Table 1.
Demographic and baseline clinical characteristics of patients in the SPIRIT‐P3 study*
|
Open‐label population (ixekizumab every 2 weeks) (n = 394) |
Randomized withdrawal ITT population | ||
|---|---|---|---|
|
Ixekizumab withdrawal (n = 79) |
Ixekizumab every 2 weeks (n = 79) |
||
| Age, years | 47 ± 11.4 | 43 ± 10.5 | 44 ± 10.8 |
| Male, no. (%) | 182 (46) | 40 (51) | 47 (60) |
| BMI, kg/m2 | 29 ± 6.3 | 29 ± 7.2 | 28 ± 5.0 |
| Time since PsA onset, years | 7.9 ± 7.1 | 7.5 ± 7.5 | 7.1 ± 6.3 |
| Current csDMARD use, no. (%)† | 291 (74) | 60 (76) | 59 (75) |
| TJC, 68 joints | 21 ± 14.3 | 16 ± 12.3 | 17 ± 11.5 |
| SJC, 66 joints | 10 ± 8.1 | 9.0 ± 5.6 | 9.4 ± 7.4 |
| HAQ DI total score | 1.2 ± 0.6 | 1.0 ± 0.5 | 1.1 ± 0.6 |
| Pain VAS score (maximum possible 100) | 61 ± 18.0 | 59 ± 18.9 | 60 ± 19.4 |
| PtGA score (maximum possible 100) | 62 ± 18.9 | 61 ± 19.5 | 59 ± 18.3 |
| PASI total score‡ | 7.1 ± 9.5 | 7.6 ± 10.2 | 8.4 ± 8.2 |
| BSA, %§ | 14 ± 17.6 | 14 ± 17.8 | 17 ± 18.2 |
| LEI score >0, no. (%) | 276 (70.1) | 47 (59.5) | 48 (60.8) |
| LEI total score¶ | 2.6 ± 1.5 | 2.5 ± 1.3 | 2.4 ± 1.3 |
| Enthesitis SPARCC score >0, no. (%) | 330 (83.8) | 57 (72.2) | 62 (78.5) |
| Enthesitis SPARCC score# | 5.3 ± 3.7 | 4.4 ± 3.3 | 4.6 ± 3.1 |
Except where indicated otherwise, values are the mean ± SD. ITT = intent‐to‐treat; BMI = body mass index; PsA = psoriatic arthritis; TJC = tender joint count; SJC = swollen joint count; HAQ DI = Health Assessment Questionnaire disability index; VAS = visual analog scale; PtGA = patient global assessment of disease activity.
Current use of conventional synthetic disease‐modifying antirheumatic drugs (csDMARDs) (methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, or cyclosporine) reported in open‐label population and at time of randomization.
In patients with a baseline Psoriasis Area and Severity Index (PASI) >0.
In patients whose percentage of body surface area (BSA) affected by psoriasis was >0 at baseline.
In patients with a baseline Leeds Enthesitis Index (LEI) >0.
Based on 16‐point entheseal point assessment in patients with a baseline Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis score >0.