Summary of primary and key secondary and exploratory efficacy results at week 16a.
| Outcome | Placebo, n = 52, n/N (%) | SEC, 300 mg, n = 103, n/N (%) | OR (95% CI) | P | SEC 150 mg, n = 103, n/N (%) | OR (95% CI) | P |
|---|---|---|---|---|---|---|---|
| Primary efficacy variable | |||||||
| ACR20 | 12/52 (23.1) | 53/103 (51.5) | 3.51 (1.65-7.45) | 0.001 | 38/103 (36.9) | 1.92 (0.89-4.15) | 0.10 |
| Secondary binary efficacy variables | |||||||
| ACR50 | 3/52 (5.8) | 29/103 (28.2) | 6.30 (1.81-21.88) | 0.004 | 25/103 (24.3) | 4.77 (1.36-16.77) | 0.02 |
| ACR70 | 1/52 (1.9) | 18/103 (17.5) | 10.50 (1.36-81.30) | 0.02 | 11/103 (10.7) | 5.42 (0.67-43.64) | 0.11 |
| Resolution of enthesitis, LEI + SPARCCb | 7/39 (17.9) | 28/74 (37.8) | 2.85 (1.08-7.50) | 0.03 | 30/76 (39.5) | 2.65 (1.01-6.93) | 0.047 |
| Resolution of dactylitisc | 4/23 (17.4) | 20/49 (40.8) | 3.27 (0.96-11.20) | 0.06 | 20/52 (38.5) | 3.40 (0.98-11.76) | 0.05 |
| PASI75d | 7/43 (16.3) | 51/79 (64.6) | 9.49 (3.73-24.16) | < 0.001 | 45/83 (54.2) | 6.38 (2.51-16.24) | < 0.001 |
| PASI90d | 4/43 (9.3) | 39/79 (49.4) | 9.86 (3.19-30.45) | < 0.001 | 30/83 (36.1) | 5.21 (1.68-16.21) | 0.004 |
| PASI100d | 1/43 (2.3) | 20/79 (25.3) | 14.38 (1.86-111.53) | 0.01 | 15/83 (18.1) | 9.82 (1.24-77.90) | 0.03 |
| MDA | 2/52 (3.8) | 27/103 (26.2) | 8.75 (1.99-38.45) | 0.004 | 27/103 (26.2) | 8.34 (1.89-36.85) | 0.005 |
| Placebo, LSM, n = 52 | SEC 300 mg, LSM, n = 103 | LSM of Treatment Difference, (SE)e [95% CI] | P | SEC 150 mg, LSM, n = 103 | LSM of Treatment Difference, (SE)e [95% CI] | P | |
| Secondary and exploratory continuous efficacy variablesf | |||||||
| Change from baseline in DAS28-CRP | -0.35 | -1.39 | -1.05 (0.203) [-1.45 to -0.65] | < 0.001 | -1.18 | -0.83 (0.207) [-1.24 to -0.43] | < 0.001 |
| Change from baseline in PASDAS | -0.36 | -1.04 | -0.68 (0.085) [-0.85 to -0.52] | < 0.001 | -0.92 | -0.57 (0.086) [-0.74 to -0.40] | < 0.001 |
| Change from baseline in SF-12 MCS | 1.54 | 3.05 | 1.51 (1.334) [-1.12 to 4.14] | 0.26 | 1.77 | 0.23 (1.353) [-2.43 to 2.90] | 0.86 |
| Change from baseline in SF-12 PCS | -0.63 | 4.82 | 5.45 (1.363) [2.76 to 8.13] | < 0.001 | 4.32 | 4.94 (1.385) [2.22 to 7.67] | < 0.001 |
| Change from baseline in HAQ-DI | -0.11 | -0.32 | -0.21 (0.081) [-0.37 to -0.05] | 0.01 | -0.24 | -0.13 (0.083) [-0.30 to 0.03] | 0.11 |
| Change from baseline in RAPID3 | -0.78 | -4.57 | -3.80 (0.941) [-5.65 to -1.94] | < 0.001 | -3.67 | -2.89 (0.960) [-4.78 to -1.00] | 0.003 |
↵aORs, 95% CIs, and P values are based on logistic regression using nonresponder imputation.
↵bResults are from the combined LEI and SPARCC subset. Enthesitis was determined in patients who had an enthesitis score ≥ 1 when sites from LEI and SPARCC were assessed together at baseline: SEC 300 mg, n = 74; SEC 150 mg, n = 76; placebo, n = 39.
↵cDactylitis was determined in patients who had a Leeds Dactylitis Index ≥ 1 at baseline: SEC 300 mg, n = 49; SEC 150 mg, n = 52; placebo, n = 23.
↵dResults are from patients having psoriatic skin involvement in ≥ 3% of their body surface area at baseline: SEC 300 mg, n = 79; SEC 150 mg, n = 83; placebo, n = 43.
↵eLSM of the treatment difference vs placebo.
↵fLSM, LSM of treatment differences, 95% CI, and P values are based on an ANCOVA model; missing data were imputed using last observation carried forward.
ACR: American College of Rheumatology; DAS28-CRP: Disease Activity Score in 28 joints using C-reactive protein; HAQ-DI: Health Assessment Questionnaire-Disability Index; LEI: Leeds Enthesitis Index; LSM: least-squares mean; MCS: mental component summary score; MDA: minimal disease activity; OR: odds ratio; PASDAS: Psoriatic Arthritis Disease Activity Score; PASI: Psoriasis Area and Severity Index; PCS: physical component summary score; RAPID3: Routine Assessment of Patient Index Data 3; SE: standard error; SEC: secukinumab; SF-12: 12-item Short Form Health Survey; SPARCC: Spondyloarthritis Research Consortium of Canada Enthesitis Index.