Efficacy of tocilizumab in the treatment of acute anterior ischemic optic neuropathy optic neuropathy in Horton's disease

Ki vehet részt

• Diagnosis of GCA (Giant Cell Arteritis)
• AION characterized by sudden and painless loss of vision, accompanied by pallid swelling of the optic disc, of no more than one-week duration
• Age of 50 years or older
• Social insurance

Ki nem vehet részt

• Patients with previously untreated tuberculosis, or imaging data suggestive of active and/or sequellar tuberculosis
• Biological targeting therapy within 3 months preceding the study
• History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
• Contraindication to steroids and/or aspirin administrated in the treatment
• Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
• HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
• Evidence of active infection
• History of recurrent infections, diverticulitis or intestinal ulceration and ASAT/ALAT > 5 * upper limit of normal, according to the Summary of Product Characteristics of tocilizumab
• Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)
• Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
• Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion
• Insufficient liver function (Child Pugh C )
• Contraindication to and precaution in use of tocilizumab according to the summary product description
• Inability to provide informed consent
• Breastfeeding women and women with childbearing potential without highly effective contraception
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and for 3 months after the last administration of tocilizumab