Table 3.
Treatment‐emergent adverse events up to week 66
| MSB11022 (n = 221) | Continued reference adalimumab (n = 119) | Reference/MSB11022 switch (n = 101) | |
|---|---|---|---|
| TEAE | 173 (78·3) | 92 (77·3) | 76 (75·2) |
| Serious TEAE | 20 (9·0) | 8 (6·7) | 5 (5·0) |
| Treatment‐related TEAE | 69 (31·2) | 41 (34·5) | 33 (32·7) |
| Serious treatment‐related TEAE | 3 (1·4) | 5 (4·2) | 0 |
| TEAE of special interesta | 12 (5·4) | 4 (3·4) | 4 (4·0) |
| Permanent treatment discontinuation due to TEAE | 10 (4·5) | 16 (13·4) | 4 (4·0) |
| Death | 0 | 1 (0·8) | 0 |
| Injection‐site reaction TEAEsb | 37 (16·7) | 21 (17·6) | 25 (24·8) |
| Hypersensitivity TEAEsc | 10 (4·5) | 4 (3·4) | 6 (5·9) |
The data are presented as the number (%) of patients. TEAE, treatment‐emergent adverse event. aSerious infection, latent tuberculosis infection, or active tuberculosis infection. bIncludes the following preferred terms: injection‐site bruising, injection‐site erythema, injection‐site haematoma, injection‐site haemorrhage, injection‐site induration, injection‐site oedema, injection‐site pain, injection‐site pruritus, injection‐site rash, injection‐site swelling. cIncludes the following preferred terms: injection‐site rash, anaphylactic shock, drug hypersensitivity, rash pustular, rhinitis allergic, dermatitis, dermatitis allergic, dermatitis contact, eczema, erythema multiforme, hypersensitivity vasculitis, idiopathic urticaria, rash, urticaria.