Table 2.
Infusion reactions per cohort, type and severity
|
Standard cohort, n (%) |
Rapid cohort, n (%) |
|
| 2214 infusions/169 patients | 1461 infusions/129 patients | |
| Mild reaction1 | ||
| RR per infusion | 0.8% | 0.7% |
| RR per patient | 10.7% | 7.8% |
| Severe reaction1 | ||
| RR per infusion | 0.2% | 0.00% |
| RR per patients | 3.0% | 0.00% |
| Total ADRs to infliximab | 23 (%) | 8 (%) |
| Mild ADRs1 (by subtype) | 16 (69.6) | 8 (100.0) |
| Serum sickness | 1 (4.3) | 1 (25.0) |
| Skin rash (including psoriasis/lupus) | 6 (26.1) | 4 (50.0) |
| Facial flushing | 1 (4.3) | 0 (0.0) |
| Hypoxia | 0 (0.0) | 2 (25.0) |
| Nausea | 2 (8.7) | 1 (12.5) |
| Pruritis | 2 (8.7) | 0 (0.0) |
| Arthralgia | 1 (4.3) | 0 (0.0) |
| Other (unspecified) | 3 (13.0) | 0 (0.0) |
| Severe ADRs1 (by subtype) | 7 (30.4) | 0 (0.0) |
| Anaphylactic (incl. angioedema) | 4 (17.4) | 0 (0.0) |
| Dyspnoea | 1 (4.3) | 0 (0.0) |
| Hypotension | 1 (4.3) | 0 (0.0) |
| Chest pain | 1 (4.3) | 0 (0.0) |
| Other (unspecified) | 0 (0.0) | 0 (0.0) |
| Retrial outcomes2 | ||
| Returned to rapid | NA | 7 |
| Returned to accelerated | NA | 1 |
| Returned to standard | 15 | 0 |
| ADR(s) occurred on retrial | 3 | 0 |
1
As per Common Toxicity Criteria definitions;
2
Fastest protocol to which tolerated on ongoing basis (i.e., ≥ 3 infusions). RR: Relative risk; ADR: Adverse drug reaction; NA: Not available.