Interferon alpha2a and systemic corticosteroids in monotherapy in chronic bilateral autoimmune posterior uveitis associated with macular edema: results of the randomised controlled BIRDFERON study

Abstract

Purpose : Purpose : Macular edema is the main leading cause of vision loss in bilateral chronic non-infectious posterior uveitis. The systemic route is often used with corticosteroids, conventional immunosuppressive agents and biotherapies, including interferon (IFN)-α. The aim of this phase II trial was to assess and compare the efficacy and safety of corticosteroids and IFN-α in monotherapy in adults with such conditions.

Methods : Methods : In this open-label, randomized, parallel-arm trial, patients received either subcutaneous IFN-α2a, systemic corticosteroids or no treatment for 4 months. The efficacy and safety were assessed for up to 4 months. Adult patients with bilateral posterior autoimmune non-infectious and non-tumoral uveitis complicated by ME in at least one eye, were recruited. Patients were randomized to receive either subcutaneous IFN-α2a (IFN-α group), systemic corticosteroids (corticosteroid group) or no treatment (control group) for 4 months. The main endpoint was the change of the central foveal thickness (CFT) measured on the retinal mapping obtained by optical coherence tomography.

Results : Results : Forty-eight patients were included. In intention-to-treat analysis, the median CFT change showed no significant difference in the global test. However, the per protocol analysis showed a significant difference for both eyes (OD and OS), and for the worst and best eyes. Statistically significant difference was found between the control and corticosteroid groups for the OD (p=0.0285), and between the control and IFN-α groups for the OD (p=0.0424) and worst eye (p=0.0354). No difference was found between the corticosteroid and IFN-α groups regardless of the ocular feature. A significant increase ≥15 ETDRS letters was found in the global test only for the worst eye (p=0.0137). Three cases with serious adverse events resolved after treatment cessation.

Conclusions : Conclusions : In patients with chronic uveitic macular edema, IFN-α and systemic corticosteroids, compared to no treatment, were associated with significant anatomic and functional macular improvement.
None conflict of interest to disclose (funded by the Health Ministry and sponsored by Assistance Publique des Hôpitaux de Paris, ClinicalTrials.gov: NCT00508040).

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.