Response to Omalizumab in Black and White Patients with Allergic Asthma

Szefler, Stanley J.; Jerschow, Elina; Yoo, Bongin; Janampally, Pranathi; Pazwash, Hooman; Holweg, Cécile; Hudes, Golda

doi:10.1016/j.jaip.2021.07.013

Cited by 7 publications

(4 citation statements)

References 41 publications

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“…A limitation of the present study is that most (>75%) participants in each group were White, potentially limiting generalisability to other racial or ethnic groups. However, previous research with reference omalizumab has not found any clinically meaningful differences in PK and PD based on race, and efficacy and safety profiles do not differ by race or ethnicity 25,27–29 . Building on the findings of the present study, the double‐blind, randomised, parallel‐group, Phase 3 CT‐P39 3.1 study (NCT04426890) is ongoing and aims to demonstrate equivalence of the clinical efficacy, PK, PD, and safety of CT‐P39 versus EU‐omalizumab in patients with chronic spontaneous urticaria 30 .…”

Section: Discussionmentioning

confidence: 70%

“…However, previous research with reference omalizumab has not found any clinically meaningful differences in PK and PD based on race, and efficacy and safety profiles do not differ by race or ethnicity. 25,[27][28][29] Building on the findings of the present study, the double-blind, randomised, parallel-group, Phase 3 CT-P39 3.1 study (NCT04426890) is ongoing and aims to demonstrate equivalence of the clinical efficacy, PK, PD, and safety of CT-P39 versus EU-omalizumab in patients with chronic spontaneous urticaria. 30 The primary endpoint of the study will assess therapeutic similarity between CT-P39 and EU-omalizumab.…”

Section: F I G U R Ementioning

confidence: 99%

“…Blood samples for PK and PD assessments were collected at screening (Day −28 to Day −2; for PD assessment of total IgE only), pre-dose on Day 1, at 6, 12, 24, 48, and 72 h after the start of study drug administration, and onDays 6,8,11,15,22,29, 43, 57, 71, 85, 106, and 127. Validated electrochemiluminescence methods were used to measure total serum omalizumab levels and serum free IgE levels; total IgE (i.e.…”

mentioning

confidence: 99%

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Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Maurer

Saini

McLendon³

et al. 2022

Clinical & Translational All

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Background CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). Methods This two‐part, randomised, parallel‐group, double‐blind Phase 1 trial (NCT04018313) was conducted in healthy individuals with a total immunoglobulin E (IgE) level ≤100 international units (IU)/ml at screening. In part 2, described herein, participants were randomised (1:1:1) to receive a single 150 mg subcutaneous dose of CT‐P39, EU‐omalizumab, or US‐omalizumab. The primary endpoint was pharmacokinetic equivalence in terms of area under the concentration–time curve (AUC) from time zero to the last quantifiable concentration (AUC 0–last ), AUC from time zero to infinity (AUC 0‐inf ), and maximum serum concentration ( C max ). Equivalence was concluded if 90% confidence intervals (CIs) of the geometric least‐squares means ratios were contained within the predefined 80%–125% equivalence margin. Additional pharmacokinetic parameters, pharmacodynamics, safety, and immunogenicity were also evaluated. Results Overall, 146 participants were randomised (CT‐P39, N = 47; EU‐omalizumab, N = 49; US‐omalizumab, N = 50). For all primary pharmacokinetic parameters, 90% CIs for pairwise treatment comparisons were within the 80%–125% equivalence margin, demonstrating pharmacokinetic equivalence. Decreases in free IgE and increases in total IgE serum concentrations were comparable across groups. CT‐P39 was well tolerated. Safety endpoints were comparable across groups: there were no treatment‐related serious adverse events, deaths, or discontinuations due to treatment‐emergent adverse events. Conclusions CT‐P39 was well tolerated and demonstrated pharmacokinetic equivalence with EU‐omalizumab and US‐omalizumab following administration of a single dose in healthy individuals.

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Section: Discussionmentioning

confidence: 70%

Section: F I G U R Ementioning

confidence: 99%

mentioning

confidence: 99%

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Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Maurer

Saini

McLendon³

et al. 2022

Clinical & Translational All

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“…1,2 Allergic asthma is a specific form of asthma characterized by coughing as the only or the main clinical manifestation, but may be accompanied by chest tightness and a runny nose, which may relapse frequently. 3,4 Clinical studies have indicated that the disease primarily involves certain cells, including eosinophils, T lymphocytes, and mast cells. Repeated respiratory tract infections can increase the frequency of asthma attacks, which can subsequently lead to the development of chronic bronchitis and even pulmonary interstitial fibrosis, thereby aggravating the disease severity and creating additional challenges for its clinical management.…”

Section: Introductionmentioning

confidence: 99%

Effects of omalizumab combined with budesonide formoterol on clinical efficacy, pulmonary function, immune function, and adverse reactions in children with moderate and severe allergic asthma

Chen

Liang

Chu

et al. 2023

Allergol Immunopathol

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Objective: To evaluate the clinical efficacy and safety of combining omalizumab with budesonide formoterol to treat children with moderate and severe allergic asthma, and investigate the effect of this combination therapy on pulmonary and immune functions. Methods: The data of 88 children with moderate and severe allergic asthma, who were admitted to our hospital between July 2021 and July 2022, were included in the study. The patients were randomly assigned either to control group (n = 44; received budesonide formoterol inhalation therapy) or experimental group (n = 44; received omalizumab subcutaneous injection + budesonide formoterol inhalation therapy) using computer-generated randomization. The clinical efficacy, asthma control (measured using childhood Asthma-Control Test [C-ACT] score), pulmonary function (forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow), immune function (cluster of differentiation 3 cells [CD3+ cells], cluster of differentiation 4 cells [CD4+ cells], immunoglobulin G, immunoglobulin A, and immunoglobulin E), and adverse reactions were observed and compared between both groups. Results: After treatment, the experimental group had improved levels of pulmonary function and immune function indexes, higher C-ACT scores, and a higher overall response rate than the control group (P < 0.05). In addition, the incidence of adverse reactions was not significantly different between both groups (P > 0.05). Conclusion: The combination of omalizumab with budesonide formoterol for treating moderate and severe allergic asthma in children demonstrated promising clinical efficacy and improved their pulmonary and immune functions, leading to more rational asthma control. The combined regimen demonstrated satisfactory clinical safety and deserved clinical promotion.

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Pathophysiology, Diagnosis, and Management of Chronic Spontaneous Urticaria: A Literature Review

Greiner

Nicks²,

Adame

et al. 2022

Clinic Rev Allerg Immunol

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Response to Omalizumab in Black and White Patients with Allergic Asthma

Cited by 7 publications

References 41 publications

Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Effects of omalizumab combined with budesonide formoterol on clinical efficacy, pulmonary function, immune function, and adverse reactions in children with moderate and severe allergic asthma

Pathophysiology, Diagnosis, and Management of Chronic Spontaneous Urticaria: A Literature Review

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