UVB: treatment of UVeitis in Behçet’s diseases with biologic

Ki vehet részt

• Age >= 18 at Inclusion
• Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
• Provide written, informed consent prior to the performance of any study-specific procedures
• Diagnosis of Behçet’s disease according to the International Criteria for Behçet's Disease (ICBD) (see appendix 18.2) or history of aphtosis
• Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis
• Sight threatening uveitis defined according to the validated international definition as 2 lines of drop in visual acuity on a 10/10 scale, and/or retinal inflammation (macular oedema and/or retinal vasculitis)
• Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to Inclusion with no evidence of active Tuberculosis, active infection, or malignancy
• For female subjects of child-bearing potential (premenopausal female capable of becoming pregnant), a negative serum pregnancy test (plasmatic or urinary)
• For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 3 and 5 months after stopping therapy for tocilizumab and adalimumab, respectively
• Negative TB test obtained within 12 weeks prior to inclusion. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or UVB protocol, version 5.0 of 02/04/2024 31/76 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course. The treatment should be started at the latest at inclusion

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• Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
• Patient on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion (these drugs must be withdrawn prior to receiving the tocilizumab or adalimumab dose on Day 0)
• Any live (attenuated) vaccine within 30 days prior to inclusion
• Positive HIV antibody and/or positive hepatitis B surface antigen and/or positive hepatitis C RNA, results obtained within 1 month prior to inclusion
• Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
• History of intestinal ulceration or diverticulitis
• Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
• Active tuberculosis or history of untreated tuberculosis and/or severe infection
• History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin
• History of severe allergic or anaphylactic reactions to monoclonal antibodies
• History of multiple sclerosis and/or demyelinating disorder
• Hypersensitivity to the active substance or an excipient of the IMP or the auxiliary medicine
• Active or suspected ocular infection
• Infection oculaire active suspectée
• Laboratory values assessed during Inclusion: a. Neutrophil < 1.0 x 10^3/mm3 ; b. Platelet count < 80x 10^3/mm3 ; c. ASAT or ALAT > 5 ULN
• Severe renal (Glomerular filtration rates (GFR) <30ml/min) or liver insufficiency (prothrombin <50% without other causes)
• Known porphyria
• Breastfeeding and pregnant women