Serious adverse events in patients with pSS by treatment
| Serious adverse event | Tocilizumab (n=55) | Placebo (n=55) |
| Between W0 and W24 | 14 (25.5%) | 6 (10.9%) |
| Type of serious adverse event | ||
| Prolonged hospitalisation for headache and nausea | 1 | |
| Infectious parotitis | 1 | 1 |
| Mononeuritis | 1 | |
| Sjögren’s flare with purpura | 1 | |
| Wrist fracture | 1 | |
| CPK increase | 1 | |
| MALT lymphoma | 1 | |
| Nodal marginal zone B-cell lymphoma | 1 | |
| Sinus tachycardia | 1 | |
| Cotunnius disease | 1 | |
| Normal pregnancy | 1 | |
| Neutropenia | 1 | |
| Gastroenteritis | 1 | |
| Sjögren flare with arthralgia | 1 | |
| Abdominal pain | 1 | |
| Cutaneous lupus erythematosus flare | 1 | |
| Hepatic cytolysis | 1 | |
| Epiretinal membrane | 1 | |
| Miscarriage | 1 | |
| Between W24 and W48 | 1 (1.8%) | 5 (9.1%) |
| Type of serious adverse event | ||
| Pneumopathy and hemoptysis | 1 | |
| Retinal detachment | 1 | |
| Non-Hodgkin's lymphoma | 1 | |
| Chest pain | 1 | |
| Ulnar nerve transposition | 1 | |
| MALT lymphoma | 1 | |
| Total events | 15 (27.3%) | 11 (20.0%) |
Data are number unless specified.
CPK, creatine phosphokinase; MALT, mucosa-associated lymphoid tissue; pSS, primary Sjögren syndrome.