Analysis Of The Efficacy And Safety Of Omalizumab In Normocomplementemic Urticarial Vasculitis

BackgroundUrticaria vasculitis(UV)is a clinicopathological syndrome characterized by urticarialike wheal(often lasting for more than 24 hours).After the rash goes down,it remains pigmented and can be accompanied by itching,fever,joint pain,and other symptoms.Histopathology shows leukocytoclastic vasculitis.Some scholars believe that the disease tends to occur in middle-aged women,with a male to female ratio of about 1:3,and rare cases in children.According to the level of serum complement,they can be divided into Normocomplementemic Urticarial Vasculitis(NUV)and Hypocomplementemic Urticarial Vasculitis(HUV).Traditional therapeutic drugs include glucocorticoids,methotrexate,dapsone,azathioprine,colchicine,cyclosporine and antihistamines.But the response rate varies from 30 to 80%,with a significant proportion of patients not responding,and long-term side effects of medication are difficult to accept.Omalizumab is a humanized monoclonal antibody against IgE,which was approved by the FDA for the treatment of moderate to severe asthma in 2003,and expanded its indications for the treatment of Chronic Spontaneous Urticaria in 2014.In recent years,case reports published abroad have shown that omalizumab has achieved good efficacy and safety in the treatment of NUV patients with poor response/tolerance to traditional drugs.Autoreactive IgE may contribute to the occurrence of NUV in some patients.Omalizumab plays a role by binding to free IgE while reducing IgE autoantibodies.Omalizumab has not been approved for the treatment of NUV,and there are limited reports on the efficacy and safety of treating NUV.ObjectiveReview cases of NUV treated with Omalizumab and relevant literature to evaluate the effectiveness and safety of this emerging therapy,providing new treatment options for patients with NUV who are poorly/insensitive to traditional therapies.MethodsThe clinical data of patients with NUV treated with Omalizumab are collected from January 2016 to March 2022 in Shandong Provincial Hospital of Dermatology,including their general situation,previous treatment,clinical symptoms,laboratory results,treatment status of Omalizumab,and adverse reactions during treatment.The relevant literature on the treatment of NUV with Omalizumab is searched through Pubmed database,Wanfang database,and CNKI for analysis.SPSS software is used for data statistical analysis.The continuous variable is expressed as a median(upper quartile,lower quartile),and the categorical variable is expressed as a quantity(percentage).Chi-square test is used to analyze the differences between groups,and Fisher’s exact test is used when the predictive value was greater than 20%and lower than 5.a=0.05,P<0.05 for both sides,indicating statistically significant differences.ResultsThis study includes 54 patients with NUV treated with Omalizumab in 6 patients admitted to our center and 48 patients reported in previous literature in other centers.Before initiating treatment with Omalizumab,the patient have used traditional treatment drugs including glucocorticoids,thalidomide,azathioprine,cyclosporin,hydroxychloroquine,and methotrexate.The definition of effective treatment includes three stages:remission,partial remission,or complete remission.There are 47 cases of remission and 7 cases of non response,with a remission rate of 87%.49 patients are treated with 300mg Omalizumab every 4 weeks,43 patients are effective,and 6 patients are unresponsive.Of the 26 patients whose remission time is recorded,the median remission time is 4(4,8)weeks.5 patients are treated with 150mg OMA every 4 weeks,4 patients are effective,l patient is ineffective,and the median remission time is 12(8,14)weeks.37 Of the 54 patients record IgE status.Of 25 patients with high IgE levels,24 are treated effectively and 1 is not effective.Of 12 patients with normal IgE,6 are treated effectively and 6 are unresponsive.Using chi-square test,there is a correlation between treatment efficacy and IgE(P=0.002).All patients receives Omalizumab 150mg or 300mg every 4 weeks.There was no significant correlation between the treatment effect and dose according to Fisher’s exact test(P=0.515).2 patients develops mild adverse reactions such as headache and rash,with an adverse reaction rate of 3.7%.Conclusion1.Omalizumab has significant efficacy(87%effective rate)and good safety(3.7%adverse reaction rate)in the treatment of NUV with poor response/tolerance to traditional drugs.2.Patients with NUV with high IgE may have better response and faster remission to treatment with Omalizumab than patients with normal IgE levels.