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Omalizumab for Patients with Chronic Spontaneous Urticaria: A Narrative Review of Current Status
AbstractChronic spontaneous urticaria (CSU) is a debilitating inflammatory disorder of the skin, characterized by a fluctuating natural history, a complex mechanism of action, and a significant burden on patients, including effect on quality of life, development of psychosocial disorders, and a range of comorbidities. Recent international guidelines recommend a therapeutic approach of first-line treatment with second generation H1-antihistamines and second-line treatment with the biologic omalizumab. Here, the salient aspects of CSU and current status of data for omalizumab for patients with CSU are reviewed, with a focus ...
Source: Dermatology and Therapy - October 30, 2023 Category: Dermatology Source Type: research

Inhibition of KIT for chronic urticaria: a status update on drugs in early clinical development
Expert Opin Investig Drugs. 2023 Oct 28. doi: 10.1080/13543784.2023.2277385. Online ahead of print.ABSTRACTINTRODUCTION: Chronic urticaria (CU), including chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), is a prevalent, enduring, mast-cell driven condition that presents challenges in its management. There is a clear need for additional approved treatment options beyond H1 receptor antagonists and the anti-IgE monoclonal antibody (mAb), omalizumab. One of the latest therapeutic strategies targets KIT, which is considered the primary master regulator for mast cell-related disorders.AREASCOVERED: T...
Source: Expert Opinion on Investigational Drugs - October 28, 2023 Category: Drugs & Pharmacology Authors: Bettina Wedi Source Type: research

Real-world super-response to biologics in severe asthma: A French monocentric retrospective cohort study
CONCLUSION: In this real-life study in severe T2-high asthma patients, a lower dose or absence of daily oral corticosteroids and absence of eosinophilic granulomatosis with polyangiitis were the only identifiable predictors of super-response to biologics. Physicians should not wait for maintenance oral corticosteroids to be required before considering the initiation of a biologic in severe asthma.PMID:37897876 | DOI:10.1016/j.resmer.2023.101055 (Source: Respiratory Care)
Source: Respiratory Care - October 28, 2023 Category: Respiratory Medicine Authors: Sol ène Valéry St éfanie Habib-Maillard Nicolas Roche Source Type: research

Response to biologics and clinical remission in the adult GAN severe asthma cohort.
Conclusion: Despite suffering from more severe asthma at baseline, patients treated with biologics had a markedly higher probability of achieving good clinical response and/or remission than patients treated without biologics. (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Milger-Kneidinger, K., Suhling, H., Skowasch, D., Holtdirk, A., Kneidinger, N., Behr, J., Timmermann, H., Schulz, C., Schmidt, O., Ehmann, R., Lommatzsch, M., Hamelmann, E., Idzko, M., Taube, C., Buhl, R., Korn, S. Tags: Allergy and immunology Source Type: research

Dupilumab may be beneficial for severe asthma patients with high FeNO And low blood eosinophil counts in real world observational study.
Conclusion: Dupilumab use might contribute to the reduction of AEs observed with the high FeNO/low b-EOS subgroup. (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Uno, T., Hoshino, Y., Soma, T., Uchida, Y., Asado, T., Ishii, R., Katayama, K., Iemura, H., Uchida, T., Shinomiya, S., Miyauchi, S., Nakagome, K., Nakamura, H., Nagata, M. Tags: Allergy and immunology Source Type: research

Impact of smoking on biologicals treatment response in patients from the German Severe Asthma (GAN) Registry
Clinical studies in asthma usually exclude smokers or ex-smokers with >10 pack-years (PY). Thus the efficiency of biological (BT) in severe smoking asthmatics is unknown.We analysed the real-life severe asthma registry cohort treated with biological to evaluate the impact of smoking on clinical outcomes.At week 16 and 52 we analysed exacerbation, lung function, asthma control, biomarkers and compared never-smokers (NS) with (ex)smokers (<10 PY, 10-20 PY, >20 PY). Linear models were fitted for each endpoint. Binary or ordinal logistic regression models were computed for non-linear endpoints.1129 patients (44,2% mal...
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Stoshikj, S., Biener, L., Brugger, J., Krall, C., Milger, K., Schulz, C., Jandl, M., Ehmann, R., Schmidt, O., Skowasch, D., Buhl, R., Hamelmann, E., Taube, C., Korn, S., Idzko, M. Tags: Allergy and immunology Source Type: research

Impact of staphylococcus aureus enterotoxins on clinical responses to omalizumab in severe asthma patients
Staphylococcus aureus (S. aureus) secreting staphylococcal enterotoxins (SEs) plays a pathogenic role in severe asthma. It is not known whether omalizumab is effective in reducing SE-IgE-mediated airway inflammatory responses in patients with either atopic or non-atopic severe asthma. We conducted a prospective observational study to assess the clinical efficacy of omalizumab therapy in severe allergic and non-allergic asthmatics with SE-IgE positivity. Bronchial biopsy tissues and pro-inflammatory cell profiles in the induced sputum were obtained before a 12-week course of omalizumab to evaluate the clinical associations....
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Wu, W.-C., Weng, C.-M., Kuo, H.-P., Chou, C.-L. Tags: Allergy and immunology Source Type: research

Sputum cell counts and FeNO levels in patients treated with anti-IgE and anti-IL-5 /IL-5R: Evidence for a dissociation between sputum eosinophil counts and FeNO levels
Anti-IgE and Anti-IL-5/IL-5R bring considerable improvement in asthma control in severe T2 high asthmatics. Here we have conducted a cross sectional retrospective study on patients in stable state who had been treated for 1 year with omalizumab (n=39), mepolizumab (n=69) and benralizumab (n=24) and compared their sputum cells counts and FeNO levels. All patients were receiving moderate to high dose ICS/LABA as standard maintenance. Results are expressed as median (IQR) and difference between the groups were analysed by a Kruskall Wallis test and, in case of significance, followed by Dunn’s test for pairwise compariso...
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: sabbe, m., Schleich, F., Bougard, N., Moermans, C., Henquet, M., Guissard, F., Sanschez, C., Paulus, V., Louis, R. Tags: Monitoring airway disease Source Type: research

Parasitic Infections and Biological Therapies Targeting Type 2 Inflammation: a Vigibase(R) Study.
In conclusion, this analysis from a world pharmacovigilance database found a higher rate of reported parasitic infections, particularly helminthiases, with benralizumab compared to controls or other biological therapies. (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Guilleminault, L., Montastruc, F., Reber, L. L., Magnaval, J.-F., Lifar, P. Tags: Airway pharmacology and treatment Source Type: research

The ERS CRC Severe Paediatric Asthma Collaborative in Europe: asthma control in Children on Biologics
Conclusions: Most children with severe asthma obtain good asthma control and quality of life on biologics, although some remain uncontrolled and may need other or new biologics. (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Liu, N. M., Pijnenburg, M. W. H., Deschildre, A., Carraro, S., Fenu, G., Ferraro, V., Fleming, L. L., Hanssens, L., Licardi, A., Lombardi, E., Valverde Molina, J., Vierhout, A., De Mir, I., Rusconi, F. Tags: Paediatric asthma and allergy Source Type: research

Real-world patient-level cost-effectiveness analysis of omalizumab in patients with severe allergic asthma
Conclusion: This data suggests that OML+SoC is cost-effective for severe asthma from the public payer perspective (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Oguzülgen, I. K., Tugay, D., Top, M., Aydın, O., Bavbek, S., Damadoglu, E., Öner Erkekol, F., Koca Kalkan, I., Kalyoncu, A. F., Karakaya, G., Türktas, H., Abraham, I. Tags: Airway pharmacology and treatment Source Type: research

Real-life data of ten years with omalizumab treatment
Conclusion: The results of our study show that initiation of omalizumab treatment in eligible patients contributes to clinical control and an increase in quality of life. (Source: European Respiratory Journal)
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Gündüz Karayazı, D., Ömeroglu Simsek, G., Sevinc, C. Tags: Airway pharmacology and treatment Source Type: research

Clinical remission (CR) in a real-world study to evaluate mepolizumab effectiveness in treating severe eosinophilic asthma (SEA) in Taiwan (REMIT)
The retrospective, observational, self-controlled REMIT study enrolled 170 pts with SEA who started mepolizumab 100 mg SC Q4W, from 17 Taiwanese centres with 12-month (mo) follow-up (FU). This post-hoc analysis of 167 pts (excluding 3 pts who died during FU) assessed the proportion of pts achieving CR after mepolizumab use in the total (TP), biologic-naïve (BNP; TP excluding pts switching from omalizumab) and biologic-switch (SP; TP who switched from omalizumab) populations. Criteria for 3-way composite CR were: no clinically significant exacerbations (CSE; no oral corticosteroids [OCS], ER visits, or hospitalisati...
Source: European Respiratory Journal - October 27, 2023 Category: Respiratory Medicine Authors: Xu, X., Zhang, S., Rojas, A. N., Perng, D.-W., Cheng, S.-L., Alfonso, R., Milea, D. Tags: Airway pharmacology and treatment Source Type: research