Table 6.
Safety outcomes over 5 years, results based on data of patients included in the post-trial follow-up (n = 226)
| TCZ+MTX (n = 75) | TCZ (n = 79) | MTX (n = 72) | P-valuea | |
|---|---|---|---|---|
| ≥1 AE, n (%) | 75 (100) | 78 (99) | 72 (100) | 1.00 |
| AE rate per 100 patient-years | 336 | 340.96 | 382 | |
| Treatment was given for AE, % | 73 | 70 | 72 | 0.13 |
| ≥1 SAE, n (%) | 21 (28) | 23 (29) | 15 (21) | 0.47 |
| SAE rate per 100 patient-years | 7.1 | 10.5 | 6.5 | |
| ≥1 serious infection, n (%) | 7 (9) | 5 (6) | 1 (1) | 0.11 |
a
Extended Fisher’s exact test. AE: adverse event; MTX: methotrexate + placebo–tocilizumab initiation strategy group; SAE: serious adverse event; TCZ: tocilizumab + placebo–methotrexate initiation strategy group; TCZ+MTX: tocilizumab + methotrexate initiation strategy group.