Table 5.
Ixekizumab Efficacy in TNFi-Experienced Psoriatic Arthritis (SPIRIT-P2)
| Outcomes | PBO | IXEQ4WK | IXEQ2WK | ||
|---|---|---|---|---|---|
| N=188 | N=122 | N=123 | |||
| Timeline | 24 weeks22 | 52 weeksa,29 | 24 weeks22 | 52 weeksa,29 | |
| ACR responses (%) | |||||
| ACR20 | 19 | 53 | 84 | 48 | 75 |
| ACR50 | 5 | 35 | 53 | 33 | 41 |
| ACR70 | 0 | 22 | 32 | 12 | 20 |
| PASI responses (%) | |||||
| PASI75 | 15 | 56 | 81 | 60 | 83 |
| PASI90 | 12 | 44 | 65 | 50 | 62 |
| PASI100 | 4 | 35 | 52 | 28 | 52 |
| Enthesitis resolution LEI=0 (%) | 22 | 35 | 65 | 31 | 53 |
| Dactylitis resolution LDI-B=0 (%) | 21 | 75 | 81 | 50 | 69 |
| HAQ-DI MCIDc (%) | 17 | 43 | 60.9 | 40 | 53.8 |
| Pain VAS MCIDb (%)32 | 31.6 | 61.9 | – | 55.9 | – |
| Fatigue NRS MCIDd (%)32 | 5.6 | 30.8 | – | 33.6 | – |
Notes: aMultiple imputation bPain VAS MCID defined as ≥ 10mm/100 improvement in patients with baseline pain ≥10; bHAQ-DI MCID defined as improvement from baseline ≥0.35 in patients with baseline score ≥0.35; cFatigue NRS MCID defined as ≥3 points/10 improvement in patients with baseline fatigue score ≥3.
Abbreviations: PBO, placebo; IXE, ixekizumab; IXEQ4W/IXEQ2W, ixekizumab 80 mg every 4 or every 2 weeks; ADA, adalimumab; ACR20/50/70, 20/50/70% American College of Rheumatology responses; PASI75/90/100, 75/90/100%, Psoriasis Area and Severity Index responses; LEI=0, Leeds Enthesitis Index = 0; LDI-B=0, Leeds Dactylitis Index-Basic = 0; VAS,Visual Analog Scale; MCID, Minimal Clinically important Difference, HAQ-DI, Health Assessment Questionnaire-Disability Index; NRS, Numeric Rating Scale.