TNFi-naive | TNFi-exposeda | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Secukinumab | Secukinumab | ||||||||
| 300 mg, N = 67 | 150 mg, N = 63 | 75 mg, N = 65 | Placebo, N = 63 | 300 mg, N = 33 | 150 mg, N = 37 | 75 mg, N = 34 | Placebo, N = 35 | ||
| ACR20%, (n/N) | Week 24 | 58.2* (39/67) | 63.5* (40/63) | 36.9§ (24/65) | 15.9 (10/63) | 45.5§ (15/33) | 29.7 (11/37) | 14.7 (5/34) | 14.3 (5/35) |
| Week 52 | 68.7 (46/67) | 79.4 (50/63) | 58.5 (38/65) | NA | 54.5 (18/33) | 37.8 (14/37) | 35.3 (12/34) | NA | |
| ACR50%, (n/N) | Week 24 | 38.8* (26/67) | 44.4* (28/63) | 24.6§ (16/65) | 6.3 (4/63) | 27.3‡ (9/33) | 18.9 (7/37) | 5.9 (2/34) | 8.6 (3/35) |
| Week 52 | 52.2 (35/67) | 49.2 (31/63) | 36.9 (24/65) | NA | 27.3 (9/33) | 21.6 (8/37) | 17.6 (6/34) | NA | |
| ACR70%, (n/N) | Week 24 | 22.4† (15/67) | 27.0* (17/63) | 6.2 (4/65) | 1.6 (1/63) | 15.2‡ (5/33) | 10.8 (4/37) | 5.9 (2/34) | 0.0 (0/35) |
| Week 52 | 26.9 (18/67) | 23.8 (15/63) | 20.0 (13/65) | NA | 18.2 (6/33) | 13.5 (5/37) | 8.8 (3/34) | NA | |
| PASI75b%, (n/N) | Week 24 | 63.3† (19/30) | 55.6§ (20/36) | 30.3 (10/33) | 19.4 (6/31) | 63.6‡ (7/11) | 36.4 (8/22) | 23.5 (4/17) | 8.3 (1/12) |
| Week 52 | 76.7 (23/30) | 61.1 (22/36) | 51.5 (17/33) | NA | 63.6 (7/11) | 50.0 (11/22) | 41.2 (7/17) | NA | |
| PASI90b%, (n/N) | Week 24 | 53.3† (16/30) | 38.9§ (14/36) | 12.1 (4/33) | 9.7 (3/31) | 36.4 (4/11) | 22.7 (5/22) | 11.8 (2/17) | 8.3 (1/12) |
| Week 52 | 60.0 (18/30) | 44.4 (16/36) | 24.2 (8/33) | NA | 45.5 (5/11) | 40.9 (9/22) | 23.5 (4/17) | NA | |
| Resolution of enthesitis %, (n/N) | Week 24c | 45.9 (17/37) | 45.9 (17/37) | 35.6 (16/45) | 28.6 (12/42) | 52.6§ (10/19) | 37.0‡ (10/27) | 26.1 (6/23) | 8.7 (2/23) |
| Week 52c | 62.2 (23/37) | 56.8 (21/37) | 48.9 (22/45) | NA | 36.8 (7/19) | 37.0 (10/27) | 39.1 (9/23) | NA | |
| Resolution of dactylitis %, (n/N) | Week 24d | 54.8‡ (17/31) | 57.1‡ (12/21) | 30.8 (8/26) | 17.6 (3/17) | 60.0‡ (9/15) | 36.4 (4/11) | 28.6 (2/7) | 10.0 (1/10) |
| Week 52d | 71.0 (22/31) | 71.4 (15/21) | 57.7 (15/26) | NA | 66.7 (10/15) | 54.5 (6/11) | 85.7 (6/7) | NA | |
| DAS28-CRP, mean change from baseline ± SE | Week 24 | −1.76 ± 0.13§ | −1.69 ± 0.13§ | −1.27 ± 0.13 | −1.11 ± 0.18 | −1.39 ± 0.20‡ | −1.45 ± 0.19‡ | −0.89 ± 0.20 | −0.69 ± 0.27 |
| Week 52 | −1.91 ± 0.13 | −1.87 ± 0.14 | −1.57 ± 0.14 | NA | −1.56 ± 0.23 | −1.45 ± 0.23 | −1.26 ± 0.27 | NA | |
| SF-36 PCS, mean change from baseline ± SE | Week 24 | 8.05 ± 0.92* | 7.91 ± 0.93† | 5.37 ± 0.94‡ | 2.08 ± 1.20 | 6.56 ± 1.20 | 4.21 ± 1.15 | 3.15 ± 1.20 | 2.65 ± 1.66 |
| Week 52 | 8.40 ± 0.94 | 8.11 ± 0.95 | 5.63 ± 0.96 | NA | 7.34 ± 1.39 | 4.63 ± 1.39 | 0.58 ± 1.5 | NA | |
| HAQ-DI, mean change from baseline ± SE | Week 24 | −0.59 ± 0.06‡ | −0.55 ± 0.06‡ | −0.37 ± 0.06 | −0.35 ± 0.07 | −0.53 ± 0.09‡ | −0.35 ± 0.08 | −0.23 ± 0.09 | −0.23 ± 0.11 |
| Week 52 | −0.60 ± 0.06 | −0.54 ± 0.06 | −0.36 ± 0.06 | NA | −0.51 ± 0.10 | −0.38 ± 0.09 | −0.26 ± 0.10 | NA | |
↵* p < 0.0001.
↵† p < 0.001.
↵§ p < 0.01.
↵‡ p < 0.05 vs placebo.
↵a Patients who had previously used up to 3 TNFi and had experienced an inadequate response or discontinued treatment owing to safety or tolerability reasons.
↵b Patients who had psoriasis affecting ≥ 3% body surface area at baseline.
↵c Resolution of enthesitis among those patients (N = 253) with this symptom at baseline.
↵d Resolution of dactylitis among those patients (N = 138) with this symptom at baseline. Missing values were imputed as nonresponse for binary variables. Least-square mean change from baseline was used for continuous variables where mixed-model repeated-measures analysis was performed. n/N for NRI analysis: no. patients who are responders with corresponding imputation approach in the treatment group/randomized patients. ACR: American College of Rheumatology; DAS28-CRP: 28-joint Disease Activity Score using C-reactive protein; HAQ-DI: Health Assessment Questionnaire–Disability Index; NA: not applicable; NRI: nonresponder imputation; PASI: Psoriasis Area and Severity Index; SF36-PCS: Medical Outcomes Study Short Form-36 health survey physical component summary; SE: standard error; TNFi: tumor necrosis factor inhibitor.