Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study

Menzies‐Gow, Andrew; Gurnell, Mark; Heaney, Liam G.; Corren, Jonathan; Bel, Elisabeth H.; Máspero, Jorge; Harrison, Timothy; Jackson, David J.; Price, David; Lugogo, Njira L; Kreindler, James L.; Burden, Annie; Giorgio-Miller, Alex de; Faison, Sarai; Padilla, Kelly; Martin, Ubaldo J.; Gil, Esther Garcia

doi:10.1183/13993003.03226-2021

Cited by 10 publications

(7 citation statements)

References 31 publications

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“…When interpreting these data it should be noted that investigators may have concerns regarding adrenal insufficiency [14,15] and there is currently no consensus on whether to reduce maintenance OCS dose in this context. However, there is consensus thatin situations where OCS maintenance treatment is required (e.g.…”

Section: Discussionmentioning

confidence: 99%

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Domingo,

Rabe,

Price

et al. 2023

ERJ Open Res

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BackgroundDupilumab has been shown to improve clinical outcomes long term while reducing oral corticosteroid (OCS) dose in patients with severe OCS-dependent asthma. Thispost hocanalysis assesses the impact of OCS dose at baseline (≤10 or >10 mg·day−1) on long-term outcomes of dupilumab treatment.MethodsAnnualised severe asthma exacerbation rates, forced expiratory volume in 1 s (FEV1), measures of asthma control and quality of life (QoL), and OCS dose were evaluated in patients from the phase 3 VENTURE trial with severe OCS-dependent asthma, further categorised by OCS dose ≤10 or >10 mg·day−1at parent study baseline (PSBL), who enrolled in TRAVERSE.ResultsDupilumab reduced the annualised exacerbation rate in VENTURE, and it remained low throughout TRAVERSE (0.202–0.265 [OCS ≤10 mg·day−1at PSBL] and 0.221–0.366 [OCS >10 mg·day−1at PSBL]). Improvements in pre-bronchodilator FEV1, asthma control and QoL observed in VENTURE dupilumab patients were sustained throughout TRAVERSE. Patients on placebo during VENTURE showed rapid improvements in FEV1upon initiating dupilumab in TRAVERSE, which were sustained to the end of TRAVERSE. Reductions in OCS dose observed in VENTURE were maintained throughout TRAVERSE, with more than two-thirds of patients achieving reductions in OCS doses to ≤5 mg·day−1by TRAVERSE Week 48.ConclusionsImprovements in clinical outcomes and reductions in OCS dose with dupilumab observed in VENTURE were maintained throughout TRAVERSE, regardless of baseline disease severity. Patients who switched from placebo in VENTURE to dupilumab in TRAVERSE had improved clinical outcomes and reductions in OCS dose comparable to those given dupilumab in VENTURE.

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Section: Discussionmentioning

confidence: 99%

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Domingo,

Rabe,

Price

et al. 2023

ERJ Open Res

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“…Poor asthma symptom control itself substantially increases the risk of exacerbations (4,17,19). However, most studies used ACQ and AQLQ as clinical endpoints for interventional phase II, III, and IV trials (20)(21)(22)(23). Therefore, we used the ACQ, AQLQ, HADS, and lung function parameters, and sought to evaluate whether they could be strong risk factors for AE and hospitalization.…”

Section: Discussionmentioning

confidence: 99%

Independent risk factors of asthma exacerbations: 3-year follow-up in a single-center prospective cohort study

He¹,

Lin²,

Zhong³

et al. 2022

Ann Transl Med

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Background: Because minimizing future risk is the goal of asthma chronic asthma management, it is particularly important to identify risk factors. We conducted this 3-year single-center prospective cohort study to determine the independent risk factors of asthma exacerbations (AEs).Methods: We performed this prospective, longitudinal, observational study with a 3-year follow-up on 257 patients aged 18-81 years with at least a 1-year history of asthma. Follow-up visits are conducted through regular annual phone calls, and the primary endpoints were AE. Results:The uncontrolled group was more likely to develop AE than the well-controlled group [odds ratio (OR): 6.34, 95% confidence interval (CI): 1.14-35.21, P<0.05]. Patients with low Asthma Quality of Life Questionnaire (AQLQ) scores were more likely to develop AE than these with high AQLQ scores (OR: 0.59, 95% CI: 0.35-0.99, P<0.05). AQLQ and Asthma Control Questionnaires (ACQ) were both strong independent risk factors within 3 years of enrollment; the cut-off values (COV) of the AQLQ and the ACQ (uncontrolled) that better evaluated the risk with the AE were ≤5.4 and >1, respectively. The AQLQ scores had a sensitivity of 79.07% and a specificity of 59.09% [area under curve (AUC): 0.70, P<0.0001], and the ACQ (uncontrolled) had a sensitivity of 81.4% and a specificity of 52.29% (AUC 0.68, P<0.0001). Conclusions:The findings of this study suggest that patients with uncontrolled asthma and a diminished health-related quality of life had an increased risk of exacerbations in the future. Defining these risk factors associated with AE is important as it will identify these at the highest risk to patients and may guide future interventions.

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“…Biologics often permit the cessation of CSs; when complete CS discontinuation is not possible, clinically meaningful reductions can be achieved. Some recent trials [ 50 ] have formally utilized adrenal function testing as part of the CS reduction protocol, introducing an algorithm (a simplified form is displayed in Fig. 1 ) for safer withdrawal of CSs.…”

Section: Cs and Adrenal Insufficiencymentioning

confidence: 99%

“…1 Suggested protocol of withdrawal, also including hypothalamic–pituitary–adrenal (HPA) axis function following prolonged corticosteroid treatment (modified from ref. [ 50 ]) …”

Section: Cs and Adrenal Insufficiencymentioning

confidence: 99%

Systemic Corticosteroids for Treating Respiratory Diseases: Less Is Better, but… When and How Is It Possible in Real Life?

et al. 2023

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Systemic corticosteroids (CSs), a keystone in pulmonology, are drugs with strong antiinflammatory activity. They are cheap, easily available, and accessible, but with common and serious side effects. Moreover, the use of exogenous CSs may suppress the hypothalamic–pituitary–adrenal (HPA) axis, predisposing to adrenal insufficiency. Safe CS treatment is a challenge of pharmacological research. This narrative review examined the indications of CSs in some respiratory diseases, analyzing what types, dosages, and length of treatment are required as the dosage and duration of CS treatments need to be minimized. Chronic maintenance treatments with CSs are associated with poor prognosis, but they are still prescribed in patients with severe asthma, Chronic obstructive pulmonary disease (COPD), and interstitial lung diseases. When CS discontinuation is not possible, all efforts should be made to achieve clinically meaningful reductions. Guidelines suggest the use of methylprednisolone at a dose of 20–40 mg/day or equivalent for up to 10 days in subjects with COVID-19 pneumonia (but not other respiratory viral diseases) and respiratory failure, exacerbations of asthma, and COPD. Some guidelines suggest that CS treatment shorter than 10–14 days can be abruptly stopped, strictly monitoring subjects with unexplained symptoms after CS withdrawal, who should promptly be tested for adrenal insufficiency (AI) and eventually treated. CSs are often used in severe community-acquired pneumonia associated with markedly increased serum inflammation markers, in acute respiratory distress syndrome (ARDS), in septic shock unresponsive to hydro-saline replenishment and vasopressors, and acute exacerbations of interstitial lung diseases. As these cases often require higher doses and longer duration of CS treatment, CS tapering should be gradual and, when useful, supported by an evaluation of HPA axis function. Supplementary Information The online version contains supplementary material available at 10.1007/s41030-023-00227-x.

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Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study

Cited by 10 publications

References 31 publications

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Long-term efficacy of dupilumab in severe asthma by baseline oral corticosteroid dose

Independent risk factors of asthma exacerbations: 3-year follow-up in a single-center prospective cohort study

Systemic Corticosteroids for Treating Respiratory Diseases: Less Is Better, but… When and How Is It Possible in Real Life?

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