Narrative review to capture patients’ perceptions and opinions about non-response and response to biological therapy for severe asthma

Coleman, Courtney; Khaleva, Ekaterina; Rattu, Anna; Frankemölle, Betty; Nielsen, Hanna; Roberts, Graham; Williams, Clare

doi:10.1183/13993003.00837-2022

Cited by 13 publications

(7 citation statements)

References 22 publications

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“…In this study, super-responders provided narratives on the range and time course of their response to biologic treatments. There is a lack of research in to patient perceptions of response to biologic treatments for severe asthma [19]. While previous qualitative research has collected data from patients on various add-on therapies [14,20], this is the first study to focus on super-responders.…”

Section: Discussionmentioning

confidence: 99%

“Life-changing”: the experience of super-responders to biologics in severe asthma

et al. 2022

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Background There is limited information on the patient’s perspective of how biologic treatments impact their lives. We conducted a qualitative study to explore the patient’s experience of being considered a super-responder from a quality of life perspective. Methods Patients with severe asthma identified as super-responders were invited to semi-structured interviews conducted online. Participants could bring a family member/friend to the interview. The interviews explored experiences of biologic treatment, were transcribed and underwent thematic analysis. Results Twenty-five participants took part in this study. Themes emerged on the impact of biologic treatment for participants and for their friends/family: (i) Words used to describe their often life-changing experiences and (ii) the positive changes noted. Biologic treatment stopped the disruption of family life and social life caused by exacerbations. Improvements in mental health were also noted. Marked individual variations in the way it affected their lives were noted. Most participants noticed improvements 2–3 months after starting their biologic, but some noticed improvement within a few days and others after 6 months. Conclusions Super-responders reported profound but heterogeneous improvements following biologic treatment beyond asthma symptoms and exacerbations including important benefits to social and family life. Improvements may be underestimated as social and family benefits are not reliably measured in current studies with implications for health economic evaluations. Not all patients are super-responders, and excellent responses may be lost in group mean data in trials. Individual time course and response patterns need further elucidation to identify who will respond best to biologics.

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Section: Discussionmentioning

confidence: 99%

“Life-changing”: the experience of super-responders to biologics in severe asthma

et al. 2022

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“…Nevertheless, studies are awaited to determine if treating the pulmonary traits alone is enough to lead to overall improvements in health outcomes. Certainly in severe asthma despite that implementation of highly effective targeted monoclonal antibody therapies, 45 patients continue to experience a residual exacerbation and symptom burden 46–49 …”

Section: Different Models Of Carementioning

confidence: 99%

“…Certainly in severe asthma despite that implementation of highly effective targeted monoclonal antibody therapies, 45 patients continue to experience a residual exacerbation and symptom burden. [46][47][48][49]…”

Section: Treatable Traits Models Targeting Dominant Traitsmentioning

confidence: 99%

Treatable traits models of care

McDonald,

Holland

2023

Respirology

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Treatable traits is a personalized approach to the management of respiratory disease. The approach involves a multidimensional assessment to understand the traits present in individual patients. Traits are phenotypic and endotypic characteristics that can be identified, are clinically relevant and can be successfully treated by therapy to improve clinical outcomes. Identification of traits is followed by individualized and targeted treatment to those traits. First proposed for the management of asthma and chronic obstructive pulmonary disease (COPD) the approach is recommended in many other areas of respiratory and now immunology medicine. Models of care for treatable traits have been proposed in different diseases and health care setting. In asthma and COPD traits are identified in three domains including pulmonary, extrapulmonary and behavioural/lifestyle/risk‐factors. In bronchiectasis and interstitial lung disease, a fourth domain of aetiological traits has been proposed. As the core of treatable traits is personalized and individualized medicine; there are several key aspects to treatable traits models of care that should be considered in the delivery of care. These include person centredness, consideration of patients' values, needs and preferences, health literacy and engagement. We review the models of care that have been proposed and provide guidance on the engagement of patients in this approach to care.

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“…Although many studies have measured responses to different biologics, there are no universally accepted criteria for what constitutes response, and the absence of guidance on criteria is reported as a high-priority research gap in both children and adults [ 27 , 28 ]. Evidence about responder definitions is critical for understanding the effectiveness of treatment for patients [ 29 ], clinicians and regulatory bodies, such as the European Medicines Agency [ 30 ] and the Food and Drug Administration [ 31 ]. Minimal clinically important difference (MCID) [ 32 ] and minimal important difference (MID) [ 33 ] are often used for assessing responses; these are defined as the smallest relevant within-person change or group differences between treatments, respectively.…”

Section: Introductionmentioning

confidence: 99%

Definitions of non-response and response to biological therapy for severe asthma: a systematic review

et al. 2023

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BackgroundBiologics have proven efficacy for patients with severe asthma but there is lack of consensus on defining response. We systematically reviewed and appraised methodologically developed, defined, and evaluated definitions of non-response and response to biologics for severe asthma.MethodsWe searched four bibliographic databases from inception to 15th March 2021 (PROSPERO: CRD42021211249).Two reviewers screened references, extracted data, assessed methodological quality of development, measurement properties of outcome measures and definitions of response based on COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN). Modified GRADE approach and narrative synthesis were undertaken.ResultsThirteen studies reported three composite outcome measures, three measures of asthma symptoms, one asthma control and one quality of life. Only four were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10/17 (58.8%) were based on Minimal Clinically Important Difference (MCID) or Minimal Important Difference (MID) and 16/17 (94.1%) had high quality evidence. Results were limited by poor methodology for development process and incomplete reporting of psychometric properties. Most measures rated “very low” to “low” for quality of measurement properties and none met all quality standards.ConclusionThis is the first review to synthesize evidence about definitions of response to biologics for severe asthma. While high quality definitions are available, most are MCIDs or MIDs which may be insufficient to justify continuation of biologics in terms of cost-effectiveness. There remains an unmet need for universally accepted, patient-centred, composite definitions to aid clinical decision making and comparability of responses to biologics.

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Narrative review to capture patients’ perceptions and opinions about non-response and response to biological therapy for severe asthma

Cited by 13 publications

References 22 publications

“Life-changing”: the experience of super-responders to biologics in severe asthma

“Life-changing”: the experience of super-responders to biologics in severe asthma

Treatable traits models of care

Definitions of non-response and response to biological therapy for severe asthma: a systematic review

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