Adverse events summary through week 48
| Ustekinumab+MTX | Guselkumab+MTX | ||||||
|---|---|---|---|---|---|---|---|
| Placebo+MTX (N=55) | 90 mg every 8 weeks (N=55) | 90 mg every 12 weeks (N=55) | Combined | 50 mg every 8 weeks (N=55) | 200 mg every 8 weeks (N=54) | Combined | |
| Through week 16 | |||||||
| Patients, n | 55 | 54 | 55 | 109 | 55 | 54 | 109 |
| Mean exposure, weeks | 15.8 | 16.3 | 15.8 | 16.0 | 16.3 | 16.4 | 16.4 |
| Patients with ≥1 AE, n (%) | 21 (38.2) | 22 (40.7) | 24 (43.6) | 46 (42.2) | 16 (29.1) | 21 (38.9) | 37 (33.9) |
| Patients with ≥1 SAE, n (%) | 1 (1.8) | 2 (3.7) | 2 (3.6) | 4 (3.7) | 0 | 1 (1.9) | 1 (0.9) |
| Through week 48 | |||||||
| Patients, n | 55 | 54 | 55 | 125* | 55 | 54 | 109 |
| Mean exposure, weeks | 23.7 | 27.8 | 26.9 | 25.4 | 28.2 | 28.0 | 28.1 |
| Patients with ≥1 AE, n (%) | 25 (45.5) | 26 (48.1) | 30 (54.5) | 63 (50.4) | 20 (36.4) | 27 (50.0) | 47 (43.1) |
| Injection site reactions through week 28, n (%) | 0 | 0 | 1 (1.8) | 1 (0.8) | 1 (1.8) | 1 (1.9) | 2 (1.8) |
| Infections, n (%) | 16 (29.1) | 13 (24.1) | 21 (38.2) | 37 (29.6) | 12 (21.8) | 13 (24.1) | 25 (22.9) |
| Common AEs, n (%) | |||||||
| Nasopharyngitis | 3 (5.5) | 5 (9.3) | 4 (7.3) | 10 (8.0) | 3 (5.5) | 4 (7.4) | 7 (6.4) |
| Influenza | 3 (5.5) | 1 (1.9) | 3 (5.5) | 4 (3.2) | 3 (5.5) | 3 (5.6) | 6 (5.5) |
| Worsening of RA | 1 (1.8) | 2 (3.7) | 5 (9.1) | 8 (6.4) | 2 (3.6) | 4 (7.4) | 6 (5.5) |
| Headache | 3 (5.5) | 2 (3.7) | 5 (9.1) | 8 (6.4) | 2 (3.6) | 3 (5.6) | 5 (4.6) |
| Hypertension | 3 (5.5) | 4 (7.4) | 2 (3.6) | 7 (5.6) | 1 (1.8) | 1 (1.9) | 2 (1.8) |
| Back pain | 1 (1.8) | 0 | 0 | 0 | 3 (5.5) | 1 (1.9) | 4 (3.7) |
| Anaemia | 1 (1.8) | 3 (5.6) | 0 | 3 (2.4) | 1 (1.8) | 3 (5.6) | 4 (3.7) |
| Patients with ≥1 SAE, n (%) | 3 (5.5) | 4 (7.4) | 3 (5.5) | 8 (6.4) | 0 | 3 (5.6) | 3 (2.8) |
| Patients with ≥1 serious infection, n (%) | 1 (1.8) | 1 (1.9) | 0 | 1 (0.8) | 0 | 2 (3.7) | 2 (1.8) |
*Includes 16 patients who entered early escape at week 16.
AE, adverse event; MTX, methotrexate; RA, rheumatoid arthritis; SAE, serious adverse event.