Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers
The objective of this randomized open-label 12-week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS-AI), (2) new PFS-NSD configuration, and (3) current PFS-NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80-1.25 range for maximum concentration (Cmax), area under the concentration-time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In to...
Source: Clinical Pharmacology in Drug Development - February 23, 2024 Category: Drugs & Pharmacology Authors: Ramachandra Sangana,
Yan Xu,
Bharti Shah,
Xianbin Tian,
Julia Zack,
Kasra Shakeri ‐Nejad,
Sampath Kalluri,
Ieuan Jones,
Monica Ligueros‐Saylan,
Angel Fowler Taylor,
Devendra Kumar Jain,
Emil Scosyrev,
Alkaz Uddin,
Nathalie Laurent,
Paola Tags: Original Article Source Type: research
Sustained control of recalcitrant chronic spontaneous urticaria after initiation of inflammatory airway diseases treatment: two case reports
ConclusionsWe suggest a novel approach of controlling remote epithelial site inflammation in these two cases that resulted in sustained-control of urticaria symptoms without the need for systemic corticosteroids or immunosuppressant. The changes of autoimmune antibodies might be the consequences of tolerance breaking from chronic lower airway inflammation as observed in other epithelial inflammatory condition like in celiac disease and rheumatoid arthritis. (Source: Journal of Medical Case Reports)
Source: Journal of Medical Case Reports - February 23, 2024 Category: General Medicine Source Type: research
Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgE < sub > Trap < /sub > -Fc protein in subjects with Atopy: Results from the First-in-Human study
CONCLUSION: This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions.PMID:38382265 | DOI:10.1016/j.intimp.2024.111706 (Source: International Immunopharmacology)
Source: International Immunopharmacology - February 21, 2024 Category: Allergy & Immunology Authors: Young-Min Ye Jung-Won Park Sae-Hoon Kim You Sook Cho Sook Young Lee Sae Young Lee Sujin Sim Eunji Song Bomin Kim Jieon Lee Su Kyung Kim Myoung Ho Jang Hae-Sim Park Source Type: research
Use of antihistamines during omalizumab therapy in chronic urticaria in the routine clinical practice. A 48-patient observational trial
Actas Dermosifiliogr. 2024 Feb 19:S0001-7310(24)00145-5. doi: 10.1016/j.ad.2023.08.015. Online ahead of print.NO ABSTRACTPMID:38382744 | DOI:10.1016/j.ad.2023.08.015 (Source: Actas Dermo-Sifiliograficas)
Source: Actas Dermo-Sifiliograficas - February 21, 2024 Category: Dermatology Authors: M Men éndez Sánchez E P érez Fernández J L L ópez Estebaranz E G ómez de la Fuente Source Type: research
Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgE < sub > Trap < /sub > -Fc protein in subjects with Atopy: Results from the First-in-Human study
CONCLUSION: This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions.PMID:38382265 | DOI:10.1016/j.intimp.2024.111706 (Source: International Immunopharmacology)
Source: International Immunopharmacology - February 21, 2024 Category: Allergy & Immunology Authors: Young-Min Ye Jung-Won Park Sae-Hoon Kim You Sook Cho Sook Young Lee Sae Young Lee Sujin Sim Eunji Song Bomin Kim Jieon Lee Su Kyung Kim Myoung Ho Jang Hae-Sim Park Source Type: research
Use of antihistamines during omalizumab therapy in chronic urticaria in the routine clinical practice. A 48-patient observational trial
Actas Dermosifiliogr. 2024 Feb 19:S0001-7310(24)00145-5. doi: 10.1016/j.ad.2023.08.015. Online ahead of print.NO ABSTRACTPMID:38382744 | DOI:10.1016/j.ad.2023.08.015 (Source: Actas Dermo-Sifiliograficas)
Source: Actas Dermo-Sifiliograficas - February 21, 2024 Category: Dermatology Authors: M Men éndez Sánchez E P érez Fernández J L L ópez Estebaranz E G ómez de la Fuente Source Type: research
Highlights from the literature
This study included children of 12 years and above in a double blind, randomised placebo controlled parallel group design recruited from 347 sites in 46 countries. Two different doses of ligelizumab were used or one dose of omalizumab or placebo in four study groups given every 4 weeks, for 52 weeks. They used an urticaria activity score (UAS7) at week 12 for primary outcome. In the study of 2057 patients both doses of ligelizumab were superior to placebo (p<0·0001), but not to omalizumab and there were no new safety signals were identified for ligelizumab... (Source: Archives of Disease in Childhood)
Source: Archives of Disease in Childhood - February 19, 2024 Category: Pediatrics Tags: Miscellanea Source Type: research
Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis
CONCLUSIONS: This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.PMID:38364218 | DOI:10.1080/07853890.2024.2317356 (Source: Annals of Medicine)
Source: Annals of Medicine - February 16, 2024 Category: Internal Medicine Authors: Maria Basaga ña Carlos Mart ínez-Rivera Clara Padr ó Ignasi Garcia-Oliv é Mimar Mart ínez-Colls Juan Navarro Laura Pardo Paula Cruz Gloria Cardona Peitx L ídia Carabias Albert Roger Jorge Abad Antoni Rosell Source Type: research
Efficacy of biological agents combined with oral immunotherapy (OIT) for food allergy: a protocol for a systematic review and meta-analysis
Introduction
Food allergy affects a large population throughout the world. Recently, oral immunotherapy (OIT) has been reported as an effective treatment for severe food allergy. Although OIT was successful in numerous trials in desensitisation, adverse events including anaphylaxis during OIT frequently occur. Additionally, some patients fail to be desensitised after OIT and the response to treatment is often not sustained. As a further adjunctive therapy to facilitate OIT, the role of biological agents has been identified. For example, efficacy and safety of omalizumab as an adjuvant therapy of OIT has become apparent thr...
Source: BMJ Open - February 7, 2024 Category: General Medicine Authors: Honda, A., Okada, Y., Matsushita, T., Hasegawa, T., Ota, E., Noma, H., Imai, T., Kwong, J. Tags: Open access, Immunology (including allergy) Source Type: research
Omalizumab for the Treatment of Multiple Food Allergy (OUtMATCH)
Food allergy is common and causes substantial morbidity. Safe and effective treatments are needed, especially for individuals with multiple food allergies. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - February 1, 2024 Category: Allergy & Immunology Authors: Robert Wood, Alkis Togias, Scott Sicherer, Wayne Shreffler, Edwin Kim, Stacie Jones, Donald Leung, Brian Vickery, J. Andrew Bird, Jonathan Spergel, Ahmar Iqbal, Julie Olsson, Monica Ligueros-Saylan, Alkaz Uddin, Agustin Calatroni, Charmaine Huckabee, Nico Source Type: research
Hospitalizations and Emergency Department Visits Before and After Omalizumab Treatment in Patients With Asthma and Food Allergies
Omalizumab is an anti-IgE antibody indicated for the treatment of moderate-to-severe persistent asthma. Food allergies may co-occur in up to 15% of patients with asthma, and children with both food allergy and asthma are at increased risk for life-threatening reactions. We compared all-cause and food allergy-related hospitalizations and emergency department (ED) visits before and after omalizumab treatment in patients with asthma and documented food allergies. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - February 1, 2024 Category: Allergy & Immunology Authors: J. Andrew Bird, Julie Wang, Arpamas Seetasith, Vincent Garmo, Stella Ko, Inyoung Lee, Elizabeth Wang, Xiaohui Zhao, Aimee Near, Sachin Gupta, David Fleischer Source Type: research
Effect of biologic treatment in uncontrolled severe chronic rhinosinusitis with nasal polyps in Belgium: A Real-World Data study
Since 2022, mepolizumab and omalizumab are reimbursed for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in Belgium. Their efficacy has been demonstrated in large double-blind placebo-controlled trials. However, only very limited reports on real-world efficacy data have been published. (Source: Journal of Allergy and Clinical Immunology)
Source: Journal of Allergy and Clinical Immunology - February 1, 2024 Category: Allergy & Immunology Authors: An-sofie Viskens, Laura Bollen, Elien Borgers, Florence Rogister, Stijn Halewyck, Valerie Hox, Mark Jorissen, Winde Lemmens, Kato Speleman, Laura Van Gerven, Olivier Vanderveken, Benedicte Verhaeghe, Peter Hellings Source Type: research
