Treatment effectiveness after 6 and 12 months of secukinumab treatment
| All patients (n=1860) | b/tsDMARD-naïve patients (n=414) | 1 prior b/tsDMARD (n=448) | 2 or more prior b/tsDMARDs (n=998) | P value* | |||
|---|---|---|---|---|---|---|---|
| Secukinumab drug retention rate, % (95% CI) | 6 months | 82% (80–84%) | 90% (87–93%) | 83% (79–86%) | 78% (76–81%) | 0.001 | |
| 12 months | 72% (69–74%) | 84% (81–88%) | 73% (69–78%) | 66% (63–69%) | <0.001 | ||
| Median (95% CI) time in weeks to secukinumab withdrawal due to loss of efficacy or adverse events before 12 months† | 21 (20–22) | 22 (16–28) | 21 (19–23) | 21 (19–23) | 0.21 | ||
| BASDAI, median (IQR) | 6 months | 3.9 (1.8–5.9) | 2.8 (1.4–4.1) | 3.0 (1.5–5.7) | 4.8 (2.7–6.6) | <0.001 | |
| 12 months | 3.9 (1.9–6.3) | 2.4 (1.3–3.9) | 3.2 (1.7–6.0) | 5.0 (2.6–6.8) | <0.001 | ||
| BASFI, median (IQR) | 6 months | 3.9 (1.8–6.3) | 2.4 (0.7–4.7) | 4.0 (1.3–6.3) | 4.4 (2.4–6.6) | <0.001 | |
| 12 months | 4.1 (1.8–6.5) | 2.1 (0.5–4.3) | 3.6 (1.4–6.4) | 4.7 (2.7–6.7) | <0.001 | ||
| ASDAS, median (IQR) | 6 months | 2.6 (1.9–3.3) | 2.2 (1.7–2.7) | 2.4 (1.7–3.1) | 2.8 (2.1–3.6) | <0.001 | |
| 12 months | 2.5 (1.8–3.4) | 1.9 (1.5–2.6) | 2.3 (1.6–3.2) | 2.8 (2.0–3.5) | <0.001 | ||
| BASDAI <2, % | 6 months | Crude | 26% | 37% | 35% | 18% | <0.001 |
| LUNDEXadjusted† | 21% | 34% | 28% | 13% | <0.001 | ||
| 12 months | Crude | 25% | 41% | 29% | 18% | <0.001 | |
| LUNDEX-adjusted† | 16% | 31% | 18% | 11% | <0.001 | ||
| BASDAI <4, % | 6 months | Crude | 51% | 71% | 60% | 40% | <0.001 |
| LUNDEX-adjusted† | 40% | 65% | 47% | 30% | <0.001 | ||
| 12 months | Crude | 51% | 76% | 56% | 39% | <0.001 | |
| LUNDEX-adjusted† | 32% | 57% | 36% | 23% | <0.001 | ||
| ASDAS <1.3, % | 6 months | Crude | 9% | 13% | 13% | 6% | 0.001 |
| LUNDEX-adjusted† | 7% | 12% | 11% | 5% | <0.001 | ||
| 12 months | Crude | 11% | 18% | 15% | 7% | 0.002 | |
| LUNDEX-adjusted† | 7% | 13% | 9% | 4% | 0.002 | ||
| ASDAS <2.1, % | 6 months | Crude | 24% | 32% | 26% | 20% | 0.002 |
| LUNDEX-adjusted† | 19% | 29% | 21% | 15% | <0.001 | ||
| 12 months | Crude | 27% | 44% | 27% | 21% | <0.001 | |
| LUNDEX-adjusted† | 17% | 33% | 17% | 12% | <0.001 | ||
| Change in BASDAI from baseline to 6 months | Mean (SD) | −2.1 (2.6) | −3.7 (2.5) | −2.1 (2.5) | −1.4 (2.3) | <0.001 | |
| Median (IQR) | −1.9 (−3.9, −0.2) | −3.9 (−5.4, −2.0) | −1.9 (−3.8, −0.1) | −1.0 (−2.8, 0.1) | <0.001 | ||
| Change in BASDAI from baseline to 12 months | Mean (SD) | −2.1 (2.5) | −3.3 (2.6) | −2.1 (2.3) | −1.4 (2.4) | <0.001 | |
| Median (IQR) | −1.6 (−3.7, −0.2) | −3.4 (−5.4, −1.2) | −1.9 (−3.6, −0.5) | −1.1 (−2.5, 0.0) | <0.001 | ||
| Change in ASDAS from baseline to 6 months | Mean (SD) | −1.1 (1.3) | −2.0 (1.1) | −1.1 (1.3) | −0.7 (1.2) | <0.001 | |
| Median (IQR) | −1.1 (−2.0, −0.2) | −1.9 (−2.9, −1.2) | −1.1 (−2.0, −0.1) | −0.6 (−1.6, 0.0) | <0.001 | ||
| Change in ASDAS from baseline to 12 months | Mean (SD) | −1.1 (1.3) | −2.0 (1.3) | −1.2 (1.2) | −0.7 (1.2) | <0.001 | |
| Median (IQR) | −0.9 (−2.0, −0.1) | −2.0 (−3.1, −1.0) | −1.2 (−2.2, −0.3) | −0.5 (−1.5,-0.1) | <0.001 | ||
| BASDAI50 response, % | 6 months | Crude | 53% | 79% | 53% | 40% | <0.001 |
| LUNDEX-adjusted† | 42% | 72% | 42% | 30% | <0.001 | ||
| 12 months | Crude | 47% | 67% | 53% | 36% | <0.001 | |
| LUNDEX-adjusted† | 29% | 51% | 34% | 21% | <0.001 | ||
| ASAS20 response, % | 6 months | Crude | 40% | 66% | 41% | 32% | <0.001 |
| LUNDEX-adjusted† | 32% | 60% | 32% | 24% | <0.001 | ||
| 12 months | Crude | 37% | 69% | 35% | 29% | <0.001 | |
| LUNDEX-adjusted† | 23% | 52% | 22% | 17% | <0.001 | ||
| ASAS40 response, % | 6 months | Crude | 28% | 57% | 23% | 19% | <0.001 |
| LUNDEX-adjusted† | 22% | 52% | 18% | 14% | <0.001 | ||
| 12 months | Crude | 22% | 55% | 19% | 14% | <0.001 | |
| LUNDEX-adjusted† | 14% | 42% | 12% | 8% | <0.001 | ||
| ASDAS-CII, % | 6 months | Crude | 49% | 77% | 52% | 35% | <0.001 |
| LUNDEX-adjusted† | 39% | 70% | 41% | 26% | <0.001 | ||
| 12 months | Crude | 46% | 72% | 52% | 33% | <0.001 | |
| LUNDEX-adjusted† | 29% | 55% | 33% | 19% | <0.001 | ||
| ASDAS-MI, % | 6 months | Crude | 25% | 46% | 25% | 15% | <0.001 |
| LUNDEX-adjusted† | 20% | 42% | 20% | 11% | <0.001 | ||
| 12 months | Crude | 26% | 51% | 27% | 17% | <0.001 | |
| LUNDEX-adjusted† | 16% | 39% | 17% | 10% | <0.001 | ||
*Drug retention rates were compared by Kaplan-Meier with log-rank test, continuous measures by ANOVA or Kruskal-Wallis, as appropriate, and proportions by χ² test.
†Patients with at least 12 months from secukinumab start to date of data cut. ASAS20/40, Assessment of Spondyloarthritis International Society 20/40 response; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-CII, ASDAS clinically important improvement (≥1.1); ASDAS-MI, ASDAS major improvement (≥2.0); ASAS20/40, Assessment of Spondyloarthritis International Society 20/40 response; b/tsDMARD, biologic/targeted synthetic disease-modifying antirheumatic drug; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50, at least 50% improvement in BASDAI score or an absolute change of 2 (on a 0–10 scale); BASFI, Bath Ankylosing Spondylitis Functional Index. Number of available cases for each of the analyses are shown in online supplemental table 1.