Table 1.
Effect of secukinumab on pain by prior TNF exposure through week 104
| Week 3 | Week 4 | Week 8 | Week 16 | Week 24 | Week 52 | Week 104 | |
|---|---|---|---|---|---|---|---|
| TNF-naïve | |||||||
| Pain VAS, mean change from baselinea | |||||||
| Secukinumab 300 mg | −19.7* | −20.7** | − 20.7* | −27.8**** | − 24.0 | −30.3 | −29.6 |
| Secukinumab 150 mg | −12.8 | −15.2 | −21.8* | − 25.1*** | −26.3 | −28.1 | −28.3 |
| Placebo | −8.5 | −11.3 | −10.1 | −11.3 | – | – | – |
| SF-36 bodily pain, mean change from baselineb | |||||||
| Secukinumab 300 mg | – | 18.4**** | 18.2* | 23.8**** | 23.9 | 24.4 | 24.2 |
| Secukinumab 150 mg | – | 18.9**** | 20.0*** | 25.4**** | 25.7 | 25.8 | 22.2 |
| Placebo | – | 5.6 | 7.3 | 8.6 | – | – | – |
| EQ-5D-3 L, no pain or discomfortc | |||||||
| Secukinumab 300 mg | – | – | – | 21.5% | 24.6% | 28.6% | 32.8% |
| Secukinumab 150 mg | – | – | – | 22.2% | 14.8% | 20.3% | 17.0% |
| Placebo | – | – | – | 6.9% | – | – | – |
| TNF-IR | |||||||
| Pain VAS, mean change from baselined | |||||||
| Secukinumab 300 mg | −13.1** | −14.9 | −16.8** | −18.2** | −20.7 | −22.5 | −19.3 |
| Secukinumab 150 mg | −14.8* | −21.3* | −21.2* | −21.1* | − 20.0 | −23.9 | − 20.4 |
| Placebo | −2.1 | −5.9 | −3.4 | −4.4 | – | – | – |
| SF-36 bodily pain, mean change from baselinee | |||||||
| Secukinumab 300 mg | – | 15.1 | 18.7* | 18.3* | 23.6 | 23.0 | 24.5 |
| Secukinumab 150 mg | – | 13.6 | 21.0*** | 17.9* | 16.0 | 19.0 | 14.0 |
| Placebo | – | 7.8 | 5.7 | 5.2 | – | – | – |
| EQ-5D-3 L, no pain or discomfortf | |||||||
| Secukinumab 300 mg | – | – | – | 12.5% | 12.5% | 15.6% | 17.2% |
| Secukinumab 150 mg | – | – | – | 10.8% | 5.9% | 20.0% | 12.5% |
| Placebo | – | – | – | 3.3% | – | – | – |
Least squares mean change using a mixed-effect model for repeated measures (MMRM) from weeks 1 to 24, and observed data from weeks 52 to 104, for pain visual analog scale (VAS) and Short Form-36 (SF-36) bodily pain scores. Observed data are presented for the EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3 L). At week 16, patients initially randomized to placebo who were non-responders switched to secukinumab treatment. Results are not shown for patients who continued on placebo after week 16. Data are presented only for evaluable patients at each time point. TNF-naïve patients originally randomized to secukinumab 300 mg = 67, to secukinumab 150 mg = 63, and to placebo = 63; patients with inadequate response to TNF (TNF-IR) originally randomized to secukinumab 300 mg = 33, to secukinumab 150 mg = 37, and to placebo = 35. P values were calculated from a MMRM analysis
aNumber of evaluable patients, week 52: 59 for secukinumab 300 mg and 150 mg; week 104: 57 for secukinumab 300 mg and 53 for secukinumab 150 mg
bNumber of evaluable patients, week 52: 62 for secukinumab 300 mg and 59 for secukinumab 150 mg; week 104: 57 for secukinumab 300 mg and 53 for secukinumab 150 mg
cNumber of evaluable patients, week 52: 63 for secukinumab 300 mg and 59 for secukinumab 150 mg; week 104: 58 for secukinumab 300 mg and 53 for secukinumab 150 mg
dNumber of evaluable patients, week 52: 30 for secukinumab 300 mg and 29 for secukinumab 150 mg; week 104: 29 for secukinumab 300 mg and 24 for secukinumab 150 mg
eNumber of evaluable patients, week 52: 32 for secukinumab 300 mg and 30 for secukinumab 150 mg; week 104: 29 for secukinumab 300 mg and 26 for secukinumab 150 mg
fNumber of evaluable patients, week 52: 32 for secukinumab 300 mg and 30 for secukinumab 150 mg; week 104: 29 for secukinumab 300 mg and 24 for secukinumab 150 mg
*P < 0.01; **P < 0.05; ***P < 0.001; ****P < 0.0001, versus placebo. TNF, tumor necrosis factor