Asthma and lower airway diseaseAsthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations
Section snippets
Methods
A robust PK-PD model15 was used to calculate serum concentrations of free IgE, omalizumab, and total IgE at any point during treatment with omalizumab, from information on the patient's body weight, baseline (total) IgE concentration, dosing history, and concentrations of omalizumab, free IgE, and total IgE during treatment. Model-derived omalizumab and free IgE concentrations were then correlated with mean changes in clinical measures (total asthma symptom score, morning peak expiratory flow
Results
There were a total of 10,872 observations (3221 omalizumab, 4450 total IgE, and 3201 free IgE) from 152 volunteers in the single-dose bioequivalence study and 476 patients in the multiple-dose INNOVATE study. Baseline demographic data are summarized in Table I.
Discussion
A previous mechanism-based population PK-PD model of the binding of an anti-IgE mAb15 has been used to calculate individual patient concentrations of drug and free IgE throughout and after treatment with omalizumab in a phase III clinical study,10 even though actual sampling was limited. To achieve this with good estimates of drug absorption parameters and to demonstrate that the model accurately describes the return of free IgE to baseline, data from a richly sampled bioequivalence study were
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Roles of omalizumab in various allergic diseases
2020, Allergology InternationalCitation Excerpt :A decline in serum free IgE levels from baseline to 16 or 32 weeks after treatment was associated with reduced exacerbation frequency 2 years after omalizumab treatment.32 A study involving omalizumab discontinuation after 28 weeks of treatment showed that suppressed free IgE levels returned to baseline within 18–20 weeks, which was accompanied with re-emergent of asthma symptoms.33 The efficacy of omalizumab may not attenuate even after long-term treatment, based on a study that examined the efficacy over 4 to 6, 12, and 24 months of treatment.
The Asthma Controller Step-down Yardstick
2019, Annals of Allergy, Asthma and Immunology48 - Modern Molecular Therapies for Application in Managing Childhood Asthma
2019, Kendig's Disorders of the Respiratory Tract in ChildrenIncreased IgE levels are linked to faster relapse in patients with omalizumab-discontinued chronic spontaneous urticaria
2017, Journal of Allergy and Clinical Immunology
Supported by Novartis Pharma AG.
Disclosure of potential conflict of interest: R. G. Slavin receives grant support from Schering-Plough and Accentia and is on the speakers' bureau for Genentech-Novartis. C. Ferioli is employed by Novartis Pharma AG. S. J. Tannenbaum owns stock in Novartis and is employed by Novartis Pharmaceuticals. C. Martin owns stock in Novartis and is employed by Novartis Horsham Research Center. M. Blogg owns stock in Novartis and is employed by Novartis. P. J. Lowe owns stock in Novartis and is employed by Novartis Pharmaceuticals.