Table 1.
Overview of the key randomized, double-blind, placebo-controlled clinical trials with secukinumab in psoriasis and rheumatic diseases
| Indication | Phase | Trial number | Trial name | Patients | Dose (mg) | Primary endpoint | Met primary endpoint? | References |
|---|---|---|---|---|---|---|---|---|
| Pso | II | NCT01071252 | – | 125 | 25, 75, 150, PBO SC 4 weeks apart |
PASI75 at week 12 | Yes: 150 mg (82%, P<0.001), 75 mg (57%, P=0.002), PBO (9%) | Papp et al85 |
| III | NCT01365455 | ERASURE | 738 | 150, 300, PBO SC 4 weeks apart after weekly SC loading |
PASI75 at week 12 | Yes: 300 mg (81.6%), 150 mg (71.6%), PBO (4.5%) (P<0.001) | Langley et al74 | |
| III | NCT01358578 | FIXTURE | 1,306 | 150, 300, PBO, ETA SC 4 weeks apart after weekly SC loading |
PASI75 at week 12 | Yes: 300 mg (77.1%), 150 mg (67.0%), ETA (44.0%), PBO (4.9%) (P<0.001) | Langley et al74 | |
| III | NCT01555125 | FEATURE | 177 | 150, 300, PBO SC 4 weeks apart after weekly SC loading |
PASI75 at week 12 | Yes: 300 mg (75.9%), 150 mg (69.5%), PBO (0%) (P<0.0001) | Blauvelt et al86 | |
| RA | II | NCT00928512 | – | 237 | 25, 75, 150, 300, PBO SC monthly |
ACR20 at week 16 | No: 25–300 mg (36.0%–53.7%) vs PBO (34%) | Genovese et al75,87 |
| PsA | II | NCT00809614 | – | 42 | 10 mg/kg, PBO twice IV 3 weeks apart | ACR20 at week 6 | No: 10 mg/kg (39%) vs PBO (23%) (P=0.27) | Novartis Pharmaceuticals90 |
| III | NCT01392326 | FUTURE 1 | 606 | 150, 300, PBO SC 4 weeks apart after IV loading |
ACR20 at week 24 | Yes: 150 mg (50.0%), 75 mg (50.5%), PBO (17.3%) (P<0.001) | Mease et al76 | |
| III | NCT01752634 | FUTURE 2 | 397 | 75, 150, 300, PBO SC 4 weeks apart after weekly SC loading |
ACR20 at week 24 | Yes: 300 mg (54%, P<0.0001), 150 mg (51%, P<0.0001), 75 mg (29%, P=0.0399) vs PBO (15%) | McInnes et al77 | |
| AS | II | NCT00809159 | – | 30 | 10 mg/kg, PBO twice IV 3 weeks apart | ASAS20 at week 6 | Yes: 10 mg/kg (59%) vs PBO (24%), Bayesian probability 99.8% | Baeten et al93 |
| III | NCT01358175 | MEASURE 1 | 371 | 10 mg/kg IV → 75 or 150 SC, PBO 3x IV 2 weeks apart > SC 4 weeks apart |
ASAS20 at week 16 | Yes: 10 IV → 75 SC (59.7%) and 10 IV → 150 SC (60.8%) vs PBO (28.7%) (P<0.01) | Baeten et al78,96 | |
| III | NCT01649375 | MEASURE 2 | 219 | 75, 150, PBO SC 4 weeks apart after weekly SC loading |
ASAS20 at week 16 | Yes: 150 mg (61.1%, P<0.0001), 75 mg (41.1%, NS) vs PBO (28.4%) | Braun et al79 Baeten et al96 |
Abbreviations: Pso, psoriasis; PBO, placebo; SC, subcutaneous; ETA, etanercept; RA, rheumatoid arthritis; ACR20, American College of Rheumatology 20% response; PsA, psoriatic arthritis; IV, intravenous; AS, ankylosing spondylitis; ASAS20, 20% Assessment of SpondyloArthritis international Society; NS, nonsignificant; FIXTURE, Full Year Investigative Examination of Secukinumab vs Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis; ERASURE, Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis.