Omalizumab In Chronic Spontaneous Urticaria Research Articles

Effectiveness of Hydroxychloroquine and Omalizumab in Chronic Spontaneous Urticaria: A Real-World Study

Chronic spontaneous urticaria (CSU) not controlled by optimized doses of antihistamines is referred to as refractory CSU. Add-on therapies recommended by guidelines include omalizumab, immunosuppressive, and anti-inflammatory agents. The objective of the study was to assess the real-world effectiveness of different add-on treatment options for refractory CSU in 2 large clinical practices. A retrospective chart review was conducted in 264 patients with refractory CSU not adequately controlled for ≥6 weeks with optimized doses of second-generation histamine-1 blockers. Omalizumab and hydroxychloroquine were the most frequently prescribed add-on therapies, allowing comparisons of clinical outcomes for these 2 agents. Complete response included absent or infrequent urticaria and patient satisfaction with treatment. Partial response was reduced hives, but requiring a second add-on therapy. Sustained response was complete response to an add-on therapy for ≥1 year. Omalizumab add-on treatment was significantly more likely to be associated with a complete response versus hydroxychloroquine. Complete sustained response at 1 year was observed in 82% (111 of 134) of patients on omalizumab and 66% (73 of 111) on hydroxychloroquine as the first add-on therapy (P < .01). Patients with thyroid disease had a poorer response to add-on treatments (45% responded vs 63%; P= .03). In patients with incomplete responses to first add-on interventions (n= 45), 65% and 62% subsequently had complete responses to omalizumab and hydroxychloroquine, respectively. Although omalizumab was superior, hydroxychloroquine achieved a complete response in two-thirds of treated patients. Given a favorable safety profile, hydroxychloroquine should be considered as an add-on treatment for refractory CSU.

Successful combined treatment with omalizumab and tocilizumab in a case of chronic spontaneous urticaria and rheumatoid arthritis: A case report and literature review

Omalizumab is a recombinant humanized monoclonal anti-IgE antibody used to treat uncontrolled chronic spontaneous urticaria (CSU). Sometimes patients with CSU also have other autoimmune conditions. Recent studies have demonstrated the safety and efficacy of a combination treatment with omalizumab and other biologics. Here, we report the first successful treatment with omalizumab for CSU and tocilizumab for rheumatoid arthritis. Since omalizumab is unlikely to cause severe immunosuppression, it may be a treatment option for CSU, even in patients treated with other biologics.

New markers to predict the response to omalizumab in chronic spontaneous urticaria

Omalizumab has high treatment efficacy in patients with chronic spontaneous urticaria (CSU) who do not respond to high doses of antihistamines. Systemic immune-inflammation index (SII) and systemic inflammation response index (SIRI) were described as novel inflammatory and prognostic biomarkers. The present study aimed to evaluate the effectiveness of SII and SIRI in patients with CSU who receive omalizumab therapy. A total of 124 patients with severe urticaria who had an urticaria activity score over 7 days (UAS-7) ≥28 were included in the study. UAS-7, C-reactive protein (CRP), SII, and SIRI values ​​were recorded before and after omalizumab treatment. Patients with UAS-7 ≤6 at week 12 and/or week 24 of omalizumab treatment were considered responders. Three months after omalizumab treatment, significant decreases were observed in SII, SIRI, CRP, and UAS-7 compared to pre-treatment values ​​(p= 0.003, p< 0.001, p=0.006, and p< 0.001, respectively). At the third and sixth months of treatment, baseline SII and SIRI levels of the omalizumab responder group were significantly higher than the non-responder group (p< 0.001). However, there was no difference in baseline CRP and UAS-7 levels between responders and non-responders (p˃0.05). After adjusting for confounding factors, only pre-treatment SII (OR: 1.002, 95% CI: 1.000-1.004, p=0.036) and SIRI (OR: 4.334, 95% CI: 1.751-10.726, p=0.002) values were independently associated with response to omalizumab at 3 months in multivariate regression analysis. SII and SIRI could be effectively used to predict the response to omalizumab therapy. More comprehensive studies are needed to validate and elaborate on this relationship.

Multicentric and Observational Study of Omalizumab for Chronic Spontaneous Urticaria in Real-Life in Colombia.

BackgroundAlthough chronic urticaria (CU) is a common, cause of medical consulting both in general practitioners and allergist specialists worldwide, there is little information about its behavior and management in Latin America. Currently, national and international guidelines recommend using Omalizumab for cases refractory to management with antihistamines. Despite advances in the knowledge of Omalizumab for the management of CU, although there are few studies in underdeveloped countries, there are many studies evaluating the impact of Omalizumab treatment. There is not clinical information related with CSU-Omalizumab in patient settled in the Caribbean area. This research aims to evaluate the management of CU with Omalizumab in a real-life scenario in Colombia.MethodologyWe conducted an observational, descriptive, and retrospective study with patient recruitment between 2014 and 2017 of individuals diagnosed with Chronic Urticaria (CU) treating allergology specialists in five Colombian cities. We included patients with CU who failed to achieve disease control after treatment for 4 weeks with fourfold doses of second-generation H1-antihistamines, as recommended by the EAACI/GA2LEN/EDF/WAO guidelines and who received treatment with Omalizumab.ResultsWe included 123 patients, 73.1% (n = 90) were women. The mean age was 47.1 years (Standard Deviation, SD: 16.2). The median of the total months of disease evolution was 30 (IQR = 13–58). 81.3 % (n = 100) of patients were diagnosed with chronic spontaneous urticarial (CSU). 4.8% (n = 6) had inducible CU (CIndU), and 13.8% (n = 17) reported mixed urticaria (spontaneous CU with at least one inducible component). Regarding emotional factors, 34.9% (n = 43) of subjects indicated anxiety symptoms, 34.1% (n = 42) had exacerbations associated with stress, and 14.6% (n = 18) manifested episodes of sadness. The percentage of patients with CSU controlled according to medical criteria at 3 months with Omalizumab were 80% (n = 80/100) and at 6 months 87% (n = 87/100). The frequency of adverse events was 29.2% (n = 36), with headache being the most frequent adverse event.ConclusionsThis real-life study with Omalizumab at CU describes percentages of effectiveness and safety similar to those observed in pivotal and real-life studies conducted in other regions around the world.

Lower efficacy of omalizumab in older adults with chronic spontaneous urticaria.

Omalizumab is known to be effective in treating chronic spontaneous urticaria (CSU) with an inadequate response to H1 -antihistamine. Although many reports have described pre-treatment biomarkers to predict the efficacy of omalizumab in CSU, there are few reports that examined the relationship between age and the therapeutic effectiveness of omalizumab. Thus, we aimed to investigate the relationship between response to omalizumab and age. This retrospective study comprised 52 CSU patients receiving three consecutive omalizumab courses during the period from April 2017 to March 2021. Participants were categorized as responders or non/partial responders using the urticaria control test to evaluate clinical variables on week 12. The female rate tended to be higher, and the mean age and the median disease duration tended to be lower with no significance in responders compared with in non/partial responders. In addition, they exhibited no significant differences regarding serum immunoglobulin E levels, basophil counts, eosinophil counts, d-dimer, and autologous serum skin test results reported as predictor in the past between two groups. Interestingly, when patients were categorized as age <65 years or ≥65 years, those in the ≥65 years group had a significantly lower response to omalizumab than those aged <65 years. These findings suggest that physicians should keep in mind that the age of their CSU patients may be a predictor of the therapeutic efficacy of omalizumab.

Increased serum free IgE levels in patients with chronic spontaneous urticaria (CSU).

BackgroundIgE bound on the surface of mast cells contributes to the pathogenesis of chronic spontaneous urticaria (CSU). Atopy is a predisposing factor for CSU, where omalizumab is a widely used monoclonal antibody to control urticaria symptoms via capturing serum free IgE. However, the role of serum free IgE is not clarified in CSU. The present study evaluated the clinical relevance of serum free IgE in patients with CSU.MethodsEighty-eight patients with CSU and 76 healthy controls (HCs) were enrolled in this study. Serum total and Dermatophagoides pteronyssinus (Der p)-specific IgE levels were measured by ImmunoCAPs. The serum free IgE levels were measured by ELISA using a novel IgETRAP, and their associations with clinical parameters, including urticaria activity score (UAS), were evaluated. Changes in serum free and total IgE levels after omalizumab treatment were observed in 23 CSU patients in comparison between responders (≥50% reduction in UAS) and non-responders (<50% reduction).ResultsSignificantly higher serum free/total IgE levels were noted in CSU patients than in HCs with a positive correlation between the 2 values (rho = 0.87, P < 0.001). Among CSU patients, atopics had significantly higher serum free IgE levels than non-atopics, while no associations were noted with UAS, urticaria duration, or the results of serum ANA or autologous serum skin tests. In addition, there were no significant changes in serum free IgE levels during 12 months of omalizumab treatment. No significant differences were noted in serum free/total IgE levels or clinical parameters between responders and non-responders, while responders have higher serum Der p-specific IgE level and its ratio to serum free/total IgE level than non-responders (P < 0.05, respectively).ConclusionsThese findings suggest that increased serum free IgE may be involved in the development of CSU by activating mast cells, especially in atopics. High Der p-specific IgE level and its ratio to serum free IgE level may be a potential biomarker for predicting favorable responses to omalizumab in CSU.

Exploring Machine Learning Techniques to Predict the Response to Omalizumab in Chronic Spontaneous Urticaria.

Background: Omalizumab is the best treatment for patients with chronic spontaneous urticaria (CSU). Machine learning (ML) approaches can be used to predict response to therapy and the effectiveness of a treatment. No studies are available on the use of ML techniques to predict the response to Omalizumab in CSU. Methods: Data from 132 CSU outpatients were analyzed. Urticaria Activity Score over 7 days (UAS7) and treatment efficacy were assessed. Clinical and demographic characteristics were used for training and validating ML models to predict the response to treatment. Two methodologies were used to label the data based on the response to treatment (UAS7 ≥ 6): (A) at 1, 3 and 5 months; (B) classifying the patients as early responders (ER), late responders (LR) or non-responders (NR) (ER: UAS 7 ≥ 6 at first month, LR: UAS 7 ≥ 6 at third month, NR: if none of the previous conditions occurred). Results: ER were predominantly characterized by hypertension, while LR mainly suffered from asthma and hypothyroidism. A slight positive correlation (R2 = 0.21) was found between total IgE levels and UAS7 at 1 month. Variable Importance Analysis (VIA) reported D-dimer and C-reactive proteins as the key blood tests for the performance of learning techniques. Using methodology (A), SVM (specificity of 0.81) and k-NN (sensitivity of 0.8) are the best models to predict LR at the third month. Conclusion: k-NN plus the SVM model could be used to identify the response to treatment. D-dimer and C-reactive proteins have greater predictive power in training ML models.

EAACI Biologicals Guidelines-Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12-17years old.

Chronic spontaneous urticaria (CSU) imposes a significant burden on patients, families and healthcare systems. Management is difficult, due to disease heterogeneity and insufficient efficacy of classical drugs such as H1 R-antihistamines. Better understanding of the mechanisms has enabled a stratified approach to the management of CSU, supporting the use of targeted treatment with omalizumab. However, many practical issues including selection of responders, the definition of response, strategies to enhance the responder rate, the duration of treatment and its regimen (in the clinic or home-based) and its cost-effectiveness still require further clarification. The EAACI Guidelines on the use of omalizumab in CSU follow the GRADE approach in formulating recommendations for each outcome. In addition, future therapeutic approaches and perspectives as well as research priorities are discussed.

A patient-oriented approach to long-term use of omalizumab in chronic spontaneous urticaria

Background Omalizumab is an effective and safe treatment for antihistamine resistant chronic spontaneous urticaria (CSU), however, long-term efficacy and safety remains unclear. Objective To evaluate the efficacy and safety of omalizumab in CSU patients treated for long term and to identify long-term management strategies. Methods We retrospectively analyzed demographic characteristics, clinical features, laboratory parameters and treatment outcomes of 41 CSU patients who received omalizumab for at least 3 years. Treatment responses were evaluated with urticaria control test (UCT). Treatment safety was evaluated by comparing laboratory findings before and three years after omalizumab initiation as well as considering patients’ adverse event reports. Results The patients (mean age 40.46 years; 63.4% women) received omalizumab for an average of 41.93 months (mean 31.68 injections/patient). The mean baseline UCT score was 5.56 and average number of injections to reach UCT score ≥12 was 3.3. Nine patients (22%) responded insufficiently to 300 mg/4 weeks omalizumab and required updosing. Thirty-eight patients (92.7%) could tolerate longer dose intervals (>4 weeks) and the dose interval was increased after a mean of 11.53 injections. There was no loss of efficacy of omalizumab. Sixteen patients (39%) had been retreated with omalizumab after a mean discontinuation time of 24 weeks. Five patients (12.2%) reported mild and transient adverse effects. Liver and renal function tests as well as full blood count before and after omalizumab were in normal ranges. Conclusion For the long-term management of CSU, omalizumab is a safe and effective treatment which can be tailored according to patients’ disease activity.

Effect of omalizumab treatment on peripheral nerves in patients with chronic spontaneous urticaria

Aim: Chronic spontaneous urticaria (CSU) is characterised by itchy, red and raised lesions that appear as an attack without any cause and last for six weeks or longer. Omalizumab is a humanised monoclonal antibody that selectively binds to the Ce3 moiety of circulating IgE and is indicated for the treatment of resistant CSU. In this study, we aimed to investigate whether there was peripheral nervous system involvement in patients with chronic urticaria receiving omalizumab treatment. Methods: Forty-seven patients who were treated with omalizumab for CSU were included in the study. Electrophysiological measurements were performed following a neurological examination before treatment and at three months after omalizumab treatment. In nerve conduction tests, eight different nerves were studied in four extremities (total 16 nerves). During these studies, two motor and two sensory nerves (median and ulnar) in the upper extremities, and two motor (tibial and common peroneal) and two sensory nerves (sural and superficial peroneal) in the lower extremities were analysed. Results: No pathological electrophysiological findings supporting neuropathy were detected in any of the measurements performed before and after treatment. When the nerve conduction velocity, amplitude and latency values ​​of all examined nerves were compared, no significant difference was found between the pre- and post-treatment values. Conclusions: It can be considered that omalizumab has no effect on peripheral nerves, and it is a safe and well tolerated agent in terms of both peripheral nerves and neurological structure.

Sex differences in the efficacy of omalizumab in the treatment of chronic spontaneous urticaria.

BackgroundOmalizumab is shown to be effective in the treatment of chronic spontaneous urticaria (CSU), a disease with high personal and social impact. Sex differences in CSU are recognized with women more frequently affected. Scarce is the knowledge about response to omalizumab between sex groups. We sought to identify any differences based on the sex of patients receiving omalizumab.MethodsWe evaluated data of patients diagnosed with CSU refractory to high-dose second-generation H1 antihistamines and treated with 300 mg omalizumab every 4 weeks for 6 months and then at relapse.ResultsDiscussion: All patients, regardless of sex, age, or any other factor, achieved the clinical remission of the disease after the first 3 doses with a reduction of the disease activity indices and impact on the quality of life. Recurrences predominate in men, two months after the suspension of the drug. Respect to sex and recurrence we did not find any correlation with age, body mass index, peripheral eosinophil counts, total IgE levels, D-dimer, plasma prothrombine level or C-reactive protein. We found no sex differences in tolerability and safety. CSU in girls may persist longer and have worse prognosis, but no one has so far noted sex differences in response to omalizumab.ConclusionsAlthough there are no certainties on the mechanism of action of omalizumab in CSU, the noticeable difference in response between males and females lead us to suppose a role of the hormonal balance both on the pathogenesis of the CSU and on the efficacy of OmAb.

Hematologic parameters as biomarkers for antihistamine and omalizumab resistance in chronic spontaneous urticaria

Background: Biomarkers of resistance to H1-antihistamines (AH) and omalizumab in chronic spontaneous urticaria (CSU) are still a matter of debate. Objective: To identify clinical and laboratory attributes of the patient that may be predictive of AH and omalizumab resistance in CSU. Methods: We conducted a retrospective observational study by using the electronic patient record data base of patients with CSU and of sex- and age-matched controls. Patients with CSU were divided into three study groups: the CSU group, patients who responded to AHs; the antihistamine-resistant CSU (AH-CSU) group, patients refractory to a fourfold AH dose; and the control group, composed of a random sample of age- and sex-matched subjects, with a case-control ratio of 1:2. The patients in the AH-CSU group treated with omalizumab were compared according to the response or resistance to omalizumab. Results: A total of 106 subjects in the AH-CSU group, 483 in the CSU group, and 1198 in the control group were compared. Both AH-CSU (112.7 ± 43.1 kU/mL) and CSU (129.5 ± 52.4 kU/mL) groups were associated with higher plasma total IgE levels than control group (103.2 ± 49.5 kU/mL; p < 0.001). The AH-CSU group was characterized by a higher plasma high-sensitivity C-reactive protein level (6.4 ± 3.7 mg/L) than the CSU group (4.3 ± 1.4 mg/L; p < 0.001) and the control group (3.1 ± 1.8 mg/L; p < 0.001). The AH-CSU and CSU groups were characterized by a lower mean ± standard deviation basophil counts (0.18 ± 0.16 cells ×109/L and 0.19 ± 0.11 cells ×109/L, respectively) than the control group (0.22 ± 0.09 cells ×109/L; p < 0.001). The mean platelet volume was higher in the AH-CSU group (11.2 ± 0.3 fL) than in the CSU group (11.1 ± 0.4 fL; p = 0.002) and in the control group (10.3 ± 0.4 fL; p < 0.001). There were no significant differences in the mean levels of lymphocytes, monocytes, eosinophils, basophils, and platelets, and the rates of eosinopenia and basopenia between the patients in the AH-CSU group who responded to and those who were resistant to omalizumab. Conclusion: This study provided additional data of interest to examine the pathophysiologic role of low-grade inflammation and basopenia in patients with CSU and resistant to AHs and omalizumab.

Practical aspects of treatment with omalizumab in chronic spontaneous urticaria during COVID-19 vaccination campaign

Omalizumab is the first monoclonal antibody approved for use in patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment. Recent data on the dosage of this drug in urticaria and practical aspects of subcutaneous administration of prefilled syringes with omalizumab during the COVID-19 vaccination campaign are presented. In our opinion, doses of omalizumab before and after COVID-19 vaccination should be injected subcutaneously in the thigh or abdomen, avoiding the same arm as the site of intramuscular injection of the vaccine. The recommendations for the time intervals between COVID-19 vaccinations and biological treatments are presented in accordance with the Position Paper of the German Society of Allergology and Clinical Immunology (DGAKI) and the German Society of Applied Allergology (AeDA). COVID-19 vaccination should be given between two administrations of omalizumab, preferably with a time lag of at least one week after the previous biological treatment and at least one week before the next planned biological treatment.

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines.

This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75years old treated with omalizumab for 16 to 40weeks were evaluated. Omalizumab 150mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25), and the itch severity score (ISS)7 (MD -2.15; 95% CI -3.2 to -1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81) and decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), the ISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty) (DLQI; MD -4.03; 95% CI -5.56 to -2.5) and decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).

Improved FcεRI-Mediated CD203c Basophil Responsiveness Reflects Rapid Responses to Omalizumab in Chronic Spontaneous Urticaria

Omalizumab is effective in patients with chronic spontaneous urticaria (CSU) although its mechanism of action is poorly understood. Several studies reported that decreased high-affinity IgE receptor (FcεRI)-mediated histamine release and/or responsiveness was characteristic of basophils in patients with CSU. However, few studies have focused on the relationship between changes in basophil responsiveness via FcεRI after omalizumab treatment and the therapeutic effect in patients with CSU. To assess basophil responsiveness via FcεRI stimulation, as well as FcεRI expression and IgE binding on blood basophils from patients with CSU before and after omalizumab treatment and its possible association with the clinical response. We analyzed 34 patients with CSU treated with omalizumab who were categorized as fast responders (FRs) (n=20) and non or slow responders (N/SRs) (n= 14). CD203c expression induced by FcεRI stimulation, and IgE and FcεRI expressions on blood basophils from patients with CSU before and after omalizumab treatment were analyzed. Basophil responsiveness via FcεRI stimulation was observed invitro using basophils pretreated with omalizumab. FRs had increased CD203c responsiveness after treatment with omalizumab compared with N/SRs. This improvement of basophil responsiveness via FcεRI stimulation in FRs was not observed in peripheral blood basophils preincubated with omalizumab invitro, suggesting that omalizumab does not directly affect circulating pre-existing abnormal basophils. Increased basophil responsiveness via FcεRI after omalizumab treatment is associated with the therapeutic effect and mechanism of action of omalizumab.

Improving of psychological status and inflammatory biomarkers during omalizumab for chronic spontaneous urticaria.

Background:Depression and anxiety are the most common psychiatric comorbidities in chronic spontaneous urticaria (CSU). Omalizumab is a monoclonal antibody approved for CSU treatment. We evaluated the prevalence of anxiety and depression in CSU patients before and after treatment with omalizumab.Materials & methods:A total of 30 patients were enrolled in the study: 15 patients affected by CSU and treated with omalizumab and the other 15 healthy subjects did not receive any systemic therapy. All patients were evaluated using Hospital Anxiety and Depression Scale, CRP and erythrocyte sedimentation rate, at baseline and after 6 months.Results:The omalizumab group after 6 months of therapy had a decrease of all the scores and biomarkers.Conclusion:Omalizumab allowed an improvement of urticaria and mental comorbidities.

Serum transglutaminase 2 activity as a potential biomarker of disease severity and response to omalizumab in chronic spontaneous urticaria

This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No.2018R1A2B6009178) and Hallym University Research Fund 2017 (HURF-2017-76). Transglutaminase 2 (TG2) is expressed in mast cells and contributes to allergic asthma. We have previously reported that TG2 was associated with the pathogenesis of chronic spontaneous urticaria (CSU). The aim of this study is to investigate the clinical implication of serum TG2 levels in CSU. Patients with CSU (n=111), acute urticaria (AU, n=31), and normal controls (NC, n=45) were enrolled. TG2 activity in serum were measured by ELISA. Serum TG2 activity was serially measured in 9 patients with CSU in accordance with omalizumab treatment. Patients were divided by disease severity (mild, moderate, severe, very severe) which is defined by the treatment level from the guidelines for treatment of CSU. Student’s T-test and Wilcoxon signed-rank test were done for statistical analyses using SPSS, ver. 21 (SPSS Inc, Chicago, Illinois). TG2 activity was significantly higher in sera of CSU patients (132.8 ± 81.6 mU/mL) than AU (86.4 ± 57.8 mU/mL) and NC (70.0 ± 42.4 mU/mL). (P < 0.05, respectively), while Serum TG2 activity in AU was not significantly different from NC (P > 0.05). Serum TG2 activity in CSU patients was significantly increased according to disease severity (mild: 87.1 ± 66.3 mU/mL, moderate: 136.1 ± 64.0 mU/mL, severe: 159.7 ± 59.0 mU/mL, very severe: 222.1 ± 68.1 mU/mL, P < 0.0001). Initial TG2 activity was significantly decreased after omalizumab treatment (P < 0.05). Serum TG2 activity represents disease severity of CSU. Serum TG2 activity could be a useful marker of disease severity and treatment response of CSU.

Long-term follow-up effect of omalizumab in chronic spontaneous urticaria and its association with serum C-reactive protein levels.

This study aims to determine the efficacy of omalizumab, a humanized monoclonal anti-immunoglobulin E antibody, in patients with chronic spontaneous urticaria (CSU) refractory to conventional therapy, together with the evaluation of serum CRP levels. All the patients with a diagnosis of CSU who were continuously treated with omalizumab (300 mg/mo) for at least 3 months between June 2016 and July 2019 were included in this study. Urticaria activity score (UAS-7) was used for assessment of disease activity. Serum CRP levels were also retrospectively analyzed. When UAS-7 scores before the initiation of therapy were compared to the week 4, 12, 24, and 36 scores after the treatment, each were significantly different from the pretreatment results (P < .01). CRP level prior to treatment was found to be strongly correlated with baseline UAS scores of the patients' (P = .00). At the 12th week of treatment, decline of CRP level was positively and strongly correlated with the decline of UAS (P = .037). In this study, mean UAS decreased, mean rescue medication use declined, and overall therapeutic response improved with omalizumab treatment. Additionally, significant correlation between the decline of CRP levels and treatment response was found.

Efficacy of omalizumab in chronic spontaneous urticaria associated with chronic inducible urticaria

Efficacy of omalizumab in chronic spontaneous urticaria associated with chronic inducible urticaria

Efficacy and Safety of Omalizumab for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Omalizumab has been proposed as a possible effective treatment of chronic spontaneous urticaria (CSU). We aimed to access the efficacy and safety of omalizumab in the treatment of CSU based on qualified, randomized controlled trials (RCTs). PubMed, the Cochrane library, and Embase databases. Computerized search by index words was performed to identify qualified RCTs, and relevant literature sources were also searched. Nine RCTs were included in the meta-analysis with 1612 patients in the omalizumab group and 1251 patients in the placebo group. Compared with the placebo group, omalizumab significantly decreased the weekly itch score after therapy [Weighted Mean Difference (WMD), -3.94; 95% confidence interval (CI), -4.64 to -3.24], the weekly hive score (WMD, -5.27; 95% CI, -6.17 to -4.38), the dermatology life quality index (DLQI; WMD, -3.58; 95% CI, -4.66 to -2.50), and the urticaria activity score over 7 days (UAS7; WMD, -9.51; 95% CI, -10.94 to -8.08). There was no significant difference in the incidence of adverse events (AE) [relative risk (RR), 1.01; 95% CI, 0.91-1.12], serious AE (RR, 0.85; 95% CI, 0.57-1.27), and severe AE (RR, 0.83; 95% CI, 0.60-1.14) between the 2 groups. Compared with the placebo, omalizumab significantly decreased the weekly itch score and weekly hive score after therapy in patients receiving 75, 150, and 300 mg omalizumab, respectively. DLQI was significantly reduced in patients receiving 150 and 300 mg of omalizumab, respectively. In all the subgroup of UAS7, omalizumab significantly decreased the score compared with the placebo. Only patients receiving 600-mg omalizumab had a significantly higher AE incidence versus placebo. There was no significant difference in serious and severe AE between the 2 groups. Omalizumab caused a significantly greater reduction in weekly itch score, weekly hive score, DLQI, and UAS7 in CSU patients than the placebo. However, high-quality, multicenter RCTs with a larger sample size are needed to confirm the safety of omalizumab, and whether AEs are caused by omalizumab or other factors.