Assessment of effectiveness and safety of omalizumab in the treatment of chronic spontaneous urticaria

INTRODUCTION: Chronic spontaneous urticaria is defined as spontaneous/induced, sudden appearance of wheals, and/or angioedema lasting more than 6 weeks duration. Omalizumab, a recombinant, humanized, monoclonal antibody against immunoglobulin IgE. It acts as neutralizing antibody by binding IgE at the same site on IgE as its high-affinity receptor, FcεRI. Omalizumab is the third line of management in the treatment of chronic spontaneous urticarial. It was approved by FDA in 2014. OBJECTIVES: To assess the effectiveness and safety of Omalizumab in the treatment of Chronic Spontanoeus Urticaria. METHODOLOGY: Place of Study: Dept of dermatology, Govt. Stanley Medical College, Chennai. TYPE OF STUDY: Non probability - convenience sampling. Prospective Study. DURATION: 1 year. SAMPLE SIZE: 30. Inclusion Criteria: Both sex; Age:>12 yrs; patients refractory to updosing of antihistamines; patients willing for informed consent; patients willing for follow up. Exclusion Criteria: Hypersensitivity to drug; Pregnancy/lactation; Parasitic infections; Tuberculosis/HIV/Hepatitis. METHODOLOGY AND FOLLOWUP: The patients who fulfilled the inclusion criteria and willing to take part in the study were screened. After obtaining informed written consent, there were admitted in our Dermatology ward and administered Inj Omalizumab 300mg subcutaneously. Patients were monitored for vitals and any adverse reactions. Patients were advised to maintain urticaria activity score7 (UAS7) and reviewed weekly as outpatient. The patient was advised to come for next 2 doses of Inj. Omalizumab 300mg every 4 weeks and followed up for next 12 weeks. The safety and effectiveness was studied by using urticarial activity score7 (UAS7). The patients who fulfilled the inclusion criteria and willing to take part in the study were screened. After obtaining informed written consent, therewere admitted in our Dermatology ward and administered Inj. Omalizumab 300mg subcutaneously. Patients were monitored for vitals and any adverse reactions. Patients were advised to maintain urticaria activity score7 (UAS7) and reviewed weekly as outpatient. The patient was advised to come for next 2 doses of Inj Omalizumab 300mg every 4 weeks and followed up for next 12 weeks. The safety and effectiveness was studied by using urticarial activity score7(UAS7). RESULTS: CSU was most common in the age group of 20-40years. The female: male ratio was 3: Among females most of them were house wives. There is no association of age or sex with angioedema, serum IgE level and Absolute eosinophil count. The prevalence of ASST positivity in our study was 6.7%. There was no relationship between number of years, number of urticarial lesions and occurrence of urticaria per week. Inj. Omalizumab is effective in controlling the disease. There was rapid and sustained improvement in the UAS7 score in the treatment period. It was found that during the follow up period there was a slight surge in the UAS7 score. But the response varies from one another in the study population. There was dramatic decrease in the wheals score component of UAS7 while there was a minimal decrease in the itch severity score component. The remission period of urticaria symptoms in this study varies from 3 to 4 months in few patients. CONCLUSION: Omalizumab has a rapid and sustained improvement in chronic spontaneous urticarial. There is reoccurrence of pruritis after the period of 2-3 months. It has low sustenance in the treatment of chronic spontaneous urticarial