Table 3.
Infections and infestations in the long-term extension
| n (%) | Placebo → 50 mg q4w n=305 |
Placebo → 100 mg q2w n=291 |
50 mg q4w Start n=605 |
100 mg q2w Start n=619 |
50 mg q4w Combined n=910 |
100 mg q2w Combined n=910 |
Combined N=1820 |
| Patients with ≥1 treatment-emergent infection | 149 (48.9) | 161 (55.3) | 296 (48.9) | 313 (50.6) | 445 (48.9) | 474 (52.1) | 919 (50.5) |
| Infections and infestations | 137 (44.9) | 156 (53.6) | 277 (45.8) | 298 (48.1) | 414 (45.5) | 454 (49.9) | 868 (47.7) |
| Viral upper respiratory tract infection | 36 (11.8) | 31 (10.7) | 62 (10.2) | 72 (11.6) | 98 (10.8) | 103 (11.3) | 201 (11.0) |
| Upper respiratory tract infection | 29 (9.5) | 34 (11.7) | 49 (8.1) | 61 (9.9) | 78 (8.6) | 95 (10.4) | 173 (9.5) |
| Bronchitis | 27 (8.9) | 18 (6.2) | 30 (5.0) | 40 (6.5) | 57 (6.3) | 58 (6.4) | 115 (6.3) |
| Cellulitis | 8 (2.6) | 9 (3.1) | 25 (4.1) | 26 (4.2) | 33 (3.6) | 35 (3.8) | 68 (3.7) |
| Urinary tract infection | 11 (3.6) | 14 (4.8) | 24 (4.0) | 17 (2.7) | 35 (3.8) | 31 (3.4) | 66 (3.6) |
| Pharyngitis | 9 (3.0) | 13 (4.5) | 23 (3.8) | 19 (3.1) | 32 (3.5) | 32 (3.5) | 64 (3.5) |
| Pneumonia | 4 (1.3) | 9 (3.1) | 15 (2.5) | 24 (3.9) | 19 (2.1) | 33 (3.6) | 52 (2.9) |
| Sinusitis | 10 (3.3) | 7 (2.4) | 13 (2.1) | 13 (2.1) | 23 (2.5) | 20 (2.2) | 43 (2.4) |
| Herpes zoster | 4 (1.3) | 5 (1.7) | 13 (2.1) | 20 (3.2) | 17 (1.9) | 25 (2.7) | 42 (2.3) |
| Oral herpes | 3 (1.0) | 7 (2.4) | 11 (1.8) | 16 (2.6) | 14 (1.5) | 23 (2.5) | 37 (2.0) |
| Influenza | 4 (1.3) | 1 (0.3) | 10 (1.7) | 12 (1.9) | 14 (1.5) | 13 (1.4) | 27 (1.5) |
| Gastroenteritis | 0 | 6 (2.1) | 11 (1.8) | 7 (1.1) | 11 (1.2) | 13 (1.4) | 24 (1.3) |
| Conjunctivitis | 2 (0.7) | 4 (1.4) | 8 (1.3) | 9 (1.5) | 10 (1.1) | 13 (1.4) | 23 (1.3) |
| Cystitis | 0 | 3 (1.0) | 10 (1.7) | 10 (1.6) | 10 (1.1) | 13 (1.4) | 23 (1.3) |
| Patients with ≥1 serious infections | 25 (8.2) | 31 (10.7) | 59 (9.8) | 62 (10.0) | 84 (9.2) | 93 (10.2) | 177 (9.7) |
| Treatment emergent serious infections and infestations | 24 (7.9) | 30 (10.3) | 57 (9.4) | 60 (9.7) | 81 (8.9) | 90 (9.9) | 171 (9.4) |
| Pneumonia | 3 (1.0) | 8 (2.7) | 9 (1.5) | 19 (3.1) | 12 (1.3) | 27 (3.0) | 39 (2.1) |
| Cellulitis | 3 (1.0) | 4 (1.4) | 11 (1.8) | 9 (1.5) | 14 (1.5) | 13 (1.4) | 27 (1.5) |
| Sepsis | 1 (0.3) | 6 (2.1) | 3 (0.5) | 4 (0.6) | 4 (0.4) | 10 (1.1) | 14 (0.8) |
| Erysipelas | 0 | 0 | 4 (0.7) | 5 (0.8) | 4 (0.4) | 5 (0.5) | 9 (0.5) |
| Osteomyelitis | 2 (0.7) | 1 (0.3) | 2 (0.3) | 3 (0.5) | 4 (0.4) | 4 (0.4) | 8 (0.4) |
| Septic shock | 1 (0.3) | 3 (1) | 0 | 2 (0.3) | 1 (0.1) | 5 (0.5) | 6 (0.3) |
| Diverticulitis | 1 (0.3) | 1 (0.3) | 1 (0.2) | 2 (0.3) | 2 (0.2) | 3 (0.3) | 5 (0.3) |
| Treatment-emergent infections and infestations leading to discontinuation | 11 (3.6) | 14 (4.8) | 21 (3.5) | 27 (4.4) | 32 (3.5) | 41 (4.5) | 73 (4.0) |
| Cellulitis | 0 | 2 (0.7) | 3 (0.5) | 3 (0.5) | 3 (0.3) | 5 (0.5) | 8 (0.4) |
| Diverticulitis | 2 (0.7) | 2 (0.7) | 1 (0.2) | 2 (0.3) | 3 (0.3) | 4 (0.4) | 7 (0.4) |
| Pneumonia | 0 | 2 (0.7) | 1 (0.2) | 4 (0.6) | 1 (0.1) | 6 (0.7) | 7 (0.4) |
| Sepsis | 0 | 2 (0.7) | 1 (0.2) | 4 (0.6) | 1 (0.1) | 6 (0.7) | 7 (0.4) |
| Osteomyelitis | 2 (0.7) | 2 (0.7) | 0 | 1 (0.2) | 2 (0.2) | 3 (0.3) | 5 (0.3) |
| Opportunistic infections | 0 | 0 | 1 (0.2) | 1 (0.2) | 1 (0.1) | 1 (0.1) | 2 (0.1) |
| Herpes zoster disseminated | 0 | 0 | 1 (0.2) | 1 (0.2) | 1 (0.1) | 1 (0.1) | 2 (0.1) |
| Ophthalmic herpes zoster | 0 | 0 | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
q2w, every 2 weeks; q4w, every 4 weeks.