Safety and efficacy outcomes up to 3 years
| Safety (SS) n (%) [EAIR/100 PY] | BKZ 160 mg [a] (n=126) | BKZ 320 mg [b] (n=78) | Total (N=206) | |||
| Any TEAE | 114 (90.5) [136.1] | 70 (89.7) [113.3] | 184 (89.3) [126.4] | |||
| Serious TEAEs | 17 (13.5) [5.2] | 5 (6.4) [2.3] | 22 (10.7) [4.1] | |||
| Key TEAEs of special monitoring | ||||||
| Serious infections | 3 (2.4) [0.9] | 1 (1.3) [0.5] | 4 (1.9) [0.7] | |||
| Candida infections | 15 (11.9) [4.7] | 9 (11.5) [4.4] | 24 (11.7) [4.6] | |||
| Inflammatory bowel disease [c] | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Malignancies [d] | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Injection site reactions | 0 | 3 (3.8) [1.4] | 3 (1.5) [0.5] | |||
| Suicidal ideation | 1 (0.8) [0.3] | 0 | 1 (0.5) [0.2] | |||
| Liver function analyses | 13 (10.3) [4.1] | 11 (14.1) [5.3] | 24 (11.7) [4.6] | |||
| Study discontinuation due to TEAEs | 12 (9.5) [3.5] | 4 (5.1) [1.8] | 16 (7.8) [2.8] | |||
| Efficacy (FAS) n (%) | BKZ 160 mg [a] (n=124) | BKZ 320 mg [b] (n=82) | Total (N=206) | |||
| OC | NRI, % | OC | NRI, % | OC | NRI, % | |
| MDA, Wk 152 | 64/95 (67.4) | 51.6 | 42/62 (67.7) | 51.2 | 106/157 (67.5) | 51.5 |
| VLDA, Wk 152 | 41/95 (43.2) | 33.1 | 21/62 (33.9) | 25.6 | 62/157 (39.5) | 30.1 |
| PASI90 [e] Wk 152 | 51/61 (83.6) | 64.6 | 37/46 (80.4) | 63.8 | 88/107 (82.2) | 64.2 |
| PASI100 [e] Wk 152 | 47/61 (77.0) | 59.5 | 32/46 (69.6) | 55.2 | 79/107 (73.8) | 57.7 |
| BSA 0% [e] Wk 48 | 48/72 (66.7) | 60.8 | 38/55 (69.1) | 65.5 | 86/127 (67.7) | 62.8 |
| Wk 152 | 46/61 (75.4) | 58.2 | 31/45 (68.9) | 53.4 | 77/106 (72.6) | 56.2 |
| Dactylitis [f]/Enthesitis [g] resolution, Wk 48 | – | 70.6/56.9 | – | 84.0/57.1 | – | 76.3/57.0 |
| Wk 152 | – | 67.6/63.1 | – | 76.0/61.9 | – | 71.2/62.6 |
No anaphylactic reactions or major adverse cardiac events were reported. [a] Includes pts within the indicated analysis set originally assigned to all arms who were subsequently re-randomized to 160 mg, or [b] 320 mg, after double-blind period; [c] Microscopic colitis; [d] Malignant melanoma in situ; [e] Pts with BL BSA ≥3%, NRI: n=79, 58, 137 respectively; [f] Pts with BL LDI >0, NRI: n=34, 25, 59 respectively; [g] Pts with BL MASES >0, NRI: n=65, 42, 107 respectively. LDI: Leeds Dactylitis Index; MASES: Maastricht AS Enthesitis Score; OC: observed case.