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Bilastina

Clinical Control of CSU with Antihistamines Allows for Tolerance of NSAID-Exacerbated Cutaneous Disease

By | New, Selected articles

Jorge Sánchez

J Allergy Clin Immunol Pract . 2020 Jul 14;S2213-2198(20)30700-5. doi: 10.1016/j.jaip.2020.06.057. Online ahead of print.

A great number of patients with chronic spontaneous urticaria experience exacerbations after treatment with non-steroidal anti-inflammatory drug (NSAID). Although international guidelines suggest that people with urticaria avoid NSAIDs, this is sometimes difficult. Some case reports recommend that H1-antihistamines can help prevent these exacerbations.

The objective of this study was to evaluate if H1-antihistamines can help prevent NSAID-exacerbated reactions in people with chronic spontaneous urticaria.

This was a cross-over, multi-center, and ambispective study in 3 centers in Medellín, Colombia that included 121 participants with chronic spontaneous urticaria and a history of NSAIDs exacerbations. A diagnostic challenge test without the use of antihistamines and a challenge test using antihistamines were performed using the NSAID reported in the medical record. The order in which test were performed in each participant was determined by the investigator: participants with a positive first diagnostic challenge, were subject to a second challenge using H1-antihistamines, those with a negative first challenge using H1-antihistamines, were subject to a second one without the use of H1-antihistamines, and those with a negative first diagnostic challenge or a positive first challenge using H1-antihistamines, did not undergo a second challenge. Some patients were subject to an alternative NSAID before the diagnostic challenge test or the challenge test using H1-antihistamines.

The diagnostic challenge test retrieved 96 participants testing positive, with 75 % (72 participants) tolerating the NSAID involved in the reaction when they added H1-antihistamines.

In conclusion, although NSAID may represent some restrictions for people with chronic spontaneous urticaria, the use of H1-antihistamines can help control further urticaria exacerbations due to NSAID treatment.

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High dose Bilastine for the treatment of Bascule Syndrome

By | Articles about Bilastine, New

L Cunningham

Clin Exp Dermatol . 2020 Jul 13. doi: 10.1111/ced.14377. Online ahead of print.

Bascule syndrome (bier anaemic spots and cyanosis with urticarial-like eruption) was described for the first time in 2016 and it remains to be fully elucidated. To date no successful treatment has been described.

This is a case study of a 16-year old boy who presented a patchy discolouration of the lower legs in a dependent position, associated with burning and stinging sensations and dizziness and light-headedness when moving from sitting to standing. These symptoms were present for a year. Allergy, neurology and cardiology consultations were inconclusive, Tilt table testing revealed no evidence of orthostatic hypotension or postural orthostatic tachycardic syndrome but triggered his symptoms. A dermatologist diagnosed him with Bascule syndrome, based on his clinical findings.

Different antihistamines were trialled (cetirizine 10 mg daily, bilastine 20 mg daily) with no success. A dose of bilastine 40 mg twice daily completely resolved his symptoms, but recurred when the dose was reduced to half.

 

This is the first documented case of a successful treatment of Bascule syndrome with bilastine. It is likely that the dose needed may be higher than usual dose antihistamines. Also, the decision to treat with antihistamines should be based on symptoms.

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Characteristics and determinants of patient burden and needs in the treatment of chronic spontaneous urticaria

By | New, Selected articles

Rachel Sommer, Neuza da Silva, Anna Langenbruch, Marcus Maurer, Petra Staubach-Renz, Matthias Augustin

Eur J Dermatol. 2020 Jun 1;30(3):259-266. doi: 10.1684/ejd.2020.3763

About 1 % of the population suffers from chronic spontaneous urticaria. The highest incidence is between 30 and 40 years of age, with women being most affected. The objective of this study was to characterise the specific needs and treatment objectives in chronic spontaneous urticaria from the view of the patient.

This was a cross-sectional study that included 103 participants from 4 German outpatient dermatology clinics. The validated Patient Needs Questionnaire (PNQ) for chronic spontaneous urticaria was used to determine patient needs and potential treatment objectives. To determine the relationship between patient needs and disease burden, different scales were used: disease-specific (CU-Q2oL), skin-generic (DLQI) and health generic (EQ VAS).

Most participants were female (71,4 %), with a mean age of 43,92 ± 14,96 years. The most important treatment objective was the absence of visible skin lesions (92,3 % considered important/ very important), then to be free of itching (91,5 %) and lately the desire to be healed of all skin defects (89,5 %). All other 26 items analysed, were considered to be quite important/ very important by, at least, 30 % of the participants. In relation to patient specific needs, this were related to gender and duration of disease.

In conclusion, these data show that people with chronic spontaneous urticaria have an individual broad range of needs, enabling specialists to adapt treatment to their needs. Innovative treatments may also help increase overall benefits. Independently of the treatment, the decision should be shared to help a better management of the condition.

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Molecular mechanisms and epidemiology of COVID-19 from an allergist’s perspective

By | New, Selected articles

Koa Hosoki, Abhijit Chakraborty, Sanjiv Sur.

J Allergy Clin Immunol. 2020 Jul 2;146(2):285-299. doi: 10.1016/j.jaci.2020.05.033. Online ahead of print.

Back in March 2020, the World Health Organization declared COVID-19 a global pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The aim of this article was to discuss how the development in some allergic rhinitis symptoms can serve as clues for the onset of COVID-19, and also to understand why patients with asthma can be at a higher risk for severe COVID-19.

There are some differences in symptoms in people with allergic rhinitis and those infected with the SARS-CoV-2. The later usually develop symptoms such as dry cough, sore throat, nasal congestion, shortness of breath, myalgia, fatigue, fever and rarely conjuctival congestion. People who suffer from allergic rhinitis present with runny itchy nose, itchy eyes, sneezing, postnasal drip and conjunctival congestion. From an allergist’s perspective, a shift from common allergic rhinitis symptoms to those related in COVID-19 (fever, cough and shortness of breath), may suggest the onset of COVID-19 in people with allergic rhinitis. Also, the prevalence of taste or olfactory dysfunctions such as anosmia and dysgeusia is higher in COVID-19 patients than in allergic rhinitis.

Wheezing, which is common in asthma exacerbations, rarely occurs in hospitalized patients with COVID-19. However, as asthma and COVID-19 are associated with cough and shortness of breath, it is important to exclude COVID-19 in people with asthma exacerbations. The mechanisms underlying the association between asthma and COVID-19 are related to the attenuated IFN-I and IFN-III response to respiratory infections that people with asthma have. Because COVID-19 infects lung and airway cells, it also induces and attenuated IFN-I and IFN-III signature, similar to the one observed in people with asthma, the reason why it is expected that COVID-19 frequently triggers asthma exacerbations.

Until an effective vaccine and treatments develop, it is important to understand the scientific rationale of the disease and to maintain mitigation strategies such as wearing facemasks and social distancing.

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Effectiveness, safety and tolerability of Bilastine 20 mg versus Levocetirizine 5 mg for the treatment of chronic spontaneous urticaria: a double-blind, parallel group, randomized controlled trial

By | Articles about Bilastine, New

Indrashis Podder, Anupam Das, Shouvik Ghosh, Debalina Biswas, Sujata Sengupta, Satyendra Nath Chowdhury

Dermatol Ther. 2020 Jul 2;e13946. doi: 10.1111/dth.13946. Online ahead of print.

Chronic urticaria is characterized by wheals with or without angioedema for, at least, 6 weeks. It is a debilitating condition that affects people’s quality of life. Bilastine is a novel non-sedative H1 antihistamine approved for symptomatic treatment of allergic rhinoconjunctivitis and urticaria in patients older than 12 years old.

The objective of this study was to compare the effectiveness, safety and tolerability of bilastine 20 mg with levocetirizine 5 mg in moderate-to-severe chronic spontaneous urticaria.

This was a double-blind, randomized, controlled study with two arms: bilastine 20 mg once daily (31 participants) and levocetirizine 5 mg once daily (27 participants) for 42 days. The severity of urticaria, global urticaria-induced discomfort and quality of life were evaluated with UAS7 (urticaria activity score), VAS (visual analogue scale) and DLQI (dermatology life quality index) at baseline and follow-up visits.

Primary objective was to assess the variation of the UAS7, and secondary objectives assessed changes in DLQI and VAS. Safety, tolerability and compliance were evaluated by analysis of drug-related adverse events, biochemical investigations and electrocardiogram.

Both bilastine and levocetirizine improved UAS7, DLQI and VAS at the end of treatment. Also, all parameters showed greater improvement with bilastine, but only the UAS7 revealed a significant reduction (p = 0,03). Sedation was also significantly less with bilastine (p = 0,04). Both treatments improved UAS7 and VAS significantly from day 14. No serious adverse effects were registered.

In conclusion, bilastine demonstrated a better efficacy and less sedation for chronic spontaneous urticaria when compared to levocetirizine, however similar effect on quality of life.

These results elucidate that bilastine has an inverse agonist activity. Taking bilastine before pollen season, the H1R gene expression level can be kept low, improving pollinosis symptoms.

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Protocols for the Study of Allergic Rhinitis Therapies

Utility of Environmental Exposure Unit Challenge Protocols for the Study of Allergic Rhinitis Therapies

By | Selected articles

Lubnaa Hossenbaccus, Lisa M. Steacy, Terry Walker, Anne K. Ellis.

Current Allergy and Asthma Reports (2020) 20:34. https://doi.org/10.1007/s11882-020-00922-8

Allergic rhinitis is an inflammatory disease of the nasal mucosa triggered by allergen exposure in sensitized patients. This study explores how the Environmental Exposure Unit (EEU) experimental model can be used to understand new therapies for allergic rhinitis. This study evaluated recent advances in allergic rhinitis therapies using the EEU model.

The EEU models are experimental models for the study of allergic rhinitis, including but not limited to phase 3 efficacy outpatient studies and outdoor park studies. Their use is increasing for the study of combination therapies, immunotherapies and novel AR treatments. Some examples include a combined antihistamine/corticosteroid nasal spray formulation, which was seen to have a faster onset of action relative to the therapies individually, house dust mite sublingual immunotherapy tables that have demonstrated to be safe and effective, a novel peptide-based immunotherapy approach effective in reducing grass pollen allergic rhinitis, and nasal filters that reduce seasonal AR symptoms.

The EEUs are controlled, reproducible and unique models for the study of allergic rhinitis therapies. EEUs provide valuable efficacy about the efficacy, onset and duration of action and dose-related impacts of allergic rhinitis therapies, with direct clinical relevance. Unlike phase 3 efficacy trials and park studies which rely on the natural environment, EEUs allow for the control of study variables, such as humidity, temperature, and allergen distribution. Allergic rhinitis symptoms generated in EEUs are comparable with natural pollen seasons which allows for allergen-specific research to continue even outside of the natural season.

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Transition of adolescents and young adults with allergy and asthma

EAACI Guideline on the effective transition of adolescents and young adults with allergy and asthma

By | Selected articles

Graham Roberts, et al.

Allergy. 2020 Jun 19. doi: 10.1111/all.14459. Online ahead of print.

Adolescents and young adults represent a large group of patients with allergic rhinitis and/or asthma. Most times their treatment is complicated due to the biological and psychosocial changes that occur as they grow. Sometimes they have difficulty in understanding the consequences of their disease, failing to take responsibility for self-management, leading to suboptimal adherence and other negative consequences. The transitional care should address the psychological, medical, educational and vocational needs of adolescents and young adults.

The European Academy of Allergy and Clinical Immunology has developed a clinical practice guideline that provides evidence-based recommendations for healthcare professionals to support the transitional care of adolescents and young adults with allergic rhinitis and/or asthma.

This guideline includes general recommendations on operating a clinical service for these patients, which include: starting the transition as early as 11-13 years old, using a structured, multidisciplinary approach, ensuring they fully understand their condition and have resources they can access, active monitoring of adherence and discussing any implications for further education and work.

Specific allergy and asthma transition recommendations include simplifying medication regimes and using reminders, focusing on areas where these patients are not confident and involving peers in training them. Identifying and managing psychological and socioeconomic issues impacting disease control and quality of life; enrolling the family in assisting them to undertake self-management and encouraging them to let their friends know about their allergies and asthma are also recommendations of this guideline.

National healthcare systems may need to adapt these recommendations according to each culture. If optimal care is received by adolescents and young adults, they will become expert adult patients with the knowledge and skills to manage their condition throughout their lifes.

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Urticaria (angioedema) and COVID- 19 infection

Urticaria (angioedema) and COVID- 19 infection

By | Selected articles

Mojgan Najafzadeh, Fanila Shahzad, Nader Ghaderi, Kaveh Ansari, Badie Jacob, Andrew Wright

J Eur Acad Dermatol Venereol . 2020 Jun 11;10.1111/jdv.16721. doi:10.1111/jdv.16721. Online ahead of print.

The relationship between urticaria and COVID-19 infection has rarely been reported, however, it has been reported that in addition to the conventional respiratory symptoms, some COVID-19 patients also have skin manifestations, such as urticaria and angioedema.

This is a case study of an elderly man who first presented with generalised pruritic hives with a diameter of 1,5 to 8,0 cm, general malaise, fatigue, temperature and sore throat. He was negative for parasitic and bacterial infections, however presented low white blood cells and lymphopenia. The CT chest showed pneumonia with bilateral and subpleural areas of ground-glass opacification, consolidation affecting the lower lobes, thus confirming the diagnosis of COVID-19.

Although the relationship between urticaria and infection has rarely been reported, literature suggests that urticaria and angioedema can be induced by viral and bacterial infections. Urticaria has been associated before with Cytomegalovirus, Herpesvirus and Epstein-Barr virus. It was also found that once the viral infection was controlled, urticaria manifestations cleared up.

One study with 88 COVID-19 patients that analysed the cutaneous involvement found that 20,4 % presented with cutaneous manifestation, 8 of them developed it at disease onset, while 10 of the, developed it after hospitalisation. The cutaneous manifestations were erythematous rash, widespread urticaria and chickenpox-like vesicles.

Urticarial skin manifestations may be used as a possible diagnostic indicator in early COVID-19 stages.

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COVID-19: organization of an allergy clinic – an EAACI/ARIA Position Paper.

COVID-19 pandemic: Practical considerations on the organization of an allergy clinic – an EAACI/ARIA Position Paper

By | Selected articles

Pfaar O, Klimek L, Jutel M, Akdis CA4, Bousquet J, Breiteneder H et al.

Allergy. 2020 Jun 12;10.1111/all.14453. doi: 10.1111/all.14453. Online ahead of print..

Earlier in March 2020, the World Health Organization (WHO) declared the “corona virus disease 2019 (COVID-19)” a pandemic viral disease, transmitted by the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Since the first cases were reported in China, the number of infected patients and fatalities have been increasing worldwide. Typical symptoms of COVID-19 include general malaise, fever, respiratory problems, and especially cough and shortness of breath. Specialists in the field of allergies and associated airways diseases have been in the front line, taking care of patients.

Coronaviruses may be associated with aggravation of asthma exacerbations and allergic diseases (allergic rhinitis, atopic dermatitis, urticaria and drug hypersensitivity).

This review identified studies that reported allergic diseases as co-morbidities of COVID-19 patients compared to non-allergic patients. A panel of experts have developed recommendations for the optimal management of allergic clinics during the pandemic to ensure necessary safety.

Allergic patients diagnosed with or suspect to have COVID-19 should follow the local area treatment and quarantine guidance. In general, most medications should be continued. For those unable to attend clinics, have examinations and/or receive prescriptions, e-health and telemedicine can assess the value of specialized treatments, provide educations for self-management without the risk of infection and triage patients for urgent consultations, such as diagnostic testing in drug allergy or application of medication. When biologicals are used, the decision to continue a treatment should be made on a case basis since the safety and efficacy of the mentioned biologics in COVID-19 patients are unknown. Psychological care for allergic patients during the pandemic is also essential.

Patients with allergic rhinitis and other allergies should be informed accordingly when new evidence is available, making it possible to adapt to new therapies.

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Elucidation of Inverse Agonist Activity of Bilastine

Elucidation of Inverse Agonist Activity of Bilastine

By | Articles about Bilastine

Hiroyuki Mizuguchi, et al.

Pharmaceutics 2020, 12, 525; doi: 10.3390/pharmaceutics12060525.

Histamine is a chemical mediator that causes pollinosis symptoms such as a sneezing, rhinorrhoea, nasal obstruction, nasal itching, and itching of the eyes. H1-antihistamines antagonize histamine H1, preventing it from binding to the histamine H1 receptor (H1R). Bilastine is a non-sedative recently launched H1-antihistamine which has high affinity for H1R. It is one of the H1-antihistamines that most satisfies the requirements of allergic rhinitis and asthma guidelines. Inverse agonists are thought to be more potent than neutral antagonists because they supress the intrinsic histamine signalling in addition to the H1-antihistamine effect. Nevertheless, there is a lack of information regarding bilastine inverse agonist activity.

This study assessed if bilastine has inverse agonist activity or not. HeLa cells that express H1R endogenously here used, and three methods applied: time-lapse Ca2+ imaging, inositol phosphates (IPs) accumulation and H1R gene expression. Intracellular calcium concentration was measured using Fluo-8. Inositol phosphates accumulation was assayed using [3H]myo-inositol. The H1R mRNA level was measured using real-time RT-PCR.

H1R intrinsic activity was shown by Ca2+ oscillation. Also, bilastine suppressed IPs formation and basal H1R gene expression in a dose-dependent manner.

These results elucidate that bilastine has an inverse agonist activity. Taking bilastine before pollen season, the H1R gene expression level can be kept low, improving pollinosis symptoms.

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