Evaluating enrollment and outcome criteria in trials of biologics for chronic rhinosinusitis with nasal polyps

Borish, Larry; Cohen, Noam A.; Chupp, Geoffrey; Hopkins, Claire; Wagenmann, Martin; Smith, Steven G.; Silver, Jared; Yang, Shibing; Mayer, Bhabita; Yancey, Steven W.; Chan, Robert; Fokkens, Wytske J.

doi:10.1016/j.anai.2022.04.004

Cited by 17 publications

(18 citation statements)

References 40 publications

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“…However, this pragmatic approach reflects current practice in recent biologics trials. 39 More importantly, medical treatment may be used with the aim to avoid the need for surgical intervention, and therefore progression to surgery is an important outcome.…”

Section: Previous Surgerymentioning

confidence: 99%

Core Outcome Measures in Chronic Rhinosinusitis With Nasal Polyps: In Practice and Research

Abdulghany

Šurda

Hopkins

2023

Am J Rhinol�Allergy

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Heterogeneity in outcomes used in clinical trials prevents meta-analysis and contributes to research waste. Core outcome sets aim to address this by defining a small number of essential outcomes that should be measured in all effectiveness trials. Adoption in routine clinical practice can further improve outcomes for patients. There has been a rapid growth in therapeutic options available for patients with chronic rhinosinusitis with nasal polyps, but difficulty comparing results leads to uncertainty into optimum management, and there is a need to define a core outcome set. We consider whether work already undertaken needs to be modified for patients with nasal polyps. We recommend that a core outcome set should include assessment of disease specific quality of life, nasal polyp score, evaluation of sense of smell, alongside need for OCS and surgical treatment and complications from the disease or treatment. Further work is required to achieve international consensus regarding the choice of nasal polyp scoring system.

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Section: Previous Surgerymentioning

confidence: 99%

Core Outcome Measures in Chronic Rhinosinusitis With Nasal Polyps: In Practice and Research

Abdulghany

Šurda

Hopkins

2023

Am J Rhinol�Allergy

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“…Recent reviews have highlighted the different enrolment criteria for the various phase III clinical trials on biologics for the treatment of CRSwNP. 32 As such, direct comparison between agents and even between different trials on the same agent remains challenging.…”

Section: Mepolizumab and Benralizumab In Patients With Ecrswnpmentioning

confidence: 99%

Current Understanding of the Role of Eosinophils in CRSwNP and Implications for Treatment with Mepolizumab and Benralizumab

Carney

Smith

2023

Am J Rhinol�Allergy

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Background International consensus statements now subdivide chronic rhinosinusitis (CRS) into several phenotypes and endotypes, including the presence of polyps (CRSwNP) and eosinophilia (eCRSwNP). Biological treatments aimed at blocking eosinophilic inflammation in CRSwNP via interleukin 5 (IL5) or the interleukin 5 receptor (IL5R) have demonstrated limited efficacy thus far. Objective To review the pathophysiology of eCRSwNP, the evidence for mepolizumab (anti-IL5) and benralizumab (anti-IL5R) in CRSwNP, and to highlight areas for future research and therapeutic intervention. Methods Primary and secondary literature search. Results Clinical trials on mepolizumab and benralizumab in CRSwNP are limited and restricted by trial design which prevents direct comparison with other interventions, including surgery. Both agents would appear to provide some benefit in reducing nasal polyp size but limited clinical patient benefit. Molecular biological research highlights that eCRSwNP can occur in the absence of IL5 and that other cells/cytokines play an important part in the disease’s pathophysiology. Conclusion Blockade of IL5/IL5R alone would appear to provide limited “real life” clinical benefit in patients with CRSwNP due to the complexities of the pathophysiology of the condition. Therapy aimed at several simultaneous cytokine targets has logic but well-designed trials are unlikely to be forthcoming in the short term due to the financial cost and commercial conflicts of interest.

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“…On the basis of currently available information, dupilumab may be the best choice for CRSwNP treatment when compared with omalizumab, mepolizumab, and benralizumab at 24 weeks of the treatment [ 143 ]. The issue of different enrolment criteria in clinical trials for biologics should also be mentioned, because comparable patient populations and standardized outcome measures would help to compare effects of different biologic agents [ 144 ]. The most reliable information would provide direct randomized trials with the use of different biologics.…”

Section: New Emerging Immunomodulating Therapeutic Options—biologicsmentioning

confidence: 99%

Perspectives in Therapy of Chronic Rhinosinusitis

et al. 2022

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The recent classification of chronic rhinosinusitis (CRS) focusses on investigating underlying immunopathophysiological mechanisms. Primary CRS is subdivided based on endotype dominance into type 2 (that relates mostly to the Th2 immune response with high levels of IL-5, IL-13, and IgE), or non-type 2 (that corresponds to the mix of type 1 and type 3). The treatment selection of CRS is dependent on endotype dominance. Currently, the majority of patients receive standardized care—traditional pharmacological methods including local or systemic corticosteroids, nasal irrigations or antibiotics (for a selected group of patients). If well-conducted drug therapy fails, endoscopic sinus surgery is conducted. Aspirin treatment after aspirin desensitization (ATAD) with oral aspirin is an option for the treatment in nonsteroidal anti-inflammatory drug (NSAID)-exacerbated respiratory disease (N-ERD) patients. However, in this review the focus is on the role of biological treatment—monoclonal antibodies directed through the specific type 2 immune response targets. In addition, potential targets to immunotherapy in CRS are presented. Hopefully, effective diagnostic and therapeutic solutions, tailored to the individual patient, will be widely available very soon.

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Evaluating enrollment and outcome criteria in trials of biologics for chronic rhinosinusitis with nasal polyps

Cited by 17 publications

References 40 publications

Core Outcome Measures in Chronic Rhinosinusitis With Nasal Polyps: In Practice and Research

Core Outcome Measures in Chronic Rhinosinusitis With Nasal Polyps: In Practice and Research

Current Understanding of the Role of Eosinophils in CRSwNP and Implications for Treatment with Mepolizumab and Benralizumab

Perspectives in Therapy of Chronic Rhinosinusitis

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