Tocilizumab for the treatment of retroperitoneal fibrosis

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In this prospective, open-label trial we will analyse the efficacy and safety of TCZ in a series of 18 patients with IRF who either experienced frequent relapses under adequate immunosuppressive therapy or had a clearly refractory disease and/or contraindications to glucocorticoid therapy. Patients will receive a monthly TCZ dose of 8 mg/kg for six months. a follow-up period of at least an additional 6 months will follow. The assessment of treatment efficacy will be evaluated as the rate of remission at months 6 and 12. Remission will be defined as absence of disease-related symptoms (abdominal or lumbar pain, testicular pain, constipation, systemic symptoms), resolution or improvement of hydronephrosis (without indwelling stents), near-normalization (i.e. normalization or reduction to <30% of basal values) of erythrocyte sedimentation rate and C-reactive protein levels, as previously described; remission will require a dose of prednisone equal to or lower than 5 mg/day. Secondary outcomes will include the assessment of the percentage of reduction in IRF thickness at CT or MRI scans and the reduction of FDG uptake (measured as SUVmax) at PET-CT. Patients will be evaluated monthly during the treatment course and every 3 months after remission. Adverse events will be assessed at each scheduled visit by physical examination and routine exams. Eventual adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.

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