Table 1.
Baseline characteristics before and after matching
| Before matching | After matching | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ADEPT | FUTURE 2 | FUTURE 2 | ||||||||
| ADA 40 mg (n = 151) | Placebo (n = 162) | SEC 150 mg (n = 100) | SEC 300 mg (n = 100) | Placebo (n = 98) | Pooled SECa (n = 299) | SEC 150 mg (ESS = 36) | SEC 300 mg (ESS = 38) | Placebo (ESS = 27) | Pooled SEC (ESS = 115) | |
| Demographics | ||||||||||
| Age, years, mean (SD) | 48.6 (12.5) | 49.2 (11.1) | 46.5 (11.7) P = 0.1826 | 46.9 (12.6) P = 0.2940 | 49.9 (12.5) | 47.3 (11.9) P = 0.2826 | 47.1 (7.0) P = 0.4888 | 49.5 (10.0) P = 0.6811 | 49.2 (7.7) | 48.6 (8.3) P = 1.000 |
| Weight, kg, mean (SD) | 86.0 (20.6) | 85.5 (16.5) | 91.2 (19.8) P = 0.0479 | 85.4 (18.4) P = 0.8140 | 86.2 (19.8) | 87.4 (19.7) P = 0.4837 | 88.5 (12.7) P = 0.4870 | 85.1 (12.5) P = 0.7972 | 85.5 (12.4) | 86.0 (13.3) P = 1.000 |
| Female, n (%) | 66 (43.7) | 73 (45.1) | 45 (45.0) P = 0.8402 | 49 (49.0) P = 0.4101 | 59 (60.2) | 146 (48.8) P = 0.3041 | (38.4)b P = 0.5994 | (32.0)b P = 0.4438 | (45.1)b | (43.7)b P = 1.000 |
| White, n (%) | 147 (97.4) | 152 (93.8) | 90 (90.0) P = 0.0130 | 96 (96.0) P = 0.5508 | 94 (95.9) | 276 (92.3) P = 0.0334 | (96.2)b P = 0.9657 | (98.0)b P = 0.9952 | (93.8)b | (97.4)b P = 1.000 |
| Disease characteristics | ||||||||||
| Psoriasis affecting ≥ 3% BSA, n (%) | 70 (46.4) | 70 (43.2) | 58 (58.0) P = 0.0709 | 41 (41.0) P = 0.4028 | 43 (43.9) | 149 (49.8) P = 0.4862 | (54.0)b P = 0.4882 | (44.1)b P = 0.8578 | (43.2)b | (46.4)b P = 1.000 |
| PASI score, mean (SD)c | 7.4 (6.0) | 8.3 (7.2) | 16.2 (14.3) P < 0.0001 | 11.9 (8.4) P = 0.0014 | 11.5 (8.3) | 13.6 (11.6) P < 0.0001 | 8.2 (3.2) P = 0.6079 | 6.9 (3.5) P = 0.7496 | 8.3 (3.2) | 7.4 (3.2) P = 1.000 |
| HAQ-DI score, mean (SD) | 1.0 (0.6) | 1.0 (0.7) | 1.2 (0.6) P = 0.0103 | 1.3 (0.6) P = 0.0001 | 1.2 (0.7) | 1.2 (0.6) P = 0.0009 | 1.0 (0.4) P = 1.000 | 1.0 (0.4) P = 1.000 | 1.0 (0.4) | 1.0 (0.4) P = 1.000 |
| Presence of dactylitis, n (%) | 117 (37.4)d | 32 (32.0) P = 0.4084 | 46 (46.0) P = 0.1592 | 27 (27.6) | 111 (37.1) P = 0.9938 | (32.5)b P = 0.6740 | (32.7)b P = 0.5272 | (37.4)b | (37.4)b P = 1.000 | |
| Presence of enthesitis, n (%) | 118 (37.7)c | 64 (64.0) P < 0.0001 | 56 (56.0) P = 0.0044 | 65 (66.3) | 188 (62.9) P < 0.0001 | (34.9)b P = 0.8553 | (47.2)b P = 0.2786 | (37.7)b | (37.7)b P = 1.000 | |
| Previous treatment | ||||||||||
| Methotrexate use, n (%) | 77 (51.0) | 81 (50.0) | 46 (46.0) P = 0.4385 | 45 (45.0) P = 0.3523 | 52 (53.1) | 138 (46.2) P = 0.3318 | (57.9)b P = 0.4281 | (54.0)b P = 0.6377 | (50.0)b | (51.0)b P = 1.000 |
| Anti-TNF-naïve, n (%) | 151 (100) | 162 (100) | 63 (63.0) P < 0.0001 | 67 (67.0) P < 0.0001 | 63 (64.3) | 195 (65.2) P < 0.0001 | 36 (100) P = 1.000 | 38 (100) P = 1.000 | 27 (100) | 115 (100) P = 1.000 |
| Variables not used in the matching | ||||||||||
| PsA duration, years, mean (SD) | 9.8 (8.3) | 9.2 (8.7) | 6.5 (8.2) | 7.4 (7.5) | 7.3 (7.8) | 6.8 (7.6) | 6.1 (5.8) | 6.0 (4.8) | 5.3 (3.3) | 6.0 (5.1) |
| SJC, mean (SD) | 14.3 (12.2) | 14.3 (11.1) | 11.9 (10.1) | 11.2 (7.8) | 12.1 (10.6) | 11.3 (9.0) | 10.9 (6.5) | 9.6 (4.1) | 9.6 (4.4) | 10.2 (5.7) |
| CRP, mg/dl, mean (SD) | 1.4 (2.1) | 1.4 (1.7) | 1.4 (2.7) | 1.1 (1.5) | 0.8 (1.3) | 1.1 (1.9) | 0.7 (0.7) | 0.8 (0.8) | 0.6 (0.4) | 0.7 (0.7) |
| TJC (SD) | 23.9 (17.3) | 25.8 (18.0) | 24.1 (19.4) | 20.2 (13.3) | 23.4 (19.0) | 22.1 (16.5) | 16.9 (9.9) | 16.2 (7.6) | 19.3 (11.3) | 17.3 (8.5) |
| SF-36 PCS, mean (SD) | 33.2 (9.9) | 33.3 (9.8) | 36.1 (8.1) | 36.9 (8.0) | 37.4 (8.8) | 36.4 (8.1) | 39.6 (4.9) | 39.7 (5.7) | 39.8 (4.9) | 39.0 (5.1) |
| SF-36 MCS, mean (SD) | 48.1 (10.2) | 46.6 (12.2) | 40.6 (11.5) | 43.6 (12.1) | 44.0 (10.7) | 42.7 (11.7) | 44.4 (8.5) | 46.4 (8.6) | 46.3 (5.3) | 45.2 (8.1) |
| PGA, mean (SD) | 47.1 (23.2) | 48.1 (21.2) | 62.0 (19.5) | 60.7 (18.9) | 57.6 (19.8) | 60.6 (19.2) | 53.9 (11.9) | 56.6 (13.5) | 50.0 (11.1) | 55.1 (13.0) |
| Patient’s assessment of PsA pain, mean (SD) | 51.1 (21.4) | 48.8 (21.7) | 58.9 (19.8) | 57.7 (19.0) | 55.4 (22.1) | 57.8 (19.9) | 52.9 (12.1) | 55.3 (13.8) | 57.4 (11.5) | 54.9 (13.2) |
| FACIT-Fatigue score, mean (SD) | 30.8 (12.1) | 30.8 (12.2) | 26.6 (11.6) | 28.6 (12.6) | 29.2 (11.8) | 28.0 (11.6) | 33.4 (6.8) | 33.5 (9.0) | 33.6 (6.0) | 32.3 (7.6) |
All P values were calculated for secukinumab versus adalimumab using t test for continuous variables and Chi-squared test for dichotomous variables
ADA adalimumab, BSA body surface area, CRP C-reactive protein, ESS effective sample size, FACIT Functional Assessment of Chronic Illness Therapy, HAQ-DI Health Assessment Questionnaire Disability Index, PASI Psoriasis Area and Severity Index, PGA patients’ global assessment, PsA psoriatic arthritis, SD standard deviation, SEC secukinumab, SF-36 MCS 36-item Short-Form Health Survey—Mental Component Summary, SF-36 PCS 36-item Short-Form Health Survey—Physical Component Summary, SJC swollen joint count, TJC tender joint count, TNF tumor necrosis factor
aPooled SEC 75 mg (n = 99), 150 mg (n = 100), and 300 mg (n = 100) matched to ADA arm of ADEPT
bInteger population (n) values are not available due to calculation of pooled SEC ESS using the equation:
cPASI data were collected only for patients with psoriasis affecting ≥ 3% BSA
dPercentages of patients with dactylitis and enthesitis are presented for the entire ADEPT study (pooled active treatment and placebo arms)