Safety, immunogenicity and effect of ADAs on safety and efficacy following TCZ as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
| TCZ-SC mono 162 mg qw or q2w (n=616) | TCZ-SC+csDMARDs 162 mg qw or q2w (n=2483) | TCZ-IV mono 4 mg/kg or 8 mg/kg q4w (n=753) | TCZ-IV+csDMARDs 4 mg/kg or 8 mg/kg q4w (n=5122) | |
|---|---|---|---|---|
| Anaphylaxis, n (%)* | 0 | 0 | 1 (0.1) | 9 (0.2) |
| Clinically significant hypersensitivity (leading to withdrawal), n (%)† | 6 (1.0) | 25 (1.0) | 12 (1.6) | 79 (1.5) |
| Serious hypersensitivity (reported as SAE), n (%)‡ | 1 (0.2) | 9 (0.4) | 9 (1.2) | 42 (0.8) |
| Injection-site reactions, n (%) | 81 (13.1) | 229 (9.2) | N/A | N/A |
| Total patients screened for ADAs, n (%) | 615 (99.8) | 2479 (99.8) | 745 (98.9) | 5061 (98.8) |
| Total patients who developed ADAs, n (%)§ | 12 (2.0) | 35 (1.4) | 5 (0.7) | 64 (1.3) |
| Positive neutralisation assay, n (%)§¶ | 7 (1.1) | 33 (1.3) | 4 (0.5) | 50 (1.0) |
| Positive IgE assay, n (%)§ | 3 (0.5) | 6 (0.2) | N/A | N/A |
| Anaphylaxis, n (%)*§ | 0 | 0 | 0 | 5 (0.1) |
| Clinically significant hypersensitivity (leading to withdrawal), n (%)†§ | 1 (0.2) | 0 | 1 (0.1) | 9 (0.2) |
| Serious hypersensitivity (reported as SAE), n (%)ठ| 0 | 0 | 0 | 6 (0.1) |
| Injection-site reactions, n (%)§ | 1 (0.2) | 3 (0.1) | N/A | N/A |
| Loss of efficacy, n (%)§** | 0 | 0 | 0 | 0 |
*Anaphylactic reactions were events that occurred during or within 24 hours of an infusion or injection and met Sampson criteria.
†Clinically significant hypersensitivity events were defined as any events that occurred during or within 24 hours of an infusion or injection and led to withdrawal from treatment.
‡Serious hypersensitivity events were defined as any events that occurred during or within 24 hours of an infusion or injection and were reported as SAEs.
§Denominator is total patients screened for ADAs.
¶The Fab assay was applied in the MUSASHI study to measure neutralisation potential.
**Loss of efficacy was defined as patients who withdrew from the study prematurely due to insufficient therapeutic response after experiencing an American College of Rheumatology criteria for 50% improvement (ACR50) or European League Against Rheumatism good response.
ADA, antidrug antibody; N/A, not available; q2w, every other week; q4w, every 4 weeks; qw, every week; SAE, serious adverse event; TCZ, tocilizumab; TCZ-IV, intravenous TCZ; TCZ-SC, subcutaneous TCZ.