TEAEs reported during the OLE
| OLE period (as of March 2017) | Patients, n (%) | nE (nE/100 PY) | ||
| Adalimumab/sarilumab (n=155) | Sarilumab/sarilumab (n=165) | Adalimumab/sarilumab (PY=165.7) | Sarilumab/sarilumab (PY=182.4) | |
| Any TEAE | 118 (76.1) | 117 (70.9) | 443 (267.4) | 420 (230.2) |
| Any treatment-emergent SAE | 17 (11.0) | 6 (3.6) | 25 (15.1) | 8 (4.4) |
| Any TEAE leading to death | 2 (1.3) | 1 (0.6) | 3 (1.8) | 1 (0.5) |
| Any TEAE leading to permanent treatment discontinuation | 10 (6.5) | 12 (7.3) | 12 (7.2) | 15 (8.2) |
| AESI type | ||||
| Infection | 65 (41.9) | 59 (35.8) | 110 (66.4) | 97 (53.2) |
| Serious infection | 3 (1.9) | 0 | 3 (1.8) | 0 |
| Opportunistic infection | 3 (1.9) | 1 (0.6) | 3 (1.8) | 1 (0.5) |
| Tuberculosis | 1 (0.6) | 0 | 1 (0.6) | 0 |
| Leucopenia | 21 (13.5) | 22 (13.3) | 46 (27.8) | 56 (30.7) |
| Thrombocytopenia | 3 (1.9) | 1 (0.6) | 5 (3.0) | 1 (0.5) |
| Hepatic disorders | 10 (6.5) | 13 (7.9) | 15 (9.1) | 20 (11.0) |
| Diverticulitis/GI perforation | 0 | 0 | 0 | 0 |
| GI ulceration | 0 | 0 | 0 | 0 |
| Elevation in lipids | 4 (2.6) | 6 (3.6) | 4 (2.4) | 7 (3.8) |
| Hypersensitivity | 8 (5.2) | 7 (4.2) | 16 (9.7) | 8 (4.4) |
| Anaphylaxis | 0 | 0 | 0 | 0 |
| Injection-site reaction | 14 (9.0) | 17 (10.3) | 66 (39.8) | 101 (55.4) |
| Malignancy | 3 (1.9) | 0 | 4 (2.4) | 0 |
| Malignancy excluding NMSC | 3 (1.9) | 0 | 4 (2.4) | 0 |
| Lupus-like syndrome | 0 | 0 | 0 | 0 |
| Demyelinating disorder | 0 | 0 | 0 | 0 |
AESI type was based on Standardised Medical Dictionary for Regulatory Activities Query or predefined search criteria.
AESI, adverse event of special interest; GI, gastrointestinal; nE, number of events; nE/100 PY, number of events per 100 patient-years; NMSC, nonmelanoma skin cancer; OLE, open-label extension; PY, patient-years; SAE, serious adverse event; TEAE, treatment-emergent adverse event.