Table 4.
MTX-treated patients with adverse events by number, type, and reason for discontinuation of previous TNF inhibitor(s) during the placebo-controlled study period (weeks 0–16)
| Placebo+MTX | Golimumab+MTX | All patients | |
|---|---|---|---|
| All Adverse Events (AEs) | 67/107 (62.6%) | 133/204 (65.2%) | 200/311 (64.3%) |
| All AEs by number of prior agents | |||
| 1 TNF inhibitor | 38/60 (63.3%) | 93/140 (66.4%) | 131/200 (65.5%) |
| 2 TNF inhibitors | 20/33 (60.6%) | 28/46 (60.9%) | 48/79 (60.8%) |
| 3 TNF inhibitors | 9/14 (64.3%) | 12/18 (66.7%) | 21/32 (65.6%) |
| All AEs by prior agent* | |||
| Adalimumab only | 10/14 (71.4%) | 21/34 (61.8%) | 31/48 (64.6%) |
| Etanercept only | 9/17 (52.9%) | 31/49 (63.3%) | 40/66 (60.6%) |
| Infliximab only | 19/29 (65.5%) | 41/57 (71.9%) | 60/86 (69.8%) |
| All AEs by reason for d/c of agent† | |||
| Lack of efficacy | 40/70 (57.1%) | 73/121 (60.3%) | 113/191 (59.2%) |
| Intolerance | 13/16 (81.3%) | 24/33 (72.7%) | 37/49 (75.5%) |
| ‘Other’ reason | 24/40 (60.0%) | 52/75 (69.3%) | 76/115 (66.1%) |
| Serious Adverse Events (SAEs) | 8/107 (7.5%) | 6/204 (2.9%) | 14/311 (4.5%) |
| SAEs by number of prior agents | |||
| 1 TNF inhibitor | 3/60 (5.0%) | 2/140 (1.4%) | 5/200 (2.5%) |
| 2 TNF inhibitors | 2/33 (6.1%) | 1/46 (2.2%) | 3/79 (3.8%) |
| 3 TNF inhibitors | 3/14 (21.4%) | 3/18 (16.7%) | 6/32 (18.8%) |
| SAEs by prior agent* | |||
| Adalimumab only | 0/14 (0.0%) | 2/34 (5.9%) | 2/48 (4.2%) |
| Etanercept only | 0/17 (0.0%) | 0/49 (0.0%) | 0/66 (0.0%) |
| Infliximab only | 3/29 (10.3%) | 0/57 (0.0%) | 3/86 (3.5%) |
| SAEs by reason for d/c of agent† | |||
| Lack of efficacy | 7/70 (10.0%) | 4/121 (3.3%) | 11/191 (5.8%) |
| Intolerance | 1/16 (6.3%) | 2/33 (6.1%) | 3/49 (6.1%) |
| ‘Other’ reason | 1/40 (2.5%) | 1/75 (1.3%) | 2/115 (1.7%) |
| Serious Infections (SIs) | 3/107 (2.8%) | 2/204 (1.0%) | 5/311 (1.6%) |
| SIs by number of prior agents | |||
| 1 TNF inhibitor | 2/60 (3.3%) | 1/140 (0.7%) | 3/200 (1.5%) |
| 2 TNF inhibitors | 1/33 (3.0%) | 0/46 (0.0%) | 1/79 (1.3%) |
| 3 TNF inhibitors | 0/14 (0.0%) | 1/18 (5.6%) | 1/32 (3.1%) |
| SIs by prior agent* | |||
| Adalimumab only | 0/14 (0.0%) | 1/34 (2.9%) | 1/48 (2.1%) |
| Etanercept only | 0/17 (0.0%) | 0/49 (0.0%) | 0/66 (0.0%) |
| Infliximab only | 2/29 (6.9%) | 0/57 (0.0%) | 2/86 (2.3%) |
| SIs by reason for d/c of prior agent† | |||
| Lack of efficacy | 2/70 (2.9%) | 1/121 (0.8%) | 3/191 (1.6%) |
| Intolerance | 0/16 (0.0%) | 1/33 (3.0%) | 1/49 (2.0%) |
| ‘Other’ reason | 1/40 (2.5%) | 1/75 (1.3%) | 2/115 (1.7%) |
Data presented are number (%) of treated patients.
*Among patients who received only one prior TNF inhibitor.
†Some patients had received more than one TNF inhibitor and could have discontinued each one for a different reason. In the vast majority of patients, the ‘other’ reason for discontinuation of previous anti-TNF agent(s) was related to cost/insurance coverage.
d/c, discontinuation; MTX, methotrexate; TNF, tumour necrosis factor.