Incidence of adverse events per 100 patient years to week 52 summarised by the actual treatment received at the time of the event
| Placebo+MTX (n=133)* | Golimumab 100 mg+ placebo (n=133) | Golimumab 50 mg+ MTX (n=212) | Golimumab 100 mg+ MTX (n=142)† | |||||
|---|---|---|---|---|---|---|---|---|
| Assessment | n (%) | Events per 100 patient years (95% CI) | n (%) | Events per 100 patient years (95% CI) | n (%) | Events per 100 patient years (95% CI) | n (%) | Events per 100 patient years (95% CI) |
| Any adverse event | 98 (73.7) | 546 (486 to 612) | 108 (81.2) | 514 (471 to 560) | 167 (78.8) | 459 (425 to 495) | 122 (85.9) | 595 (552 to 641) |
| Serious adverse events | 6 (4.5) | 15 (6 to 29) | 16 (12.0) | 28 (19 to 40) | 17 (8.0) | 14 (9 to 22) | 26 (18.3) | 34 (24 to 46) |
| Any infection | 42 (31.6) | 132 (104 to 167) | 69 (51.9) | 133 (112 to 158) | 98 (46.2) | 114 (98 to 133) | 75 (52.8) | 156 (135 to 181) |
| Serious infections | 1 (0.8) | 2 (0 to 10) | 5 (3.8) | 8 (3 to 15) | 4 (1.9) | 3 (1 to 8) | 10 (7.0) | 10 (5 to 18) |
| Bacterial arthritis | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 1 (0.7) | 1 (0 to 5) |
| Infective arthritis | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 0 (0) | 0 (0 to 2) | 0 (0) | 0 (0 to 3) |
| Bronchitis | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 1 (0.7) | 1 (0 to 5) |
| Cellulitis | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 1 (0.5) | 1 (0 to 5) | 2 (1.4) | 2 (0 to 6) |
| Colitis | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 0 (0) | 0 (0 to 2) | 0 (0) | 0 (0 to 3) |
| Diarrhoea | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 0 (0) | 0 (0 to 2) | 0 (0) | 0 (0 to 3) |
| Lower respiratory tract infection | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 1 (0.7) | 1 (0 to 5) |
| Lung disorder | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 1 (0.7) | 1 (0 to 5) |
| Pneumonia | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 1 (0.5) | 1 (0 to 4) | 0 (0) | 0 (0 to 3) |
| Fever | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 0 (0) | 0 (0 to 2) | 0 (0) | 0 (0 to 3) |
| Sepsis | 0 (0) | 0 (0 to 6) | 2 (1.5) | 2 (0 to 7) | 0 (0) | 0 (0 to 2) | 3 (2.1) | 3 (1 to 7) |
| Sinusitis | 0 (0) | 0 (0 to 6) | 1 (0.8) | 1 (0 to 5) | 0 (0) | 0 (0 to 2) | 0 (0) | 0 (0 to 3) |
| Skin laceration | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 1 (0.7) | 1 (0 to 5) |
| Subcutaneous abscess | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 1 (0.5) | 1 (0 to 4) | 0 (0) | 0 (0 to 3) |
| Tuberculosis pleurisy | 0 (0) | 0 (0 to 6) | 0 (0) | 0 (0 to 3) | 1 (0.5) | 1 (0 to 4) | 0 (0) | 0 (0 to 3) |
| Urinary tract infection | 1 (0.8) | 2 (0 to 10) | 0 (0) | 0 (0 to 3) | 0 (0) | 0 (0 to 2) | 2 (1.4) | 2 (0 to 6) |
| Injection-site reaction | 4 (3.0) | 11 (4 to 24) | 16 (12.0) | 45 (33 to 60) | 10 (4.7) | 16 (10 to 24) | 13 (9.2) | 36 (26 to 49) |
| Malignancies | 2 (1.5) | 7 (2 to 19) | 2 (1.5) | 5 (2 to 11) | 3 (1.4) | 3 (1 to 8) | 3 (2.1) | 3 (1 to 7) |
| Adverse events leading to discontinuation | 8 (6.0) | 18 (9 to 34) | 10 (7.5) | 19 (12 to 30) | 7 (3.3) | 7 (3 to 12) | 9 (6.3) | 12 (6 to 20) |
Adverse events are categorised according to the treatment the patient was receiving at the time of the event.
↵* One patient who discontinued study treatment before week 16 met early escape criteria at week 16 and was included in the efficacy analysis. This patient did not receive golimumab and therefore was not included in the safety analysis.
↵† Two patients received golimumab 100 mg plus methotrexate in error. One patient was originally assigned to placebo plus methotrexate, crossed over to golimumab at week 24, received an errant dose of golimumab 100 mg plus methotrexate and resumed 50 mg plus methotrexate in subsequent doses. The other patient was originally assigned to golimumab 50 mg plus methotrexate, received an errant dose of 100 mg plus methotrexate and resumed 50 mg plus methotrexate in subsequent doses. Both patients are counted in the denominator for each dose to which they were exposed.
MTX, methotrexate.