Other efficacy endpoints at weeks 12 and 52
| Treatment period 1 (week 12) | |||
| Criteria | Secukinumab 300 mg s.c. n=164 | Secukinumab 150 mg s.c. n=157 | Placebo n=164 |
| ASAS20, % responders | 63% | 66% | 31% |
| OR vs placebo (95% CI) | 3.8 (2.4 to 6.1)* | 4.4 (2.7 to 7.0)* | – |
| ASAS40, % responders | 44% | 40% | 12% |
| OR vs placebo (95% CI) | 5.6 (3.2 to 9.8)* | 4.7 (2.7 to 8.3)* | – |
| BASDAI50, % responders | 37% | 33% | 10% |
| OR vs placebo (95% CI) | 5.6 (3.0 to 10.2)* | 4.5 (2.4 to 8.3)* | – |
| Spinal pain VAS, LSM change (SE) | −26.5 (1.8) | −28.5 (1.9) | −13.6 (1.8) |
| LSM difference vs placebo (SE) | −12.9 (2.6)* | −14.9 (2.6)* | – |
| SPARCC score, LSM change (SE) | −2.4 (0.2) | −2.2 (0.2) | −1.7 (0.2) |
| LSM difference vs placebo (SE) | −0.7 (0.3) | −0.5 (0.3) | – |
| HAQ-DI score, LSM change (SE) | −0.4 (0.04) | −0.3 (0.04) | −0.2 (0.04) |
| LSM difference vs placebo (SE) | −0.2 (0.05)* | −0.2 (0.05)† | – |
| FACIT-Fatigue, LSM change (SE) | 7.6 (0.7) | 8.0 (0.7) | 4.2 (0.7) |
| LSM difference vs placebo (SE) | 3.4 (1.0)† | 3.8 (1.0)† | – |
| ASAS health index, LSM change (SE) | –2.8 (0.3) | –2.9 (0.3) | –1.2 (0.3) |
| LSM difference vs placebo (SE) | −1.7 (0.4)* | −1.7 (0.4)* | – |
| ACR20, % responders | 52% | 57% | 19% |
| OR vs placebo (95% CI) | 4.8 (2.8 to 8.2)* | 5.7 (3.3,10.0)* | – |
| ASDAS-CRP, LSM change (SE) | –1.3 (0.1) | –1.3 (0.1) | –0.4 (0.01) |
| LSM difference vs placebo (SE) | –0.9 (0.1)* | –0.8 (0.1)* | – |
| Treatment period 2 (week 52) | ||||
| Secukinumab 300 mg s.c. n=164 | Secukinumab 150 mg s.c. n=157 | Placebo-secukinumab 300 mg s.c. n=81 | Placebo-secukinumab 150 mg s.c. n=80 | |
| ASAS20, n/M % responders | 113/139 (81%) | 113/141 (80%) | 54/72 (75%) | 59/74 (80%) |
| ASAS40, n/M % responders | 96/139 (69%) | 91/141 (65%) | 45/72 (63%) | 40/74 (54%) |
| BASDAI50, n/M % responders | 95/139 (68%) | 83/142 (59%) | 40/72 (56%) | 40/74 (54%) |
| Spinal pain VAS, Mean change (SD) | n=140 –42.4 (27.0) | n=142 –43.8 (26.2) | n=72 –43.1 (25.0) | n=74 –36.4 (25.2) |
| SPARCC score, Mean change (SD) | n=139 –3.1 (3.6) | n=141 –3.0 (4.0) | n=72 –3.4 (4.1) | n=73 –3.2 (4.2) |
| HAQ-DI score, Mean change (SD) | n=140 –0.5 (0.5) | n=142 –0.5 (0.6) | n=72 –0.5 (0.5) | n=74 –0.4 (0.5) |
| FACIT-fatigue, Mean change (SD) | n=141 11.7 (9.3) | n=146 11.2 (12.4) | n=72 13.3 (11.8) | n=75 10.0 (10.3) |
| ASAS health index, Mean change (SD) | n=141 –3.9 (4.1) | n=144 –4.2 (5.0) | n=73 –4.0 (4.6) | n=74 –3.0 (4.3) |
| ACR20, n/M % responders | 81/112 (72%) | 84/107 (79%) | 45/61 (74%) | 40/61 (66%) |
| ASDAS-CRP, Mean change (SD) | n=136 –1.9 (1.1) | n=139 –1.8 (1.0) | n=71 –1.8 (1.1) | n=72 –1.4 (1.0) |
*P<0.0001.
†P<0.001 versus placebo. OR and p values versus placebo using logistic regression with treatment and concomitant MTX intake status as factors. LSM treatment difference and p values versus placebo using an analysis of covariance model with treatment group, visit and concomitant MTX intake status, as factors and baseline score as continuous covariate.
ACR, American College of Rheumatology; ASAS, Assessment of Spondyloarthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy Fatigue Scale; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; M, number of patients with evaluation; n, number of subjects satisfying the criterion; N, total number of randomised patients (full analysis set); SEC, secukinumab; VAS, Visual Analogue Scale.