Ocular Manifestations in Late Onset Behçet's Disease.

BACKGROUND: 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. ; Methods: A retrospective study was performed on 38 eyes of 21 oculo-Behçet patients over a seven- year period. ; Results: The mean age of our patients was 54.81 years. The sex ratio M/F was 2.5. The period between the onset of the first symptom and diagnosis of Behçet's disease varied from 3 days to 2 years. The primary complaint was a decrease in visual acuity, reported in 8 patients. Ocular involvement revealed Behçet's disease in 2 patients, bilateral in 17 patients, and active in 31 eyes. The ocular manifestations in late-onset Behçet's disease were dominated by uveal involvement (30 eyes). The most frequent form of uveitis was panuveitis noted in 13 eyes. Ocular complications were dominated by macular involvement in 8 patients (14 eyes). Blindness was noted in 4 eyes of 4 patients (10.5%). Topical corticosteroids were used in 30 eyes. Three patients were treated only with oral corticosteroid and 9 patients with a combination of oral corticosteroid and immunosuppressive agents. ; Conclusion: Since the course of the ocular involvement in late-onset Behçet's disease is regarded to be relatively mild, it is noteworthy that our study revealed that blindness was noted in 10,5% and posterior uveitis and panuveitis were the most common uveal lesion.

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. The primary endpoint was change in modified Rodnan skin score (mRSS) from baseline to week 24. RESULTS: Ninety-seven patients were randomised to romilkimab (n=48) or placebo (n=49) for 24 weeks. Least-squares mean (SE) change in mRSS was -4.76 (0.86) for romilkimab versus -2.45 (0.85) for placebo yielding a mean (SE) (90% CI) difference of -2.31 (1.21) (-4.32 to -0.31; p=0.0291, one-sided). Treatment-emergent AEs were balanced between placebo (n=41; 84%) and romilkimab (n=40; 80%). Most were mild-to-moderate and discontinuations were low (three overall). There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related. Two patients in the placebo group had a cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy), but there were no cardiac safety signals with romilkimab. CONCLUSION: This study demonstrated significant effects on skin changes with romilkimab in early dcSSc that require confirmation with a longer and more comprehensive phase III study to determine clinical relevance. TRIAL REGISTRATION NUMBER: NCT02921971.