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1.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927846

ABSTRACT

Introduction:Dupilumab is an anti-IL4R monoclonal antibody (mAb) with proven efficacy in severe eosinophilic asthma (SEA). We have previously identified that a suboptimal response to the eosinophil targeting anti-IL5/5R mAbs mepolizumab and benralizumab is seen in 27% and 14% of patients with SEA respectively1,2. The mechanism of this is not well-understood. It is unknown whether such patients respond in a clinically meaningful way following a switch to dupilumab. Methods:We performed a retrospective analysis of the clinical effectiveness of dupilumab (minimum 6 months treatment) in patients with SEA at our tertiary severe asthma centre who had failed to adequately respond to at least one of the anti-IL-5/5R mAbs. Change in the annualised exacerbation rate (AER), maintenance oral corticosteroids (mOCS) requirements, ACQ-6 and mAQLQ was recorded. Results:Thirty-two patients (mean age 41.2, 68.8% female, 71.9% atopic) were included in the analysis. 13/32(40.6%) had co-morbid nasal polyposis and 5/32(15.6%) had eczema. The baseline FeNO was 60ppb(IQR 39.6-87.5) and peak eosinophil count prior to any mAb was 0.6(IQR 0.5-0.9). 23/32(71.8%) were switched from benralizumab, of whom, 12/23(52.2%) had also failed to respond to at least one other anti-IL5 mAb previously. At six months, the daily median mOCS dose in those requiring mOCS at baseline (n=18) fell from 10mg(IQR 5-25mg) to 3mg(IQR 0-5mg), p≤0.001. 4/18(22%) were able to stop mOCS completely. Mean(SD) AER improved from 2.34(1.89) to 0.44(0.95), p≤0.001. There were also significant improvements in ACQ6 and mAQLQ that exceeded twice the MCID for both measures: mean (SD) ACQ6 improved from 3.04(1.26) to 1.82(1.28), p≤0.001;mAQLQ improved from 3.90(SD 1.40) to 5.36(SD 1.05), p≤0.001. Due to the COVID-19 pandemic, FEV1 data was only available for 8 patients. However, there was nonetheless a significant rise in FEV1 (%predicted) from 55.6% (9.78) to 68.5%(16.9), p=0.011. One patient discontinued dupilumab during the follow-up period. Conclusion: A minority of individuals with SEA have a suboptimal response to eosinophil targeted therapy with an anti-IL5/5R mAb. In these patients, we report significant clinical improvements following initiation with dupilumab suggesting an important role for the IL-4/-13 pathway in these patients. Further research is required to understand whether these patients represent a distinct subphenotype of T2-high asthma.

2.
American Journal of Respiratory and Critical Care Medicine ; 205:2, 2022.
Article in English | English Web of Science | ID: covidwho-1880776
4.
Thorax ; 76(Suppl 2):A178, 2021.
Article in English | ProQuest Central | ID: covidwho-1505966

ABSTRACT

BackgroundBlood eosinopaenia was one of the earliest reported findings in hospitalised patients with COVID-19, questioning whether eosinophils could have an anti-viral or deleterious role in the immune response against SARS-CoV2. Benralizumab is an anti-IL5R monoclonal antibody licensed for the treatment of severe eosinophilic asthma (SEA) and causes the near-complete depletion of blood and tissue eosinophils. As such, it offers the opportunity to explore the impact of eosinopaenia at the time of infection on outcome with COVID-19.MethodPatients started on treatment with benralizumab (up until April 2021) for SEA at our regional asthma centre were contacted by telephone throughout May and June 2021 to establish whether they had experienced a confirmed (PCR-positive) SARS-CoV2 infection since commencing benralizumab. Clinical and demographic characteristics were recorded along with the outcome of infection, including the need for hospitalisation or intensive care admission. Patients requiring hospitalisation were compared to those experiencing mild infections.ResultsData on 268 patients treated with benralizumab was collected with 24/268 (9%) confirming SARS-CoV2 infection with a positive PCR test. Of these 18/24 (75%) experienced mild infections that did not require hospitalisation. Of the 6/24 requiring hospitalisation, the median (IQR) length of stay was 6 (1–8) days. No patients required ICU admission or mechanical ventilation. There was no significant difference in baseline characteristics between hospitalised and non-hospitalised patients. However, it is noteworthy that a higher proportion of hospitalised patients were male (50.0% vs 38.9%) and had a higher mean BMI (32.1 vs 29.5).DiscussionIn the context of drug-induced eosinopaenia with benralizumab, 75% of patients with severe asthma experienced mild COVID-19 disease. This is likely to be an underestimate given that other patients may have experienced an asymptomatic infection or not pursued PCR testing in the context of mild infection. Although caution is needed due to the small sample size, these results do not support a significant role for eosinophils in SARS-CoV2 infection.

5.
Thorax ; 76(Suppl 2):A26-A27, 2021.
Article in English | ProQuest Central | ID: covidwho-1505867

ABSTRACT

Introduction and ObjectiveThe COVID-19 pandemic has witnessed a reduction in asthma exacerbations in the UK. Several factors may underpin this, including reduced transmission of seasonal viruses and improved use of or adherence to inhaled corticosteroids (ICS). This study aims to investigate whether ICS use has changed during the pandemic for patients with asthma.MethodsUsing the OpenPrescribing database, we analysed prescribing patterns of ICS, salbutamol and peak flow meters from January 2019 to January 2021 across England. Additionally, using a sample asthma cohort from 3 primary care practices, we assessed individual prescription patterns and ICS adherence across the two-year period. ICS adherence has been defined according to the medication possession (MPR) ratio: good (≥75%), sub-optimal (50–74%), poor (25–49%) and non-adherence (<25%).ResultsA sharp increase in national ICS prescriptions was observed at the start of the pandemic in March 2020 representing a 50% increase compared to February 2020. Thereafter national ICS prescription rates appear to have returned to normal levels. The sample asthma cohort included 1132 patients (762 patients treated with ICS across 2019 and 2020). Overall, adherence to ICS improved in 2020 (P<0.001), with the proportion of patients meeting ‘good adherence’ (≥75%) increasing from 34% to 42% (P<0.001). Analysis of this cohort suggested the March 2020 spike predominantly reflected improved adherence rather than a hoarding effect of multiple inhalers or new prescriptions for ICS-naïve individuals. Increasing age was associated with higher levels of ICS adherence. A similar spike in salbutamol occurred in March 2020, however, an overall reduction in salbutamol prescriptions was seen in 2020 (P=0.039). National figures highlighted a progressive increase in prescription of peak flow meters over 2020.ConclusionA marked spike in national ICS prescriptions occurred in March 2020. This increase appears to reflect improved adherence in patients with low levels of adherence rather than a hoarding effect or large-scale initiation in ICS-naïve patients. Despite a comparable spike in salbutamol prescriptions, 2020 saw an overall reduction in salbutamol prescriptions. Prescription of peak flow meters steadily increased over 2020 in keeping with the need for more remote monitoring.

6.
Thorax ; 76(SUPPL 1):A234-A235, 2021.
Article in English | EMBASE | ID: covidwho-1194362

ABSTRACT

Introduction During the first wave of the COVID-19 pandemic in the UK there was a reduction in A&E attendances and hospital admissions. Monthly excess deaths peaked in April 2020;driven by COVID-19.1 We investigated whether hospital admissions due to asthma were reduced in April 2020 compared to the previous five years and if this was accompanied by an increase in asthma deaths. Methods Five-year data were obtained from Public Health Scotland from the time period January 2015 to June 2020. Hospital admission data was sourced from Public Health Scotland's Scottish Morbidity Records, death certificate data from National Records of Scotland and A&E attendance data from Public Health Scotland. Data were analysed using statistical process control charts. Results A&E presentations in April 2020 reduced to 44% of April 2019. Hospital admissions for all conditions reduced, as did asthma admissions (figure 1a) [218 in April 2020 versus previous 5 year mean of 418]. 7958 deaths occurred in April 2020;an excess of 2731 from previous 5-year mean. In 130 deaths asthma was recorded on the death certificate as either the underlying or the contributory cause, giving rise to around 100 apparent excess deaths versus the previous 5-year mean of 27.5 (figure 1b). Asthma was recorded as the underlying cause of death in 7 cases, comparable with the previous 5 year mean of 9.2 deaths (figure 1c). The age distribution of those with asthma on the death certificate was: 97-65, 27 aged 45-65, 6 aged 18-44 and 0 <18 years. Of the 123 patients with asthma recorded as a contributory cause, 81 had COVID-19 recorded as the underlying cause of death. All 7 patients with asthma recorded as underlying cause of death were elderly and the location of death was: 3 at home, 2 in residential care, 1 in hospital and 1 in a hospice. Conclusions Reduced acute healthcare utilisation by people with asthma during the first peak of COVID-19 did not appear to result in increased mortality where asthma was the primary underlying cause of death.

7.
Thorax ; 76(SUPPL 1):A18, 2021.
Article in English | EMBASE | ID: covidwho-1194238

ABSTRACT

Introduction Severe asthma patients were assumed to be at greater risk of morbidity from infection with the novel severe acute respiratory syndrome coronavirus (COVID-19), hence, in the UK, were advised to shield. Community data on COVID-19 infection in severe asthmatics is lacking. We assessed the burden of shielding, the impact of COVID-19 and the effect of asthma medication on the UK severe asthma population. Methods Adults previously consented to inclusion in the UK Severe Asthma Registry (UKSAR) across 14 centres were contacted in June 2020 to collect data on potential COVID-19 infection, asthma control and shielding. Electronic records, where available, were reviewed for confirmation. Data was combined with clinical data from the UKSAR. Univariate and multivariate logistic regression analyses were performed to identify risk factors for COVID-19 infection. Results 1365 patients were included. 1268 (93%) were advised to shield, 1131 (89%) patients who received shielding advice followed it. Men (OR 0.4, p=0.045) and those in non-shielding households (OR 0.27, p=0.001) were less likely to follow shielding advice. 544 (47%) of patients advised to shield reported worsening of mental health;females (OR 1.59, p=0.001) and those with history of anxiety or depression (OR 2.12 p=0.001) were at greater risk. 97 (7.1%) patients had suspected/confirmed COVID-19 infection, 19 (1.39%) PCR/serology confirmed infection, 13(0.95%) were hospitalised and 2 patients (0.15%) died (table 1). 918 (67%) were on biologic therapy, 515 (37%) maintenance oral corticosteroid (mOCS). Multivariate analysis showed neither biologic therapy (OR 0.73, p=0.165) nor mOCS (OR 1.18, p=0.427) increased the risk of COVID-19 infection. Patients on biologics were less likely to require an acute course of corticosteroids for asthma symptoms (OR 0.6, p=0.002) while patients on mOCS were more likely (OR 1.96 p£0.001). Inhaled corticosteroids (ICS) were not associated with COVID-19 infection, including high dose (2000 mcg BDP equivalent) (OR 0.64, p=0.234). Hospitalised patients were on lower median doses of ICS vs non-hospitalised patients (1000 vs 2000 mcg BDP equivalent, p=0.002). Conclusion Hospitalisation and death occurred in small numbers in our severe asthma population. From this observational data, biologic agents for asthma were not associated with increased risk of COVID-19 infection or hospitalisation.

8.
Thorax ; 76(SUPPL 1):A144-A145, 2021.
Article in English | EMBASE | ID: covidwho-1146446

ABSTRACT

Introduction: Mepolizumab is a biologic agent targeting interleukin (IL)-5 which is currently licensed as add-on therapy for severe eosinophilic asthmatic (SEA). It is usually administered in a hospital setting but with the option of homecare being introduced in 2019, the 4-weekly subcutaneous injections can be self-administered at home. We investigated whether there was a change in asthma control following the transition to home administration and whether a differential response to treatment exists following transition to homecare before and after the onset of the COVID-19 pandemic. Methods: Patients receiving mepolizumab via home care were stratified according to those who had a planned transition to homecare prior to 1st Feb 2020 versus those who had an unplanned transition after this date necessitated by the COVID-19 pandemic. The last Asthma Control Questionnaire-6 (ACQ6) measured in clinic ('baseline') was compared with that collected by telephone consultation 6-8 weeks after transition ('homecare'). Patients were excluded if both values were not available. Results: Of 87 mepolizumab patients included in the analysis, 46 were planned transitions. There was no significant (Figure presented) difference in the pre-biologic ACQ6 (p=0.07) between groups. Immediately prior to transition to homecare (baseline), the planned group had a lower mean ACQ6 than those in the unplanned group (1.19 vs 1.90, P=0.004). The ACQ6 on homecare decreased significantly in both groups (-0.47 in the planned group vs -0.56 in the unplanned group, both P<0.001). The ACQ6 for the planned cohort during homecare was significantly lower than that for the unplanned group (0.72 vs 1.34, P=0.012) (figure 1). (Table presented) Conclusions: We found a significant improvement in ACQ6 for all SEA patients established on Mepolizumab who transitioned to home mepolizumab administration. This improvement occurred irrespective of whether the transition was 'planned' or 'unplanned'. Further research is required to understand the potential influence of shielding during lockdown and the method of ACQ assessment (telephone vs face-to-face ACQ reporting in clinic) on this improvement.

9.
Thorax ; 76(SUPPL 1):A144, 2021.
Article in English | EMBASE | ID: covidwho-1146445

ABSTRACT

Introduction: The COVID-19 pandemic necessitated the rapid transition of large numbers of patients onto homecare to facilitate on-going therapy in a cohort of patients who were 'shielding'. Alongside this, patients continued to need to be initiated on biologic therapy in spite of the pandemic. The impact of administering biologic therapy at home is largely unknown, yet crucial to optimise patient outcome and minimise steroid burden. We investigated whether there was a differential response following transition to homecare of established patients versus those newly started. Methods: Patients with severe eosinophilic asthma receiving home benralizumab were stratified according to those who had received ≥3 doses prior to COVID-19 lockdown on the 15th March 2020 ('established' patients) versus those who were initiated after this date ('new' patients). We compared the last Asthma Control Questionnaire-6 (ACQ6) measured in clinic with that collected by telephone consultation 8-12 weeks after transition to homecare. Patients were excluded if both values were not available. Results: 246 benralizumab patients were included in the analysis, of whom 49 (20%) were new. There was no significant difference in pre-biologic ACQ6, pre-homecare (baseline) (Figure presented) ACQ6 or post-homecare ACQ6 between the new and established patient groups. Both cohorts exhibited a similar magnitude of improvement in their ACQ6 following the transition to homecare (-0.73 in the established group vs -0.73 in the new group, both P<0.0001) (figure 1). Conclusions: We have demonstrated that early transition to homecare in patients treated with benralizumab is not associated with worse clinical outcomes as assessed by ACQ6. The improvements in ACQ6 were seen irrespective of whether they were 'established' on therapy at time of transition or 'new'. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.

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