Omalizumab for chronic spontaneous urticaria in “complex” patients: data from real-life clinical practice

Laura Vollono1, Arianna Piccolo1, Caterina Lanna1, Maria Esposito2, Mauro Bavetta1, Elena Campione1, Luca Bianchi1, Laura Diluvio1 1Dermatology Department, University of Rome, Tor Vergata, Italy; 2Dermatology Department, University of L’Aquila, L’Aquila, ItalyCorrespondence: Laura VollonoDermatology Department, University of Rome Tor Vergata, Viale Oxford 81, Rome 00133, ItalyTel +39 06 2090 0252Email laura.vollono@gmail.comIntroduction: Omalizumab is a recombinant humanized anti-IgE monoclonal antibody, approved for patients affected by chronic spontaneous urticaria resistant to antihistamines. Although the clinical benefit of omalizumab has been established in several clinical trials, there are very little data about long-term treatment with this drug and real-life reports regarding its use in patients affected by comorbidities other than urticaria are lacking.Objectives: To assess omalizumab efficacy and safety in a heterogeneous population of patients affected by chronic spontaneous urticaria and several comorbidities in a real-world setting.Materials and methods: Patients affected by chronic spontaneous urticaria with weekly urticaria activity score >16 resistant to antihistamines were treated with omalizumab 300 mg injection as add-on to H1-antihistamines administered every 4 weeks for 6 months. Clinical assessment of weekly urticaria activity score, dermatology life quality index and blood tests were performed at baseline, 12, 24 and 52 weeks of treatment. Response was assessed based on reduction weekly urticaria activity score.Results: Thirty-two patients (22F; 10M) with a mean age of 52.4 years (range 27–72) affected by chronic spontaneous urticaria were enrolled. Comorbidities affecting our study population were divided into 6 categories: cardio-metabolic (77%), oncologic (19%), infectious (16%), allergic (45%) immunologic (41%) and others (18%). Omalizumab determined a satisfactory reduction of symptoms of chronic spontaneous urticaria and an amelioration of quality of life within our population. No relevant alterations regarding patients’ underlying conditions were encountered. This is the first study regarding the use of omalizumab for chronic spontaneous urticaria in a population of adult patients affected by several comorbidities, eg, cardio-metabolic, oncologic, infectious, allergic, immunologic and psychiatric diseases. Real-life data represent a valuable source of information about a drug’s safety and efficacy profile, especially in patients affected by different comorbidities that are widely diffused in Western countries.Keywords: chronic spontaneous urticaria, omalizumab, oncologic, cardiovascular, allergic and immunologic conditions, comorbidities