title: Preclinical and clinical study of FK506 in uveitis.
abstract: Efficacy of a new immunosuppressive agent, FK506, in refractory uveitis was studied in 8 patients: 5 with Behcet's disease and 3 with idiopathic retinal vasculitis. The agent was given by oral administration every 12 hours. The previous therapy with systemic corticosteroids or immunosuppressive agents including cyclosporine failed to subside uveitis in these cases. During the observation period of 21.6 +/- 7.8 weeks (mean +/- SD) under FK506 at doses with 0.05, 0.1, 0.15 or 0.2 mg/kg/day, the visual acuity was increased in 44% of treated eyes, unchanged in 44% and decreased in 12%. The inflammatory activity in the ocular fundus was improved in 69% and unchanged in 6% of treated eyes. The effects of FK506 on uveitis by the criteria of improvement of visual acuity and uveitis activity was dose-dependent: 0.05 and 0.1 mg/kg/day were ineffective but 0.15 and 0.2 mg/kg/day were effective in most cases. One patient with Behcet's disease converted from cyclosporine developed moderate renal impairment in 4 weeks under FK506 and the therapy was discontinued in 8 weeks, though the uveitis activity as well as visual acuity was markedly improved. Other 7 cases had no side effect of FK506. Although the number of cases was small and observation period was short, the present clinical data indicate that FK506 is effective to treat refractory uveitis.
authors.affiliation: Department of Opthalmology, Kurume University School of Medicine, Fukuoka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Mochizuki
authors.forename: E
authors.initials: E
authors.lastname: Ikeda
authors.forename: M
authors.initials: M
authors.lastname: Shirao
authors.forename: S
authors.initials: S
authors.lastname: Fujito
authors.forename: K
authors.initials: K
authors.lastname: Yoshimura
authors.forename: N
authors.initials: N
authors.lastname: Shimada
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000818:Animals; D000941:Antigens; D019393:Arrestin; D001324:Autoantigens; D001327:Autoimmune Diseases / Q000188:drug therapy; D001528:Behcet Syndrome / Q000188:drug therapy; D004353:Drug Evaluation, Preclinical; D005136:Eye Proteins; D005260:Female; D006801:Humans; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D051381:Rats; D011917:Rats, Inbred Lew; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014605:Uveitis / Q000139:chemically induced / Q000188:drug therapy*; D014657:Vasculitis / Q000188:drug therapy; D014792:Visual Acuity
chemical_list: D000941:Antigens; D019393:Arrestin; D001324:Autoantigens; D005136:Eye Proteins; D016559:Tacrolimus