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      Balanced discussion of second-generation antihistamines’ data

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      Therapeutics and Clinical Risk Management

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          Abstract

          Dear editor It is with interest that we read the paper “Treatment of allergic rhinitis and urticaria: a review of the newest antihistamine drug bilastine” by Wang et al,1 in which the authors provide insights into the burden of allergic diseases in the Asia-Pacific region. Unfortunately, we found that the review provides some unsubstantiated information, incorrect statements, and/or data inconsistencies as listed below. The abstract states that bilastine “has very low potential for drug–drug interactions”; however, the drug label lists interactions with ketoconazole, erythromycin, diltiazem, and other intestinal efflux transporters, leading to 2–3-fold increases in drug maximum serum concentration and area under the curve.2 Also, food interactions decrease bilastine’s bioavailability by 30%, and the label recommendation is that it is taken 1 hour before or 2 hours after intake of food or fruit juice.2 Table 2 presents a comparison between widely used antihistamines; however, the +++ score for bilastine’s H1-selectivity is not substantiated by the provided reference.2 Also, the highest Allergic rhinitis and its impact on asthma (ARIA)3 score attributed to bilastine in Table 2 is in contrast to the information provided in Table 1; ie, bilastine does not have higher potency or efficacy than other antihistamines (demonstrated by several studies4–8); has clinically relevant interactions with food;2 has the same indications and is effective on the same symptoms as other antihistamines;2 has only one pediatric study;9 and its side effect profile2 and pharmacodynamic properties are similar to other antihistamines.2 Many papers have reported that it has efficacy and safety similar to cetirizine,4,7,8 desloratadine,5 fexofenadine,8 and levocetirizine.6 Table 2 contains incorrect information about the age groups of the pediatric indications for cetirizine and levocetirizine, both of which are approved by the US Food and Drug Administration for use in children as young as 6 months of age.10,11 Also, Table 2 inaccurately states that bilastine has no contraindications; according to the product label,2 “hypersensitivity to the active substance or to any of the excipients […]” is a contraindication. The section “Bilastine efficacy” states that “the bilastine clinical trial program was designed before the publication of the 2001 ARIA guidelines, so the patient inclusion criteria were based on the former classification of seasonal and perennial allergic rhinitis”; however, this seems to be in contrast to the information on www.ClinicalTrials.gov, where the oldest bilastine study has a start date of April 2003;12 and the other bilastine studies appear with start dates of 2004 through 2016. A 12-month open-label safety analysis7 was described by the authors as “the longest analysis to date with any antihistamine”; however, safety analyses from double-blind randomized trials with cetirizine,13 loratadine,14 and levocetirizine15 over periods of 12–18 months of treatment have already been published. The section “No QTc prolongation” states that “to date, bilastine is the only commercially available anti histamine that has been tested using the stringent ICH E/14 criteria for effects on QT interval”. This is incorrect as a publication in 2007 presented data from an ICH E-14 QT study with levocetirizine.16 The section “Lack of sedation” is misleading, since the bilastine product label2 lists somnolence as a “common” adverse event (ie, occurring in 1%–10% of patients), which is supported by data from several clinical trials reporting somnolence rates with bilastine of 5.8%,6 3.9%,5 3.7%,7 and 1.8%.4 Figure 9 incorrectly presents that updosing with bilastine (80 mg) appears to have 2 to 3 times as many responders as those treated with desloratadine 20 mg or levocetirizine 20 mg. These data come from two clinical trials17,18 with completely different designs, and therefore direct comparison between them is inappropriate. The bilastine data come from a provocation test in subjects without symptoms at the time of study recruitment, whereas the levocetirizine and desloratadine data come from a real clinical trial with difficult-to-treat urticaria patients. Also, the original paper reported 12 patients (~30%) as responders (symptom-free) on levocetirizine 20 mg and 1 responder (<3%) on desloratadine 20 mg. In addition, Figure 9 uses another review article19 as a reference, instead of the primary publications.17,18 As there is an unmet need in the management of allergic rhinitis in the Asia-Pacific region, we welcome novel treatment options. However, based on the available data, there is no evidence to suggest that bilastine provides superior clinical efficacy to other commonly used second-generation antihistamines.4–8

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          Most cited references 16

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          The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria.

          H(1)-antihistamines are first line treatment of chronic urticaria, but many patients do not get satisfactory relief with recommended doses. European guidelines recommend increased antihistamine doses of up to 4-fold. To provide supportive evidence for the European guidelines. Eighty tertiary referral patients with chronic urticaria (age range, 19-67 years) were randomized for double-blind treatment with levocetirizine or desloratadine (40/40). Treatment started at the conventional daily dose of 5 mg and then increased weekly to 10 mg, 20 mg, or 20 mg of the opposite drug if relief of symptoms was incomplete. Wheal and pruritus scores, quality of life, patient discomfort, somnolence, and safety were assessed. Thirteen patients became symptom-free at 5 mg (9 levocetirizine vs 4 desloratadine), compared with 28 subjects on the higher doses of 10 mg (8/7) and 20 mg (5/1). Of the 28 patients nonresponsive to 20 mg desloratadine, 7 became symptom-free with 20 mg levocetirizine. None of the 18 levocetirizine nonresponders benefited with 20 mg desloratadine. Increasing antihistamine doses improved quality of life but did not increase somnolence. Analysis of the effect of treatment on discomfort caused by urticaria showed great individual heterogeneity of antihistamine responsiveness: approximately 15% of patients were good responders, approximately 10% were nonresponders, and approximately 75% were responders to higher than conventional antihistamine doses. No serious or severe adverse effects warranting discontinuation of treatment occurred with either drug. Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria.
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            Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients.

            Bilastine is a novel, nonsedating H(1)-antihistamine developed for symptomatic treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria. The objective of this study was to compare the efficacy and safety of bilastine 20 mg vs placebo and desloratadine 5 mg in subjects with seasonal allergic rhinitis (SAR). This randomized, double blind, placebo-controlled, parallel-group multicentre study evaluated the effect of 2 weeks' treatment with bilastine 20 mg, desloratadine 5 mg or matched placebo once daily, in 12-70 years old symptomatic SAR patients. All subjects assessed the severity of nasal (obstruction, rhinorrhoea, itching, and sneezing) and nonnasal (ocular itching, tearing, ocular redness, itching of ears and/or palate) symptoms on a predetermined scale to provide a total symptom score (TSS), composed of nasal and nonnasal symptom scores (NSS and NNSS, respectively). The primary efficacy measure was the area under the curve (AUC) for the TSS over the entire treatment period. Bilastine 20 mg significantly reduced the AUC of TSS to a greater degree from baseline compared to placebo (98.4 with bilastine vs 118.4 with placebo; P < 0.001), but not compared to desloratadine 5 mg (100.5). Bilastine 20 mg was not different from desloratadine 5 mg but significantly more effective than placebo in improving the NSS, NNSS, and rhinitis-associated discomfort scores (P < 0.05), and rhinoconjunctivitis quality of life questionnaire total (P < 0.005) and four out of seven individual domain (P < 0.05) scores. The incidence of treatment emergent adverse events was similar for bilastine (20.6%), desloratadine (19.8%), and placebo (18.8%). Bilastine 20 mg once daily was efficacious, safe and not different from desloratadine 5 mg once daily in the treatment of SAR symptoms.
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              Safety of levocetirizine treatment in young atopic children: An 18-month study.

               F Simons,   (2007)
              There are more than 40 H(1)-antihistamines available worldwide. Most of these medications have never been optimally studied in prospective, randomized, double-masked, placebo-controlled trials in children. The aim was to perform a long-term study of levocetirizine safety in young atopic children. In the randomized, double-masked Early Prevention of Asthma in Atopic Children Study, 510 atopic children who were age 12-24 months at entry received either levocetirizine 0.125 mg/kg or placebo twice daily for 18 months. Safety was assessed by: reporting of adverse events, numbers of children discontinuing the study because of adverse events, height and body mass measurements, assessment of developmental milestones, and hematology and biochemistry tests. The population evaluated for safety consisted of 255 children given levocetirizine and 255 children given placebo. The treatment groups were similar demographically, and with regard to number of children with: one or more adverse events (levocetirizine, 96.9%; placebo, 95.7%); serious adverse events (levocetirizine, 12.2%; placebo, 14.5%); medication-attributed adverse events (levocetirizine, 5.1%; placebo, 6.3%); and adverse events that led to permanent discontinuation of study medication (levocetirizine, 2.0%; placebo, 1.2%). The most frequent adverse events related to: upper respiratory tract infections, transient gastroenteritis symptoms, or exacerbations of allergic diseases. There were no significant differences between the treatment groups in height, mass, attainment of developmental milestones, and hematology and biochemistry tests. The long-term safety of levocetirizine has been confirmed in young atopic children.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2016
                24 November 2016
                : 12
                : 1777-1781
                Affiliations
                [1 ]UCB Pharma, Bulle, Switzerland
                [2 ]UCB Pharma, Brussels, Belgium
                [1 ]Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, People’s Republic of China
                [2 ]St Luke’s Medical Center, Quezon City, Manila, Philippines
                [3 ]Department of Otorhinolaryngology, Head & Neck Surgery, University Malaya Faculty of Medicine, Kuala Lumpur, Malaysia
                [4 ]Rhinology and Allergy Division, Department of Otorhinolaryngology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                [5 ]Department of Otolaryngology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
                Author notes
                Correspondence: Rossen Boev, UCB Farchim SA, Chemin De Croix Blanche 10, 1630 Bulle, Switzerland, Email rossen.boev@ 123456ucb.com
                Correspondence: De Yun Wang, Department of Otolaryngology, Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, Singapore 119228, Tel +65 6772 5373, Fax +65 6775 3820, Email entwdy@ 123456nus.edu.sg
                Article
                tcrm-12-1777
                10.2147/TCRM.S124148
                5167562
                © 2016 Boev and Bentz. This work is published and licensed by Dove Medical Press Limited

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