Efficacy Of Omalizumab Research Articles

Does NSAID exacerbated respiratory disease (N-ERD) accompanying severe asthma affect biological treatment response? Efficacy of omalizumab and mepolizumab in N-ERD

IntroductionNon-steroidal anti-inflammatory drug (NSAID)-exacerbated respiratory disease (N-ERD) accompanies severe asthma in about 15% of the patients and may adversely affect the prognosis. Omalizumab and mepolizumab are biologics used in patients with severe asthma. The objective of this study is to assess the respiratory improvements, after these biologics in severe asthmatic patients stratifed by the presence of concomitant Non-erosive reflux disease (N-ERD) and the effect of omalizumab and mepolizumab in severe asthmatics with N-ERD. Material & methodThe population of this three-center, retrospective, cross-sectional, observational study comprised patients using omalizumab or mepolizumab for severe asthma. Patients administered these biologics for severe asthma were comparatively analyzed for the presence of N-ERD; asthma control test (ACT) scores, number of attacks, and the changes in forced expiratory volume in 1 s (FEV1) were assessed. Subsequently, patients who were found to have N-ERD were analyzed using visual analog scale (VAS) in terms of the changes in their nasal parameters (ie, nasal obstruction, facial pain, anterior-posterior rhinitis, and hyposmia), according to whether they use omalizumab or mepolizumab. ResultsThe use of biologics resulted in a significant improvement in ACT and FEV1 and reduction in attacks in 28 severe asthmatics with N-ERD and 125 without N-ERD. Although both biologics resulted in a significant improvement in the respiratory parameters, omalizumab treatment resulted in a significant improvement in nasal parameters except hyposmia, mepolizumab treatment resulted in a significant improvement only in posterior rhinitis, and nasal obstruction among the nasal parameters. ConclusionThis study is the first to address both omalizumab and mepolizumab treatments in severe asthmatics with N-ERD. The improvement in nasal parameters was more pronounced in patients who were administered omalizumab. Large-scale randomized controlled studies are needed to corroborate the findings of this study.

Omalizumab in Chronic Spontaneous Urticaria (CSU): Real-Life Experience in Dose/Interval Adjustments and Treatment Discontinuation.

Data on real-life experience with omalizumab dose/interval adjustments are still limited, as well as on omalizumab discontinuation. To evaluate efficacy and safety of omalizumab dose/interval adjustment in a Portuguese cohort of patients with chronic spontaneous urticaria (CSU) and to characterize those who discontinued omalizumab. A retrospective study of patients who started omalizumab for CSU at a Portuguese Urticaria Center of Reference and Excellence (UCARE) was conducted between 2009 and 2021. Response criteria were based on a weekly Urticaria Activity Score (UAS7) <7 points (partial: UAS7 7-15 points; nonresponders: UAS7 >15 points) and minimal important difference >10 points. A total of 138 patients were enrolled in the study; 83% of them were women, and the median age was 49 years (interquartile range: 40-58 years). On 300 mg q4 weeks, 96 (70%) patients were responders, 29 (21%) partial responders, and 13 (9%) nonresponders. After dose/interval adjustments (up to 600 mg q2 weeks), 108 (78%) were responders, 27 (20%) partial responders, and 3 (2%) nonresponders. No adverse events were reported. Updosing was more frequent in patients with angioedema, body mass index >30 kg/m2, positive basophil activation test, and autologous serum test. A total of 71 (51%) patients lengthened interval, presenting higher median pre-omalizumab D-dimer (0.2 vs 0 mcg/mL, P= .038) and C-reactive protein (0.3 vs 0.1 mg/dL, P= .030) values than those with a standard dose. In total, 37 patients (27%) stopped omalizumab, but 14 (38%) of them needed retreatment on average 11 months after discontinuation. Patients with angioedema and a longer omalizumab duration had higher chance of relapse. Omalizumab dose and/or interval adjustment is effective and safe and should be implemented in partial/nonresponders for response improvement and in responders for further discontinuation. A protocol for regimen adjustments is proposed.

PD04 Real-life experience of Scottish patients with idiopathic solar urticaria

Abstract We conducted a retrospective study to characterize our most recent cohort of patients with idiopathic solar urticaria (SU), to compare with our previous findings (Beattie PE, Dawe RS, Ibbotson SH, Ferguson J. Characteristics and prognosis of idiopathic solar urticaria: a cohort of 87 cases. Arch Dermatol 2003; 139:1149–54). We analysed data derived from our in-house database and paper and electronic records of patients with SU seen through the Scottish Photobiology Service between 2003 and 2022. Eighty-four patients with SU were seen in this period, 57 (68%) women and 27 (32%) men. Twenty-nine (35%) had a single consultation/phototesting and 55 (65%) had follow-up assessments. The average age of onset was 37 years, with the average age of diagnosis being 41 years, with delays from symptom onset to diagnosis ranging from 6 months to 24 years. Importantly, 20 (24%) patients self-reported systemic symptoms, most commonly fatigue, dizziness and nausea. Of 61 patients using antihistamines before diagnosis, 31 (51%) reported benefit. Of patients who tried sunscreens, 31 of 65 (48%) reported benefit. On monochromator phototesting, sensitivity predominantly involved the ultraviolet (UV)A waveband (335–400 + 27 nm in 55%), extending into the visible spectrum (&amp;gt; 430 + 27 nm) in 44% and UVB waveband (305 + 5 nm) in 1%, consistent with previous reports of predominant UVA/visible light dependency in SU. On review of follow-up data, we analysed the fold benefit in minimal urticaria dose (MUD) from testing on H1 antihistamines alone, H1 and H2 antihistamines combined and the addition of montelukast. Most (65%) responded with a more than twofold improvement in MUD after a single dose of H1 antihistamine, with only 35% not responding. Increasing the dose of H1 antihistamine did not provide notable additional benefit. There was a suggestion of improved responses by the addition of an H2 antagonist (in 76% vs. 66% with H1 antagonist alone), but this was not statistically significant (P &amp;gt; 0.05). No additional improvement in threshold sensitivity (MUD) was observed by the addition of montelukast. Small numbers of patients used other treatments such as photo(chemo)therapies and systemic immunosuppressants, and these were found to be of limited benefit. Since 2011, we have used omalizumab for patients with treatment-resistant SU. Of the current cohort, 13 received omalizumab, with 62% reporting a good clinical response and a further 15% a partial clinical response. Phototesting in these patients showed complete abolition of photosensitivity or excellent responses (more than fivefold increase in MUD) in 73%, demonstrating the efficacy of omalizumab in recalcitrant SU. Given the systemic features reported by some patients with SU, this supports a management approach, which includes systemic immunomodulation as a potentially effective option.

A Study of 105 Patients Treated with Omalizumab for Chronic Idiopathic Urticaria

Omalizumab (Xolair®) was approved for the treatment of chronic idiopathic urticaria in 2017. Furthermore, consistent with international guidelines published in 2018, the Urticaria Clinical Practice Guidelines by the Japanese Dermatological Association provide detailed instructions for the use of omalizumab. However, there are no reports summarizing the efficacy of omalizumab in chronic idiopathic urticaria in Japan. The subjects of our study were 105 patients treated with omalizumab 300 mg/month for chronic idiopathic urticaria at Tokyo Medical University Hospital from June 2017 to March 2021, inclusive of 23 male and 82 female patients, with a mean age of 45.4 ± 16.0 and disease duration of 46.9 ± 99.4 months. Three months after treatment, omalizumab was discontinued in 63 patients with a Urticaria Control Test score of 16. The mean number of dose completions was 6.4 ± 4.1. There were nine cases of relapse in which seven of the nine cases discontinued omalizumab within six doses. Most of the relapsed cases improved with re-administration of omalizumab, but it was again discontinued in five cases. Omalizumab has lesser side effects than steroids and cyclosporine, and the criteria for its use were revised in 2018, requiring an allergist or dermatologist to be available to treat adverse events such as asthma and anaphylaxis at the facility or in collaboration with neighboring medical institutions. Omalizumab can also be used in dermatology clinics. The drug is an effective treatment for severe chronic idiopathic urticaria and is anticipated to be used by more dermatologists.

Efficacy of two-year anti-IgE therapy in patients with severe allergic bronchial asthma in Sverdlovsk region

Introduction. The study of omalizumab efficacy in patients with severe bronchial asthma (SA) in randomized clinical trials is limited to 52 weeks. In real clinical practice, patients can receive the drug for much longer.Aim. Evaluate the one-year and two-year efficacy of omalizumab in patients with SA in Sverdlovsk region.Material and methods. The study included patients (n = 54) with allergic and mixed SA from the registry of Sverdlovsk region. Omalizumab efficacy was assessed over 12 and 24 months of therapy by dynamics of asthma exacerbations frequency, the use of health care resources, the need for short-acting beta-agonists (SABA) and systemic glucocorticosteroids (SGCS), the level of asthma control according to ACT, and the quality of life according to AQLQ, FEV1 levels and peripheral blood eosinophils.Results. During 12 months of omalizumab therapy, the reduction in asthma exacerbation rate was 63.7% (from 2.01 ± 1.51 per patient per year to 0.73 ± 1.03) (p &lt; 0.001), which was accompanied by a decrease in emergency calls and hospitalizations rates by 92.4 and 84.1%, respectively (p &lt; 0.001). Improved asthma control (by ACT) from 9 (Q1-Q3: 7–13) to 20 points (Q1-Q3: 16–23); the proportion of patients with uncontrolled SA decreased from 97.4 to 48.7% (p &lt; 0.001). The need for SABA decreased to 92.9% (p &lt; 0.001). The proportion of patients on SGCS decreased from 60.5% to 15.8% (p &lt; 0.001). The quality of life (AQLQ) significantly improved, FEV1 increased (p &lt; 0.001), the number of eosinophils in peripheral blood decreased (p = 0.015). By the end of the second year of therapy, the trend of improvement in indicators of efficacy continued.Conclusions. During 1 year of therapy with omalizumab, patients with allergic SA experienced a significant decrease in the number of exacerbations and use of health care resources, improved quality of life and asthma control, reduced need for SABA and SGCS, and improved respiratory function. In patients treated with omalizumab for 2 years, there was a further improvement or stabilization of efficacy indicators.

Analysis of the Efficacy and Recurrence of Omalizumab Use in the Treatment of Chronic Spontaneous Urticaria and Chronic Inducible Urticaria

Introduction: Chronic urticaria (CU) is a common skin condition that can be divided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Omalizumab is one treatment option for CU, but currently there are limited clinical studies of omalizumab’s efficacy for treating CU in Chinese patients. This study sought to investigate the efficacy and safety of omalizumab treatment for CU patients in a Chinese patient population. Specifically, we aimed to compare the differential efficacy of omalizumab for CSU and CIndU patients and predict risk factors for recurrence. Methods: We completed a retrospective clinical data review of 130 CU patients who received omalizumab treatment from August 2020 to May 2022, with a maximum follow-up period of 18 months. Results: A total of 108 CSU patients and 22 CIndU patients were included in the study. After treatment with omalizumab, the response rate in the CSU group was higher than that in the CIndU group (93.5% vs. 68.2%), and CSU patients accounted for a higher proportion of responders and early responders (responders: 87.1% vs. 12.9%, p < 0.001; early responders: 95.7% vs. 4.3%, p = 0.001). Nonresponders had lower total immunoglobulin E (IgE) levels (75.0 vs. 167.5 IU/mL, p = 0.046) and a relatively shorter duration of treatment (1.0 vs. 3.0 months, p = 0.009) compared to responders. Early responders had shorter disease duration (1.0 vs. 3.0 years, p = 0.028), higher baseline UCT (4.0 vs. 2.0, p = 0.034), lower baseline DLQI (18.0 vs. 18.5, p = 0.026), and shorter total treatment time (2.0 vs. 4.0 months, p < 0.001) compared to late responders. All adverse events reported during treatment were mild. Seventy-four patients with CU discontinued the drug after achieving complete disease control, of which 26 (35.1%) relapsed for 2.0 months (interquartile range: 1.0–3.0 months). Compared with nonrelapsed patients, relapsed patients often had other allergic diseases (42.3% vs. 18.8%, p = 0.029), higher basal levels of total IgE (263.0 vs. 140.0 IU/mL, p = 0.033), and longer disease duration (4.2 vs. 1.0 years, p = 0.002). Relapsed patients could still achieve good disease control after restarting omalizumab therapy. Conclusion: Omalizumab was effective and safe for CSU and CIndU patients. Patients with CSU responded more quickly to omalizumab and showed a relatively better treatment effect. However, there was a possibility of relapse after discontinuation of omalizumab after complete control of CU, and in these cases, restarting omalizumab treatment after relapse was effective.

Omalizumab ameliorates extrarespiratory symptoms in patients with aspirin-exacerbated respiratory disease

Omalizumab, an anti-immunoglobulin E antibody, has clinical efficacy against respiratory symptoms of aspirin-exacerbated respiratory disease (AERD). However, some patients with AERD also present with extra-respiratory (chest, gastrointestinal, and/or cutaneous) symptoms, which are resistant to conventional treatment but can be alleviated by systemic corticosteroids. To evaluate the efficacy of omalizumab on extra-respiratory symptoms related to AERD. In Study 1, 27 consecutive patients with AERD initially prescribed omalizumab at Sagamihara National Hospital between July 2009 and March 2019 were studied retrospectively. The frequency of exacerbations of AERD-related extra-respiratory symptoms was compared before and after the initiation of omalizumab treatment. In Study 2, we reported three AERD cases with aspirin challenge-induced extra-respiratory symptoms among patients studied in our previous randomized trial (registration number: UMIN000018777), which evaluated the effects of omalizumab on hypersensitivity reactions during aspirin challenge to AERD patients. The extra-respiratory symptoms induced during the aspirin challenge were compared between the placebo and omalizumab phases. In Study 1, omalizumab treatment was associated with a decrease in the frequency of exacerbation of chest pain (n [%] of patients with exacerbation frequency ≥1 time per year, 6 [22.2%] vs. 0 [0%]; P<0.001), gastrointestinal symptoms (9 [33.3%] vs. 2 [7.4%]; P=0.016), and cutaneous symptoms (16 [59.3%] vs. 2 [7.4%]; P<0.001), even under conditions of a treatment-related reduction in systemic corticosteroid dose. Omalizumab also attenuated all the extra-respiratory symptoms during the aspirin challenge in Study 2. Omalizumab ameliorated the extra-respiratory symptoms at baseline (without aspirin exposure) and during aspirin challenge.

A real-life comparison of pulmonary and nasal outcomes in patients with severe asthma and nasal polyposis treated with T2-biologics

BackgroundSevere asthma (SA) with comorbid chronic rhinosinusitis with nasal polyps (CRSwNP) is frequently associated with type 2 (T2) inflammatory endotype. Consequently, therapeutic targets are T2 biologics. The present retrospective study aimed to analyze and compare the clinical efficacy of mepolizumab, benralizumab, omalizumab, and dupilumab in patients with SA and comorbid CRSwNP. Methods115 adult patients with SA and CRSwNP receiving 1 of the 4 biologics (mepolizumab n = 31; benralizumab n = 27; dupilumab n = 27; omalizumab n = 30) were included in the retrospective open monocentric study. Pulmonary and rhinological parameters were evaluated by Asthma Control Test (ACT), FEV1%, GINA-severity grade, rhinological questionnaires (CRS VAS-scores and sinonasal QoL RSOM-31) before and after 4–6 months of therapy. ResultsAfter 4–6 months of therapy, the Asthma Control Test and FEV1% significantly improved in all biologics groups (p < 0.01). GINA-score significantly improved in the omalizumab group only (p < 0.01). Overall, most nasal scores measured by VAS, total and nasal RSOM-31 subscores improved in all treatment groups (p < 0.05). Interestingly, the most significant differences in pre/post scores were observed in the patients receiving dupilumab, with the most notable improvement for all nasal symptoms, RSOM-31 total score, and RSOM-31 nasal subscore. There were no significant changes in the VAS scores loss of smell in the benralizumab group and postnasal drip in the mepolizumab group. ConclusionT2-targeting biologics effectively treat asthma in patients with severe asthma and comorbid CRSwNP. However, the efficacy of T2 biologics differs regarding the outcome in CRSwNP.

Clinical efficacy of omalizumab for treatment of moderate or severe allergic asthma in children with serum immunoglobulin E levels >1 500 IU/mL: a prospective study

To evaluate the clinical efficacy of omalizumab in the treatment of moderate or severe allergic asthma in children with serum total immunoglobulin E (IgE) levels >1 500 IU/mL. A total of 95 children with moderate or severe allergic asthma, who were treated at the Department of Respiratory Medicine in Anhui Provincial Children's Hospital from December 2020 to May 2022, were enrolled. Based on their serum total IgE levels and whether they received omalizumab treatment, they were divided into a control group (IgE >1 500 IU/mL, no omalizumab treatment), a normal treatment group (IgE levels between 30 and 1 500 IU/mL, omalizumab treatment), and an ultra-high IgE treatment group (IgE >1 500 IU/mL, omalizumab treatment). The differences in clinical characteristics, Childhood Asthma Control Test (C-ACT) scores before and after treatment, the proportion of acute attacks, IgE levels, pulmonary function indicators, and fractional exhaled nitric oxide (FeNO) concentrations were analyzed among the three groups. At the 8th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores, forced expiratory volume in first second (FEV1) as a percentage of predicted value (FEV1%pred), FEV1/forced vital capacity (FVC) ratio (FEV1/FVC), and peak expiratory flow (PEF) as a percentage of predicted value (PEF%pred), as well as a lower proportion of acute attacks and FeNO concentration compared to the control group (P<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (P>0.05). At the 16th week of treatment, the normal treatment group and the ultra-high IgE treatment group had higher C-ACT scores and pulmonary function indicators including FEV1%pred, FEV1/FVC, PEF%pred, and forced expiratory flow at 25% vital capacity (FEF25) as a percentage of predicted value (FEF25%pred) compared to the control group (P<0.05). The proportion of acute attacks and FeNO concentration in the ultra-high IgE treatment group were lower than those in the control group (P<0.05). There were no statistically significant differences in the comparison of various indicators between the ultra-high IgE treatment group and the normal treatment group (P>0.05). Omalizumab therapy has a certain clinical efficacy in children with moderate or severe allergic asthma and serum total IgE levels >1 500 IU/mL, with no significant difference in efficacy compared to children with serum total IgE levels between 30 and 1 500 IU/mL.

Efficacy and safety of omalizumab in adult patients with wheat-dependent exercise-induced anaphylaxis: Reduction of in vitro basophil activation and allergic reaction to wheat

BackgroundIn patients with wheat-dependent exercise-induced anaphylaxis (WDEIA), anaphylactic shock occurs frequently, therefore avoidance of wheat products is recommended. We aimed to evaluate efficacy and safety of long-term omalizumab treatment for adult patients with WDEIA. MethodsIn this phase 2, multicentre single-arm trial, 20 adult patients with WDEIA were enrolled (UMIN 000019250). All patients were administered 150–600 mg of omalizumab subcutaneously and evaluations (basophil activation and blood examination) were performed at regular intervals during administration period (0–48 weeks) and observation period (48–68 weeks). Primary endpoint was proportion of the patients who achieved a basophil activation rate below 10% with fractionated wheat preparations, and secondary endpoint was proportion of the patients with no allergic reactions after wheat products ingestion. ResultsDuring the omalizumab treatment, more than 80% of the patients achieved the basophil activation rate less than 10% against all fractionated wheat preparations, and 68.8% of the patients who achieved the primary endpoint experienced no allergic reaction. During the observation period, the proportion of the patients who achieved a basophil activation rate below 10% decreased gradually, and the proportion of patients with positive allergic reactions increased gradually thereafter and reached maximum of 46.7%. Severe adverse events were not observed during the study. ConclusionsLong-term omalizumab treatment is safe and effective for adult patients with WDEIA when assessed by basophil activation rate with wheat allergens as well as allergic reactions after lifting of restrictions on wheat intake. However, this is not enough to achieve desensitization.

Тяжелая бронхиальная астма у детей – возможен ли контроль заболевания?

The management of severe asthma in children is challenging due to the risks associated with an uncontrolled disease progression, which significantly increases the likelihood of acute exacerbations, hospitalizations, and even adverse outcomes. In this case, targeted immunobiological agents, particularly omalizumab, may be used to improve disease control. Objective. This open-label prospective clinical study aimed to evaluate the efficacy and safety of omalizumab in children with uncontrolled persistent asthma in clinical practice. Patients and methods. The study included 82 children aged 6 to 18 years (mean age: 12.2 ± 1.4 years) with moderate to severe asthma uncontrolled with medium- or high-dose inhaled corticosteroids (ICS) in combination with long-acting beta-2-agonists (LABAs). Omalizumab was prescribed considering the level of IgE and body weight, and the frequency of administration was once a month. Follow-up duration was 12 months. Asthma control (frequency of exacerbations, need for systemic CS during exacerbations, volume of standard therapy) and adverse events were assessed at baseline and 12 months after the initiation of therapy with omalizumab. Results. After 12 months of omalizumab therapy, we revealed a significant reduction in the frequency of exacerbations by 67% (p &lt; 0.005), including the number of exacerbations requiring systemic CS administration (by 75% from baseline, p &lt; 0.001). There was also a reduction in the volume of standard therapy in 48% of patients and in the use of short-acting beta-2-agonists (SABAs), which was reflected in improved asthma control (the percentage of patients with controlled asthma increased from 0 to 42.6 and 65.8 after 3 and 6 months of therapy, respectively). Conclusion. Omalizumab significantly improves the course of severe asthma in patients with allergic phenotype. Key words: children, bronchial asthma, targeted immunobiologic therapy

Severe allergic asthma: Does alexithymia interfere with omalizumab treatment outcome?

Alexithymia is among psychological factors reported to interfere with asthma management. Severe allergic asthma (SAA) is characterized by uncontrolled asthma despite maximal standard pharmacological treatment which can benefit from an add-on treatment with Omalizumab, an anti-IgE monoclonal antibody. To evaluate if alexithymia influences the efficacy of omalizumab in SAA. The total alexithymia score 20 (TAS 20) questionnaire allowed to detect alexithymia. SAA was monitored recording number of exacerbations, asthma control test (ACT) and asthma quality of life questionnaire (AQLQ) scores, as well as forced expiratory volumes in 1 second % (FEV1%) levels before starting omalizumab, 1 and 2 years after. The study was conducted on 18 patients; Group 1, TAS 20 ≥ 61, was of 2 males and 4 females with SAA and alexithymia, while Group 2 , TAS 20 ≤ 51, was of 8 males and 4 females, without alexithymia. Group 1 had a statistically significant decrease in asthma exacerbations "p = 0.004", while ACT "p = 0.008" and AQLQ scores statistically increased. FEV1 values increased but not statistically significantly. Group 2 had a highly statistically significant decrease in the number of exacerbations and a highly statistically significant increase of ACT "p < 0.0001", FEV1 "p = 0.008" and AQLQ scores. Regardless the presence or not of alexithymia, all patients with SAA obtained a marked improvement after starting treatment with omalizumab. Therefore alexithymia does not seem to influence the treatment outcome of omalizumab.

Prospective, monocentric, observational study of the long-term effectiveness of omalizumab in chronic urticaria.

Omalizumab, a monoclonal antibody targeting IgE, has been approved in 2014 for the treatment of H1 antihistamine-refractory chronic urticaria. Data on long-term effectiveness and predictive factors for treatment response are currently limited. In this monocentric, prospective, observational study, 112 patients with chronic spontaneous urticaria (CSU) and 32 patients with chronic inducible urticaria (CIndU) were included. In addition to a rapid response, omalizumab also showed good effectiveness on both forms of chronic urticaria over 2 years. Low total IgE and elevated Yersinia IgA were identified as potential predictive markers for slower treatment responses in CSU. In conclusion, the present study highlights the efficacy of omalizumab for the treatment of chronic urticaria. With emerging new therapeutic options for chronic urticaria, further genetic as well as molecular markers are needed to establish patient-specific therapy selection.

A Pilot Study of Omalizumab to Treat Severe Allergic Asthma in South Indian Population

Background: Asthma is a respiratory disease that affects your lungs. In asthma, airways of the lungs constrict due to swelling and accumulation of mucus. Newer remedies known as targeted therapies have evolved as a result of advancements in medical research, greatly relieving these patients. The biologics used in the severe allergic asthma is Omalizumab.&#x0D; Purpose: Demonstrating the clinical efficacy of Omalizumab in severe allergic asthma by reducing exacerbation rates and increasing quality of life.&#x0D; Methods: A single-arm prospective pilot study of omalizumab in severe allergic asthma was conducted in a tertiary care hospital for the duration of one year with the help of Asthma Quality of Life Questionnaire (AQLQ).&#x0D; Results and discussions: On an initial dose of omalizumab of 150 mg in 2 vials subcutaneously every month for 6 months, among our study population, 45% of the patients had their symptoms improve more than they had with prior medications. Results show that the patient's overall score has improved by nearly 50%. This shows that omalizumab improves the quality of life of severe asthmatic patients.&#x0D; Conclusion: Patients treated with omalizumab have improved their clinical conditions and quality of life, and it can prevent exacerbations by controlling the severity of the condition.&#x0D; Keywords: AQLQ, Allergic asthma, Exacerbation, IgE, Omalizumab.

Response to Omalizumab as an Add-On Therapy in the Treatment of Allergic Asthma in Adult Chinese Patients-A Retrospective Study.

(a) Background: Omalizumab is an anti-IgE humanized monoclonal antibody marketed in China for the conventional treatment of poorly controlled moderate-to-severe allergic asthma. Numerous clinical trials have demonstrated the effectiveness of omalizumab, but the data from studies in actual clinical treatment are still relatively limited. (b) Methods: Thirty-two patients with moderate-to-severe allergic asthma treated with omalizumab on the basis of ICS-LABA (inhaled corticosteroids/long-acting beta2-agonist) were selected. Clinical characteristics before and after treatment were collected to analyze the relationship between changes in serum total IgE levels and peripheral blood EOS (eosinophil) levels, FEV1 (forced expiratory volume in 1 second), PEF (peak expiratory flow), OCS (oral glucocorticoid) dosage, ATC (asthma control test) score, and the number of acute exacerbations and the treatment response, in order to observe the efficacy of omalizumab in addition to primary therapy, and to investigate whether baseline clinical characteristics such as serum total IgE and EOS levels could predict a treatment response. (c) Results: Using the ACT score as an evaluation, 68.75% of patients benefited from omalizumab treatment at the end of 16 weeks. The response group has a reduction in OCS dosage (p-values of 0.026 and 0.039), a significant reduction in ACT scores (both p &lt; 0.001), and a reduction in the number of acute exacerbations (p = 0.034 and 0.025, respectively) after omalizumab treatment. The binary logistics analysis of factors affecting the effectiveness of omalizumab in the treatment of allergic asthma were total serum IgE and the presence of comorbidities (p-values of 0.039 and 0.046, respectively). (d) Conclusions: Combining omalizumab with ICS-LABA for 16 weeks significantly improves asthma symptoms in Chinese adults and can be used as an add-on treatment. In addition, high serum IgE levels and the presence of comorbidities were predictors of its therapeutic efficacy.

Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China

BackgroundOmalizumab is an effective treatment for chronic spontaneous urticaria (CSU) patients aged ≥12 years, but its efficacy in patients aged <12 years has not been fully documented. We evaluated the therapeutic efficacy and safety of omalizumab in Chinese CSU population across all age groups. ObjectivesTo assess the efficacy and safety of omalizumab treatment against CSU in China. MethodsThis study was a retrospective and observational study, and the clinical data of CSU patients treated with omalizumab from October 2018 to August 2021 were collected and analyzed. ResultsWe enrolled 235 patients in this study, and 54.0% (n = 127/235) of patients were female. All patients received at least three injections of omalizumab treatment, and the mean treatment duration was 3.4 ± 1.0 months. At the end of week-12, 98.7% (n = 232/235) of patients responded to omalizumab, among which 91.1% (n = 214/235) achieved a complete response (CR). An excellent response to omalizumab treatment was observed across all ages. All patients aged <12 years (n = 26) achieved a CR at the end of week-12, and clinical improvement was maintained until treatment cessation. Eighty-seven patients received 3–9-month follow-up after the end of treatment, with a mean duration of 5.7 ± 2.0 months, and 17.2% (n = 15/87) patients experienced recurrence after discontinuing treatment. No factors associated with therapeutic response and recurrence to omalizumab treatment were found in this study. ConclusionOmalizumab is a safe and efficacious therapy for CSU patients, including those aged <12 years. We recommend addition of omalizumab to the treatment regimen in CSU patients under 12 years of age. Trial registration numberThis study was registered in Chinese Clinical Trial Registry (www.chictr.org.cn, Registration number: ChiCTR2200056599).

Omalizumab and allergen immunotherapy for respiratory allergies: A mini-review from the Allergen-Immunotherapy Committee of the Italian Society of Pediatric Allergy and Immunology (SIAIP).

Although currently approved to treat severe asthma and chronic spontaneous urticaria, omalizumab has also been an effective and safe add-on treatment for other allergic diseases. Namely, omalizumab has been proposed to be used as add-on therapy in patients with allergic rhinitis and asthma and undergoing specific allergen immunotherapy (AIT). AIT is the only treatment that modifies the natural history of IgE-mediated diseases. This brief review summarizes the available evidence and controversies on the efficacy and safety of omalizumab combined with specific AIT.

OMALIZUMAB FOR SKEETER SYNDROME: THREE SUCCESSFULLY TREATED PATIENTS

<h3>Introduction</h3> Skeeter syndrome is a rare disease associated with an overwhelming immunologic response to proteins in mosquito saliva. Typical symptoms include large local reactions, hives, swelling, blisters, fever, malaise and rarely anaphylaxis. Prevention measures include mosquito avoidance, use of insect repellants and prophylaxis with oral nonsedating H1 antihistamines. Systemic steroids are often required for severe cases. To date there is no FDA-approved treatment for Skeeter syndrome. Thousands of patients in Skeeter syndrome support groups express dissatisfaction with the lack of treatment options. Allergists have similarly been frustrated by the lack of options available for their Skeeter syndrome patients. Case reports have demonstrated the efficacy of omalizumab in treating other blistering disorders such as bullous pemphigoid. I hypothesized that omalizumab would be effective for reducing the severity of these reactions in patients who continue to suffer despite avoidance measures and standard of care. <h3>Case Description</h3> I treated three adult patients with Skeeter syndrome with 300 mg of omalizumab every four weeks initiated one month prior to the onset of summer. Treatment was continued throughout the duration of summer months when mosquito exposure remained highest. Among the three patients treated with omalizumab, over 100 bites were sustained during therapy. All three patients demonstrated a rapid improvement in the size of their local reactions with no further development of bullae after the first dose of omalizumab. <h3>Discussion</h3> This report highlights a potential therapeutic option for a rare disease and calls for further studies to demonstrate the efficacy of omalizumab for Skeeter syndrome.

Regarding the Manufacturing of the Medicine Omalizumab, How Extensively is the Overall Efficacy of Omalizumab Regarding Asthma and Allergies Maintained?

Abstract: A medication that can be used to treat inflammation caused by allergies andasthma, omalizumab, is really a special medication. Omalizumab’s efficacy has been previously tested in both real-life and controlled settings, in previous studies. In those studies Omalizumab is found to be both safe and efficient, for asthma and allergies, evenfor prolonged usage. But my question is, how this safety and efficiency is maintained in omalizumab throughout its manufacturing process. Here, I will be looking at and explaining the process of how omalizumab is maintained, through my insight from an internship at Kashiv Biosciences, a biosimilar pharmaceuticals company

Comparison between chronic spontaneous urticaria and chronic induced urticaria on the efficacy of omalizumab treatment: A systematic review and meta-analysis.

This meta-analysis aimed to assess the efficacy of omalizumab in the treatment of refractory-to-antihistamines chronic induced urticaria (CIndU) in comparison with that of refractory-to-antihistamines chronic spontaneous urticaria (CSU).We retrieved interventional studies and observational studies on omalizumab efficacy to CIndU patients and efficacy comparison between CSU and CIndU both refractory to H1-antihistamines in electronic databases (accessed till May 2022). The odd ratio (OR) and 95% confidence interval (CI) was calculated with a random-effect model in this meta-analysis. The majority of patients with different CIndU subtypes gained complete or partial response and good safety after omalizumab treatment. A total of five studies with 355 CSU patients and 103 CIndU patients were included for the meta-analysis. There was no significant difference in the efficacy of omalizumab in the treatment of CSU and CIndU (OR -0.83, 95% CI [0.84, 2.21], P > 0.05). Based on the validity of omalizumab in the treatment of various CIndU subtypes and non-differential efficacy between CSU and CIndU, it is reasonable to list omalizumab as a third-line treatment of refractory CIndU.