Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience

Background: Multiple evidence have shown that omalizumab, a subcutaneous (SC) anti-IgE monoclonal antibody, is highly effective for the treatment of chronic spontaneous urticaria (CSU). Objective: The objective is to evaluate the safety and efficacy of omalizumab administered 300 mg SC 1st month fol...

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Main Authors: Gautam Kumar Singh, Manas Chatterjee, Rajesh Verma
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2018-01-01
Series:Indian Journal of Drugs in Dermatology
Subjects:
Online Access:http://www.ijdd.in/article.asp?issn=2455-3972;year=2018;volume=4;issue=1;spage=18;epage=22;aulast=Singh
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spelling doaj-b8c2b253980b4e1a9b4322425be8b2022020-11-25T00:30:55ZengWolters Kluwer Medknow PublicationsIndian Journal of Drugs in Dermatology2455-39722455-39722018-01-0141182210.4103/ijdd.ijdd_2_18Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experienceGautam Kumar SinghManas ChatterjeeRajesh VermaBackground: Multiple evidence have shown that omalizumab, a subcutaneous (SC) anti-IgE monoclonal antibody, is highly effective for the treatment of chronic spontaneous urticaria (CSU). Objective: The objective is to evaluate the safety and efficacy of omalizumab administered 300 mg SC 1st month followed by 150 mg every month for another 5 months in cases of refractory CSU in a routine clinical setting. Materials and Methods: This was open-label, prospective, pilot study to know the efficacy and safety profile of omalizumab administered 300 mg SC first 1st month followed by 150 mg every month for another five 5 months in refractory CSU. The study was conducted at tertiary center in routine clinical setting. The primary efficacy evaluation was a change in Urticaria Activity Score-7 (UAS-7) and Urticaria Control Test (UCT) from baseline. Results: A total of 13 patients (7 females and 6 males) were enrolled in the study with the mean age of 35 years, having CSU from the mean duration of 3.15 years. Mean UAS-7 of patients decreased from 31.62 at baseline to 6.85 after the first dose of omalizumab treatment. This further reduced to 2.31 after 6 months (P = 0.001). Mean UCT increased from 4.46 at baseline to 13.92 after 1 month and further increased to 14.85 after 6 months (P = 0.001). A total of 11 patients (84.6%) achieved complete remission. Conclusion: Injection omalizumab is safe and highly effective therapy for refractory CSU in the routine clinical setting. It can be made cost effective without compromising the efficacy in resource-poor country of Indian subcontinent if barring first dose other can be halved of recommended dose. However, small number of patients, uncontrolled study and lack of long-term follow-up data are the limitations of the study.http://www.ijdd.in/article.asp?issn=2455-3972;year=2018;volume=4;issue=1;spage=18;epage=22;aulast=SinghChronic spontaneous urticariaomalizumaburticaria activity score 7urticaria control test
collection DOAJ
language English
format Article
sources DOAJ
author Gautam Kumar Singh
Manas Chatterjee
Rajesh Verma
spellingShingle Gautam Kumar Singh
Manas Chatterjee
Rajesh Verma
Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
Indian Journal of Drugs in Dermatology
Chronic spontaneous urticaria
omalizumab
urticaria activity score 7
urticaria control test
author_facet Gautam Kumar Singh
Manas Chatterjee
Rajesh Verma
author_sort Gautam Kumar Singh
title Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
title_short Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
title_full Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
title_fullStr Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
title_full_unstemmed Role of omalizumab in refractory chronic spontaneous urticaria: A single referral center experience
title_sort role of omalizumab in refractory chronic spontaneous urticaria: a single referral center experience
publisher Wolters Kluwer Medknow Publications
series Indian Journal of Drugs in Dermatology
issn 2455-3972
2455-3972
publishDate 2018-01-01
description Background: Multiple evidence have shown that omalizumab, a subcutaneous (SC) anti-IgE monoclonal antibody, is highly effective for the treatment of chronic spontaneous urticaria (CSU). Objective: The objective is to evaluate the safety and efficacy of omalizumab administered 300 mg SC 1st month followed by 150 mg every month for another 5 months in cases of refractory CSU in a routine clinical setting. Materials and Methods: This was open-label, prospective, pilot study to know the efficacy and safety profile of omalizumab administered 300 mg SC first 1st month followed by 150 mg every month for another five 5 months in refractory CSU. The study was conducted at tertiary center in routine clinical setting. The primary efficacy evaluation was a change in Urticaria Activity Score-7 (UAS-7) and Urticaria Control Test (UCT) from baseline. Results: A total of 13 patients (7 females and 6 males) were enrolled in the study with the mean age of 35 years, having CSU from the mean duration of 3.15 years. Mean UAS-7 of patients decreased from 31.62 at baseline to 6.85 after the first dose of omalizumab treatment. This further reduced to 2.31 after 6 months (P = 0.001). Mean UCT increased from 4.46 at baseline to 13.92 after 1 month and further increased to 14.85 after 6 months (P = 0.001). A total of 11 patients (84.6%) achieved complete remission. Conclusion: Injection omalizumab is safe and highly effective therapy for refractory CSU in the routine clinical setting. It can be made cost effective without compromising the efficacy in resource-poor country of Indian subcontinent if barring first dose other can be halved of recommended dose. However, small number of patients, uncontrolled study and lack of long-term follow-up data are the limitations of the study.
topic Chronic spontaneous urticaria
omalizumab
urticaria activity score 7
urticaria control test
url http://www.ijdd.in/article.asp?issn=2455-3972;year=2018;volume=4;issue=1;spage=18;epage=22;aulast=Singh
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AT rajeshverma roleofomalizumabinrefractorychronicspontaneousurticariaasinglereferralcenterexperience
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