Table 4.
Safety data in OCRE‐SE and pooled OPERA I/II and ORATORIO populations.
| Adverse event |
OCRE‐SE (n = 228) |
OPERA I/II 3 (n = 825) |
ORATORIO 4 (n = 488) |
|---|---|---|---|
| Total patient‐years (PY) | 231 | 1448 | 1606 |
| Adverse events leading to discontinuation (rate per 100 PY) | 0.43 | 2.35 | 1.25 |
| Serious adverse events (SAE) (rate per 100 PY) | 1.73 | 5.4 | 10.2 |
| Infections (rate per 100 PY) | 10.82 | 84.5 | 70.8 |
| Urinary tract infection, n/total (%) | 10/228 (4.4) | 96/825 (11.6) | 195/488 (40.1) |
| Upper respiratory tract infection, n/total (%) |
4/228 (1.8) |
125/825 (15.2) ‐ |
59/488 (12.1) ‐ |
| COVID‐19, n/total (%) | 3/228 (1.3) | ‐ | ‐ |
| Cellulitis, n/total (%) | 2/228 (0.9) | 17/825 (2.1) | ‐ |
| Herpes zoster, n/total (%) | 2/228 (0.9) | ‐ | ‐ |
| Gastroenteritis, n/total (%) | 2/228 (0.9) | ‐ | ‐ |
| Others 1 , n/total (%) | 5/228 (2.2) | ||
| Serious infections (rate per 100 PY) | 0.43 | 0.83 | 2.74 |
| Infusion‐related reactions (rate per 100 PY) | 22.94 | 34.9 | 31.0 |
| Malignancies (rate per 100 PY) | 0.43 | 0.28 | 0.93 |
| Others 2 (rate per 100 PY) | 1.73 | ||
| Deaths (rate per 100 PY) | 0.43 | 0.07 | 0.25 |
1
Other infections: 1 herpes simplex labialis, 1 pneumonia, 1 dental abscess, 1 oral candidiasis, 1 otitis.
2
Others: 1 bilateral pulmonary thromboembolism, 1 recurrent skin rash, 1 biliary colic, 1 alopecia areata.
3
Pooled data from OPERA I and II. Hauser SL et al. Neurology. 2020.
4
ORATORIO adapted from Montalban X et al, NEJM, 2017