Table 3.
Frequently reported treatment-emergent AEs in ASCERTAINa
| AE | Tocilizumab q4w i.v. + csDMARDs (n = 102)b | Sarilumab 150 mg q2w s.c. + csDMARDs (n = 49) | Sarilumab 200 mg q2w s.c. + csDMARDs (n = 51) |
|---|---|---|---|
| Infection | 32 (31.4) | 20 (40.8) | 11 (21.6) |
| Nasopharyngitis | 4 (3.9) | 6 (12.2) | 3 (5.9) |
| Urinary tract infection | 6 (5.9) | 4 (8.2) | 2 (3.9) |
| Upper respiratory tract infection | 7 (6.9) | 2 (4.1) | 1 (2.0) |
| Gastroenteritis | 1 (1.0) | 3 (6.1) | 0 |
| Neutropenia | 4 (3.9) | 6 (12.2) | 8 (15.7) |
| Injection-site erythema | 1 (1.0) | 4 (8.2) | 4 (7.8) |
| Accidental overdosec | 9 (8.8) | 1 (2.0) | 3 (5.9) |
| Dizziness | 4 (3.9) | 1 (2.0) | 3 (5.9) |
| Hypercholesterolaemia | 6 (5.9) | 2 (4.1) | 1 (2.0) |
| Nausea | 7 (6.9) | 1 (2.0) | 1 (2.0) |
| RA | 6 (5.9) | 1 (2.0) | 0 |
Values are n (%). aAt least 5% in any treatment group. bTocilizumab q4w i.v. starting at 4 mg/kg could be increased to 8 mg/kg based on clinical response as assessed by the investigator. cAn overdose was defined as the administration of ≥2 sarilumab doses in <11 calendar days or ≥2 tocilizumab doses in <21 calendar days or at least twice of the intended dose within the intended therapeutic interval for sarilumab or tocilizumab. AE: adverse event; csDMARD: conventional synthetic DMARD; q2w: every 2 weeks; q4w: every 4 weeks.