Table 6.
Additional secondary outcomes – improvement in score from baseline to week 48 (evaluable patient population)
| Tight control | Standard care | |
|---|---|---|
| Measures of disease activity | ||
| PASI1, median improvement (IQR) | 1·2 (0·5, 3·2) | 1·0 (-0·4 , 2·5) |
| Non-missing N (total N) | 75 (81) | 81 (93) |
| PASI20, N (%) | 58/75 (77·3) | 48/81 (59·3) |
| PASI90, N (%) | 32/75 (42·7) | 19/81 (23·5) |
| Enthesitis2, median improvement (IQR) | 2·0 (0·0, 4·0) | 1·0 (-1·0, 4·0) |
| Non-missing N (total N) | 73 (82) | 72 (80) |
| Dactylitis3, median improvement (IQR) | 38.0 (20·0, 72·0) | 58.5 (30·0, 112·0) |
| Non-missing N (total N) | 31 (35) | 22 (27) |
| mNAPSI4, median improvement (IQR) | 3·0 (1·0, 9·0) | 2·0 (1·0, 8·0) |
| Non-missing N (total N) | 57 (62) | 53 (62) |
| Total joint count (TJC), median improvement (IQR) | 4·0 (1·0, 11·0) | 3·0 (-1·0, 9·5) |
| Non-missing N (total N) | 92 (101) | 92 (105) |
| Swollen joint count (SJC), median improvement (IQR) | 4·0 (2·0, 7·5) | 2·5 (1·0, 6·0) |
| Non-missing N (total N) | 92 (101) | 92 (105) |
| Patient reported outcomes | ||
| BASDAI score (cm), median improvement (IQR) | 2·4 (0·9, 5·2) | 1·5 (-0·2, 3·3) |
| Non-missing N (total N) | 81 (101) | 79 (105) |
| BASDAI MCID, N (%) | 57/81 (70·4) | 44/79 (55·7) |
| BASDAI score (cm)5, median improvement (IQR) | 3.9 (-0·3, 5·8) | 0.9 (-0·1 , 3·0) |
| Non-missing N (total N) | 18 (20) | 21 (23) |
| BASFI score (cm), median improvement (IQR) | 1.2 (0·3, 3·7) | 0.2 (-0·6, 1·7) |
| Non-missing N (total N) | 81 (101) | 80 (105) |
| BASFI MCID, N (%) | 49/81 (60·5) | 32/80 (40·0) |
| BASFI score (cm)6, median improvement (IQR) | 2.0 (0·0, 5·5) | -0·1 (-0·6, 1·3) |
| Non-missing N (total N) | 18 (20) | 21 (23) |
| PsAQoL, median improvement (IQR) | 3.0 (0·0, 7·0) | 0.5 (-1·0, 3·5) |
| Non-missing N (total N) | 80 (101) | 84 (105) |
| HAQ score, median improvement (IQR) | 0·5 (0·1, 0·9) | 0·1 (0·0, 0·5) |
| Non-missing N (total N) | 91 (101) | 90 (105) |
| HAQ MCID, N (%) | 53/91 (58·2) | 37/90 (41·1) |
| ASAS 20, N (%) | 49/80 (61·3) | 33/79 (41·8) |
| ASAS 40, N (%) | 37/80 (46·3) | 25/81 (30·9) |
Patients with skin psoriasis at baseline
Patients with enthesitis at baseline
Patients with dactylitis at baseline
Patients with nail disease at baseline
Patients with axial disease at baseline
Patients with axial disease at baseline
Improvement (baseline – 48 weeks), where a positive score indicates an improvement Summaries correspond to those patients with non-missing data at baseline and week 48
BASDAI MCID, change in score from baseline to week 48 of at least 1.0cm
BASFI MCID, change in score from baseline to week 48 of at least 0.7cm
HAQ MCID, change in score from baseline to week 48 of at least 0.35
PASI, Psoriasis Area Severity Index; mNAPSI, Modified Nail Psoriasis Severity Index; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; MCID, Minimum Clinically Important Difference; BASFI, Bath Ankylosing Spondylitis Functional Index; PsAQoL, Psoriatic Arthritis Quality of Life Questionnaire; ASAS, ASsessment in Ankylosing Spondylitis; HAQ, Health Assessment Questionnaire.