Summary of efficacy at weeks 12 and 24 among randomised PsA patients with peripheral arthritis and physician-reported spondylitis at baseline in PSUMMIT-1 and PSUMMIT-2
| Placebo | Ustekinumab Combined | |
|---|---|---|
| Randomised patients with spondylitis at baseline, N | 92 | 164 |
| Randomised patients with BASDAI assessment at baseline and week 12, N | 85 | 151 |
| Mean (SD) improvement from baseline to week 12 in BASDAI | 0.62 (1.511) | 1.78 (2.015) |
| Randomised patients with BASDAI assessment at baseline and week 24, N | 79 | 157 |
| Mean (SD) improvement from baseline to week 24 in BASDAI | 0.74 (1.606) | 2.05 (2.249) |
| Mean (SD) improvement from baseline to week 24 in BASDAI questions* | ||
| Question 1 (fatigue/tiredness) | 0.39 (2.218) | 1.77 (2.520) |
| Question 2 (neck/back/hip pain) | 0.24 (2.309) | 1.85 (2.678) |
| Question 3 (pain/swelling in joints other than neck/back/hips) | 1.13 (2.355) | 2.50 (2.810) |
| Question 4 (discomfort from any areas tender to touch/pressure) | 0.97 (2.161) | 2.22 (2.785) |
| Question 5 (morning stiffness since arising) | 1.27 (2.168) | 2.56 (2.789) |
| Question 6 (length of morning stiffness since arising) | 0.71 (2.527) | 1.93 (2.825) |
| BASDAI responses at week 24 | ||
| BASDAI20, n (%) | 26 (32.9) | 86 (54.8) |
| p Value | 0.002 | |
| BASDAI50, n (%) | 9 (11.4) | 46 (29.3) |
| p Value | 0.002 | |
| BASDAI70, n (%) | 0 | 24 (15.3) |
| p Value | <0.001 | |
| HAQ-DI improvement from baseline to week 24 | ||
| N | 92 | 164 |
| Mean (SD) | 0.11 (0.386) | 0.33 (0.533) |
| p Value | <0.001 | |
| Randomised patients with ≥3% BSA psoriasis skin involvement at baseline | 69 | 137 |
| DLQI improvement from baseline to week 24 | ||
| N | 64 | 134 |
| Mean (SD) | 1.97 (5.252) | 8.09 (6.706) |
| p Value | <0.001 | |
| Randomised patients with dactylitis at baseline | 46 | 86 |
| % improvement in dactylitis score at week 24, N | 41 | 83 |
| Mean (SD) | 11.0 (77.67)% | 57.5 (62.84)% |
| p Value | <0.001 | |
| Patients with dactylitis at week 24, n (%) | 31 (75.6) | 43 (51.8) |
| p Value | 0.010 | |
| Randomised patients with enthesitis at baseline† | 71 | 135 |
| % improvement in enthesitis score at week 24, N | 63 | 132 |
| Mean (SD) | 16.0 (99.93)% | 46.7 (48.69%) |
| p Value | 0.017 | |
| Patients with enthesitis at week 24, n (%) | 53 (84.1) | 87 (65.9) |
| p Value | 0.009 | |
*Question 1—‘How would you describe the overall level of fatigue/tiredness you have experienced?’; Question 2—‘How would you describe the overall level of neck, back or hip pain you have had?’; Question 3—‘How would you describe the overall level of pain/swelling in joints other than neck, back or hips you have had?’; Question 4—‘How would you describe the overall level of discomfort you have had from any areas tender to touch or pressure?’; Question 5—‘How would you describe the overall level of morning stiffness you have had from the time you wake up?’; Question 6—‘How long does your morning stiffness last from the time you wake up?’.
†Based on MASES.
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score.