TABLE 4.
PASI response and AEs by exposure quartile from part 1 of the reSURFACE trials
| Placebo | 100 mg Q1 | 100 mg Q2 | 100 mg Q3 | 100 mg Q4 | 200 mg Q1 | 200 mg Q2 | 200 mg Q3 | 200 mg Q4 | |
|---|---|---|---|---|---|---|---|---|---|
| Efficacy (at week 12) | |||||||||
| n | 350 | 154 | 154 | 152 | 152 | 153 | 153 | 155 | 155 |
| Cavg12 (μg mL−1) | 4.4 (2.1, 5.2) | 5.7 (5.2, 6.4) | 7.0 (6.4, 7.8) | 8.7 (7.8, 16.1) | 8.7 (4.2, 10.4) | 11.5 (10.4, 12.5) | 14.1 (12.5, 15.5) | 17.3 (15.5, 30.6) | |
| PASI75 | 18 (5.9) | 90 (58.4) | 96 (62.3) | 90 (59.2) | 112 (73.7) | 81 (52.9) | 105 (68.6) | 100 (64.5) | 116 (74.8%) |
| PASI90 | 5 (1.6) | 46 (29.9) | 59 (38.3) | 47 (30.9) | 75 (49.3) | 32 (20.9) | 58 (37.9) | 62 (40) | 73 (47.1%) |
| PASI100 | 1 (0.3) | 14 (9.1) | 22 (14.3) | 16 (10.5) | 29 (19.1) | 10 (6.5) | 26 (17) | 21 (13.5) | 24 (15.5%) |
| Safety | |||||||||
| n | 310 | 154 | 154 | 154 | 154 | 156 | 155 | 155 | 156 |
| Cavg12, (μg mL−1) | 0 | 4.4 (2.1, 5.2) | 5.7 (5.2, 6.4) | 7.0 (6.4, 7.8) | 8.7 (7.8, 16.1) | 8.7 (4.2, 10.4) | 11.5 (10.4, 12.5) | 14.1 (12.5, 15.5) | 17.3 (15.5, 30.6) |
| Any AE | 160 (51.6) | 76 (49.4) | 71 (46.1) | 62 (40.3) | 73 (47.4) | 72 (46.2) | 70 (45.2) | 68 (43.9) | 74 (47.4) |
| Infection | 63 (20.3) | 33 (21.4) | 33 (21.4) | 27 (17.5) | 36 (23.4) | 35 (22.4) | 30 (19.4) | 32 (20.6) | 30 (19.2) |
| Severe infection | 1 (0.3) | 1 (0.6) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) | 1 (0.6) | 0 (0) |
| URTI | 30 (9.7) | 19 (12.3) | 18 (11.7) | 17 (11) | 22 (14.3) | 19 (12.2) | 18 (11.6) | 20 (12.9) | 16 (10.3) |
| Malignancies | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) |
| Nonmelanoma skin cancer | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) |
| Melanoma skin cancer | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Confirmed extended MACE | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) | 0 (0) | 1 (0.6) | 0 (0) | 0 (0) | 0 (0) |
| Drug‐related hypersensitivity | 1 (0.3) | 0 (0) | 0 (0) | 0 (0) | 1 (0.6) | 1 (0.6) | 0 (0) | 0 (0) | 0 (0) |
PASI response and AEs are presented as n (%) and Cavg12 is reported as median (range).
AE, adverse event; Cavg12, average concentration from weeks 1 to 12; MACE, major adverse cardiovascular event; PASI, Psoriasis Area and Severity Index; Q, quartile; URTI, upper respiratory tract infection.