Abstract: We aimed to assess the ecacy of biologic therapy in refractory non-Multiple Sclerosis
(MS) Optic Neuritis (ON), a condition more infrequent, chronic and severe than MS ON. This was
an open-label multicenter study of patients with non-MS ON refractory to systemic corticosteroids
and at least one conventional immunosuppressive drug. The main outcomes were Best Corrected
Visual Acuity (BCVA) and both Macular Thickness (MT) and Retinal Nerve Fiber Layer (RNFL) using
Optical Coherence Tomography (OCT). These outcome variables were assessed at baseline, 1 week,
and 1, 3, 6 and 12 months after biologic therapy initiation. Remission was defined as the absence of ON symptoms and signs that lasted longer than 24 h, with or without an associated new lesion
on magnetic resonance imaging with gadolinium contrast agents for at least 3 months. We studied
19 patients (11 women/8 men; mean age, 34.8 13.9 years). The underlying diseases were Bechet?s
disease (n = 5), neuromyelitis optica (n = 3), systemic lupus erythematosus (n = 2), sarcoidosis (n = 1),
relapsing polychondritis (n = 1) and anti-neutrophil cytoplasmic antibody -associated vasculitis (n = 1).
It was idiopathic in 6 patients. The first biologic agent used in each patient was: adalimumab (n = 6),
rituximab (n = 6), infliximab (n = 5) and tocilizumab (n = 2). A second immunosuppressive drug was
simultaneously used in 11 patients: methotrexate (n = 11), azathioprine (n = 2), mycophenolate mofetil
(n = 1) and hydroxychloroquine (n = 1). Improvement of the main outcomes was observed after 1 year
of therapy when compared with baseline data: mean SD BCVA (0.8 0.3 LogMAR vs. 0.6 0.3
LogMAR; p = 0.03), mean SD RNFL (190.5 175.4 m vs. 183.4 139.5 m; p = 0.02), mean SD
MT (270.7 23.2 m vs. 369.6 137.4 m; p = 0.03). Besides, the median (IQR) prednisone-dose was
also reduced from 40 (10?61.5) mg/day at baseline to. 2.5 (0?5) mg/day after one year of follow-up;
p = 0.001. After a mean SD follow-up of 35 months, 15 patients (78.9%) achieved ocular remission,
and 2 (10.5%) experienced severe adverse events. Biologic therapy is e ective in patients with
refractory non-MS ON.
