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June 2022

A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine

By Articles about Bilastine, Publicaciones sobre Bilastina

Shah B, Dhoot D, Choudhary A, Jangid N, Mistry D, Shah S, Kamat S, Barkate H

Clin Cosmet Investig Dermatol. 2022 Feb 18;15:261-270. doi: 10.2147/CCID.S350122.

Chronic spontaneous urticaria (CSU) is a common skin condition associated with angioedema, wheals, or both. Although second-generation antihistamines (SGAH) are first-line drugs in CSU, half of the patients do not respond to them. Guidelines recommendation for these patients is to up-dose SGAH or combine different antihistamines. The objective of this study was to examine the effectiveness and tolerability of up-dosing of bilastine and fexofenadine up to two times and combination of non-sedating second-generation antihistamines; levocetirizine and first-generation antihistamine; and hydroxyzine in patients with CSU.

This was a comparative, three-arm study, which randomized CSU participants to receive standard dose of either bilastine, fexofenadine, or levocetirizine for 2 weeks. After 2 weeks of treatment, non-responders received double dose of either bilastine or fexofenadine, while hydroxyzine 25 mg once daily was added in the levocetirizine group. Participants were assessed for better outcomes in CSU, quality of life, and somnolence.

The study included 110 participants with CSU. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine, and levocetirizine groups indicated improvement in urticaria symptoms. At week 2, the urticaria activity score improvement showed no statistical difference between any of the groups; however, at week 4, there was a statistical difference between the bilastine and levocetirizine groups (p<0.05). Somnolence was significantly lower in the bilastine group (p<0.05). Bilastine was statistically significant (p<0.05) in the improvement of quality of life as compared to both groups. There was no report of major adverse events during the study period; however, bilastine was related to significantly lower levels of adverse events compared to levocetirizine (p<0.05).

In conclusion, a two-fold up-dosing of bilastine improves CSU symptoms with no changes in safety as compared to two-fold up-dosing of fexofenadine and combination of first- and second-generation antihistamines.

This document is only available for registered healthcare professionals


Intralymphatic immunotherapy with one or two allergens renders similar clinical response in patients with allergic rhinitis due to birch and grass pollen

By Artículos seleccionados, Selected articles

Ahlbeck L, Ahlberg E, Björkander J, Aldén C, Papapavlou G, Palmberg L, Nyström U, Retsas P, Nordenfelt P, Togö T, Johansen P, Rolander B, Duchén K, Jenmalm MC

Clin Exp Allergy. 2022 Jun;52(6):747-759. doi: 10.1111/cea.14138. Epub 2022 Apr 1. PMID: 35332591

Nearly 1/3 of the adult population of Sweden report allergic rhinitis. Although the prevalence of allergic sensitization is up to nearly half of the patients, there is a gap for a fast, efficient, and safe way to stimulate tolerance in patients with severe allergic rhinitis.

The aim of this study was to assess the safety and efficacy after intralymphatic immunotherapy with one or two allergens: birch- or grass pollen or both and to determine its immune modulatory effects including changes in spontaneous and allergen-induced cytokine and chemokine production, and proportions of T helper cell subsets in circulation.

People with severe birch and timothy allergy were randomized and received three doses of 0.1 ml of birch and 5-grass allergen extracts (10,000 SQ units/ml), or birch and placebo or 5-grass and placebo by ultrasound-guided injections into inguinal lymph nodes at monthly intervals. Characteristics reported before treatment and after each birch and grass pollen season included: rhinoconjunctivitis total symptom score, medication score and rhinoconjunctivitis quality of life questionnaire and circulating proportions of T helper subsets and allergen-induced cytokine and chemokine production (analysed by flow cytometry and Luminex).

After treatment with one or two allergens, the three groups related less symptoms, littler use of medication and better quality of life during the birch and grass pollen seasons, at an approximate rate. The most common adverse event reported was mild local pain. IgE levels to birch decreased, whereas birch-induced IL-10 secretion increased in all three groups. IgG4 levels to birch and timothy and skin prick test reactivity persisted mainly unaffected. Conjunctival challenge tests with timothy extract indicated a superior threshold for allergen. In all three groups, regulatory T cell frequencies were augmented 3 years after treatment.

In conclusion, intralymphatic immunotherapy with one or two allergens in people with grass and birch pollen allergy was effective and safe and may be associated with other immune modulatory responses.

This document is only available for registered healthcare professionals


Experience with bilastine in the management of urticaria: Original Real-world cases of Bilastine In Treatment (ORBIT) in Asia

By Articles about Bilastine, Publicaciones sobre Bilastina

Cheong WK, Chan AWM, Ch’ng CC, Chung WH, Gabriel MT, Godse K, Mitthamsiri W, Nguyen HT, Tiongco-Recto M, Nagrale D

Drugs Context. 2022 Mar 15;11:2021-12-2. doi: 10.7573/dic.2021-12-2. PMID: 35371270; PMCID: PMC8932249

People with urticaria have a compromised quality of life and sleep, and school/work due to its incapacitating condition. It presents with red and itchy rash with characteristic wheals, and/or angioedema. Current guidelines recommend second generation H1-antihistamine as first-line treatment of urticaria. Bilastine is a second-generation H1-antihistamine indicated in children aged ≥6 years and adults (Europe) for the symptomatic treatment of urticaria and allergic rhino-conjunctivitis. It has a well-documented efficacy and safety profile, with a rapid onset and a prolonged duration of action and a low sedative potential.

The objective of the Original Real-world cases of Bilastine In Treatment (ORBIT) study was to evaluate real-world cases published from the Asia-Pacific region in adults and children using bilastine for the long-term management of urticaria.

Eight cases diagnosed and classified according to international guidelines as chronic spontaneous urticaria or inducible urticaria were presented:

  • Case 1: 35-year-old man complaining of an itchy skin rash for the previous 6 months
  • Case 2: 10-year-old boy who developed recurrent hives over the past 3-4 years
  • Case 3: 54-year-old woman with poorly controlled chronic urticaria and intolerance to sedating antihistamines
  • Case 4: 33-year-old woman with cholinergic urticaria
  • Case 5: 20-year-old woman with intensely itchy rash
  • Case 6: 61-year-old woman with atopic (allergic rhinitis) with new-onset urticaria
  • Case 7: An elderly man with recalcitrant CSU unresponsive to second-generation antihistamines
  • Case 8: Chronic rash in an elderly man with multiple comorbidities

Although this was a small and diverse group of patients with urticaria considered difficult to treat, the administration of bilastine as per the approved label was well tolerated and effective in the long-term management of urticaria.

This document is only available for registered healthcare professionals

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