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<0.0001) reduction in UAS from Day 0(15.8 ±6.1) to Day 28(6.0±6.2). 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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