Omalizumab Initiation Research Articles

Lin-CD117+CD34+FcεRI+ progenitor cells are increased in chronic spontaneous urticaria and predict clinical responsiveness to anti-IgE therapy.

Chronic spontaneous urticaria (CSU) is a common, debilitating skin disorder characterized by recurring episodes of raised, itchy and sometimes painful wheals lasting longer than 6 weeks. CSU is mediated by mast cells which are absent from peripheral blood. However, lineage-CD34hiCD117int/hiFcεRI+ cells in blood have previously been shown to represent a mast cell precursor. We enumerated FcεRI-, FcεRI+ and FcεRIhi lineage-CD34+CD117+ cells using flow cytometry in blood of patients with CSU (n = 55), including 12 patients receiving omalizumab and 43 not receiving omalizumab (n = 43). Twenty-two control samples were studied. Disease control and patient response to omalizumab was evaluated using the urticaria control test. We performed single-cell RNA sequencing (scRNA-Seq) on lineage-CD34hiCD117hi blood cells from a subset of patients with CSU (n = 8) and healthy controls (n = 4). CSU patients had more lineage-CD34+CD117+FcεRI+ blood cells than controls. Lineage-CD34+CD117+FcεRI+ cells were significantly higher in patients with CSU who had an objective clinical response to omalizumab when compared to patients who had poor disease control 90 days after initiation of omalizumab. scRNA-Seq revealed that lineage-CD34+CD117+FcεRI+ cells contained both lymphoid and myeloid progenitor lineages, with omalizumab responsive patients having proportionally more myeloid progenitors. The myeloid progenitor lineage contained small numbers of true mast cell precursors along with more immature FcεRI- and FcεRI+ myeloid progenitors. Increased blood CD34+CD117+FcεRI+ cells may reflect enhanced bone marrow egress in the setting of CSU. High expression of these cells strongly predicts better clinical responses to the anti-IgE therapy, omalizumab.

Results of omalizumab treatment in chronic eosinophilic pneumonia: Real-life data.

Recurrences occur when corticosteroid therapy is discontinued or reduced during the treatment of chronic eosinophilic pneumonia (CEP). The probability of recurrence is once in 50% of patients and twice or more in 25%. In such instances, new treatment options are deemed necessary. This study aims to assess the efficacy of omalizumab treatment as a steroid-sparing drug in patients with CEP. The clinical features of patients treated with omalizumab for recurrent CEP were evaluated retrospectively before and after treatment. All data from patients and diagnoses were reviewed. The effects of treatment on recurrence rate, oral corticosteroid (OCS) use and lung functions, peripheral eosinophil values, and symptom scores were evaluated. Radiological regression was also evaluated. In the final analysis, we included ten patients with a median follow-up of 22 months after initiation of omalizumab. During this follow-up period, the results were associated with a significant reduction in the number of asthma attacks per year, the number of CEP relapses, the rate of hospitalization, the amount of corticosteroids consumed daily, and the total corticosteroid dose. In addition, improvement was observed in the symptom scores and lung functions of the patients. Systemic steroids were completely discontinued in two patients receiving omalizumab treatment. In other patients, the mean steroid dose was reduced by 77.2 percent in the first year of omalizumab treatment and 82 percent in the second year, respectively. Nevertheless, there was no elevation in peripheral eosinophil count, and radiological regression was observed. Omalizumab can be an effective treatment for CEP and can be used as a steroid-sparing agent.

Effectiveness of omalizumab across different dosing regimens in patients with moderate-to-severe allergic asthma

For patients with moderate-to-severe persistent allergic asthma, omalizumab is approved for subcutaneous administration according to a recommended dosing table based on weight and total immunoglobulin E (IgE) level. The aim of this analysis was to assess asthma outcomes including quality of life in patients with allergic asthma initiated on omalizumab in the PROSPERO trial; patients were stratified by where their IgE and body weight fell on the approved dosing table. Patient groups were defined as Inside Dosing Table: patients whose IgE and weight fell within the approved dosing table (n = 506); Insufficient Data to Recommend a Dose: patients who fell into the section of the approved dosing table where not enough clinical data were available to make dosing recommendations (n = 72); and Outside Dosing Table: patients who fell outside the approved dosing table due to baseline IgE and/or weight (n = 209). Overall, asthma and quality of life outcomes were improved after omalizumab initiation for both patients who fall within the recommended dosing table or those who fall outside the recommended dosing table. Our results suggest that omalizumab treatment may be effective in a wide range of patients with moderate-to-severe allergic asthma.ClinicalTrials.gov identifier NCT01922037.

Omalizumab for Chinese patients with moderate-to-severe allergic asthma in real-world clinical setting: a prospective, observational study

BackgroundWe aimed to investigate the effectiveness of omalizumab, a monoclonal anti-immunoglobulin E antibody, in Chinese patients with moderate-to-severe allergic asthma in real-world clinical practice.MethodsThis single-centre, prospective, observational study included Chinese...

Delayed‐type hypersensitivity gastrointestinal symptoms induced by food oral immunotherapy and efficiently treated by dupilumab: A case report

Delayed‐type hypersensitivity gastrointestinal symptoms induced by food oral immunotherapy and efficiently treated by dupilumab: A case report

EE6 Economic Burden of Severe Asthma in Adults and Children Treated With Omalizumab From 2012 to 2019

Uncontrolled asthma is a condition associated with high morbidity and healthcare costs. We described healthcare resource use (HCRU) and related costs in asthma adults and children treated with omalizumab (OMA) before and after OMA initiation (T0).

Real-world effectiveness of omalizumab for severe allergic asthma treatment in Colombia

BackgroundThe allergic phenotype is responsible for more than 50% of severe asthma cases. In a stepwise approach, add-on treatments such as anti-IgE are used for severe allergic asthma (SAA). This study was aimed to describe the real-world effectiveness of omalizumab in adult and pediatric patients with SAA in Colombia.MethodsThis was an observational, non-interventional, retrospective study. Data from patients with SAA that received at least one month of treatment with omalizumab was obtained from medical records at eight sites in Colombia. Time-zero (t − 0) was defined as the date of initiation of omalizumab, and data was gathered for a 12-month period before t − 0 and a 12-month period after t − 0. Clinical outcomes, including exacerbations, were assessed at 6 and 12 months. Effectiveness of omalizumab was evaluated in terms of the reduction of the risk of exacerbations (annualized rate).ResultsWe included 143 patients with SAA. There was a decrease of 72.4% of the annualized rate of clinically significant asthma exacerbations during the year after omalizumab (from 1.74 before to 0.48 after) with a substantial reduction of the risk of exacerbations by 56.7% (RR [95% CI] 0.43 [0.30–0.63] p < 0,001).ConclusionThe use of omalizumab in Colombia as a treatment for SAA notably reduced the risk of clinically significant exacerbations. This study is the first to evaluate omalizumab real-life effectiveness in pediatric and adult patients in the country.

OMALIZUMAB TREATMENT OF CHRONIC SPONTANEOUS URTICARIA: EFFECTIVENESS AND SATISFACTION ASSESSED BY A REAL-WORLD SURVEY

<h3>Introduction</h3> Chronic spontaneous urticaria (CSU) is a debilitating disorder characterized by recurrent itch, hives, and angioedema. Omalizumab is approved for treatment of CSU and here we describe real-world effectiveness and satisfaction. <h3>Methods</h3> Physician-reported and patient-reported data were collected via the Adelphi CSU Disease Specific Programme™ (cross-sectional survey; United States; Q4:2020-Q3:2021). We describe outcomes for patients with moderate-to-severe CSU after initiation of omalizumab (OMA; n=129) versus other prescription medication (non-OMA; n=222). Bivariate analysis was conducted. <h3>Results</h3> Patients on OMA (mean(SD) 43.8(15.3) years; 66.7% female) were on their current treatment for mean(SD) 2.0(2.0) versus 1.2(1.5) years for patients on non-OMA (mean(SD) 38.8(13.7) years; 64.0% female). Following treatment initiation, proportion of patients experiencing moderate-to-severe severity declined to 15.6% and 34.7% for OMA and non-OMA groups (p<0.001), and more patients on OMA than non-OMA reported resolution of itch/hives (46.0/57.9% versus 27.4/39.2%; p<0.001). Patient-reported quality of life was better for OMA than non-OMA (mean(SD) Dermatology Life Quality Index score 2.4(3.6) versus 4.6(6.0); p<0.001). A greater proportion of patients on OMA (78.1%) versus non-OMA (55.4%) were satisfied the best control had been achieved with their current treatment (p<0.001). Satisfaction levels (of 8-10, range 0-10 with 10=extremely satisfied) with OMA were reported for symptom relief (by 87.7% of patients), quick onset of action (79.5%), tolerability (85.2%), convenience (59.0%), and dosing frequency (56.5%). <h3>Conclusions</h3> Patients with moderate-to-severe CSU at initiation of omalizumab experienced better treatment outcomes, reported better quality of life, and had a higher level of satisfaction with treatment than patients initiated on other prescription medications.

EFFECT OF SEX ON RESPONSE TO OMALIZUMAB IN PATIENTS WITH ASTHMA

<h3>Introduction</h3> There are sex-related disparities in asthma. Before puberty, males have increased prevalence and severity of asthma compared with females, and this pattern reverses after the onset of puberty. Omalizumab, an IgE antibody, is an effective treatment for allergic asthma, but sex-specific responses have not been studied in detail. <h3>Methods</h3> Post hoc analysis examined data from randomized, placebo-controlled IA05 trial of omalizumab treatment (52 weeks; 75-375 mg sc every 2-4 weeks; N=627; 6 to <12 years, ie children) and open-label, single-arm PROSPERO study (NCT01922037; 48-weeks; N=801; ≥12 years ie adolescents/adults (n=732 ≥18 years); both included patients with moderate-severe allergic asthma. <h3>Results</h3> In IA05/PROSPERO, baseline characteristics of mean age and IgE levels were similar for female and male participants (females 8.4/47.8 versus males 8.6/46.2 years; IgE levels females 463.2/560.3 versus males 472.8/615.0 IU/mL). Asthma exacerbation rates following omalizumab treatment were similar for females and males. In IA05 (children), asthma exacerbation rates were: females - placebo 0.74 versus omalizumab 0.46, males - placebo 0.55 versus omalizumab 0.43, and the interaction test of effect of sex on omalizumab response was not significant (p=0.4821). In PROSPERO (adolescents/adults), asthma exacerbation rates in females were 0.74 versus males 0.77 (p=0.787). Overall safety reported previously for IA05, Lanier JACI 2009;124;1210-6 and PROSPERO, Casale JACI:IP 2019;7(1):156-64. <h3>Conclusions</h3> Despite differences in asthma between females and males, we found no evidence that the effect of omalizumab in children was dependent on sex, and no evidence that the rate of exacerbations was dependent on sex following omalizumab initiation in adolescents/adults.

TIME TO CLINICALLY MEANINGFUL RESPONSE TO OMALIZUMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA

<h3>Introduction</h3> Chronic spontaneous urticaria (CSU) is a debilitating skin disorder associated with decreased quality of life and psychological comorbidities. Omalizumab is currently the only biologic approved for the treatment of CSU, however data is lacking describing the pattern of response to omalizumab, including the time to a clinically meaningful response. <h3>Methods</h3> Post-hoc analysis examined pooled data from ASTERIA-I (N=319; NCT01287117) and ASTERIA-II (N=323; NCT01292473; for both studies - injections every 4 weeks of omalizumab 150mg, 300mg, or placebo). Time to minimally important difference (MID) (reduction from baseline ≥11) analyses were performed via Kaplan-Meier curves, and percent responders/complete responders to 12 weeks (weekly). Responders were defined as Urticaria Activity Score (UAS; range 0 [no symptoms] to 42)7≤6; complete responders defined as UAS7=0. <h3>Results</h3> Time to MID analyses revealed statistical superiority of omalizumab compared with placebo (P<0.0001 for both doses); median time to MID, 5 weeks for placebo and 2 weeks for 150mg/300 mg omalizumab (Figure). The percent of responders/complete responders to omalizumab increased dose-dependently over time. At Week 1, percent of responders was greater for omalizumab (150mg 6.2%, 300mg 6.3%) than placebo (1.9%). By Week 12, percent of both responders and complete responders was greater for omalizumab (150mg 41.4%/18.5%, 300mg 58.8%/40.0%) than placebo (15.1%/6.9%). Overall safety results are available (Saini JID 2015;135;67-75; Maurer NEJM 2013;368:924-935). <h3>Conclusions</h3> Patients with moderator-severe CSU on omalizumab had a significantly superior time to clinically meaningful response compared with placebo, and improvements in urticaria symptoms were observed as early as 1 week after omalizumab initiation.

Severe non-atopic asthma: omalizumab can reduce severe asthma exacerbations

Introduction Humanized monoclonal anti-IgE antibody (omalizumab) has demonstrated efficacy in severe atopic asthma. However, few studies have assessed its efficacy in non-atopic and even less in T2-low severe asthma. The objective was to determinate the omalizumab response according to atopic status. Methods This retrospective, real-world study was performed in the Chest Diseases Department of Strasbourg University Hospital from January 1, 2006, to June 30, 2017. The response to omalizumab was assessed in 139 patients 4, 6, and 12 months after treatment and compared to data collected prior to omalizumab initiation. Results Forty-four patients (31.7%) had severe non-atopic asthma and 95 (68.3%) had a severe atopic asthma. In the non-atopic group, omalizumab significantly reduced the severe exacerbation rate by 44% (95% CI 18-64%, p < 0.05), 43% (CI 95% 20-60%, p < 0.05), and 54% (CI 95% 36-67%, p < 0.05), at 4, 6 and 12 months, respectively. A trend toward improvement in FEV1, asthma control and oral corticosteroid use was also observed. These results were not significantly different from those obtained in atopic asthmatics except a more effective oral corticosteroid sparing in atopic group (p < 0.05). Similar reduction of severe exacerbation rates were observed in T2-low asthma subgroup (non-atopic, non-eosinophilic). Conclusion Omalizumab was effective in severe asthma, regardless of atopic status.

Real-life omalizumab exposure and discontinuation in a large nationwide population-based study of paediatric and adult asthma patients

This real-life study aimed to assess omalizumab treatment patterns in adult and paediatric asthma patients, and to describe asthma control and healthcare resource use (HCRU) at omalizumab initiation and discontinuation. The French healthcare database system (Système National des Données de Santé (SNDS)) was used to identify asthma patients aged ≥6 years who initiated omalizumab for at least 16 weeks from 2009 to 2019. We examined omalizumab treatment patterns using dispensation records. We identified 16 750 adults and 2453 children initiating omalizumab. Median treatment persistence before discontinuation (TSTOP) was 51.2 (95% CI 49.3-53.4) months in adults and 53.7 (95% CI 50.6-56.4) months in children. At 2 years of omalizumab exposure, rate of hospitalisation for asthma decreased by 75% and use of oral corticosteroids (OCS) by 30%, in adults and children. Among adults who discontinued omalizumab while asthma was controlled, 70%, 39% and 24% remained controlled and did not resume omalizumab at 1, 2 and 3 years after discontinuation, respectively. These proportions were higher in children (76%, 44% and 33%, respectively). Over 2 years of follow-up after discontinuation, HCRU remained stable in adults and children, notably rate of hospitalisations for asthma (none before TSTOP, 1.3% and 0.6% at 2 years) and use of OCS (in adults and children, respectively: 20.0% and 20.2% before TSTOP, 33.3% and 24.6% at 2 years). This is the first large-scale study describing omalizumab real-life exposure patterns in adult and paediatric asthma patients in France with >10 years of follow-up. We showed the long-term maintenance of low HCRU in adults and children who discontinued omalizumab while asthma was controlled, notably for OCS use and hospitalisations for asthma.

Long-term outcome of omalizumab-assisted desensitisation to cow's milk and eggs in patients refractory to conventional oral immunotherapy: real-life study.

Oral immunotherapy (OIT) is a promising approach to cow's milk and egg allergies, but reactions are frequent and some patients cannot be desensitized. To evaluate long-term OIT outcomes with omalizumab (OMZ) in paediatric patients with severe egg and/or milk allergies. This retrospective real-life study analysed findings in children with Immunoglobulin E-mediated allergy to cow's milk and/or hen eggs refractory to conventional OIT, who underwent OIT with OMZ in our department between 1 January 2010 and 31 December 2015. In all, 41 patients were included (median age: 7 years; interquartile range [IQR]: 5.5-9.5); 26/41 (63.4%) underwent OIT for milk, 8/41 (19.5%) for egg and 7/41 (17.1%) for both. The median time between initiation of OMZ and OIT was 27 weeks (IQR: 22-33). Forty (97.56%) patients reached the maintenance phase (200 mL of cow's milk and 30 mL of raw egg or 1 cooked egg) in a median time of 27 weeks (IQR: 18-37). The median total time with OMZ was 117 weeks (IQR: 88-144). During the OMZ period, 2.44% (1/41) of patients presented anaphylaxis. After discontinuation of OMZ, 29.3% (12/41) presented anaphylaxis, 50% of them had a poor adherence to daily ingestion. One patient (2.44%) was diagnosed with eosinophilic esophagitis after 2 years of discontinuation of OMZ. Currently, after a median time of 9 years (IQR: 7-10) since the initiation of OMZ, 75.6% (31/41) are desensitized (27/31 without OMZ). Omalizumab allows desensitisation of children with severe allergies to cow's milk and/or egg without developing severe reactions while receiving this treatment. However, discontinuation of OMZ leads to severe allergic reactions, and hence must be monitored carefully.

High-dose non-sedating antihistamines are used insufficiently in chronic urticaria patients treated with omalizumab.

BackgroundThe lifetime prevalence of chronic urticaria (CU) is 0.5%–1%. In some patients with CU, symptomatic control is not achieved with non‐sedating second‐generation H1 antihistamines (nsAH1) alone, even with quadrupled standard doses as recommended in international guidelines. In these cases, biological treatment with omalizumab can be added. Since omalizumab is expensive compared to antihistamines, lack of adherence to guidelines for high dose nsAH1 (up to four‐fold standard dose per day) may be associated with substantial unnecessary costs. The aim was to measure the use nsAH1 before and during omalizumab use for the first time in an omalizumab treated CU population.MethodsWe identified all Danish patients with CU who initiated omalizumab from March 2014 to December 2018 and evaluated new and ongoing nsAH1 treatments using the Danish nationwide registries.ResultsA total of 955 CU patients initiated treatment with omalizumab within the study period (median age 40 years [IQR 28–50], 74.5% females). During the 12 months prior to omalizumab initiation, 95.6% of the patients filled at least one prescription with nsAH1 at some point, while 84.7% filled at least one prescription during the three months before omalizumab. From 3 months before omalizumab initiation till 3 months after, the proportions of users of high‐dose nsAH1 was maximum 31.1%.ConclusionsOmalizumab was usually administered before sufficient nsAH1 treatment was tried. In despite of the labelling that omalizumab should be co‐administered with high dose nsAH1, this does not happen This may lead to substantial unnecessary costs.

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.

Long-term efficacy and safety of omalizumab in patients with allergic asthma: A real-life study

Background: The efficacy and safety of omalizumab in patients with severe allergic asthma have been established in both randomized controlled trials and real-life studies. Objective: To evaluate the sustained effectiveness and safety of long-term treatment with omalizumab in a real-world setting. Methods: In this retrospective study, we included patients treated with omalizumab for at least 8 years in four asthma clinics in Greece. Pulmonary function, asthma control, oral corticosteroids (OCS) dose, and exacerbations were recorded before treatment, 6 months later, and annually thereafter. Adverse events were also recorded. Results: Forty-five patients (66.7% women), mean ± standard deviation (SD) age 55.3 ± 12.2 years, were included. The duration of treatment with omalizumab was 10.6 ± 1.2 years. The annual exacerbation rate decreased from 4.1 before omalizumab initiation to 1.1 after 1 year of treatment and remained low up to the 8th year of treatment (p < 0.001). From the 19 patients who were receiving OCS at baseline, 21.1% patients discontinued after 6 months, 47.4% were still on OCS after 4 years of therapy, and 31.6% were on OCS after 8 years. With regard to the OCS dose, 36.8% of the patients reduced the dose ≥ 50% after 6 months and 68.4% achieved 50% reduction after 2 years. The mean daily OCS dose before omalizumab initiation was 7.8 mg of prednisolone or the equivalent, reduced to 4.7 mg/day after 6 months, which reached 1.6 mg/day after 8 years (p < 0.001). Treatment with omalizumab resulted in significant improvements of asthma control and lung function. No severe adverse events were reported. Conclusion: In this real-life study, omalizumab resulted in significant and sustained improvements in asthma exacerbations, asthma control, and lung function, and had a steroid sparing effect and a good safety profile.

Omalizumab response in patients with asthma by number and type of allergen

BackgroundThe anti–immunoglobulin E therapy, omalizumab, improves asthma control and reduces exacerbations in patients with moderate-to-severe allergic asthma. However, it has been suggested that omalizumab should be reserved for highly allergic patients with multiple allergen sensitivities or perennial-only sensitivities. ObjectiveTo examine impact of allergy burden, including number and type of allergen sensitivities, on omalizumab response in a real-world setting. MethodsThis post hoc analysis evaluated a subset of omalizumab-treated patients from the Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (NCT01922037) who had completed 13 allergen assessments (N=478). Patients were classified by allergen burden (nonsensitized, 1, 2-4, or ≥5 allergen sensitivities) and type of allergen (nonsensitized, seasonal, perennial, or both). Outcome measures included exacerbation rate vs previous year and improvements in lung function and Asthma Quality of Life Questionnaire (AQLQ). ResultsComparable adjusted exacerbation rates were observed after omalizumab initiation, regardless of number or type of allergen sensitizations (0.56-0.85/y). Improvements in forced expiratory volume in 1 second from baseline at months 6 (0.03-0.09 L) and 12 (–0.08 to 0.08 L) were also similar across subgroups. Least squares mean change in AQLQ from baseline at months 6 (1.0-1.2) and 12 (1.1-1.4) was comparable across patient subgroups, and similar percentages of patients achieved AQLQ minimal clinically important difference of at least a 0.5-point improvement at month 6 (71%-75%), which was maintained or improved to month 12 (71%-89%). In all analyses, 95% confidence intervals overlapped. ConclusionOverall findings suggest that patients with allergic asthma achieved comparable improvements across distinct outcome measures after omalizumab therapy in a real-world setting, regardless of number and type of allergen sensitizations. Trial RegistrationClinicalTrials.gov Identifier: NCT01922037.

Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma.

Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date. ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients<18years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period. Of the 484 patients included, 101 (20.9%) reached 6years of treatment. The mean±standard deviation number of exacerbations decreased during the first year of treatment (7.9±6.6 to 1.1±2.0, P<.001) and remained likewise for up to 6years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution. In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma.

No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities

BackgroundComorbidities are common in asthma and may complicate treatment response. ObjectiveTo examine response to omalizumab in patients with moderate-to-severe allergic asthma by asthma-related and allergic comorbidities. MethodsPatients aged 12 years or more from placebo-controlled 008/009 (n = 1071), EXTRA (n = 848), and INNOVATE (n = 419), and single-armed PROSPERO (n = 801) omalizumab studies were included. Poisson regression/analysis of covariance models were used to estimate adjusted exacerbation rates and forced expiratory volume in 1 second (FEV1) change from baseline after omalizumab initiation for subgroups by number of comorbidities (0, 1 [008/009]; 0, 1, ≥2 [EXTRA and INNOVATE]; 0, 1, 2, ≥3 [PROSPERO]). Self-reported comorbidities included allergic rhinoconjunctivitis, chronic rhinosinusitis, recurrent acute sinusitis, nasal polyps, atopic and contact dermatitis, urticaria, food allergy, anaphylaxis, other allergies, gastroesophageal reflux disease, eosinophilic esophagitis, and eosinophilic granulomatosis with polyangiitis. ResultsIn the EXTRA and INNOVATE studies, no consistent pattern was observed for placebo-corrected relative rate reduction in normalized asthma exacerbations among omalizumab-treated comorbidity subgroups. In PROSPERO, on-study exacerbation rates in the comorbidity subgroups were similar (0, 0.68; 1, 0.70; 2, 0.77; ≥3, 0.80). FEV1 improvements were observed throughout the study for omalizumab vs placebo for all comorbidity subgroups. There were no consistent differences in FEV1 improvements among comorbidity subgroups in 008/009, EXTRA, or INNOVATE. Similarly, no among-group differences were observed for FEV1 change from baseline at month 12 in PROSPERO (0, 0.05 L; 1, 0.08 L; 2, 0.00 L; ≥3, 0.04 L). The 95% confidence intervals overlapped substantially in all instances. ConclusionIn these analyses of placebo-controlled/single-armed studies, on-study exacerbation rates and FEV1 improvements with omalizumab treatment were similar irrespective of comorbidity burden. Trial RegistrationClinicalTrials.gov identifiers are as follows: EXTRA, NCT00314574 (https://clinicaltrials.gov/ct2/show/NCT00314574); INNOVATE, NCT00046748 (https://clinicaltrials.gov/ct2/show/NCT00046748); and PROSPERO, NCT01922037 (https://clinicaltrials.gov/ct2/show/NCT01922037).

H1-Antihistamines May No Longer Be Necessary for Patients With Refractory Chronic Spontaneous Urticaria After Initiation of Omalizumab.

H1-Antihistamines May No Longer Be Necessary for Patients With Refractory Chronic Spontaneous Urticaria After Initiation of Omalizumab.