Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study

Llano, Luis A. Pérez de; Cosío, Borja G.; Domingo, Christian; Urrutia, Isabel; Bobolea, Irina; Valero, Antonio; Costa, Luis Manuel Entrenas; Quirce, Santiago; Paredes, Pilar; Malanda, Nuria Marina; Andrés, Luis Prieto; Álvarez-Gutiérrez, Francisco Javier

doi:10.1016/j.jaip.2019.01.017

Cited by 37 publications

(28 citation statements)

References 24 publications

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“…Currently, only a few studies have been conducted on biological drug switching in patients with severe asthma. One of these, a 24-week prospective, multicenter, open-label, single-group, self-controlled study, showed that reslizumab significantly improved asthma control in patients with severe eosinophilic asthma and a poor response to omalizumab [74]. In the OSMO study, a multicenter, open-label, single-arm, 32-week trial, patients with severe asthma uncontrolled by omalizumab showed an improvement in asthma control after switching to mepolizumab [75].…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

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

et al. 2019

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“…Currently, two phase III RCTs evaluating the efficacy of reslizumab SC (ClinicalTrials.gov identifier: NCT02452190 and NCT02501629) and a phase II–III study on patients with steroid-dependent refractory eosinophilic asthma previously treated with mepolizumab and subsequently treated with IV reslizumab for 4 months (ClinicalTrials.gov identifier: NCT02559791) are ongoing. The efficacy of reslizumab was also confirmed in a 24-week switch study on patients with severe eosinophilic asthma previously treated with omalizumab without clinical benefits 34. At the end of the study (week 24), 60% of patients showed a significant improvement of asthma control test (ACT) score and experienced no more exacerbations.…”

Section: Anti-il-5 and Anti-eosinophils Monoclonal Antibodies For Sevmentioning

confidence: 78%

Targeting eosinophils: severe asthma and beyond

Caminati¹,

Menzella²,

Guidolin³

et al. 2019

DIC

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Recent research in the field of bronchial asthma has mainly focused on eosinophilic disease phenotype. Several trials proved the efficacy and safety profile of eosinophils and interleukin (IL)-5 targeting molecules, currently approved for severe asthma and available on the market. They include mepolizumab and reslizumab, IL-5 blocking molecules, and benralizumab, targeting the IL-5 receptor and eliciting a NK cell-mediated antibody-dependent cellular cytotoxicity against eosinophils. Eosinophilic inflammation represents the common pathophysiological background of several conditions, providing the rationale for the use of the same biologics beyond asthma. Although with different evidence grade, from clinical trials to case reports, anti-IL-5 biologics have been investigated in eosinophilic granulomatosis with polyangitis, allergic bronchopulmonary aspergillosis, chronic eosinophilic pneumonia, nasal polyposis, hypereosinophilic syndrome, and eosinophilic esophagitis. However, non-negligible differences between asthma and other eosinophilic diseases, particularly in eosinophils homing (blood and/or tissues), target organs and thus clinical features, probably account for the different response to the same drug in different clinical conditions and highlights the need for tailoring the therapeutic approach by modulating the drug dose and/or by combination therapy with multiple drugs. The optimal safety and tolerability profile of anti-IL-5 drugs warrants further and larger experimental and real-life investigations, which are needed especially in the field of non-asthma eosinophilic diseases. This review aims at summarizing the rationale for the use of biologics in eosinophilic diseases and their mechanisms of action. The current efficacy and safety evidence about eosinophils and IL-5 targeting molecules in asthma and in eosinophilic conditions beyond bronchi is also discussed.

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“…In a recent study, one case of toxicoderma (the 4th dose of the drug 12 h after administration) was reported [20]. The patient developed a symmetrical rash on the trunk and proximal limbs, and the symptoms improved after administration of systemic corticosteroids and antihistamines.…”

Section: Reslizumabmentioning

confidence: 99%

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

Gülşen¹,

Wedi²,

Jappe³

2020

Allergo J

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Purpose: Biotechnological substances (BSs) are strongly relied upon to prevent rejection of transplanted organs, and to treat oncological, allergological, and other inflammatory diseases. Allergic reactions to partly foreign biologics can occur due to their potential immunogenicity. The severity of an immune response to a biological drug may range from no clinical significance to a severe, life-threatening anaphylactic reaction. Methods: Detailed searches were performed on Pubmed, Web of Science, and Google Scholar to include all available publications. In addition, the Food and Drug Administration, the European Medicines Agency, and British Columbia Cancer Agency Drug Manual databases were screened for hypersensitivity reaction (HSR), infusion reaction, injection site reaction, urticaria, and anaphylaxis for individual BSs. Results: Treatment with BSs can cause various types of HSR. These are mentioned in the literature with definitions such as allergic reactions, anaphylactoid reactions, anaphylaxis, HSR, infusion reactions, injection site reactions, cytokine release syndrome, and urticaria. Due to the overlap in signs and symptoms in the reported descriptions, it is not always possible to differentiate these reactions properly according to their pathomechanism. Similarly, many data reported as anaphylaxis actually describe severe anaphylactic reactions (grades III or IV). Conclusion: There is an urgent need for a simpler symptom-or system-based classification and scoring system to create an awareness for HSRs to BSs. A better understanding of the pathophysiology of HSRs and increased clinical experience in the treatment of side effects will provide timely control of unexpected reactions. As a result, immunotherapy with BSs will become safer in the future. Cite this as Gülsen A, Wedi B, Jappe U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events.

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Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study

Cited by 37 publications

References 24 publications

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

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

Targeting eosinophils: severe asthma and beyond

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

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