Secondary end points included changes in the physician and patient global assessment of disease activity (10-point visual analog scale VAS) and changes in inflammation markers C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) during the 16 weeks following canakinumab treatment as compared to baseline. Methods Eligibility criteria To be included in the study, patients had to fulfill the following diagnostic criteria of UV: (1) urticarial rash with individual lesions persisting for more than 24 hours and (2) UV confirmed by biopsy from lesional skin showing signs of leukocytoclasis (fragmentation of neutrophils with nuclear dust) and/or fibrinoid deposits in perivascular and interstitial locations.E1 Participation in the study required active UV and insufficient response to treatment with antihistamines, nonsteroidal anti-inflammatory drugs, and/or immunomodulating or immunosuppressive drugs.