Table 2.
Efficacy of secukinumab at weeks 24 and 52 in the overall populationa
| 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 | – |
Data presented as nonresponder imputation and rescue penalty (binary variables) and mixed-model repeated measures and rescue penalty (continuous variables)
ACR20/50 20%/50% improvement in American College of Rheumatology response criteria; BSA body surface area, DAS28-CRP 28-joint Disease Activity Score using C-reactive protein, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy—Fatigue, HAQ-DI Health Assessment Questionnaire—Disability Index, N number of patients, PASI Psoriasis Area Severity Index, PsA psoriatic arthritis, SE standard error, SF-36 PCS Short Form-36 Physical Component Summary, VAS visual analog scale
*p < 0.0001, †p < 0.001, §p < 0.01, ‡p < 0.05 versus placebo. p values adjusted for multiplicity of testing for overall population data (except for pain and FACIT-Fatigue)
aPrespecified primary and secondary endpoints were analyzed according to a statistical hierarchy except for pain and FACIT-Fatigue. Endpoints are shown in the order of testing
bPASI 75 and PASI 90 denote improvements of 75% and 90%, respectively, in the score on the Psoriasis Area Severity Index. Assessed in patients with psoriasis on at least 3% of their BSA
cResolution of dactylitis and enthesitis among those patients with these symptoms at baseline: dactylitis, N = 46 (300 mg), 36 (150 mg), and 36 (placebo); enthesitis, N = 88 (300 mg), 95 (150 mg),and 98 (placebo)