Development of a Tool to Measure the Clinical Response to Biologic Therapy in Uncontrolled Severe Asthma: The FEV1, Exacerbations, Oral Corticosteroids, Symptoms Score

Llano, Luís Pérez de; Dávila, Ignacio; Martínez‐Moragón, Eva; Domínguez‐Ortega, Javier; Almonacid, Carlos; Colás, Carlos; García-Rivero, Juan Luis; Carmona, Loreto; Yébenes, María Jesús García de; Cosío, Borja G.; Torrego, Alfons; Mena, Alicia Habernau; López-Viña, Antolín; Arrondo, Antonio Parra; Crespo, Astrid; Santana, Aythamy Henrquez; Cisneros, Carolina; Picado, César; Domingo, Cristian; Antolin, Dario; Álvarez, Francisco; Soto, Gregorio; Ercoreca, Ignacio Antepara; Ojanguren, Íñigo; Bobolea, Irina; Urrutia, Isabel; Moguel, Ismael García; Domínguez, Jorge; Rivera, José M.; Chicote, José María Vega; Serrano, José; Miralles, J C; Romero, Julio Delgado; Rial, Manuel Jorge; Mosteiro, Mar; Blanco, Marina; Perpiñá, M.; Mozo, Paloma Campo; Sanz, P. Barranco; Contreras, Remedios Cardenas; Gancedo, Santiago Quirce; Cabrës, Valentina Gutiérrez Vall De; Plaza, Vicente; Gallardo, Victoria García; Muñoz, Xavier

doi:10.1016/j.jaip.2021.01.033

Cited by 28 publications

(31 citation statements)

References 15 publications

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“…A multifaceted approach is generally employed to evaluate treatment, including OCS reduction, symptom control, lung function, and exacerbations. 101 Where improvement in any of the prespecified goals may be considered treatment success, exacerbations are the most important of the outcomes.…”

Section: Resultsmentioning

confidence: 99%

Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion

Buhl¹,

Bel

Bourdin

et al. 2022

The Journal of Allergy and Clinical Immunology: In Practice

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Severe asthma often remains uncontrolled despite effective treatments and evidence-based guidelines. A group of global experts in asthma and biologic medications from 9 countries considered the most relevant clinical variables to manage severe asthma in adult patients and guide treatment choice. The resulting recommendations address the investigation of biomarker levels (blood eosinophil count along with fractional concentration of exhaled nitric oxide [FeNO]), clinical features (oral corticosteroid [OCS] dependence, specific comorbid disease entities associated with severe type 2 asthma), and safety considerations. Current evidence suggests that biomarkers, including both blood or sputum eosinophil counts as well as FeNO, add prognostic and predictive value and should be measured in all patients with severe asthma. OCS use is an

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Section: Resultsmentioning

confidence: 99%

Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion

Buhl¹,

Bel

Bourdin

et al. 2022

The Journal of Allergy and Clinical Immunology: In Practice

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“…We have also analyzed the variation in the FEV1, Exacerbations, Oral corticosteroids, Symptoms (FEOS) score. 8 We used the FEOS score to quantify response to reslizumab. This score assigns relative weights to four domains (FEV1, exacerbations, oral corticosteroids and symptoms) covering all possible clinically relevant changes in patients’ clinical condition after starting a biologic treatment.…”

Section: Methodsmentioning

confidence: 99%

“…Higher scores indicate better response and the range of responses runs from 0 (worsening) to 100 (best possible response). 8 The score does not provide an estimate of the level of asthma control attained after biologics therapy, but it reflects how much a given asthmatic improves. The quantification of the achieved improvement depends on the baseline disease burden, and those patients with poorer asthma control before biologic initiation have the potential to obtain higher scores after treatment than those with better pre-treatment clinical condition.…”

Section: Methodsmentioning

confidence: 99%

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Asthma Control in Patients with Severe Eosinophilic Asthma Treated with Reslizumab: Spanish Real-Life Data

Llano

Cosío

Astiárraga

et al. 2022

JAA

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Background Reslizumab is an anti-interleukin 5 monoclonal antibody that has demonstrated to reduce the risk of severe exacerbations and to improve symptoms, lung function, and quality of life in randomized controlled trials that included patients with severe eosinophilic uncontrolled asthma (SEUA) and a history of severe exacerbations. Objective The aim of the present study was to evaluate the effectiveness of add-on reslizumab in a cohort of patients with SEUA under real-life conditions. Methods This was a multi-centre, retrospective, real-life study that included subjects with SEUA treated with reslizumab in 44 asthma units throughout Spain. Eligible patients were those who had received at least one dose of reslizumab as part of normal clinical practice. The primary endpoint was complete asthma control at 52 weeks, defined as absence of severe exacerbations, ACT ≥20 and no maintenance oral corticosteroids (OCS). Demographic, clinical, and functional data were collected at baseline (T0), after four to six months (T1); after 12 months (T2) and beyond 12 months of therapy (T3). Results Treatment with reslizumab achieved complete asthma control in 40% of the 208 included SEUA patients and led to a significant reduction in exacerbations (from 3.0; IQR: 2.0–4.0 at V0 to 0.0; IQR: 0.0–0.0 at V2), maintenance OCS use (from 54.8% (95% CI: 48.0–61.6 at T0 to 18.5% (95% CI: 12.5–24.5 at T2) and a meaningful improvement in symptoms in the entire treated population: ACT increased from 12.8 ± 4.5 at V0 to 20.0 ± 5.1 at V2 (p < 0.001). Most of the improvement achieved at 12 months was obtained at 4–6 months. The retention (continuation) rate of reslizumab was 75% through 2 years (95CI%: 1.9–2.1). Overall, reslizumab showed an adequate safety profile. Conclusion Reslizumab is an effective therapy for SEUA with adequate safety profile in real-life conditions.

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“…Recently Perez de Llano and colleagues have developed a linear 100 points scale to quantify response to asthma biotherapies which may help weighting partial response but do not suggest failure cut-point to date. 9 The practices for assessing therapeutic response and failure remain therefore highly heterogeneous. The identification of patients who do not adequately respond to a given mAb treatment represent nevertheless an important issue for prescribers.…”

Section: Introductionmentioning

confidence: 99%

Anti-interleukin 5 therapies failure criteria in severe asthma: a Delphi-consensus study

Mattei

Suehs

Alagha

et al. 2021

Ther Adv Respir Dis

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Background: Current practices for assessing response to anti-interleukin 5/R treatment in severe asthma patients are heterogeneous. The objective of this study was to achieve an expert consensus defining failure criteria for anti-interleukin 5/R treatment in severe asthma patients. Methods: Experts were invited to a 5-round Delphi exercise if they were pulmonologists managing ⩾30 patients at a nationally recognized severe asthma expert centre. Following two rounds of statement-generating brainstorming, the expert panel ranked each statement according to a 5-point Likert-type scale during three additional rounds. Positive consensus was considered achieved when ⩾80% of experts agreed with a statement with >50% strong agreement and <15% disagreement. Results: Twenty experts participated in the study. All experts agreed that predefined treatment goals defining effectiveness should be personalized during shared decision making via a patient contract. Treatment failure was defined as (1) absence of a reduction in exacerbation rates by ⩾25% or (2) absence of a reduction in oral corticosteroid therapy by ⩾25% of the initial dosage or (3) occurrence of emergency room visits or hospitalizations after 6 months of treatment. Treatment failure should result in discontinuation. For partial responders, treatment discontinuation was not recommended unless an alternative from another therapeutic class exists and should be discussed in a multidisciplinary consultation. Conclusion: The present study provides objective criteria for anti IL5 or IL5R failure in severe asthma and suggests consensus based guidelines for prescription, evaluation and discontinuation decision-making.

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Development of a Tool to Measure the Clinical Response to Biologic Therapy in Uncontrolled Severe Asthma: The FEV1, Exacerbations, Oral Corticosteroids, Symptoms Score

Cited by 28 publications

References 15 publications

Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion

Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion

Asthma Control in Patients with Severe Eosinophilic Asthma Treated with Reslizumab: Spanish Real-Life Data

Anti-interleukin 5 therapies failure criteria in severe asthma: a Delphi-consensus study

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