Infliximab Biosimilar in Takayasu's Arteritis (TAKASIM)

We anticipate to include about 30 patients with Takayasu's arteritis (TA). Specifically, the study will include:

I) TA patients refractory to treatment with corticosteroid and/or immmunosuppressive therapy, not previously treated with infliximab (the naive arm).

II) TA patients refractory to treatment with corticosteroid and/or immmunosuppressive therapy, already receiving treatment with originator infliximab (the switch arm).

Inclusion Criteria:

• age> 18 years;
• negative pregnancy test;
• use of a reliable contraceptive method by all potentially fertile patients during the study and for the six months following the end of therapy;
• diagnosis of TA according to the Classification criteria of the American College of Rheumatology 1990;
• Multifocal vascular aortic and arterial involvement as evaluated by imaging examinations (angiography / angio-MRI / vascular ecocolordoppler / PET);
• failure to respond to corticosteroid therapy after 6-8 weeks of prednisone therapy at a dose of 1 mg / Kg per day, or impossibility to reduce the dose of prednisone to 0.5 mg / Kg within 3 months of initiation of therapy and to less than 0.2 mg / kg per day within 6 months of initiation of therapy (may also include patients who, despite receiving combination therapy with prednisone and cyclophosphamide, azathioprine, methotrexate, cyclosporin A, mycophenolate mofetil, leflunomide and rapamycin for at least 3 months, could not reduce the prednisone dose to 0.5 mg / Kg per day within 3 months of initiation of therapy, or to less than 0.2 mg / kg per day within 6 months of initiation of therapy);
• ongoing anti-TNF-alpha treatment with originator infliximab (inclusion criterion for the switch arm).

Exclusion Criteria:

• history of lymphoproliferative disease or solid neoplasm in the last 5 years, with the exception of successfully treated and completely resolved squamous cell skin carcinoma;
• history of uncontrolled diabetes, unstable cardiac ischaemia, congestive heart failure (NYHA class III and IV), active intestinal inflammatory disease, active peptic ulcer, recent stroke (within 3 months) and any other pathological conditions that, according to the treating physician, could expose the subject to the risk of adverse events;
• serological tests for hepatitis B or C indicating an active infection;
• history of HIV infection;
• chronic infection, or severe infections requiring hospitalization or intravenous antibiotic treatment within 30 days prior to inclusion in the study, or requiring treatment with oral antibiotics within 14 days prior to enrollment;
• ongoing pregnancy or lactation;
• history of drug or alcohol abuse;
• Previous diagnosis or signs of demyelinating disease of the central nervous system;
• history of active tuberculosis, histoplasmosis or listeriosis;
• previous infection with M. tuberculosis (as documented by chest x-rays and / or positive quantiferon test), in which case patients will only be enrolled after initiating prophylactic therapy according to current guidelines.