Table 7.
Participant Baseline Characteristics in Ixekizumab Clinical Trials
| Characteristic* | PBO | IXEQ4WK | IXEQ2WK | ADAQ2WK |
|---|---|---|---|---|
| Numbers | ||||
| SPIRIT-P123,26 | N=106 | N=107 | N=103 | N=101 |
| H2H7,31 | – | N=283 | – | N=283 |
| SPIRIT-P240 | N=118 | N=122 | N=123 | – |
| Age, Mean (yrs) | ||||
| SPIRIT-P123,26 | 51 | 49 | 50 | 49 |
| H2H7,31 | – | 48 | – | 48 |
| SPIRIT-P240 | 52 | 53 | 52 | – |
| Women, % | ||||
| SPIRIT-P123,26 | 55 | 58 | 53 | 49 |
| H2H7,31 | – | 43 | – | 47 |
| SPIRIT-P240 | 53 | 48 | 59 | – |
| Weight, Mean (kg) | ||||
| SPIRIT-P123,26 | 84 | 86 | 82 | 92 |
| H2H7,31 | – | 85 | – | 82 |
| SPIRIT-P240 | 91 | 90 | 85 | – |
| BMI, Mean (kg/m2) | ||||
| SPIRIT-P123,26 | 29 | 30 | 29 | 32 |
| H2H7,31 | – | 30 | – | 30 |
| SPIRIT-P240 | 32 | 31 | 30 | – |
| Race, % | ||||
| White | ||||
| SPIRIT-P123,26 | 93 | 95 | 93 | 94 |
| H2H7,31 | – | 78 | – | 75 |
| SPIRIT-P240 | 92 | 91 | 93 | – |
| Asian | ||||
| SPIRIT-P123,26 | 5 | 2 | 5 | 3 |
| H2H7,31 | – | 10 | – | 12 |
| SPIRIT-P240 | 6 | 6 | 6 | – |
| American Indian or Alaska native | ||||
| SPIRIT-P123,26 | 2 | 2 | 2 | 3 |
| H2H7,31 | – | 0 | – | 0 |
| SPIRIT-P240 | 0 | 0 | 0 | – |
| Other | ||||
| SPIRIT-P123,26 | 0 | 1 | 0 | 0 |
| H2H7,31 | – | 0 | – | 0 |
| SPIRIT-P240 | 3 | 3 | 2 | – |
| PsA duration, Mean (yrs) | ||||
| SPIRIT-P123,26 | 7 | 6 | 8 | 8 |
| H2H7,31 | – | 7 | – | 6 |
| SPIRIT-P240 | 7 | 10 | 7 | – |
| Psoriasis duration, Mean (yrs) | ||||
| SPIRIT-P123,26 | 16 | 17 | 17 | 16 |
| H2H7,31 | – | 13 | – | 13 |
| SPIRIT-P240 | 15 | 16 | 17 | – |
| Methotrexate use, current, % | ||||
| SPIRIT-P123,26 | 56 | 53 | 52 | 56 |
| H2H7,31 | – | 59 | – | 60 |
| SPIRIT-P240 | 34 | 39 | 50 | – |
| Active psoriasis (%) | ||||
| SPIRIT-P123,26 | 96 | 94 | 92 | 96 |
| H2H7,31 | – | 100 | – | 100 |
| SPIRIT-P240 | 92 | 97 | 92 | – |
| Psoriasis ≤3% | ||||
| SPIRIT-P123,26 | 68 | 73 | 65 | 72 |
| H2H7,31 | – | 100 | – | 100 |
| SPIRIT-P240 | 57 | 56 | 55 | – |
| Any current nail psoriasis, % | ||||
| SPIRIT-P123,26 | 70 | 65 | 72 | 70 |
| H2H7,31 | – | 68 | – | 63 |
| SPIRIT-P240 | 62 | 73 | 60 | – |
| Dactylitis, current, % | ||||
| SPIRIT-P123,26 | 37 | 51 | 40 | 23 |
| H2H7,31 | – | 15 | – | 21 |
| SPIRIT-P240 | 12 | 23 | 16 | |
| Enthesitis, current, % | ||||
| SPIRIT-P123,26 | 54 | 65 | 57 | 55 |
| H2H7,31 | – | 56 | – | 52 |
| SPIRIT-P240 | 58 | 56 | 68 | – |
| Swollen joint count (out of 66), Mean | ||||
| SPIRIT-P123,26 | 7 | 8 | 7 | 7 |
| H2H7,31 | – | 8 | – | 8 |
| SPIRIT-P240 | 10 | 13 | 14 | – |
| Tender joint count (out of 68), Mean | ||||
| SPIRIT-P123,26 | 13 | 14 | 14 | 13 |
| H2H7,31 | - | 13 | - | 15 |
| SPIRIT-P240 | 23 | 22 | 25 | - |
| Disability HAQ-DI, Mean | ||||
| SPIRIT-P123,26 | 1.2 | 1.2 | 1.2 | 1.1 |
| H2H7,31 | – | 1.2 | – | 1.3 |
| SPIRIT-P240 | 1.2 | 1.2 | 1.2 | – |
| Inflammation, CRP, Mean (mg/L) | ||||
| SPIRIT-P123,26 | 15 | 13 | 15 | 13 |
| H2H7,31 | – | 10 | – | 11 |
| SPIRIT-P240 | 12 | 17 | 14 | – |
Note: *Values are rounded to the nearest whole number.
Abbreviations: PBO, placebo; IXE, ixekizumab; IXEQ4W/IXEQ2W, ixekizumab 80 mg every 4 or every 2 weeks; ADA, adalimumab; ADAQ2W, adalimumab 40 mg every 2 weeks; HAQ-DI, Health Assessment Questionnaire-Disability Index; CRP, C-reactive protein.