Effectiveness of canakinumab treatment in Schnitzler's syndrome: a multi-center randomized placebo-controlled study

Methods The current placebo-controlled multi-center study was designed to assess the effects of the anti-IL-1ß monoclonal antibody canakinumab (CAN) on the clinical signs and symptoms of SchS. We randomly assigned 20 patients with active disease to receive CAN 150 mg or placebo s.c. injections (day 0). Following the evaluation of treatment responses on day 7 the study was continued by a 16-week open label phase with CAN injections upon confirmed relapse of clinical symptoms. Efficacy was determined by changes in the physician’s global assessment (PGA; range 0-20), a combined symptom score which includes 5 key symptoms of SchS (urticarial rash, fever, fatigue, myalgia and arthralgia/bone pain), measurement of the inflammation markers C-reactive protein (CRP) and serum amyloid A (SAA) as well as changes in quality of life assessment (DLQI, SF-36).