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Autohemotherapy is a commonly used treatment for recalcitrant chronic urticaria in some countries. Herein we report our experience using autologous serum therapy in eight patients with recalcitrant chronic spontaneous urticaria. Autologous serum therapy was initiated weekly for nine weeks followed by every fortnightly. Urticaria Activity Score (UAS) 7, Dermatology Life Quality Index (DLQI), and reduction of antihistamine usage were used to assess the treatment response. Eight patients (age range: 25-76 years old; four females and four males) had one to ten years of duration of recalcitrant chronic spontaneous urticaria. All failed to respond to high doses of second-generation antihistamines and five to immune-modulating agents. Three did not respond to omalizumab. At week nine, the reduction of UAS7 ranged from 76.2 to 100. There was more than an 80 improvement in DLQI in all patients. The number of wheals seemed to be reduced first followed by pruritus. Three patients had stopped antihistamines by week eight of treatment. No adverse events were reported in all eight patients. Autologous serum therapy may serve as an alternative treatment for recalcitrant chronic spontaneous urticaria. Apart from the practicality, which requires frequent clinic visits, venipuncture, and centrifugation, it is cheap and effective with minimal adverse events. Keywords: Atopic dermatitis, autologous serum therapy, omalizumab, recalcitrant chronic spontaneous urticarial, Author(s): Ingrid Ting Pao Lin (corresponding author) [1]; Nurul Izyan Ghazali [2]; Yan Teo [1]; Siaw Ling Lai [1]; Mohammed Faizal Bakhtiar [3]; Min Moon Tang [1] Introduction Chronic spontaneous [...]

Backgrounds: A large proportion of patients with chronic spontaneous urticaria (CSU) are resistant to a standard dose of antihistamine. Acknowledged biomarkers for identifying these patients have not been determined. The neutrophil/lymphocyte ratio (NLR) has been considered as an important indicator of inflammation in chronic diseases. Aims: To explore whether NLR could serve as a biomarker for predicting the response to H1-antihistamine in patients with CSU. Methods: This hospital-based, retrospective study included 109 patients with CSU diagnosed from 2017 to 2020 in our clinic and divided them into two groups by their responses to the 2-week antihistamine therapy of standard-dose: 69 with H1-antihistamine-refractory and 40 with non-H1-antihistamine-refractory CSU. The laboratory test results were collected from the hospital information system and integrated with SPSS software. Results: Patients refractory to H1-antihistamine had significantly higher median NLR (P = 0.039), age (3 P = 0.021), complement C3 (P = 0.026), presence of elevated WBC (P = 0.026) and elevated monocytes (MONO) (P = 0.045) and significantly lower IgM (P = 0.022). The binary logistic regression model revealed that NLR was significantly associated with H1-antihistamine-refractory of CSU (odds ratio (OR) 1.717, 95 confidence interval (CI) 1.065-2.766, P = 0.026), which was consistent with that after adjusted for potential confounding factors including age, complement C3, presence of elevated WBC and MONO, and IgM (OR 1.681, 95 CI 1.019-2.773, P = 0.042). Conclusion: Our results showed a strong and significant association between higher NLR and H1-antihistamine resistance in CSU, suggesting that NLR may be a potential biomarker for predicting the response to H1-antihistamine therapy in patients with CSU. Keywords: Biomarker, CSU, H1-antihistamine, refractory, neutrophil/lymphocyte ratio, Author(s): Xiaonan Qiu [1]; Qiao Ran [1]; Juanjuan Pan [1]; Guozhen Tan (corresponding author) [1] Introduction Chronic urticaria, one of the most frequent skin disorders, is characterized by the presence [...]

Chronic spontaneous urticaria (CSU) involves recurrent, pruritic wheals lasting more than 6 weeks in response to various etiologies, including unknown causality. Though most cutaneous reactions to the COVID-19 vaccine series are self-limited and of short duration, more complex presentations including chronic spontaneous urticaria have been described. To the best of our knowledge, this is the first report of chronic spontaneous urticaria following heterologous mRNA COVID-19 booster vaccination that includes vaccination with both forms of the mRNA vaccine. Our patient received Pfizer-BioNTech for the primary series and Moderna for the booster. After failing several therapies, our patient's urticaria was refractory even to omalizumab. The source for chronic spontaneous urticaria development in our patient may be related to the unique humoral response elicited by receipt of a different mRNA vaccine manufacturer.

Background Methods Results Conclusions Chronic spontaneous urticaria (CSU) exhibits notable responsiveness to omalizumab (OMA). The prognosis and subsequent therapeutic strategies warrant comprehensive exploration in cases exhibiting inadequate responses to OMA.We conducted a multicenter retrospective analysis to investigate the 12‐month prognosis of patients inadequately responding to three injections of OMA. The endpoints encompassed identifying predictive factors for a favorable prognosis and assessing interventions related to an ameliorated prognostic outlook.The study involved 48 patients who met the inclusion criteria. After three OMA administrations, therapeutic interventions included the continuation of OMA in 34 patients, systemic corticosteroids in seven patients, and immunosuppressants in 12 patients. After 12 months, 28 of the 48 patients exhibited a good prognosis, whereas the remaining 20 displayed a less favorable prognosis. Good prognostic determinants encompassed the duration of CSU within 51 weeks, the presence of angioedema, IgE levels ≤100 IU/mL pre‐OMA, blood eosinophil counts ≥100/mm3 post‐OMA, and urticaria control test (UCT) scores ≥5 pre‐OMA and ≥6 post‐OMA. Following the third OMA injection, the implementation of immunosuppressants presented an association with a good prognosis, while the employment of systemic corticosteroids correlated with an unfavorable prognosis.More than half of patients inadequately responding to OMA achieved a good prognosis 12 months later. Several clinical variables appear to be predictive of prognosis, and certain therapeutic agents can be associated with prognostic outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Chronic inducible urticaria (CIndU) is a subtype of chronic urticaria (CU), which requires specific triggers to occur. Despite their common occurrence, treatment response rates and predictors of treatment responses are largely lacking in the literature. This study evaluates antihistamine (AH) and omalizumab response rates in the most common CIndU subtypes and examines whether certain features can predict treatment responses. Methods: We retrospectively analyzed CU patients with at least one CIndU subtype and performed comparisons between subgroups, in a total of 423 patients (70% CIndU, 30% chronic spontaneous urticaria [CSU] plus CIndU). Results: The treatment response rates in CIndU were 51.6%, 51.5%, and 86.5% with standard-dose second-generation H1-antihistamines (sgAHs), updosed/combined sgAH, and omalizumab, respectively. Overall AH response was higher in CIndU than CSU plus CIndU (78.3% vs. 62%, p = 0.002) and in symptomatic dermographism (SD) and cold urticaria (ColdU) than cholinergic urticaria (ChoU) (83.2% vs. 78.3 vs. 60.9%, p = 0.04). AH-refractory patients had a longer disease duration (45.2 ± 56.7 months vs. 37 ± 51.9 months, p = 0.04), more angioedema, accompanying CSU, mixed CIndU subtypes (37.5% vs. 21.1%, p = 0.003; 45.1% vs. 27.1%, p = 0.002; 8.8% vs. 2.4%, p = 0.014), and lower baseline urticaria control test scores (5.86 ± 3.3 vs. 8.6 ± 3.6, p < 0.001) than AH-responsive patients. Conclusion: CIndU exhibits a good response to both AHs and omalizumab. Notably, the response to AHs is more pronounced in SD and ColdU compared to ChoU. Disease duration, angioedema, accompanying CSU, mixed CIndU, and lower baseline UCT scores may be used to predict AH treatment outcome in CIndU. [ABSTRACT FROM AUTHOR]

Delayed pressure urticaria (DPU) is a subset of chronic inducible urticaria. It is characterized by the formation of wheals anytime between 30 minutes and 24 hours after stimulus exposure of localized pressure application. In this case report, we discuss a military flight crew member with no significant past medical history who developed DPU following rapid decompression in an altitude chamber. The chamber training included an uneventful ascent to 45,000 feet, higher than he had been previously, and a rapid decompression. About 16 hours later, he developed pruritic swelling of his hands and feet, along with diffuse deep nodular swelling, erythematous plaques, and erythematous nodules. His DPU was refractory to monotherapy treatment with antihistamines, and he continued to develop lesions in weight-bearing areas. Control of symptoms was achieved through combination treatment of a second-generation antihistamine, a leukotriene receptor antagonist, and an immunosuppressant (cyclosporine). His waiver to return to flight status was denied while on cyclosporine. He was transitioned to a monoclonal antibody that binds free immunoglobin E (omalizumab) with resolution of symptoms and was cleared to return to active duty. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the benefits of combining omalizumab with specific immunotherapy (SCIT) in the treatment of children with bronchial asthma. Methods: In this study, 83 children with asthma were treated at the Allergy Department of Qingdao University from January 2019 to February 2020. Participants were divided into three groups: SCIT, combination (omalizumab + SCIT), and control (standard asthma medications). We assessed Asthma Control Questionnaire (ACQ) scores, Visual Analogue Scale (VAS) scores, and lung function at baseline, 24 wk, and 48 wk. Additionally, asthma medication scores were compared at 24 and 48 wk. Adverse reactions were monitored in both the SCIT and combination groups. Results: The combination group demonstrated lower ACQ scores at both 24 and 48 wk, and improved VAS scores at 48 wk compared to the other groups. Additionally, lung function parameters (FEV1 and FEF50) showed significant improvement in the combination group. Reduced asthma medication scores were noted in the combination group at 24 and 48 wk. Local adverse reactions were fewer in the combination group, and no systemic adverse reactions were reported. Conclusion: Combining omalizumab with SCIT provides quicker asthma control, lowers medication requirements, and enhances lung function with fewer adverse effects, making it a safe and effective treatment for children with bronchial asthma. [ABSTRACT FROM AUTHOR]

Background: Clinical remission has recently been proposed as a possible treatment goal even in severe asthma. In this real-world study, we aimed to assess the achievement rate and predictive factors of clinical remission using omalizumab in patients with severe asthma. Methods: This retrospective observational study included patients with severe asthma initiated with omalizumab therapy and recruited from the asthma clinic of the Akdeniz University Hospital, Turkey. Clinical remission was defined as patients who received no oral corticosteroid (OCS) therapy; showed no exacerbations; showed an asthma control questionnaire score of ≤ 1, asthma control test (ACT) of ≥ 20, or both and, FEV1 of ≥ 80% predicted. Results: A total of 58 patients were included in the study, with an average age of 56.4 ± 13.6 years. The mean duration of asthma was 23.5 ± 11.8 years and the mean duration of omalizumab treatment was 80.05 ± 35.04 months. Clinical remission rates were 25.9% in the first and second year, 34.0% in the third year, 34.1% in the fourth year and 47.4% in the fifth year. Pre-omalizumab ACT, FEV1 (%) and OCS use were significantly higher in patients with clinical remission at 1 year. Logistic regression analyses showed that none of the factors predicted clinical remission. Conclusion: Omalizumab has the potential to induce disease remission in a significant proportion of people with severe asthma, and this is maintained and improved over time. [ABSTRACT FROM AUTHOR]

Key points Omalizumab enables children who are intolerant to AIT to initiate AIT successfully. Combination therapy better improves asthma and rhinitis symptoms, FeNO, and lung function compared to single SCIT or omalizumab treatment. Combination therapy reduces the incidence of adverse reactions during the initial phase of SCIT and enhances its safety. Omalizumab enables children who are intolerant to AIT to initiate AIT successfully.Combination therapy better improves asthma and rhinitis symptoms, FeNO, and lung function compared to single SCIT or omalizumab treatment.Combination therapy reduces the incidence of adverse reactions during the initial phase of SCIT and enhances its safety. [ABSTRACT FROM AUTHOR]

Background Objective Methods Results Conclusion Long‐term data on the effectiveness and safety of omalizumab for chronic inducible urticaria (CIndU) in large populations are lacking.To evaluate the effectiveness, safety, estimated omalizumab treatment duration and its predictors, as well as differences between CIndU subtypes, in a large long‐term CIndU cohort.A multinational multicenter study was conducted at 14 specialized urticaria centres (UCAREs), including all CIndU patients ever treated with omalizumab from 2009 until July 2022. Kaplan–Meier survival and regression analyses were performed.Across 234 CIndU patients (55% female; mean age 37 years), 76% (n = 178) had standalone CIndU and 24% (n = 56) had predominant CIndU plus minor CSU, with an observation period up to 13 years. Most CIndU patients (73%, n = 145/200 with available data on response) had complete/good response to omalizumab treatment, without significant differences between CIndU subtypes. Sixty‐two (26%) patients discontinued omalizumab; due to well‐controlled disease (47%, n = 29), ineffectiveness (34%, n = 21), side effects (3%, n = 2), combination of ineffectiveness and side effects (3%, n = 2) and other reasons (13%, n = 8). The median estimated omalizumab treatment duration exceeded 5 years (54% drug survival at 5 years) and was mostly determined by well‐controlled disease. Higher age predicted a lower chance to discontinue omalizumab due to well‐controlled disease (HR 0.969, 95%CI 0.945–0.995). CIndU subtype and presence of minor CSU were not related to response and time until omalizumab discontinuation for any reason.Omalizumab is highly effective and safe in CIndU patients, with long estimated treatment duration mainly reflecting long disease duration. Our data show omalizumab's high potential as treatment in any subtype of CIndU and support its clinical use for these patients. [ABSTRACT FROM AUTHOR]

Key points: CRSwNP‐specific mean total annual spending ranged from $5,837 (EDS‐FLU) to $28,058 (dupilumab).Most CRSwNP patients receiving biologics had comorbid asthma and did not undergo sinus surgery.While biologics were covered by most Medicare Part D plans, only 37% of plans covered EDS‐FLU. [ABSTRACT FROM AUTHOR]

Introduction: Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) is heterogeneous in both phenotypes and endotypes. Due to insufficient head-to-head comparison studies, it is hard to decide which biological to initiate. This study aimed to compare the efficacy of omalizumab and mepolizumab which can be used in the treatment of patients with severe eosinophilic asthma diagnosed with N-ERD. Methods: The population of this observational, cross-sectional study comprised of N-ERD patients who received omalizumab or mepolizumab for at least 6 months for severe asthma. Outcomes included the asthma control test (ACT), and sino-nasal outcome test scores (SNOT-22), blood eosinophil counts at initiation of biological treatment (T0, baseline) and at the end of 6th months (T6). Adverse effects related to biological treatment and changes of oral corticosteroids dose was recorded. Results: The study included a total of 22 patients, of whom 11 received mepolizumab and 11 received omalizumab. The change in ACT, SNOT-22, eosinophil counts, and adverse effects related to biologicals were similar at T6 (p = 0.606, p = 0.168, p = 0.05, p = 0.053, respectively). However, when examining the SNOT-22 and ACT based on the cumulative distribution curve (SUCRA), mepolizumab (SUCRA value: 0.61, 0.72, respectively) demonstrated greater efficacy compared to omalizumab (SUCRA value: 0.19, 0.35, respectively). The oral corticosteroids discontinuation rate was similar between the two groups (p = 0.05). Conclusion: We found both omalizumab and mepolizumab to be effective in treatment; however, we determined that mepolizumab may have a potential superiority in efficacy. [ABSTRACT FROM AUTHOR]

Purpose: Several studies have shown that subcutaneous injections of omalizumab can treat chronic idiopathic/spontaneous urticaria (CIU/CSU) patients by only assessing the efficacy on specific endpoints. This study aimed to quantitatively analyze different doses of omalizumab in CIU/CSU and compare it with ligelizumab. Methods: Literature searches were performed in PubMed, Embase, and Web of Science databases. A model-based meta-analysis (MBMA) was utilized to develop a model incorporating time since the initiation of treatment and dose for omalizumab, with the change from baseline in Urticaria Activity Score (CFB-UAS7) as the primary efficacy endpoint. The time-course and dose-effect relationship throughout the omalizumab treatment period was analyzed, and the findings were compared with those of the investigational ligelizumab. Results: The model equation for the CFB-UAS7 was established as E = –Emax × time/(ET50 + time) × (b0 + b1 × dose). The estimated values of the model parameters E max , ET 50 , b 0 , and b 1 were −1.16, 1.26 weeks, −9.90, and −0.0361 mg−1, respectively. At week 12 after the first dose, the model-predicted CFB-UAS7 for 150 mg and 300 mg of omalizumab were −16.0 (95% CI, −17.2 to −14.8) and −21.7 (95% CI, −22.9 to −20.5), respectively. In the PEARL-1 trial, the CFB-UAS7 for 72 mg and 120 mg of ligelizumab were −19.4 (95% CI, −20.7 to −18.1) and −19.3 (95% CI, −20.6 to −18.0), respectively. In the PEARL-2 trial, these values were −19.2 (95% CI, −20.5 to −17.9) and −20.3 (95% CI, −21.6 to −19.0), respectively. Conclusion: Omalizumab showed a significant dose-dependent effect in the treatment of CSU. Both 72 mg and 120 mg ligelizumab might have the potential to outperform 150 mg (but not 300 mg) omalizumab. [ABSTRACT FROM AUTHOR]

Purpose: Research and regulatory approval for pediatric uses of prescription drugs often lag years after adult approvals, during which time substantial off‐label use of medications in children can occur. We evaluated whether US Food and Drug Administration (FDA) regulatory actions affected the pediatric use of omalizumab, a biologic drug used to treat asthma. Methods: In this serial cross‐sectional study, we identified quarterly cohorts of children (0–18 years) with moderate‐to‐severe asthma within two large national claims databases of those with commercial insurance and Medicaid from 2003 to 2019. Using an interrupted time‐series analysis, we fit segmented linear regression models to identify changes in the incidence of omalizumab use in 6–11‐year‐old children compared with 12–18‐year‐olds after two time points: (1) 2009Q3 when an FDA advisory committee voted against use for 6–11‐year‐old children and (2) 2016Q2 when FDA expanded omalizumab's labeling to include 6–11‐year‐old children. Results: We identified 9298 new pediatric omalizumab users (84% Medicaid). Among 6–11‐year‐old children, the incidence of omalizumab use did not change following the FDA's initial review of evidence in 2009 and increased after 2016 Q2 FDA approval for this age group in both Medicaid (58 per 100 000 children with asthma, 95% confidence interval [CI] 27–89, p < 0.001) and commercial insurance (57 per 100 000, 95% CI 21–94, p = 0.003) compared with 12–18‐year‐old children. Conclusions: The use of omalizumab among asthmatic children aged 6–11 years remained steady after FDA advisory committee concerns in 2009 and increased after FDA expanded the indication to include this population in 2016. Additional market incentives may help to ensure the timely generation of evidence and regulatory approval of medications for children. [ABSTRACT FROM AUTHOR]

Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan–Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, χ2 = 9.692), without autoimmune thyroiditis (p = 0.007, χ2 = 12.037), and those with higher IgE levels (p = 0.039, χ2 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393–15.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128–8.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness. [ABSTRACT FROM AUTHOR]

Background Objective Methods Results Conclusions Trial Registration Number In Europe, Omalizumab (anti‐IgE) is indicated for the treatment of moderate to severe asthma, but not for IgE‐mediated food allergy (FA).We assessed the impact of Omalizumab on efficacy, safety, and quality of life (FA‐QoL) in patients with moderate to severe asthma and who have a history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat.Food‐allergic children (6–18 years) with moderate to severe asthma underwent oral food challenges (OFCs) to establish the threshold of reaction to the culprit food(s) at baseline (T0) and at 4‐month intervals (T1, T2, and T3) during their first year of treatment with Omalizumab. We recorded the number and severity of food‐allergic reactions, Asthma Control Test (ACT) scores, FA‐QoL, and total IgE levels.In 65 patients allergic to 107 foods, the No Observed Adverse Events Level (NOAEL) at T1 increased: 243‐ and 488‐fold for fresh and baked milk, respectively; 172‐ and 134‐fold for raw and baked egg; 245‐fold for hazelnut; 55‐fold for peanut; 31‐fold for wheat; and 10‐fold for fish. Full tolerance was achieved in 66.4% of OFCs at T1, 58.3% at T2, and 75% at T3. Ninety‐five foods were liberalized in the diet of 55 patients; the remaining 12 were introduced by 10 patients at least in traces. Throughout the study, 40 out of 65 were able to get a free diet. ACT increased from 17 (Q1‐Q3: 15–17) to 23.6 (Q1‐Q3: 23–25). The FA‐QoL score in children ≤12 years decreased from 4.63 ± 0.74 to 2.02 ± 1.13, and in adolescents from 4.68 ± 0.92 to 1.90 ± 1.50.During Omalizumab therapy, a safe reintroduction of allergenic foods is feasible.ClinicalTrials.gov, NCT06316414. [ABSTRACT FROM AUTHOR]

Background: Chronic spontaneous urticaria (CSU) is a highly prevalent and difficult to manage cutaneous disease characterized by the presence of recurrent urticaria, angioedema, or both, for a period of 6 weeks or longer. One of the biological treatments used for patients with CSU with an autoimmune background and bad control of the disease is omalizumab, an anti-IgE monoclonal antibody. The understanding of the mechanism of action of this biological drug in CSU along with the identification of potential biomarkers of clinical response can be helpful in the personalized management of the disease. Objective: The purpose of this study was to analyze the effect of omalizumab on peripheral blood lymphocyte subpopulations in patients with CSU in order to identify potential biomarkers of treatment response. Methods: We analyzed 71 patients with CSU [33 under omalizumab and 38 under non-immunomodulatory drugs (treated with antihistamines; NID)] and 50 healthy controls. An exhaustive immunophenotyping of whole blood T-cell subpopulations, including naïve, central memory, effector memory, effector cells, Th1, Th2, and Th17 was performed by multiparametric flow cytometry. Moreover, in CSU patients, we analyzed markers of inflammation (ESR, DD, CRP), atopy (prick test, IgE quantification), and autoimmunity (anti-thyroid antibodies and indirect basophil activation test).To evaluate the clinical activity, the Urticaria Activity Score 7 (UAS 7) test was used. Results: In patients with CSU under treatment with omalizumab, there was a significant decrease in the percentage of naïve and an increase in the percentage of central memory CD4 T cells as well as a decrease in the percentage of naïve and increase in the percentage of effector CD8 T-cell subsets. Moreover, patients under treatment with omalizumab had higher percentages of Th1 and Th2 cells than patients under treatment with NID. Conclusion: The immune monitoring of T-cell subpopulations in patients with CSU starting omalizumab, may be a useful strategy to analyze treatment response in the clinical practice. [ABSTRACT FROM AUTHOR]

Chronic spontaneous urticaria (CSU) is associated with skin mast cell activation, and its triggering mechanisms are not completely elucidated. Evidence suggests an autoimmune component of CSU. Our aim was to assess the usefulness of an autoimmune mast cell activation test (aiMAT) for diagnosing and differentiating CSU into different subtypes. We enrolled 43 patients with active, uncontrolled CSU before starting treatment with omalizumab and 15 controls. Patients were evaluated based on omalizumab response. aiMATs were performed using non-IgE-sensitized (NS) or myeloma IgE-sensitized (S) LAD2 cells, which were then stimulated with CSU/control sera (25 µL and 10 µL). The expression of CD63 was assessed with flow cytometry. CD63 response on NS-LAD2 was significantly increased in CSU patients compared to controls after the stimulation with 25 µL CSU/control sera (p = 0.0007) and with 10 µL CSU/control sera (p = 0.0001). The ROC curve analysis demonstrated an area under the curve (AUC) of 0.82. The cutoff for autoimmune-non-IgE-sensitized-MAT was 40.3% CD63+ LAD2, which resulted in 73.3% sensitivity and 81.4% specificity. CD63 response on S-LAD2 was significantly increased in CSU patients compared to controls after the stimulation with 25 µL CSU/control sera (p = 0.03). The ROC curve analysis demonstrated an AUC of 0.66. The cutoff for the autoimmune-myeloma IgE-sensitized-MAT was 58.4% CD63+ cells, which resulted in 62.8% sensitivity and 66.7% specificity. Overall, 36 out of 43 (84%) patients responded to omalizumab, and 7 (16%) were nonresponders. We found no differences between LAD2 CD63 response and response to omalizumab. In conclusion, aiMAT could represent a new diagnostic tool in CSU. Additional studies are needed to evaluate the potential benefits during omalizumab therapy. [ABSTRACT FROM AUTHOR]

Background Bullous pemphigoid (BP) is the most common autoimmune blistering disease. Most patients are older and have associated multiple comorbidities. Topical and systemic corticosteroids are considered the first-line treatment for BP, and immunosuppressants are used as steroid-sparing treatments. However, both have side-effects and contraindications, which are even more common in this older population. New treatments targeting interleukins and receptors related to BP pathogenesis have been proposed to decrease these side-effects while achieving equal or better effectiveness and response rates. Omalizumab is a monoclonal antibody that targets IgE and has been proposed for the treatment of BP due to the evidence that IgE autoantibodies play an essential role in BP pathogenesis. Objectives To assess the efficacy and safety of omalizumab for the treatment of BP. Methods We carried out a multicentre, retrospective, observational study including patients diagnosed with BP who received omalizumab for ≥ 3 months from 15 tertiary hospitals in Spain. IgE levels prior to treatment were measured, and we evaluated the possible correlation with clinical response. We excluded patients treated with omalizumab for < 3 months, as we consider this duration to be insufficient for a comprehensive assessment of its efficacy. To evaluate the effectiveness of the treatment, we used the percentage of body surface area improvement. Results We included 36 patients. The vast majority had associated multiple comorbidities, and all patients had used other systemic therapies apart from corticosteroids before omalizumab. In total, 83% experienced some kind of treatment response and 42% of all patients treated achieved complete response. We did not find any correlation between higher IgE levels and a better response (P = 0.2). All patients tolerated omalizumab without reported side-effects. Conclusions Omalizumab is a good therapeutic alternative for BP as it provided clinical response in most patients, and nearly one-half of the cases achieved complete response. It showed no side-effects, which is crucial in older patients with BP. [ABSTRACT FROM AUTHOR]

Background: Limited information is available on the use of omalizumab (OMA) updosing since its introduction as a second‐line therapy in chronic spontaneous urticaria (CSU) in 2014. Practical guidelines from health authorities are lacking, and the specific characteristics of patients requiring higher doses remain unknown. Our objectives were to characterize the patterns of OMA updosing (defined as changes in dose and/or injection intervals), to identify the predictive factors associated with updosing, and to improve CSU management. Methods: We conducted a prospective, multicentric, real‐life observational study, including patients diagnosed with CSU and starting OMA. The data were collected at 0, 3, 6, and 9 months. The primary endpoint was the frequency of OMA updosing at 3 months. The secondary endpoints included an analysis of updosed patients' profile, and an assessment of OMA efficacy and safety. Results: We included 153 patients. Twenty percent of patients were updosed at 3 months, and 27% in total during the 9‐month follow‐up. Practitioners mainly chose to increase the frequency of injections (66%). At baseline, the updosed patients were more likely to have more severe CSU (UCT < 4, p < 0.030), a lower lymphocyte count (<2000/mm3, p = 0.037), and low IgE levels (<70 UI/mL, p = 0.024). The side effects of OMA were not more frequent after updosing. Conclusion: One in five patient underwent updosing within just 3 months. OMA updosing is frequent in particular in cases of severe disease and low IgE blood levels. [ABSTRACT FROM AUTHOR]

This article discusses a retrospective cohort study that aimed to predict relapse in patients with chronic spontaneous urticaria (CSU) who were treated with omalizumab. CSU is a condition that affects a small percentage of the population and significantly impacts patients' quality of life. Omalizumab is the only registered therapy for CSU, but its discontinuation remains uncertain. The study found that approximately 30% of patients achieved long-term remission after 24 weeks of therapy, and most relapse episodes occurred within the first 6 weeks after treatment discontinuation. Factors such as higher Urticaria Activity Score (UAS7) after 24 weeks, longer time to treatment, and prior relapses increased the risk of relapse, while Hashimoto's disease favored remission. The findings can help determine appropriate treatment duration and withdrawal regimens. Further research is needed to optimize omalizumab withdrawal and identify additional predictive factors for long-term remissions and relapse rates in CSU patients. [Extracted from the article]

Objective: Modification of the immune system with biologics raises theoretical concerns about the risk of infections but it is still unclear whether currently routinely used biologics in severe asthma may facilitate the development of pneumonia. Therefore, we aimed to determine whether omalizumab, mepolizumab, benralizumab, and dupilumab are associated with pneumonia in a real-world setting. Methods: A retrospective disproportionality analysis was performed using adverse event (AE) reports submitted to FAERS from January 2020 to September 30, 2023. MedDRA was used to identify infections and infestations and then pneumonia cases. ROR and PRR were used to measure disproportionality. Results: The percentage of reported cases of pneumonia compared to infections and infestations was highest for mepolizumab (36.8%), followed by omalizumab (32.6%), benralizumab (19.2%) and dupilumab (5.7%). We found a moderate or strong signal for increased risk of pneumonia with mepolizumab (ROR = 3.74, 95%CI 3.50–4.00), omalizumab (ROR = 3.26, 95%CI 3.06–3.49) and benralizumab (ROR = 2.65, 95%CI 2.49–2.83). Conclusions: Mepolizumab, omalizumab and benralizumab, but not dupilumab, were associated with high odds of reporting pneumonia. Our results represent only potential associations between these biologics and pneumonia but not causality. The nature of the FAERS database is such that the cause of the reported events is uncertain. Therefore, we can only roughly estimate the incidence of AEs by the signal strength (ROR value). Nevertheless, although causality could not be assessed, the signal from our study is interesting. We believe it deserves to be further substantiated by real-world studies with robust designs. [ABSTRACT FROM AUTHOR]

Background: The intrinsic link between food allergy and asthma is well-established, and comorbidity can exacerbate both conditions. Omalizumab, an anti-immunoglobulin E (IgE) antibody, has the biological plausibility to manage both conditions, but only a few small studies have assessed omalizumab in patients with comorbid asthma and food allergy. Patients and Methods: We conducted a post hoc analysis of placebo-controlled, randomized clinical trials (IA05 in children and 008/009 in adolescents/adults) and real-world observational studies (EXCELS and PROSPERO). For each study, patients with asthma were stratified by whether they had physician-reported food allergy, as per baseline characteristics data. Results: For patients with comorbid food allergy, there was evidence for increased atopy at baseline (numerically higher total IgE levels and atopic comorbidities). The collective body of evidence found that omalizumab consistently improved general and asthma-specific patient-centered outcomes (food allergy-specific outcomes were not available). For patients with asthma, omalizumab improved healthcare resource use (emergency room visits, hospitalizations, unscheduled doctor visits), quality of life (asthma-specific Asthma Quality of Life Questionnaire), productivity (missed work/school days and the Work Productivity and Activity Impairment: Asthma), and asthma outcomes (asthma exacerbations and Asthma Control Test score) regardless of comorbid food allergy. Conclusion: There was no loss of omalizumab efficacy even though patients with both asthma and food allergy appeared to be generally more atopic. Omalizumab may be a viable management option for patients with these comorbidities. Clinical trial registration: NCT00079937; NCT01922037; NCT00252135. Plain Language Summary: Food allergy and asthma are linked and if you have both conditions then you can feel worse. There is a treatment available, called omalizumab, that helps people with asthma and helps people with food allergy, but it's not clear if it can help people with both conditions. Here, we look at whether omalizumab can help people with bad to very bad asthma (also called moderate to severe asthma) who also have food allergy. We found that omalizumab improved many aspects of a person's life, including whether they visited the emergency room, were admitted to hospital, their quality of life, whether they missed school or work, and whether their asthma improved. These improvements occurred in all people with moderate to severe asthma, whether they had food allergy or did not have food allergy. This suggests that omalizumab can help people with both conditions. [ABSTRACT FROM AUTHOR]

Autohemotherapy is a commonly used treatment for recalcitrant chronic urticaria in some countries. Herein we report our experience using autologous serum therapy in eight patients with recalcitrant chronic spontaneous urticaria. Autologous serum therapy was initiated weekly for nine weeks followed by every fortnightly. Urticaria Activity Score (UAS) 7, Dermatology Life Quality Index (DLQI), and reduction of antihistamine usage were used to assess the treatment response. Eight patients (age range: 25–76 years old; four females and four males) had one to ten years of duration of recalcitrant chronic spontaneous urticaria. All failed to respond to high doses of second-generation antihistamines and five to immune-modulating agents. Three did not respond to omalizumab. At week nine, the reduction of UAS7 ranged from 76.2% to 100%. There was more than an 80% improvement in DLQI in all patients. The number of wheals seemed to be reduced first followed by pruritus. Three patients had stopped antihistamines by week eight of treatment. No adverse events were reported in all eight patients. Autologous serum therapy may serve as an alternative treatment for recalcitrant chronic spontaneous urticaria. Apart from the practicality, which requires frequent clinic visits, venipuncture, and centrifugation, it is cheap and effective with minimal adverse events.