Interferon-alpha2a and Systemic Corticosteroid in Monotherapy in Chronic Uveitis: Results of the Randomized Controlled BIRDFERON Study.
OBJECTIVE
Macular edema is the leading cause of vision loss in bilateral chronic noninfectious posterior uveitis, and is currently being treated using corticosteroids, immunosuppressive agents, and biotherapies. The aim of this trial was to assess and compare the efficacy and safety of corticosteroids and interferon-α (IFN-α) in adults with such conditions.


METHODS
Randomized controlled trial.


METHODS
Subjects: Adult patients with bilateral posterior autoimmune noninfectious and nontumoral uveitis complicated by macular edema in at least 1 eye.


METHODS
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.


METHODS
The main endpoint was the change of the central foveal thickness (CFT) obtained by optical coherence tomography.


RESULTS
Forty-eight patients were included. In intention-to-treat analysis, the median CFT change showed no significant difference. However, the per-protocol analysis showed a significant difference between groups for both eyes (OD and OS), and for the worse and better eyes. Statistically significant difference was found between the control and corticosteroid groups for the OD (P = .0285), and between the control and IFN-α groups for the OD (P = .0424) and worse eye (P = .0354). Serious adverse events occurred in 2 patients in the IFN group, in 1 patient in the corticosteroid group, and in 2 patients in the control group and were completely resolved after switch.


CONCLUSIONS
IFN-α and systemic corticosteroids, compared with no treatment, were associated with significant anatomic and visual improvement shown in the per-protocol study.
Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France. Electronic address: christine.fardeau@aphp.fr.
Christine
C
Fardeau
Internal Medicine Department, Pr S. Herson, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Anne
A
Simon
Psychiatry Department, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Benoît
B
Rodde
Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France.
Fabiana
F
Viscogliosi
Ophthalmology Department, University Hospital, Lille, France.
Pierre
P
Labalette
Department of Biostatistics Public Health and Medical Informatics, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Vincent
V
Looten
Department of Biostatistics Public Health and Medical Informatics, Pitié-Salpétrière Hospital, University Paris VI, Paris, France.
Sophie
S
Tézenas du Montcel
Ophthalmology Department, Reference Centre for Rare Diseases, Pitié-Salpétrière Hospital, University Paris VI, DHU Sight Restore, Paris, France.
Phuc
P
LeHoang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005584:Fovea Centralis / Q000473:pathology; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D015866:Uveitis, Posterior / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D014792:Visual Acuity; D055815:Young Adult
D005938:Glucocorticoids; D007155:Immunologic Factors; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins