Monthly Archives

August 2021

The challenges of chronic urticaria part 2: Pharmacological treatment, chronic inducible urticaria, urticaria in special situations

By | New, Selected articles

Mario Sanchez-Borges, Ignacio J. Ansotegui, Ilaria Baiardini, Jonathan Bernstein, Giorgio Walter Canonica, Motohiro Ebisawa, Maximiliano Gomez, Sandra Nora Gonzalez-Diaz, Bryan Martin, Mario Morais-Almeida and Jose Antonio Ortega Martell

World Allergy Organ J . 2021 Jun 3;14(6):100546. doi: 10.1016/j.waojou.2021.100546. eCollection 2021 Jun.

Chronic spontaneous urticaria consists in the occurrence of wheals, angioedema, or both more than 6 weeks, and 1-2% of the population is affected. It is more prevalent in women and frequently compromises quality of life and the costs for national health systems can be considerable.

The World Allergy Organization (WAO) has reviewed a position paper published in 2012 regarding diagnosis and treatment of urticaria and angioedema. Since then, there have been advances in the knowledge of urticaria mechanism of action, and new treatments (biologics) have been released for severe refractory disease.

This is the second part of an update from the WAO, which intention is to provide an updated guidance for urticaria, especially in special situations such as childhood and pregnancy.

Second generation H1 antihistamines are recommended in major guidelines as the first line treatment for urticaria, as they are effective and safe. Some guidelines include first generation antihistamines for non responders. The dose can also be increased up to 4 times to improve efficacy (and without compromising safety). Combination of antihistamines does not seem to induce better effects, and patients who are refractory to antihistamines are candidates to omalizumab or cyclosporin-A. Omalizumab is the only biological approved for the treatment of antihistamine-refractory patients with moderate to severe urticaria. Cyclosporin-A is an immunosuppressing drug that inhibits T helper cells by blocking the production of inflammatory cytokines.

Special conditions associated with urticaria include autoinflammatory syndromes and various forms of urticarial vasculitis, which are treated with second generation antihistamines and systemic glucocorticoids, and alternatively immunomodulators and immunosuppressors.

 

Specialists are recommended to follow the guidelines, use validated PRO instruments and use effective and safe medications.

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The challenges of chronic urticaria part 1: Epidemiology, immunopathogenesis, comorbidities, quality of life, and management

By | Artículos seleccionados, Selected articles

Mario Sanchez-Borges, Ignacio J. Ansotegui, Ilaria Baiardini, Jonathan Bernstein, Giorgio Walter Canonica, Motohiro Ebisawa, Maximiliano Gomez, Sandra Nora Gonzalez-Diaz, Bryan Martin, Mario Morais-Almeida and Jose Antonio Ortega Martell World Allergy Organ J. 2021 Jun 1;14(6):100533. doi: 10.1016/j.waojou.2021.100533. eCollection 2021 Jun.

Chronic spontaneous urticaria consists in the occurrence of wheals, angioedema, or both more than 6 weeks, and 1-2% of the population is affected. It is more prevalent in women and frequently compromises quality of life and the costs for national health systems can be considerable.

The World Allergy Organization (WAO) has reviewed a position paper published in 2012 regarding diagnosis and treatment of urticaria and angioedema. Since then, there have been advances in the knowledge of urticaria mechanism of action, and new treatments (biologics) have been released for severe refractory disease. Urticaria pathological mechanisms include different cell types, mainly mast cells, basophils, eosinophils, T and B lymphocytes and epithelial and endothelial cells. The dysregulation of intracellular signaling pathways and autoimmune mechanisms have an important role in the activation of mast cells/basophils, which leads to the release of inflammatory mediators resulting in wheals and angioedema.

This is the first part of an update from the WAO, which intention is to provide an updated guidance for urticaria.

Biomarkers have been identified for the prognosis of chronic urticaria (total IgE, CRP, ASST, Anti-TPO, IL-17, IL-31, IL-33) and the assessment of the response of different therapies. Specialists are recommended to follow the guidelines, use validated PRO instruments and use effective and safe medications.

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Real-Life Experience of Efficacy and Safety of Bilastine in the Refractory Cases of Chronic Spontaneous Urticaria and its Effect on the Quality of Life of Patients

By | Articles about Bilastine, New

Abhishek De, Kiran Godse, Dhiraj Dhoot, and Aarti Sarda

Indian J Dermatol . Mar-Apr 2021;66(2):159-164. doi: 10.4103/ijd.IJD_771_20.

Chronic spontaneous urticaria is a skin condition with wheals and angioedema, for more than six weeks. Second-generation H1-antihistamines are the first line treatment for these allergic conditions, namely bilastine. The aim of this study was to assess long-term efficacy and tolerability of bilastine in patients with chronic spontaneous urticaria in India.

This was a retrospective analysis that identified patients with urticaria who were prescribe bilastine between May, 1, 2019 to March, 20, 2020 from analysis of electronic medical records. Patients with unsatisfactory response to previous treatment were also included. Unsatisfactory treatment was assessed as per Urticaria Activity Score 7 (UAS7). The efficacy of the treatment was evaluated by revising their UAS7 score ate weeks 4, 8, 12, 16, 20. DLQI was also evaluated and compared at baseline and week 24.

The study included 49 patients. At 24 weeks, 51% of them had achieved treatment response (UAS = 0) and the remaining 49% had a well-controlled urticaria (UAS <6). At 24 weeks, mean UAS7 was statistically significant compared to baseline values (1,35 ± 1,61 vs. 20,2 ± 5,73), and mean DLQI score also decreased to 1,63 ± 1,18, compared to 8,39 ± 2,49 at baseline.

In conclusion, this study demonstrated that patients who usually had an inadequate response with commonly used antihistamines, when switched to bilastine had their quality of life and symptoms improved.

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Pharmacokinetics and Safety of a Bilastine Once-Daily, Preservative-Free, Ophthalmic Formulation

By | Articles about Bilastine, Publicaciones sobre Bilastina

Dolores Ochoa, Manuel Roman, Carmen Belmonte, Samuel Martin-Vilchez, Gina Mejia-Abril, Francisco Abad-Santos, Gonzalo Hernandez, Paula Arranz, Lorena Elgezabal, Nieves Fernandez

Adv Ther . 2021 Jun 12. doi: 10.1007/s12325-021-01801-y. Online ahead of print.

Bilastine is a second-generation H1 antihistamine for allergic conditions. A new ophthalmic formulation was developed based on the efficacy and safety profiles of the oral formulation. The aim of this study was to assess the safety and pharmacokinetics of ophthalmic bilastine (6 mg/ml) in adults after one and various doses.

This was an open-label, single-centre, phase 1, bioavailability study that included 12 healthy participants (aged 18-55 years old). Participants were administered one drop of the bilastine eye formulation in each eye for five days. Serum levels of bilastine were assessed by HPLC-MS/MS and adverse drug reactions registered during administration and follow-up.

After various admininistrations, bilastine blood levels were 2682,26 ± 1615,88 pg/mL at 2,5 hours. The half-life of bilastine was 7,88 ± 6,72 h. Area under the curve was 19512,51 ± 9248,76 h/pg/mL. Dysgeusia was the main adverse event, which was mild and transient.

The ophthalmic formulation has proved to be absorbed in low amounts to the bloodstream, showing a good safety profile after administration of various doses.

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Application of a dual mechanistic approach to support bilastine dose selection for older adults

By | Articles about Bilastine, New

Chaejin Kim, Valentina Lo Re, Monica Rodriguez, John C Lukas, Nerea Leal, Cristina Campo, Aintzane Garcia-Bea, Elena Suarez, Stephan Schmidt, Valvanera Vozmediano

CPT Pharmacometrics Syst Pharmacol . 2021 Jun 22. doi: 10.1002/psp4.12671. Online ahead of print.

Bilastine is a second-generation H1-selective antihistamine for the treatment of allergic conditions in adults and children. It has a rapid onset and a long duration of action. Its pharmacokinetic and pharmacodynamic properties are favorable for all ages, although there’s a lack of studies in older adults, who are heterogenous in different aspects, namely age, comorbidities and comedication.

The aim of this study was to assess the recommendation of the dose of bilastine in older adults.

This was done by integration of bilastine in vitro and in vivo physicochemical data from young adults and studying the effect of aging with two different approaches: a physiologically based pharmacokinetic (PBPK) model and a semi-mechanistic population pharmacokinetic model (Senescence). The PBPK model used intestinal apical efflux and basolateral influx transporters to capture the results from young adults after single IV (10 mg) and 20 mg oral doses, which supports the hypothesis of gut transporters involvement on secretion. The Senescence model was developed from a published PopPK model adding up declining functions on different physiological systems and body composition changes with age.

Both models were then qualified using data from 16 older adults, mean age 68,7 years. The PBPK model was also used to assess the dose in older people (80 years old).

Both models showed that a daily dose of 20 mg is safe and effective in older people, supporting the existing information in this age group.

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