Kiran Godse

Abstract

Objective: To evaluate efficacy and safety of bilastine in higher than usual doses in patients with chronic spontaneous urticaria (CSU). Material and Methods: Adult patients with CSU with pruritus and wheal score of more than two were investigated for complete blood count, urine examination, blood sugar level and thyroid-stimulating hormone level and treated with bilastine 20 mg (one tablet) before breakfast. In patients who did not show satisfactory response, dose was increased to 40 mg (two tablets) before breakfast at the end of one week and 80 mg (two divided doses) at the end of two weeks, if no response seen after the end of one week. Symptoms were evaluated using urticaria activity score (UAS) and sedation score. Results: A total of 30 patients (mean age 30.5 years; 56.67% females; baseline mean UAS 5.2) with mean duration of CSU of 18.9 months were enrolled. Fourteen (51.85%), 10(37.04%) and 2(7.41%) patients became symptom-free with 20,40, and 80 mg dose of bilastine respectively whereas 1(3.70%) patient not responding to 80 mg bilastine required cyclosporine. After 1 week of treatment, 3 patients were lost to follow up. Bilastine was well tolerated without any serious adverse events. Conclusion: Bilastine is effective and well tolerated in higher (up to 4 times) than normal doses in the management of chronic spontaneous urticaria. Keywords: Bilastine, Chronic spontaneous urticaria, Efficacy.

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Abstract

Introduction: Chronic urticaria consists of itchy rash on most days for at least six weeks. It is caused by release of histamine and other mediators from degranulated cutaneous mast cells. Antihistamines, the current treatment mainstay, do not provide relief in many cases and necessitates the use of adjunctive treatment. Histaglobin, through the synthesis of histamine-neutralizing antibodies, can serve as an adjunct. The current study was aimed to evaluate the efficacy and safety of Histaglobin, as adjunctive therapy, in patients with chronic urticaria. Materials and Methods: Patients with chronic urticaria were enrolled in this single-centre, prospective open-label study. Patients were administered 3 injections of Histaglobin (1ml), subcutaneously, at intervals of 7 days. Efficacy was assessed by grading the change in disease activity, measured using urticarial activity score (UAS 7) on days 0, 7, 14, 28 and 42. Adverse events (AEs) and concomitant medications were also recorded at each study visit. Results: Thirty-seven of the 38 enrolled patients completed study by following-up on day 28. Thirtyfour (91.9%) patients showed improvement; 21 (56.8%) showed ‘moderate improvement’ and 13(35.1%) showed ‘clear cut improvement’. There was a significant (p 6.1) to Day 28(6.06.2). There was one patient who developed redness at injection site. Half the patients on antihistamines and all those on steroid treatment were able to reduce/stop these treatments at the end of study. Conclusion: Histaglobin treatment was found to be effective in the treatment of chronic urticaria. It was also well tolerated and reduced antihistamines and steroids pill burden. Histaglobin, is a safe, well-tolerated and valuable adjunct to antihistamines in the management of chronic urticaria.

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Abstract

Urticaria or hives is a common skin condition that affects population with a lifetime prevalence of up to 22% and point prevalence of 1%. Antihistamines play a very important role in the treatment of chronic urticaria. International guidelines recommend second-generation, non-sedating H1-antihistamines as the first line therapy for management of chronic urticaria. Uncontrolled symptoms in many patients demand a new antihistamine which offers significant efficacy without or with minimal adverse events especially sedation. Bilastine, a second generation H1-antihistamine, offers significant benefits over most antihistamines including once daily dosage, significant efficacy in relieving symptom, minimal risk of drug to drug interactions and adverse events. This consensus statement is prepared to discuss the role of bilastine in the management of chronic urticaria among Indian patients. Comprehensive review of published literature was done to prepare a draft of consensus statement. The draft was circulated to the experts for their review and comments. Final document was prepared with incorporation of their comments. Keywords: Bilastine, C hronic urticaria, Consensus statement.

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