Long-term daclizumab therapy for the treatment of noninfectious ocular inflammatory disease

Abstract

Objective Safety and efficacy of daclizumab during an 11-year period. Design Structured, retrospective chart review. Participants Thirty-nine patients. Methods Patients with chronic, noninfectious intermediate and/or posterior uveitis. Results Thirty-nine patients (78 eyes) were treated for a mean of 40.3 months. Visual acuity improved by ≥2 lines in the better eye in 7 patients (18.4%) and worsened by 2 lines in 6 patients (15.8%) with a mean of 2.8 Snellen lines of vision lost per eye. Six eyes with vitreous cell less than grade 2 lost 2 lines of vision and 7 eyes with less than grade 2 vitreous cell improved 2 lines. Mean number of immunosuppressive medications per patient decreased from 1.89 medications/patient to 1.17 medications/patient. The average number of periocular injections per patient was 1.46 (range, 0–9). The mean number of flares was 2.05/patient (range, 0–12), with the rate being 0.62 flares per patient-year. Four patients developed cancer during the course of this study. Mean time to onset of malignancy was 26 months and the mean age in this group was 49 years. Conclusions Daclizumab demonstrated efficacy in the reduction of concomitant immunosuppressive medication, stabilization of visual acuity, and the prevention of uveitic flares in most cases. Dermatologic complications were the most frequently observed adverse event in our series. Four patients developed solid tumor malignancies during this 11-year period.

The use of biologic agents in the management of uveitis

“…Daclizumab significantly improved visual acuity in 18.4% of patients, but worsened visual acuity in 15.8% of patients. Unfortunately, there was a new malignancy reported in 10% of patients (renal cell carcinoma, squamous skin cell carcinoma, oesophageal cancer and vulvar carcinoma), with mean time to malignancy onset 26 months . The malignancy rate warrants closer review; however, as these patients had underlying systemic disease and were on additional immunosuppression therapy, causality is not clearly determined.…”

The Future Is Now: Biologics for Non-Infectious Pediatric Anterior Uveitis

“…It was used primarily as a transplant drug, but also for lymphoma, graft vs. host disease, multiple sclerosis, and uveitis. Although vision improved, uveitic flares were less frequent, and the need for IMT decreased in patients on daclizumab, it did not gain widespread use (118). Production was halted in the US in 2009, although it is gaining momentum towards returning to market for multiple sclerosis.…”

Treatment of Intermediate Uveitis

“…Four out of 39 patients developed solid tumor malignancies during the 11-year period of observation. The side effect profi le of daclizumab seems acceptable in the context of side effects associated with more conventional immunosuppressives, but the malignancy rate of this drug merits further review [ 112 ] (EBM 2-D).…”