British Association of Dermatologists guidelines for the management of people with chronic urticaria 2021*

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Abstract

Plain language summary available online The guideline is presented as a detailed review with highlighted recommendations for practical use in primary, secondary and tertiary care, in addition to an updated patient information leaflet (PIL; available on the BAD Skin Health Information website, https://www.skinhealthinfo.org.uk/a-z-conditions-treatments). Other than providing background information, the guideline does not cover angio-oedema without weals [other than idiopathic, which is now classified as part of chronic spontaneous urticaria (CSU)], hereditary angio-oedema, autoinflammatory syndromes or differential diagnosis. Additionally, the guideline focuses on chronic rather than acute urticaria. This set of guidelines has been developed using the BAD’s recommended methodology.1 Further information can be found in Appendix J (see Supporting Information) with reference to the AGREE II instrument (www.agreetrust.org)2 and GRADE.3 The recommendations were developed for implementation in the UK National Health Service (NHS). The Guideline Development Group (GDG), which consisted of eight consultant dermatologists managing adults, children and young people; a consultant immunologist; a consultant psychodermatologist; a drug allergy specialist; two patient representatives and a technical team (consisting of an information scientist, guideline research fellows and a project manager providing methodological and technical support), established a number of clinical questions pertinent to the scope of the guideline and two sets of outcome measures of importance to patients, ranked according to the GRADE methodology (section 2.1; and Appendix A; see Supporting Information). A systematic literature search of the PubMed, MEDLINE, Embase and Cochrane databases was conducted to identify key articles on urticaria from January 2007 to March 2020. An additional, targeted literature search for the antihistamines acrivastine and bilastine was also carried out (from January 1980 to March 2020). Subsequently published papers known to the GDG were included. The final literature searches were run ahead of journal submission in 2021 to ensure currency. The search terms and strategies are detailed in Appendix K (see Supporting Information). Additional references relevant to the topic were also isolated from citations in the reviewed literature and the previous version of the guideline.4 Evidence from the included studies was graded according to the GRADE system (high, moderate, low or very low certainty). The recommendations are based on evidence drawn from systematic reviews of the literature pertaining to the clinical questions identified, following discussions with the entire GDG and factoring in all four factors that would affect their strength rating according to the GRADE approach (i.e. balance between desirable and undesirable effects, quality of evidence, patient values and preferences, and resource allocation). All GDG members contributed towards drafting and/or reviewing the narratives and information in the guideline and Supporting Information documents. When there was insufficient evidence from the literature, informal consensus was reached based on the experience of medical and patient GDG members. The summary of findings with forest plots (Appendix B), tables Linking the Evidence To the Recommendations (LETR; Appendix C), GRADE evidence profiles indicating the quality of evidence (Appendix D), summary of included studies (Appendix E), narrative findings for noncomparative studies (Appendix F), PRISMA flow diagram (Appendix G), list of excluded studies (Appendix H) and AMSTAR 2 appraisal of the included systematic reviews (Appendix I) are detailed in the Supporting Information. The strength of recommendation is expressed by the wording and symbols shown in Table 1. The GDG established the following clinical questions pertinent to the scope of the guideline. Review question 1: investigation Do tests, such as blood tests and the autologous serum skin test, alter the management of urticaria? Review question 2: treatment What is the clinical effectiveness of any H1-antihistamine compared with another for the treatment of urticaria? Review question 3: treatment Would changing from one H1-antihistamine to another lead to benefit in the treatment of urticaria? Review question 4: treatment Would adding an H2-antihistamine to an H1-antihistamine lead to benefit in the treatment of urticaria? Review question 5: treatment What is the effectiveness of leukotriene receptor antagonists in the treatment of urticaria? Review question 6: treatment What are the effectiveness and safety of increasing doses of H1-antihistamines? Review question 7: treatment Would adding other therapies to an H1-antihistamine lead to benefit in the treatment of urticaria, including sulfasalazine, dapsone, thyroxine, tricyclic antidepressants, hydroxychloroquine, methotrexate, danazol, tranexamic acid, mycophenolate mofetil, intravenous immunoglobulins (IVIg) and anticoagulants? Review question 8: treatment What is the effectiveness of taking systemic corticosteroids for the treatment of urticaria? Review question 9: treatment What is the effectiveness of dietary exclusions or supplements for the treatment of urticaria? Review question 10: treatment What is the effectiveness of Helicobacter pylori eradication for the treatment of urticaria? Review question 11: treatment What is the effectiveness of avoiding nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of urticaria? Review question 12: treatment What is the effectiveness of ciclosporin for the treatment of urticaria and are there any long-term benefits? Review question 13: treatment What is the effectiveness of omalizumab for the treatment of urticaria? Review question 14: treatment Is the response to treatment for inducible urticarias (e.g. symptomatic dermographism, delayed pressure urticaria, cold urticaria, cholinergic urticaria, vibratory angio-oedema, localized heat urticaria) the same as for CSU? Review question 15: treatment Do any other specific interventions work for inducible urticarias, such as antibiotics in cold urticaria, sulfasalazine in delayed pressure urticaria, phototherapy in dermographism, plasmapheresis in solar urticaria and anticholinergics in cholinergic urticaria? Review question 16: treatment Which H1-antihistamines can be used in pregnancy? Review question 17: treatment Which H1-antihistamines can be used during breastfeeding? Review question 18: treatment What are the key differences in the diagnosis and management of paediatric compared with adult urticaria (if there are any)? Review question 19: treatment What is the clinical effectiveness of miscellaneous monotherapies compared with each other for the treatment of urticaria? The GDG also established two sets of outcome measures of importance to patients (for treatment and investigation), ranked according to the GRADE methodology,5 by the patient representatives (for the full review protocol see Appendix A in the Supporting Information). In the investigation protocol, the outcome is either ‘yes’ or ‘no’. The treatment outcomes (Table 2) use a nine-point scale; outcomes ranked 9, 8 or 7 are critical for decision making; those ranked 6, 5 or 4 are important but not critical for decision making; and those ranked 3, 2 or 1 are the least important for decision making. The following recommendations and ratings were agreed upon unanimously by members of the GDG and patient representatives. For further information on the wording used for recommendations and strength of recommendation ratings see Table 1. The evidence on which the recommendations are based is featured and discussed in Appendices B–E (see Supporting Information). The GDG is aware of the lack of high-quality evidence for many of these recommendations, therefore, strong recommendations with an asterisk (*) are based on available evidence, as well as informal consensus and specialist experience of medical and patient GDG members. Good practice point (GPP) recommendations are derived from informal consensus. Licensing information, dosages and monitoring requirements for specific drugs are not included. However, of note, apart from H1-antihistamines, oral steroids and omalizumab, none of the other treatment options discussed are licensed in the UK for use in urticaria. Except where otherwise stated, we recommend adherence to published guidelines, for example by the manufacturer, the BAD or, in the UK, the British National Formulary (www.bnf.org). In particular, note the licensed dosages for people aged < 14 years (also see Table 3). The recommendations relate to chronic spontaneous and inducible urticarias. Acute urticaria, angio-oedema without weals (other than idiopathic, which is now classified as part of CSU), hereditary angio-oedema and autoinflammatory diseases are not covered. For clarity, we have divided the management options into sections (general treatment, first-, second- and third-line options). However, depending on disease severity, disease fluctuation, comorbidities and the national criteria for use of drugs, the order and combinations of treatment may vary and may change during the course of each person’s disease. We note that, since submission of this article for publication, a new international guideline on the management of urticaria has been published.6 Broadly, the recommendations are similar, except that the international guideline favours omalizumab over ciclosporin for CSU. General management for people with all types of chronic urticaria The most important step is to take a detailed clinical history, with examination supplemented by people’s own photographs. In most cases this will provide an accurate clinical diagnosis (section 5.2), which will guide management. Disease pathogenesis may also be important in management (section 5.3). R1 (↑) Only consider baseline investigations if clinically indicated (see (GPP) using to disease and for example 7 and/or (GPP) or a patient information leaflet on urticaria or angio-oedema (GPP) to and treatment for and the of the where The can be for the and (GPP) such as a (GPP) of or such as drugs, and in for inducible urticarias. in people with angio-oedema without General management for people with chronic spontaneous urticaria in people to be by this of (↑) treatment to a if and not there is a of acute of for However, evidence of benefit from as an to an drug is to the National for Health and British of and or of and if to is (GPP) Do not dietary from a detailed history, to a is insufficient evidence to recommend for is insufficient evidence to a recommendation on dietary Do not for Helicobacter treatment options for people with chronic spontaneous urticaria a using a licensed (Table Do not H1-antihistamines there is to their and long-term on the (i.e. increasing the the licensed of a by to the licensed to people are by the licensed is and there is or (see and Appendix following is evidence to guide the of or of Do not (see (GPP) from one H1-antihistamine to another in people not or not the drug or is insufficient evidence to a recommendation on using two H1-antihistamines the same Do not H1-antihistamines (see (↑) in addition to a in people are by and doses of of treatment options (see 2 in is insufficient evidence to recommend addition of to H1-antihistamines for people are by the However, may be if urticaria is with be (↑) oral (e.g. for of a as treatment to in addition to use of a Do not long-term systemic corticosteroids there is other the for the treatment options for people with chronic spontaneous urticaria For people with with an response to treatment, the following investigations may be relevant the treatment Do not autologous serum skin tests or autologous skin tests (↑) a may a of disease to omalizumab, a may disease to ciclosporin (section and Appendix (↑) consider a is not to a national quality A may a of disease to ciclosporin and or delayed response to omalizumab, a may a of disease to omalizumab (section and Appendix and are and may not clinical in all omalizumab, in addition to a to people are by ciclosporin for in addition to a to people are by long-term use of ciclosporin where if use the treatment to and consider (see and treatment options for people with chronic spontaneous urticaria options for inducible urticarias is evidence available than for but for people with all types of inducible urticaria the following are recommended on and treatment options for people with all types of inducible urticaria a using a licensed (Table Do not H1-antihistamines there is to their and long-term on the of a H1-antihistamine by to the licensed to people are by the licensed is and there is or (section and Appendix following is evidence to guide the of or of Do not (see (GPP) from one H1-antihistamine to another in people not or not the drug the or is insufficient evidence to a recommendation on using two H1-antihistamines the same Do not H1-antihistamines (see is insufficient evidence to recommend use of there is evidence to use in of inducible urticaria. treatment options for people with all types of inducible urticaria (↑) omalizumab, in addition to a in people are by to and (GPP) if for those of for example in with cold or cholinergic urticaria. treatment options for people with all types of inducible urticaria the following in addition to H1-antihistamines, in people with specific types of inducible urticaria, are to and treatment or where the are or urticaria (GPP) drugs (e.g. or (e.g. or danazol, or urticaria (GPP) is insufficient evidence to recommend use of antibiotics (e.g. or (GPP) Do not cold pressure urticaria (↑) or urticaria (GPP) and (↑) phototherapy using the of relevant to the following and from a a specialist is evidence to recommend plasmapheresis or for people with solar urticaria. (↑) a course of if but not for (GPP) not for (GPP) for other of inducible urticaria. is insufficient evidence to a recommendation the safety of use of antihistamines during and However, in disease and the patient with any of urticaria, where consider or (see the drug summary of for information on safety during and the in Appendix research recommendations The following list research recommendations Further investigation of the and/or factors that the of all types of urticaria and/or angio-oedema, including the new of and of the of and and as of drug Development of to to and other the from to the of and new new the safety and of one H1-antihistamine compared with using two H1-antihistamines the same in people with CSU. the safety and of omalizumab in people with all of inducible urticaria. the safety and of other treatment options featured in the treatment in people with all of inducible urticaria. the safety and of for people with all types of urticaria, including the new and new treatment options such as receptor receptor antagonists and drugs (see of the of the treatment options available to people with all types of urticaria. into disease and the of investigations as or and the safety and of the and treatment options in children and young people with urticaria and/or angio-oedema of all The recommendations, discussions in the (Appendix and consensus specialist experience were used to management for with chronic urticaria see 1. of angio-oedema or are the of angio-oedema are on the disease angio-oedema or weals may be is divided into acute and chronic chronic or weals for or many of acute urticaria of urticaria may be by systemic such as or and/or Acute urticaria may be a of The of urticaria from to with a of for chronic The point of chronic urticaria from in to in The disease is in except in young if have any of urticaria, and chronic disease may have a on quality of the treatment for many types of urticaria is similar, there are important accurate clinical based on a detailed and examination (section and an of disease pathogenesis (section are to guide investigation and management. note, of urticaria is in than of people with acute urticaria drugs, including and 1 and in many of those with (see for pathogenesis of for to but the of angio-oedema may for to urticaria urticarias by the same without weals with urticarias are are by the same a of the and for < 2 the delayed pressure urticaria, where weals may take to to and for a The and of the weals may for example weals in dermographism, or weals by a in cholinergic or urticarias. inducible urticarias as a of from urticaria and angio-oedema to urticarias can be on (see Disease may be the of this can be and urticarias to be is However, is important not to cases of angio-oedema where the drug be where the angio-oedema may or many years drug or cases of (see may and to the treatment for of the is in inducible urticarias, this is by a response the of of a may the is and for < 2 However, the disease is not and the is not but may be any of a of for example or are of may be rather than and or can be to from delayed pressure urticaria. However, in there are systemic there may be or an with other diseases and A skin is to the diagnosis (see syndromes with with in disease is and with adult of cold autoinflammatory and diseases are (for pathogenesis see in but are all by and of cases of acute or urticaria and cases of urticaria are to by 1 of people with have either or A new is of 1 or in which are an of may on or has been that there are and to treatment with omalizumab This has to the that the response may be to omalizumab the may be to the of and of The importance of is there is evidence that and may a in patients with are by of in the of and is by cases of are to or in the in of the and of is now to be to in but these have not been in the clinical is is by the of a of but people with that factors including and or their urticaria, but the are may urticaria by (Table system system Other An may also as a of or be a of and may with other such as systemic is an between and is evidence that Helicobacter pylori may be with an of CSU. is evidence as to of pylori pylori in any be (see Appendix narratives for question the between chronic urticaria and including disease in and clinical of diseases but in the of is not The most important part of is a clinical and This will lead to accurate clinical In many in acute and chronic spontaneous or inducible urticarias, to H1-antihistamines, there is for further can have a on people’s be as to the the disease is on the person’s quality of (e.g. using or (e.g. using the and or The of the disease be (e.g. using or on treatment Skin tests and/or blood tests for may to 1 as a if tests are not in chronic urticaria. A full blood and and may be in A may be to identify the of cases with an An may a urticaria or a may be in and in or autoinflammatory or, may systemic and are in may investigations for autoinflammatory disease or to the between and (section for and may be a number of tests and may be of benefit in CSU. In and tests for (if may to the between the treatment omalizumab in the new such as the and ciclosporin (see and tests may also be in disease pathogenesis and in providing an to the with urticaria. are low and well The is the most established for is to may by other is well or has been to national quality tests are not or Further research is to the of tests in treatment in CSU. For see Appendix be by and In cold urticaria, may be are if are with or disease. are to and is be weals the cold a of a are with systemic or in and/or there is a history, investigations be for cold autoinflammatory (section In solar urticaria, and be the diagnosis is or if the disease is to treatment, to a specialist for an if may In an is as this may be with and other is by low between and during are and be In of cases of hereditary angio-oedema are but in the is are of not specific All of be to for further investigation and in with national and international consensus A skin a is to the but the are of with or and are A full be to for such as disease or and and may a disease with a for systemic systemic and and are as is serum which be and serum be to for in a can be to tests be if is In patients be to by for investigation and these are as in the recommendations (section However, a important are discussed of the evidence for each recommendation can be found in Appendix H1-antihistamine was found to out as than in the Cochrane However, the GDG and to be a by in of by Appendix question for further information, including a published in 2021 that graded antihistamines in order of and but that this was based on licensed doses of H1-antihistamines the GDG agreed that evidence on the of H1-antihistamines for where and in the of were for and quality of but the for further research was The GDG recommended a from one H1-antihistamine to another in people with not to the or if The GDG does not recommend combinations of two H1-antihistamines the same to people with was that people may The safety of two H1-antihistamines dosages has not been and there is published evidence on using such The GDG does not recommend H1-antihistamines in people with CSU. In evidence the safety of to of H1-antihistamines, where and in the of However, the following be studies have that a of people may such as on The of H1-antihistamines be discussed with people with urticaria. the summary of on specific information on the and of antihistamines and these be with other drugs (e.g. drugs with (e.g. and and people and disease. the to the also be for all For other is in people with known or or with in or in clinically and where used with known to the such as and The GDG does not recommend The GDG that most studies on have shown in terms of specific antihistamines and and recommended that high-quality studies be is published evidence that in with a H1-antihistamine may be than taking a H1-antihistamine for people with are available for inducible urticarias, there is evidence for in delayed pressure and members of the GDG in people with inducible urticarias. may also be specific this may be such as urticaria is by or where angio-oedema is the can be in without monitoring of blood tests, but a and of the that may in a of in be as to be for these is insufficient evidence to recommend addition of to H1-antihistamines for people with chronic urticaria are by the However, people may if urticaria is with However, be an H2-antihistamine is the licensed for is to the has a of and with with H1-antihistamines, their which may of the of many years However, there are very on the use of in urticaria. is of note that we recommend as has been by the to with a known are very published on the use of systemic corticosteroids in people with inducible urticarias. for a course of oral may be for may not be as of may be where disease is can be However, where there is a of people be to For in cold urticaria, in cold in the or lead to a in or of of the in with very to that the of such as the receptor treatment may disease A can be used as a A number of drugs are investigation and/or in clinical for for omalizumab are a new may be and than receptor that the and the as and and are all for CSU. Other receptor on and the receptor and the of people with to H1-antihistamines licensed and that to of the may to of those to H1-antihistamines to and a similar, but to there is evidence for the note, the response and full disease may not be in many people with with these of people with into to 5 years if there is but have disease and In urticaria can be very to and This is for people with inducible urticarias, where there are options and to is insufficient evidence to a recommendation the safety of using most drugs during and to the summary of or other published However, in disease and the with any of urticaria, where consider or (see Appendix narratives for available information on to there is evidence of to the or from the use of omalizumab in or the be of the lack of available The recommendation of cases is to in the to a and between However, to this recommendation may to all cases in the Appendix Information) for the set of and The and Supporting Information were available to the BAD British Group British for and the of for which were by the further the version was for review by the of the of the to submission for This has been on of the BAD and is based on the available the was is that may be to from the guidelines and that the of studies may of the recommendations to be to to these guidelines not be adherence to these recommendations a a of the review to references was a but the this may important information published in other The for this set of recommendations is for where important will be updated on the BAD We are very to this guideline project of the patient representatives including for their in the clinical of the reviewing the evidence and the and all those on the during the Appendix A review and clinical Appendix plots for Appendix Linking the Evidence To the Recommendations Appendix GRADE evidence Appendix of included Appendix findings for noncomparative Appendix PRISMA diagram Appendix excluded from Appendix AMSTAR 2 critical appraisal of the included systematic Appendix J Appendix K Appendix and The is not for the or of any information by the (other than be to the for the

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