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      Management of chronic urticaria in children: a clinical guideline

      review-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 2 , 12 , 13 , 14 , 3 , 15 , 16 , 11 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 10 , 25 , 11 , 26 , 18 ,
      Italian Journal of Pediatrics
      BioMed Central
      Allergy, Angioedema, Chronic urticaria, Chronic spontaneous urticaria, Children, Inducible uricaria, Management, Omalizumab, Pathogenesis, Pediatric, Therapy, Urticaria

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          Abstract

          The aim of this guidance is to provide recommendations to clinicians and other interested parties on chronic urticaria in children. The Italian Society for Pediatrics (SIP), the Italian Society for Allergy and Immunology (SIAIP), the Italian Society for Pediatric dermatology (SIDerP) convened a multidisciplinary panel that prepared clinical guidelines for diagnosis and management of chronic urticaria in childhood. Key questions on epidemiology, natural history, diagnosis, and management were developed. The literature was systematically searched and evaluated, recommendations were rated and algorithms for diagnosis and treatment were developed. The recommendations focus on identification of diseases and comorbidities, strategies to recognize triggering factors, improvement of treatment by individualized care.

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          Most cited references209

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          The EAACI/GA²LEN/EDF/WAO Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update

          This evidence- and consensus-based guideline was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. The conference was held on 1 December 2016. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-founded network of excellence, the Global Allergy and Asthma European Network (GA²LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) with the participation of 48 delegates of 42 national and international societies. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria are disabling, impair quality of life and affect performance at work and school. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors and pathomechanisms. In addition, it outlines evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria.
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            Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria.

            Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody [corrected] that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients. In this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching). The baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was -5.1±5.6 in the placebo group, -5.9±6.5 in the 75-mg group (P=0.46), -8.1±6.4 in the 150-mg group (P=0.001), and -9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each). Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.).
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              Practice guidelines developed by specialty societies: the need for a critical appraisal.

              There is increasing concern about the quality, reliability, and independence of practice guidelines. Because no information is available on the methodological quality of the guidelines developed by specialty societies, we undertook a survey on those published in peer-reviewed journals. Practice guidelines produced by specialty societies and published in English between January, 1988, and July, 1998, where identified through MEDLINE. Their quality was assessed in terms of whether they reported: the type of professionals and stakeholders involved in the development process; the strategy to identify primary evidence; and an explicit grading of recommendations according to the quality of supporting evidence. Overall, 431 guidelines were eligible for the study. Most did not meet the criteria: 67% did not report any description of the type of stakeholders, 88% gave no information on searches for published studies, and 82% did not give any explicit grading of the strength of recommendations. There was improvement over time for searches (from 2% to 18%, p<0.001) and explicit grading of evidence (from 6% to 27%, p<0.001). All three criteria for quality were met in only 22 (5%) guidelines. Despite improvement over time, the quality of practice guidelines developed by specialty societies is unsatisfactory. Explicit methodological criteria for the production of guidelines shared among public agencies, scientific societies, and patients' associations need to be set up. Common standards of reporting, following the same principles that led to the CONSORT statement for randomised clinical trials, should be promoted.
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                Author and article information

                Contributors
                carlo.caffarelli@unipr.it
                paravati.f@tiscali.it
                may.elhachem@opbg.net
                marzia.duse@uniroma1.it
                marcelloberga54@gmail.com
                giovanni.simeone@gmail.com
                massimo_barbagallo@libero.it
                roberto.bernardini@uslcentro.toscana.it
                paolo.bottau@gmail.com
                segreteria@federasmaeallergie.org
                sissi_del_78@hotmail.com
                fernandachiera@hotmail.it
                crisafullig@unime.it
                cristiana.deranieri@opbg.net
                dora.dimauro@hotmail.com
                andrea.diociaiuti@opbg.net
                allped@libero.it
                massimo.gola@uslcentro.toscana.it
                amelialicari@gmail.com
                lucialiotti@libero.it
                carla.mastrorilli@icloud.com
                domenico.minasi@tiscali.it
                f.mori@meyer.it
                iria.neri@aosp.bo.it
                apantaleo@ao.pr.it
                francescasaretta@gmail.com
                presidente@federasmaeallergie.org
                giovanni.corsello@unipa.it
                gl.marseglia@smatteo.pv.it
                alberto.villani@opbg.net
                fabiocardinale@libero.it
                Journal
                Ital J Pediatr
                Ital J Pediatr
                Italian Journal of Pediatrics
                BioMed Central (London )
                1824-7288
                15 August 2019
                15 August 2019
                2019
                : 45
                : 101
                Affiliations
                [1 ]ISNI 0000 0004 1758 0937, GRID grid.10383.39, Clinica Pediatrica, Dipartimento Medicina e Chirurgia, , Università di Parma, ; Parma, Italy
                [2 ]Pediatric Unit, Maternal Infant Department, Azienda Sanitaria Provinciale Crotone, Crotone, Italy
                [3 ]ISNI 0000 0001 0727 6809, GRID grid.414125.7, Dermatology Unit, Bambino Gesù Children’s Hospital, IRCCS, ; Rome, Italy
                [4 ]GRID grid.7841.a, Department of Pediatrics, Policlinico Umberto I, , Sapienza University of Rome, ; Rome, Italy
                [5 ]Generalist Pediatrician, Local Health Unit of Ferrara, Ferrara, Italy
                [6 ]Primary care Pediatrician, Local Health Unit of Brindisi, Brindisi, Italy
                [7 ]Pediatric Unit, Azienda di rilievo nazionale ARNAS “GARIBALDI”, Catania, Italy
                [8 ]Paediatric Unit, “San Giuseppe” Hospital, Empoli, Italy
                [9 ]Pediatric and Neonatology Unit, Imola Hospital, Imola, BO Italy
                [10 ]FEDERASMA e Allergie Onlus – Federazione Italiana Pazienti, Prato, Italy
                [11 ]ISNI 0000 0004 1762 5736, GRID grid.8982.b, Pediatric Clinic, Foundation IRCCS Policlinico San Matteo, , University of Pavia, ; Pavia, Italy
                [12 ]ISNI 0000 0001 2178 8421, GRID grid.10438.3e, UO Allergologia, Dipartimento di Pediatria, , Università di Messina, ; Messina, Italy
                [13 ]ISNI 0000 0001 0727 6809, GRID grid.414125.7, Clinical Psychology Unit, , Bambino Gesù Children’s Hospital, IRCCS, ; Rome, Italy
                [14 ]ISNI 0000 0004 1758 0937, GRID grid.10383.39, Clinica Pediatrica, Department of Medicine and Surgery, , University of Parma, ; Parma, Italy
                [15 ]ISNI 0000 0004 1759 6306, GRID grid.411490.9, UOC Pediatria, Azienda Ospedaliero-Universitaria “Ospedali Riuniti”, ; Ancona, Italy
                [16 ]ISNI 0000 0004 1757 2304, GRID grid.8404.8, Allergological and Pediatric Dermatology Unit, , AUTC and University of Florence, ; Florence, Italy
                [17 ]Department of Pediatrics, Senigallia Hospital, Senigallia, Italy
                [18 ]ISNI 0000000106347353, GRID grid.490699.b, Department of Pediatrics and Emergency, Pediatric Allergy and Pulmunology Unit, Azienda Ospedaliera-Universitaria “Consorziale-Policlinico”, , Ospedale Pediatrico Giovanni XXIII, ; Bari, Italy
                [19 ]ISNI 0000 0000 9051 0784, GRID grid.414504.0, UOC di Pediatria Azienda Ospedaliera “Bianchi-Melacrino-Morelli”, ; Reggio Calabria, Italy
                [20 ]ISNI 0000 0004 1759 0844, GRID grid.411477.0, Allergy Unit, Department of Pediatric Medicine, , Anna Meyer Children’s University Hospital, ; Florence, Italy
                [21 ]ISNI 0000 0004 1757 1758, GRID grid.6292.f, Dermatology Unit, , University of Bologna, ; Bologna, Italy
                [22 ]GRID grid.411482.a, Clinica Pediatrica, Azienda Ospedaliero-Universitaria di Parma, ; Parma, Italy
                [23 ]Pediatric Department, AAS2 Bassa Friulana-Isontina, Palmanova-Latisana, Italy
                [24 ]Pediatric Allergy Unit, Department of Medicine, Udine, Italy
                [25 ]ISNI 0000 0004 1762 5517, GRID grid.10776.37, Clinica Pediatrica Università degli Studi di Palermo, ; Palermo, Italy
                [26 ]ISNI 0000 0001 0727 6809, GRID grid.414125.7, UOC di Pediatria Generale e Malattie Infettive, , Ospedale Pediatrico Bambino Gesù, ; Rome, Italy
                Article
                695
                10.1186/s13052-019-0695-x
                6694633
                31416456
                1fd934a6-07cb-4949-824f-15870c902621
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 9 May 2019
                : 1 August 2019
                Categories
                Review
                Custom metadata
                © The Author(s) 2019

                Pediatrics
                allergy,angioedema,chronic urticaria,chronic spontaneous urticaria,children,inducible uricaria,management,omalizumab,pathogenesis,pediatric,therapy,urticaria

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