Martin K. Church, Marysia Tiongco-Rectob, Erminia Ridoloc and Zoltan Novàk.
Bilastine is a potent and highly selective H1-antihistamine approved for the treatment of allergic rhinoconjunctivitis and urticaria. This article summarizes available data on the use of bilastine in the treatment of allergic disorders in different age groups, including younger and older adults, and school-age children and adolescents.
Lavorini F, Matucci A, Rossi O, Pistolesi M; SKY study investigators.
A double-blind, double-dummy, randomised, active-controlled, parallel group design (The SKY study) compared the efficacy and efficacy of concomitant therapy with bilastine and montelukast with each substance alone in patients with seasonal allergic rhinoconjunctivitis and asthma for four weeks.
419 adults with seasonal allergic rhinoconjunctivitis and mild-to-moderate asthma partially controlled by beclomethasone dipropionate or equivalent were included. They had a forced expiratory volume (FEV1) >70%, a positive skin prick test to one or more allergens and nasal/ocular total symptom score (TSS) >3. Participants were screened for one week and then a twelve weeks treatment.
Allergic rhinoconjunctivitis score (TSS), daytime nasal and non-nasal symptom scores and use of rescue medications were registered.
Contrary to the original hypothesis, concomitant administration of bilastine with montelukast was as effective as either agent alone for allergic rhinoconjunctivitis symptoms, however bilastine alone improved allergic rhinoconjunctivitis symptoms more than montelukast in the first two weeks of treatment.
The SKY study investigators concluded that there is no benefit of using bilastine plus montelukast to provide relief of allergic rhinoconjunctivitis in patients with mild-to-moderate asthma.
Serra E, Campo C, Novák Z, Majorek-Olechowska B, Pulka G, García-Bea A, Labeaga L.
PURPOSE: To evaluate the efficacy/safety of bilastine in pruritus relief in patients with chronic spontaneous urticaria (CSU) or other pruritic skin diseases.
CONCLUSIONS: Bilastine relieved pruritus associated with urticaria and other skin diseases, with a very good safety profile.
Andac Salman and Elif Comert
(2019) Journal of Cutaneous Medicine and Surgery
A retrospective cohort study was conducted to investigate the effectiveness and safety of 450 mg of omalizumab in chronic spontaneous urticaria.
Omalizumab is a third-line treatment for chronic spontaneous urticaria, however there are not enough studies regarding its use in patients that are unresponsive to regular doses of omalizumab.
A total of 72 patients were included, according to their Urticaria Activity Score over 7 days and the Urticaria Control Test and divided in two groups. Group 1 (n=59) included those showing a complete response to omalizumab 300 mg and group 2 (n=13) included those who received at least 3 doses of omalizumab 450 mg between 2016 and 2018.
The mean Urticaria Activity Score over 7 days decreased from 18,6 to 5,1 and the mean Urticaria Control Test score increase from 8,6 to 12 in group 2 participants after a mean 4,3 courses of omalizumab 450 mg. Of all 13 participants from group 2, 6 of them had a complete response, and 3 a good disease control. Those whose response to treatment was lower had low baseline total IgE levels (<43 IU/mL).
In conclusion, this team demonstrated that higher doses of omalizumab are effective and safe in patients with chronic spontaneous urticaria that is unresponsive to omalizumab 300 mg. Also, they predict that lower baseline total IgE levels might be related to a nonresponse to omalizumab and the need for higher doses.
On the occasion of the celebration of the 38th congress of the European Academy of Allergy and Clinical Immunology (EAACI), which will take place between 1 and 5 June in Lisbon, Faes Farma announces the holding of an important symposium specifically aimed at its antihistamine. own research, bilastine.
This meeting is scheduled for June 2 at 5:30 pm in Hall 5 of the conference venue.
With the title “BILASTINE: A lifetime companion. Value every moment of your life. “, counts as chairman with Prof. Martin Church (UK) and three specialist speakers of international prestige.
The first presentation will be made by Dr. Ralph Mösges (Germany) and will deal with the on-off relationship of patients with their treatments of allergic rhinitis.
The second presentation will be offered by Dr. Marysia Recto (Philippines) and will analyze the needs not covered in patients with urticaria.
Finally, Dr. Zoltán Nóvak (Hungary) will show the need for antihistamine treatments not to affect the life and daily activities of pediatric allergic patients.
You are cordially invited.
You can access the audiovisual contents of other editions in this link.
Jimena Coimbra, Cristina Campo, Luis Labeaga, Montserrat Puntes, Ignasi Gich, Joan Martínez, Rosa Antonijoan.
The main objective of this study was to compare the efficacy of bilastine 20mg administered orally, under fasting and fed conditions, in the reduction of histamine-induced skin reactivity (wheal and flare response) in healthy volunteers, taking into account the first treatment day (Day1) and the steady state (Day4). The final aim of this study was to assess the clinical relevance of this food-drug interaction.
As a conclusión of the study, the pharmacokinetic interaction of bilastine with food does not imply a significant reduction of its antihistamine efficacy, and the interaction of bilastine with food lacks clinical relevance since no significant pharmacodynamic interaction was observed.
Esther Serra, Cristina Campo, Zoltan Novák, Bernardetta Majorek-Olechowska, G Pulka, Aintzane García-Bea & Luis Labeaga (2019)
Journal of Dermatological Treatment
An exploratory, international and multicenter study to evaluate the efficacy of bilastine in the relief of pruritus associated with urticaria and other skin diseases was performed in patients diagnosed of Chronic Spontaneous Urticaria (CSU), eczema/dermatitis, prurigo or cutaneous pruritus.
The first 2 weeks, they were treated with bilastine 20 mg daily. The daily pruritus severity score was assessed. Responders patients stayed on this treatment for the remaining 6 weeks while non-responders were updosed to 40 mg.
The mean change in weekly pruritus severity score from baseline to week 8 was -1.63 ± 0.77 for all patients (p<0.001). The mean change per group was: CSU (-2.1 ± 0.44), cutaneous pruritus (-1.66 ± 0.63), eczema/dermatitis (-1.36 ± 0.79) and prurigo (-1.30 ± 0.92) (all p-values <0.001).
Bilastine at 20 mg and 40 mg showed an excellent profile for both efficacy and safety in reducing pruritus in patients with CSU and other skin disorders.
Antihistamines targeting the histamine H₁ receptor play an important role in improving and maintaining the quality of life of patients with allergic rhinitis. For more effective and safer use of second-generation drugs, which are recommended by various guidelines, a classification based on their detailed characteristics is necessary. Antihistamines for first-line therapy should not have central depressant/sedative activities.
Among the non-sedating group, fexofenadine and bilastine are classified into “non-brain-penetrating antihistamines”.
This review summarizes that the non-brain-penetrating antihistamines should be chosen for the first-line therapy of mild allergic rhinitis.
Bilastine shows a long drug-target residence time at the H1 receptor (73 ± 5 min) and this results in a prolonged H1 receptor antagonism in vitro (Ca2+ mobilization in Fluo-4 loaded HeLa cells), following a washout of unbound antagonist. Hence, the long residence time of bilastine can explain the observed long duration of drug action in vivo.
Bilastine has a proven, long-term safety record with use by over 71 million patients in over 104 countries. This novel, second generation antihistamine is non-sedating due to the fact that it does not cross the blood brain barrier. As well, bilastine is not metabolized and does not interact with CYP450.
This study is the first done in patients with allergic rhinitis and/or chronic urticaria using a F1-high speed simulator-driving test evaluating subjects’ performance under bilastine treatment.
A number of second-generation non-sedating antihistamines are used in clinical practices over the world. However, long-term safety and efficacy have not been proved high level evidence based medicine.
In conclusion, long-term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with hronic spontaneous urticaria (CSU) or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment.
Bilastine exhibits similar single- and multiple-dose pharmacokinetic and pharmacodynamic characteristics in healthy Japanese subjects compared with those observed in Caucasian subjects in previous studies.
The conclusion of the study demonstrated the efficacy, rapid onset, and long duration of action of BIL in subjects with Japanese cedar pollinosis exposed to cedar pollen using the OHIO Chamber.
After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with perennial allergic rhinitis (PAR), and exhibited a rapid onset of action.
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