Cold-Induced Urticaria: Rilonacept Evaluation

Adult patients with symptomatic ColdU, that is, cold‐induced wheals and itch for more than 6 weeks, who were resistant to conventional antihistamine treatment in standard doses were recruited at Urticaria Centers of Reference and Excellence²⁹ (UCAREs; Department of Dermatology and Allergy, Charité—Universitätsmedizin Berlin; Department of Dermatology, Universitätsmedizin Johannes Gutenberg‐Universität, Mainz, both Germany). Patients with a positive cold stimulation test at 4°C (assessed by TempTest^® 3.0; EMO Systems GmbH, Berlin Germany) were included. The main exclusion criteria were concurrent/ongoing treatment with immunosuppressive medication, ongoing use of IL‐1 blockers or other biologics; H2 antihistamines, leukotriene antagonists and H1 antihistamines other than rescue medication, known hypersensitivity to rilonacept; significant concomitant illness; pregnancy or breast‐feeding; treatment with a live (attenuated) virus vaccine during 3 months prior to randomization, evidence of active, recurrent or latent systemic infection; and a history of malignancies within 5 years before screening. During the course of the study regular intake of antihistamines was not allowed. However, if necessary, patients were allowed to take rescue medication (loratadine, up to a maximum of 4 tablets of 10 mg per day) throughout the study except the 3 days prior to each study visit. Patients were asked to document the intake of the exact amount of rescue medication for each day.
The study received approval from the study center's Institutional Review Board (Landesamt für Gesundheit und Soziales, Ethik‐Kommission des Landes Berlin) (EudraCT number: 2012‐005726‐30; ClinicalTrials.gov identifier: NCT02171416). All patients provided written informed consent, and the study was conducted according to the Good Clinical Practice Guideline, the Declaration of Helsinki and the International Conference on Harmonization.