A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.

Objectives: Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis.

Methods: Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy, were randomised (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks in this double-blind, proof-of-concept, phase II study.

Ocular Manifestations in Late Onset Behçet's Disease.

Behçet's disease is frequent in Tunisia and potentially serious, which can endanger both the vital and visual prognosis. Late occurrence of the disease is uncommon and less frequently investigated. ; Aims: The aim of this study was to analyse the demographic characteristics and ocular manifestations of patients with late-onset Behçet disease in Tunisia, North Africa.