Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach

Singh, Harjinder; Peters, Jay I.; Kaur, Yogeet; Maselli, Diego J.; Diaz, Joseph D.

doi:10.1016/j.anai.2019.07.026

Cited by 19 publications

(9 citation statements)

References 28 publications

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“…In the phase 4 Real-life Effectiveness of Omalizumab Therapy (REALITY) study (NCT01776177), a single-center, retrospective, observational, longterm, real-life investigation demonstrated that overall visit adherence upon treatment with omalizumab was 78%, although the adherence rate decreased by 20% every year [31]. The response to therapy rate was assessed via the Standardized Measure to Assess Response to Therapy (SMART) tool, according to which the response rate increased over time, with the highest level achieved after 5 years of treatment (85%) [31]. Omalizumab was well tolerated, with no serious AEs reported [31].…”

Section: Monoclonal Antibodies In Severe Asthma Omalizumabmentioning

confidence: 99%

“…The response to therapy rate was assessed via the Standardized Measure to Assess Response to Therapy (SMART) tool, according to which the response rate increased over time, with the highest level achieved after 5 years of treatment (85%) [31]. Omalizumab was well tolerated, with no serious AEs reported [31].…”

Section: Monoclonal Antibodies In Severe Asthma Omalizumabmentioning

confidence: 99%

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Severe Asthma and Biological Therapy: When, Which, and for Whom

et al. 2019

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Asthma is a heterogeneous chronic inflammatory disease of the airways that affects approximately 300 million people worldwide. About 5-10% of all asthmatics suffer from severe or uncontrolled asthma, associated with increased mortality and hospitalization, reduced quality of life, and increased health care costs. In recent years, new treatments have become available, and different asthma phenotypes characterized by specific biomarkers have been identified. Biological drugs are currently indicated for patients with severe asthma that is not controlled with recommended treatments. They are mostly directed against inflammatory molecules of the type 2 inflammatory pathway and are effective at reducing exacerbations, maintaining control over asthma symptoms, and reducing systemic steroid use, which is associated with well-known adverse events. Although biological drugs for severe asthma have had a major impact on the management of the disease, there is still a need for head-to-head comparison studies of biologics and to identify new biomarkers for asthma diagnosis, prognosis, and response to treatment. Identifying novel biomarkers could facilitate the development of therapeutic strategies that are precisely tailored to each patient's requirements.

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Section: Monoclonal Antibodies In Severe Asthma Omalizumabmentioning

confidence: 99%

Section: Monoclonal Antibodies In Severe Asthma Omalizumabmentioning

confidence: 99%

Severe Asthma and Biological Therapy: When, Which, and for Whom

et al. 2019

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“…On the one hand, the criteria for reimbursement for omalizumab treatment depend on local regulations 1 , 3 , 10 , 18 , 19 and on the other hand, there are no uniform criteria for assessing the effectiveness of therapy. 10 , 18 , 20 , 21 In our study, the patient population was determined by the criteria of the National Treatment Regime. Our patient characteristics were similar to those of other severe asthma populations in terms of mean age (46.8 years), gender (62% female), number of exacerbations within the year before omalizumab treatment, 4 , 7 baseline ACQ-7, and miniAQLQ.…”

Section: Discussionmentioning

confidence: 99%

“…Although the effectiveness of omalizumab was assessed in real-life studies, either the treatment period was short (16-52 weeks to a maximum of 2 years) or the group of patients was small. [20][21][22][23][24][25][26][27] In the first published study of the response to omalizumab treatment, episodes of NFA in the previous year, a high beclomethasone dipropionate dose and poor lung function (FEV1≤65%) were good clinical predictors. 28 These results are inconsistent with our study.…”

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confidence: 99%

<p>Clinical Determinants of Successful Omalizumab Therapy in Severe Allergic Asthma Patients: 4-Year-Long, Real-Life Observation</p>

Kucharczyk

Więsik-Szewczyk

Poznańska

et al. 2020

JAA

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Introduction Omalizumab is a high-cost therapy recommended for the treatment of severe allergic asthma. Objective To find clinical parameters that are related to the sustained response to omalizumab. Patients and Methods This retrospective, real-life, 4-year follow-up was provided in Poland between March 2013 and May 2019. The success of omalizumab was assessed based on composed subjective and objective criteria. Simple/multiple regression analyses were performed to search for predictors of the response to omalizumab. Results A total of 989 severe allergic asthma patients were referred for omalizumab therapy, of whom 854 patients were considered eligible for treatment. At weeks 16 and 52, omalizumab was successful in 84% and 91% of patients, respectively. Treatment effectiveness was maintained up to the 4-year follow-up. Four predictors of the response to omalizumab were found at week 16 and two at week 52. The results at week 16 may be used as predictors of success at week 52 based on the model including baseline FEV1% and change in ACQ-7 and miniAQLQ score at week 16: the area under the ROC curve equals 0.746 [95% CI: 0.672–0.820]. Conclusion Omalizumab therapy is very effective, with this efficacy sustained after 4 years of treatment. Success of the therapy can be predicted from the baseline FEV1% and clinical improvement (based on ACQ-7 and miniAQLQ scores) at week 16.

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“…The Real-life Effectiveness of Omalizumab Therapy (REALITY) study evaluated The Standardized Measure to Assess Response to Therapy (SMART) tool was designed to define response by physician's subjective assessment of asthma symptoms and control and objective assessment of 6 parameters (exacerbations, steroid bursts, emergency department visits, and hospitalizations; lung function; ACT score). True responders are defined as meeting both subjective and objective criteria 122…”

Section: Efficacy Versus Effectiveness – Biologicals In Real Lifementioning

confidence: 99%

Critical Points on the Use of Biologicals in Allergic Diseases and Asthma

Agache

Cojanu

Laculiceanu

et al. 2020

Allergy Asthma Immunol Res

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Improved understanding of the contribution of immune-inflammatory mechanisms in allergic diseases and asthma has encouraged development of biologicals and small molecules specifically targeting the innate and adaptive immune response. There are several critical points impacting the efficacy of this stratified approach, from the complexity of disease endotypes to the effectiveness in real-world settings. We discuss here how these barriers can be overcome to facilitate the development of implementation science for allergic diseases and asthma.

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Long-term evaluation of response to omalizumab therapy in real life by a novel multimodular approach

Cited by 19 publications

References 28 publications

Severe Asthma and Biological Therapy: When, Which, and for Whom

Severe Asthma and Biological Therapy: When, Which, and for Whom

<p>Clinical Determinants of Successful Omalizumab Therapy in Severe Allergic Asthma Patients: 4-Year-Long, Real-Life Observation</p>

Critical Points on the Use of Biologicals in Allergic Diseases and Asthma

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