Eustachio Nettis1, Luca Cegolon2, Elisabetta Di Leo3, Fabio Lodi Rizzini4, Aikaterini Detoraki5, Giorgio Walter Canonica6. 1. Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology, University of Bari Aldo Moro, Bari, Italy. 2. Scientific Directorate, IRCCS Burlo Garofolo, Trieste, Italy. 3. Section of Allergy and Clinical Immunology, Unit of Internal Medicine-"F. Miulli" Hospital, Acquaviva delle Fonti, Bari, Italy. 4. Allergy Unit, University of Brescia, Spedali Civili, Brescia, Italy. 5. Department of Clinical Immunology, Clinical Pathology, Infectious Diseases and Dermatology, Azienda Ospedaliera Universitaria Federico II, Naples, Italy. Electronic address: caterina.detoraki@gmail.com. 6. Department of Internal Medicine, Respiratory Disease Clinic, IRCCS Humanitas Clinical and Research Center, Humanitas University, Milan, Italy.
Abstract
BACKGROUND: Omalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU). OBJECTIVE: This multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity. METHODS: This retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined "responders") with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed. RESULTS: Omalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2% of patients had a UAS7 score of 6 or less and 66.7% had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be "slow responders" to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P < .001). No treatment-related adverse events were recorded. CONCLUSION: Monitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.
BACKGROUND:Omalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU). OBJECTIVE: This multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity. METHODS: This retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined "responders") with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed. RESULTS:Omalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2% of patients had a UAS7 score of 6 or less and 66.7% had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be "slow responders" to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P < .001). No treatment-related adverse events were recorded. CONCLUSION: Monitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.
Authors: Ivan Cherrez-Ojeda; Marcus Maurer; Jonathan A Bernstein; Emanuel Vanegas; Miguel Felix; German D Ramon; Luis Felipe Ensina; José Ignacio Larco Sousa; Edgar Emilio Matos Benavides; R Cardona Villa; P Latour Staffeld; Blanca María Morfin-Maciel; Jose Mori; Paul Wilches C; Valeria L Mata; Annia Cherrez Journal: World Allergy Organ J Date: 2019-02-23 Impact factor: 4.084