Table 1.
Demographics and baseline disease characteristics of patients from SPIRIT-P1 and SPIRIT-P2 treated with ixekizumab Q4W
| Concomitant background treatment | Ixekizumab monotherapya Ns = 89 |
Ixekizumab + MTX Ns = 88 |
Ixekizumab + any csDMARDb Ns = 113 |
|---|---|---|---|
| Age (years) | 51.1 (11.9) | 51.0 (12.1) | 50.1 (12.4) |
| Male, n (%) | 43 (48.3) | 41 (46.6) | 54 (47.8) |
| Race, n (%) | |||
| White | 86 (96.6) | 80 (90.9) | 103 (91.2) |
| Asian | 1 (1.1) | 3 (3.4) | 5 (4.4) |
| American Indian or Alaska Native | 0 | 2 (2.3) | 2 (1.8) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (1.1) | 1 (0.9) |
| Black or African American | 1 (1.1) | 0 | 0 |
| Multiple | 1 (1.1) | 2 (2.3) | 2 (1.8) |
| Weight, kg | 87.8 (22.7) | 87.4 (20.1) | 87.3 (20.3) |
| BMI, kg/m2 | 30.0 (7.3) | 30.6 (6.7) | 30.5 (6.8) |
| Previous PsA systemic therapy, n (%) | |||
| No prior treatment | 8 (9.0%) | 25 (28.4%) | 29 (25.7%) |
| Non-biologic only | 28 (31.5%) | 23 (26.1%) | 30 (26.5%) |
| TNFi only | 0 | 21 (23.9%) | 24 (21.2%) |
| TNFi and non-biologic | 53 (59.6%) | 19 (21.6%) | 30 (26.5%) |
| Corticosteroid use, n (%) | 13 (14.6) | 12 (13.6) | 14 (12.4) |
| Time since PsA diagnosis, years | 17.5 (13.8) | 14.6 (12.8) | 14.8 (12.7) |
| Baseline disease characteristics | |||
| n = 88 | n = 88 | n = 113 | |
| Tender joints (68 assessed) | 22.0 (13.7) | 20.7 (14.8) | 21.0 (14.4) |
| n = 88 | n = 88 | n = 113 | |
| Swollen joints (66 assessed) | 12.2 (8.6) | 11.6 (10.6) | 12.3 (11.2) |
| n = 89 | n = 88 | n = 113 | |
| LEI > 0, n (%) | 49 (55.1) | 54 (61.4) | 67 (59.3) |
| n = 87 | n = 87 | n = 110 | |
| LDI-B > 0, n (%) | 24 (27.6) | 26 (29.9) | 35 (31.8) |
| n = 87 | n = 82 | n = 107 | |
| PASI | 7.4 (8.7) | 6.4 (6.3) | 6.2 (6.2) |
| n = 60 | n = 65 | n = 78 | |
| NAPSIc | 24.2 (22.7) | 17.9 (16.3) | 18.7 (16.2) |
| n = 89 | n = 83 | n = 106 | |
| % BSA | 13.3 (18.4) | 14.0 (15.8) | 13.6 (15.7) |
| SF-36 | n = 87 | n = 85 | n = 110 |
| PCS | 32.5 (9.6) | 32.6 (9.5) | 32.7 (9.5) |
| MCS | 47.3 (13.6) | 46.4 (12.5) | 46.6 (12.3) |
| Baseline radiographic scoresd | n1/N1 = 23/36 | n1/N1 = 32/48 | n1/N1 = 41/59 |
| ESd | 9.7 (13.6) | 10.8 (17.4) | 11.0 (17.0) |
| JSNd | 6.7 (13.3) | 8.4 (19.7) | 8.5 (18.4) |
| mTSSd | 16.5 (26.8) | 19.2 (36.4) | 19.5 (34.8) |
Values are mean (SD) unless otherwise indicated
All patients were initially randomized to ixekizumab
aPatients receiving no MTX or other csDMARDs
bPatients receiving any csDMARD, including MTX
cPatients initially randomized to ixekizumab with fingernail involvement at baseline
dPatients from the SPIRIT-P1 trial
BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; ES, Bone Erosion Score; IXE, ixekizumab; JSN, Joint Space Narrowing score; LDI-B, Leeds Dactylitis Index-Basic; LEI, Leeds Enthesitis Index; MCS; mental component score; mTSS, modified Total Sharp Score; MTX, methotrexate; Ns, number of patients in the treatment subgroup; N1, number of patients in the specified treatment subgroup from SPIRIT-P1; n, number of patients in the specified category; n1, number of patients in the specified category from SPIRIT-P1; NAPSI, Nail Psoriasis Severity Index; PCS, physical component score; PASI, Psoriasis Area and Severity Index; Q4W, every 4 weeks; SD, standard deviation; SF-36, 36-Item Short Form Health Survey; TNFi, tumor necrosis factor inhibitor