Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis

Exclusion Criteria

• •Person not affiliated to or not benefiting from a health insurance system
• •Weight \< 40kg or \> 100kg (at inclusion)
• •Non-compliant patient
• •Adult unable to express consent
• •Patient with a psychotic state not controlled by treatment
• •Person subject to a measure of legal protection (curatorship, guardianship)
• •Person subject to judicial control
• •Women who have not gone through menopause
• •Hypersensitivity to ustekinumab, to any of its excipients or to any other murine or human monoclonal antibody
• •Latex hypersensitivity (because the packaging of ustekinumab contains latex, which is only present in syringes)
• •Relapse with the presence of obvious ophthalmological signs requiring high-dose corticotherapy (1 mg/kg and/or methylprednisolone bolus)
• •Surgery scheduled within 12 months (excluding low-risk surgery: endoscopy, bronchoscopy, hysteroscopy, cystoscopy, biopsy or breast surgery, dental care, dental extractions, eye surgery, outpatient surgery, skin surgery)
• •Patient with other autoimmune or auto-inflammatory disease (except RPP, autoimmune thyroiditis, Addison's disease, type 1 diabetes, Biermer's disease and presence of autoantibodies without clinical manifestation)
• •Neoplasia \< 5 years (excluding in situ cervical cancer and skin carcinomas, excluding melanomas, with healthy margin resections \[R0\]).
• •Patient who has received an organ transplant (apart from a corneal transplant)
• •Patient who has received an autograft or hematopoietic marrow allograft
• •Unstable or poorly controlled disease, acute or chronic, not related to GCA and considered by the investigator as a contraindication to ustekinumab treatment (examples: recurrent infections, ulcers of the lower limbs poorly controlled, unstable ischemic cardiovascular disease, terminal renal failure, liver failure, heart failure ≥ stage III/IV NYHA, diabetes poorly controlled...).
• •Other treatments :
• •* Patient who has received at least 3 systemic corticoid cures for a condition other than GCA within the last 6 months (dermocorticoids and inhaled corticoids are allowed)
• •* Patient receiving long-term corticosteroid treatment (excluding dermocorticoids and inhaled corticosteroids) for a condition other than GCA
• •* Patient currently treated or having received, within 4 weeks, cytotoxic, immunosuppressive (except methotrexate and azathioprine which should however be stopped before inclusion), immunomodulatory (except dapsone which should however be stopped before inclusion) or biotherapic treatment.
• •* Live vaccine injected within 30 days of inclusion
• •Infections :
• •Chronic (or acute) viral hepatitis B or C
• •HIV infection
• •Persistent infection or severe infection requiring hospitalization or intravenous antibiotic treatment within 30 days of inclusion (trial antibiotics, regardless of duration and route of administration, are not an exclusion criterion).
• •Infection requiring oral antibiotic treatment within 14 days of inclusion (trial antibiotics, regardless of duration and route of administration, are not an exclusion criterion).
• •History of histoplasmosis or listeriosis
• •Active tuberculosis
• •Sign of latent tuberculosis (based on a history of untreated contagion, an opacity greater than 1 cm in diameter on chest X-ray, or a positive in vitro test \[QuantiferonR or T-spot-TBR\]). A history of tuberculosis disease or latent tuberculosis whose treatment has been completed and which has been properly conducted does not constitute an exclusion criterion, regardless of the outcome of the QuantiferonR or T-spot-TBR.