Bilastine for the treatment of chronic spontaneous urticaria: Consensus statement for Indian patients

Godse, Kiran; De, Abhishek; Zawar, Vijay; Shah, Bela; Girdhar, Mukesh

doi:10.18231/j.ijced.2019.039

Cited by 5 publications

(3 citation statements)

References 38 publications

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“…An updated consensus statement in 2019 of expert dermatologists from India also strongly recommends preference for bilastine over other antihistamines as first-line treatment due to excellent tolerability profile, faster onset, and longer duration of action and its non-sedative nature. 46 The limitations of this study is the small sample size. Future studies with a large sample size at multiple sites would provide good-quality clinical evidence and support the use of bilastine as the first-line treatment for CSU.…”

Section: Discussionmentioning

confidence: 89%

A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine at the Standard Dose and Bilastine vs Fexofenadine at Higher Than the Standard Dose (Up-Dosing) vs Levocetirizine and Hydroxyzine (in Combination) in Patients with Chronic Spontaneous Urticaria

Shah¹,

Dhoot²,

Choudhary³

et al. 2022

CCID

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Introduction Though second-generation antihistamines (SGAH) are first-line drugs in chronic spontaneous urticaria (CSU), 50% of patients do not respond to them. In such patients, guidelines recommend either up-dosing of SGAH or combination of different antihistamines. However, the studies comparing these treatment regimens are limited. Methods In this comparative, three-arm study, CSU patients were randomized 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. Patients were primarily evaluated for improvement in CSU, quality of life, and somnolence. Results A total of 110 patients with CSU were recruited. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine, and levocetirizine groups showed improvement in urticaria symptoms. At week 2, there was no statistical difference in urticaria activity score (UAS7) improvement 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. No major adverse events were reported during study period; however, bilastine was associated with significantly lower levels of AEs compared to levocetirizine ( p <0.05). Conclusion Two-fold up-dosing of bilastine improves CSU symptoms without compromising safety as compared to two-fold up-dosing of fexofenadine and combination of first- and second-generation antihistamines.

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Section: Discussionmentioning

confidence: 89%

A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine at the Standard Dose and Bilastine vs Fexofenadine at Higher Than the Standard Dose (Up-Dosing) vs Levocetirizine and Hydroxyzine (in Combination) in Patients with Chronic Spontaneous Urticaria

Shah¹,

Dhoot²,

Choudhary³

et al. 2022

CCID

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“…[ 7 ] It is highly selective for the H1 histamine receptor and has a well-established effectiveness and safety profile that includes a rapid onset and sustained duration of action with less sedative potential than most other second-generation antihistamines. [ 8 ]…”

Section: Introductionmentioning

confidence: 99%

Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study

De,

Singh,

Chakraborty

et al. 2024

Indian Journal of Dermatology

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Introduction: The treatment options for chronic spontaneous urticaria (CSU) primarily include second generation non-sedative antihistamine (SGAHs). Bilastine is a newer, nonsedating SGAH approved for urticaria in February 2019 by the Drugs Controller General of India. Its major advantages are in terms of superior efficacy, lack of drug interactions and adverse effects, including sedation, compared to conventional SGAHs. The role of cytokines in the pathogenesis of CSU is well known. However, there is a shortage of data regarding the change in serum levels of proinflammatory cytokines following H1 antihistamines. We conducted this trial to evaluate the role of bilastine in cytokine modulation and autoimmunity, thereby explaining its role in modifying the disease process in CSU. Materials and Methods: This prospective study was conducted in a tertiary institute in Kolkata on patients aged 12 years and above with a CSU >6 months. These patients had an unsatisfactory response, as per the Urticaria Activity Score 7 (UAS7), to previous antihistamine therapies in standard doses. Treatment effectiveness was determined by comparing the UAS7 at baseline with that at weeks 4, 8 and 12. Also, baseline serum interleukin-6 (IL-6) and IL-17 were compared with those at the end of the study, that is, 12 weeks. Results: Thirty patients who matched the inclusion criteria and signed informed consent were included in the study. At the end of 12 weeks, 10% of patients (n = 3) achieved a complete treatment response (UAS = 0), whereas 43.33% of patients (n = 13) were labelled as having well-controlled urticaria (UAS <6). At 12 weeks, the mean UAS7 score (6.47 ± 4.45) was statistically significant compared to the baseline score (25.47 ± 7.74). The mean values of serum IL-6 (pg/ml) and IL-17 (pg/ml) at baseline were 5.96 ± 5.24 pg/ml and 6.96 ± 5.97 pg/ml, respectively. At the end of treatment, that is, 3 months, the mean values were reduced to 4.61 ± 4.56 pg/ml and 5.08 ± 3.87 pg/ml. The reduction was statistically significant for both serum IL-6 (P < 0.001) and IL-17 (P < 0.0001). Conclusion: We conclude that bilastine at a once-daily continuous dose of 40 mg for 3 months is safe and effective in CSU patients who are refractory to treatment at the standard doses of SGAHs. Improved symptomatic control with bilastine was also associated with better control over the inflammatory process, as suggested by the lowering of mean cytokine levels in our study.

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“…The systematic review and meta-analysis have shown that individuals with allergic rhinitis or chronic urticaria benefit from the medication's strong efficacy, excellent safety profile, and increased quality of life when given the recommended adult dose of 20 mg once a day and 10 mg once a day for children up to 12 years 2 . Based on the International clinical trials in the Indian scenario, consensus statements have been prepared for using bilastine as a first-line AH in treating chronic urticaria 9 . A recent review on bilastine provides specific and best use among special populations with diverse clinical manifestations 10 .…”

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confidence: 99%

An emerging antihistamine drug with multiple therapeutic benefits: Bilastine

Jacob,

Thangaraj Uthra,

Gupta

et al. 2024

Pharm Sci Asia

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Histamine mediates numerous physiological processes. It is crucial in controlling allergic reactions, immune system responses, and also plays a significant role in allergic inflammation. Histamine mainly exhibits its effects in the human body by mediating through receptors such as H1, H2, H3, and H4. H1 receptor is widely distributed in major cells types such as immune and inflammatory cells. The binding of histamine to this receptor the chronotropic and vasoconstriction effects, rendering H1 receptor as an essential therapeutic target for medications that treat various allergic illnesses, including allergic rhinoconjunctivitis, urticarial, or atopic dermatitis 1 . H1 AHs, structurally distinct from histamine, stabilize the receptor's inactive conformation by acting as an inverse agonist. The first and second-generation H1 antihistamines (AHs) are inverse agonists that stabilize the inactive conformation of the receptor in its active state. First-generation agents such as bromopheniramine, dimenhydrinate, diphenhydramine, and doxylamine can frequently interact with other receptors due to poor receptor selectivity, leading to anti-cholinergic,

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Bilastine for the treatment of chronic spontaneous urticaria: Consensus statement for Indian patients

Cited by 5 publications

References 38 publications

Bilastine in Refractory Chronic Spontaneous Urticaria: Disease Control and Cytokine Modulation in an Open-label Prospective Study

An emerging antihistamine drug with multiple therapeutic benefits: Bilastine

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