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. 2020 Aug 11;9(8):2608.
doi: 10.3390/jcm9082608.

Biologic Therapy in Refractory Non-Multiple Sclerosis Optic Neuritis Isolated or Associated to Immune-Mediated Inflammatory Diseases. A Multicenter Study

Alba Herrero-Morant  1 , Carmen Álvarez-Reguera  1 , José L Martín-Varillas  2 , Vanesa Calvo-Río  1 , Alfonso Casado  1 , Diana Prieto-Peña  1 , Belén Atienza-Mateo  1 , Olga Maiz-Alonso  3 , Ana Blanco  3 , Esther Vicente  4 , Íñigo Rúa-Figueroa  5 , Laura Cáceres-Martin  5 , José L García-Serrano  6 , José Luis Callejas-Rubio  6 , Norberto Ortego-Centeno  6 , Javier Narváez  7 , Susana Romero-Yuste  8 , Julio Sánchez  9 , Paula Estrada  10 , Rosalía Demetrio-Pablo  1 , David Martínez-López  1 , Santos Castañeda  4 , José L Hernández  1 , Miguel Á González-Gay  1 , Ricardo Blanco  1
Affiliations

Biologic Therapy in Refractory Non-Multiple Sclerosis Optic Neuritis Isolated or Associated to Immune-Mediated Inflammatory Diseases. A Multicenter Study

Alba Herrero-Morant et al. J Clin Med. .

Abstract

We aimed to assess the efficacy 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 μm vs. 183.4 ± 139.5 μm; p = 0.02), mean ± SD MT (270.7 ± 23.2 μm vs. 369.6 ± 137.4 μm; 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 effective in patients with refractory non-MS ON.

Keywords: adalimumab; biologic therapy; infliximab; optic neuritis; rituximab; tocilizumab.

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Conflict of interest statement

Disclosures that might be interpreted as constituting of possible conflict(s) of interest for the study: Dr. José L. Martín-Varillas received grants/research supports from AbbVie, Pfizer, Lilly, Janssen and Celgene; Dr. Vanesa Calvo-Río received grants/research supports from MSD and Roche and had consultation fees/participation in company-sponsored speaker’s bureau from Abbott, Lilly, Celgene, Grünenthal and UCB Pharma; Dr. Ana Blanco had consultation fees/participation in company-sponsored speaker’s bureau from AbbVie. Dr. Javier Narváez had consultation fees/participation in the company-sponsored speaker’s bureau from Bristol-Myers Squibb. Professor Miguel A. González-Gay received grants/research supports from AbbVie, MSD, Jansen and Roche and had consultation fees/participation in company-sponsored speaker’s bureau from AbbVie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD. Dr. Ricardo Blanco received grants/research supports from AbbVie, MSD and Roche and had consultation fees/participation in company-sponsored speaker’s bureau from AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Novartis, Sanofi, Lilly and MSD. The following authors did not declare financial disclosures: Alba Herrero-Morant, Carmen Álvarez-Reguera, Alfonso Casado, Diana Prieto-Peña, Belén Atienza-Mateo, Olga Maiz-Alonso, Esther Vicente, Iñigo Rúa-Figueroa, Laura Cáceres-Martin, José L. García-Serrano, José Luis Callejas-Rubio, Norberto Ortego-Centeno, Susana Romero-Yuste, Julio Sánchez, Paula Estrada, Rosalía Demetrio-Pablo, David Martínez-López, Santos Castañeda and José L. Hernández.

Figures

Figure 1
Figure 1
Flow-chart of biologic therapy in refractory non-Multiple Sclerosis optic neuritis. Abbreviations: ADA: Adalimumab, IFX: Infliximab; IS: Immunosuppressive, RTX: Rituximab; TCZ: Tocilizumab.
Figure 2
Figure 2
Improvement in (a) Best Corrected Visual Acuity (BCVA) and (b) Optical Coherence Tomography (OCT) measurements. Abbreviations: BCVA: Best Corrected Visual Acuity; MT: Macular Thickness, OCT: Optical Coherence Tomography; RNFL: Retinal Nerve Fiber Layer. * p < 0.05 compared with basal data.
Figure 3
Figure 3
Glucocorticoid sparing effect of biologic therapy in refractory non-Multiple Sclerosis Optic Neuritis. * p < 0.05 compared with basal data.
See this image and copyright information in PMC

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