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

Drug Design, Development and Therapy Dovepress open access to scientific and medical research Drug Design, Development and Therapy downloaded from https://www.dovepress.com/ by 205.185.223.177 on 12-Jul-2020 For personal use only. Open Access Full Text Article ORIGINAL RESEARCH Omalizumab for chronic spontaneous urticaria in “complex” patients: data from real-life clinical practice This article was published in the following Dove Press journal: Drug Design, Development and Therapy Laura Vollono 1 Arianna Piccolo 1 Caterina Lanna 1 Maria Esposito 2 Mauro Bavetta 1 Elena Campione 1 Luca Bianchi 1 Laura Diluvio 1 1 Dermatology Department, University of Rome, Tor Vergata, Italy; 2Dermatology Department, University of L’Aquila, L’Aquila, Italy Introduction: 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 Introduction Correspondence: Laura Vollono Dermatology Department, University of Rome Tor Vergata, Viale Oxford 81, Rome 00133, Italy Tel +39 06 2090 0252 Email 3181 submit your manuscript | www.dovepress.com Drug Design, Development and Therapy 2019:13 3181–3186 DovePress © 2019 Vollono et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms. php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). http://doi.org/10.2147/DDDT.S214307 Powered by TCPDF (www.tcpdf.org) Chronic spontaneous urticaria (CSU) is a condition characterized by the presence of wheals lasting for more than 6 weeks, variably associated with the presence of angioedema.1,2 CSU is the most common type of urticaria and affects about 1% of the population, causing a notable deterioration in the patient’s quality of life and bearing a substantial social and health care burden.3–6 The presence of angioedema in patients Dovepress Drug Design, Development and Therapy downloaded from https://www.dovepress.com/ by 205.185.223.177 on 12-Jul-2020 For personal use only. Vollono et al affected by CSU has been associated with a prolonged disease duration compared with those experiencing wheals only.7 CSU is twice as common in women as in men, and most commonly affects patients aged 20–40 years.4,8 Unlike inducible urticaria, which is provoked by a variety of physical stimuli (cold, heat, pressure, etc.), its exact nosology is still not fully elucidated. The release of histamine from mast cells in the skin is considered a key factor in its pathogenesis.2,8–10 A role of functional autoantibodies against the high-affinity immunoglobulin E (IgE) receptor and other autoantibodies such as anti-thyroperoxidase has been postulated.8,11 Although modern second-generation H1-antihistamines are the standard of care for patients with CSU, adjunctive treatments may be required for effective control of symptoms in many patients.4 Omalizumab is a humanized IgG1k monoclonal antibody that specifically binds to free human IgE, firstly indicated for the treatment of allergy-induced asthma.12,13 In 2014, FDA approved omalizumab also for patients affected by CSU aged 12 years or older who continue to have symptoms despite antihistamines treatment. Omalizumab represents the first biologic medicine and the first new class of pharmacological agent approved for CSU since the introduction of nonsedating H1-antihistamines and it is available in Italy since 2015. Randomized controlled trials showed a good safety and tolerability profile in patients affected by CSU.14–16 However, safety data of long-term treatment with this biologic drug are scarce and real-life reports regarding its use in patients affected by comorbidities other than CSU are lacking. We hereby present our experience with the use of omalizumab in a heterogeneous Italian population of patients affected by CSU and other different comorbidities in a real-life setting. Materials and methods This study is a retrospective analysis of data collected at the Urticaria Clinic of the Dermatology Department of Policlinico Tor Vergata, Rome, Italy. Written informed consent was obtained from all patients included in the study. In view of the retrospective nature of the study, only a notification to the Ethical Committee of the investigator Center (Policlinico Tor Vergata, Rome, Italy) was required and submitted. Patients aged >18 years affected by moderate-to-severe CSU [defined as weekl (...truncated)