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Aimmune Therapeutics, London, UK; 3Anaphylaxis Campaign, Farnborough, UK; 4Department of Paediatric Allergy, Division of Asthma, Allergy and Lung Biology, MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, King's College London, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UKCorrespondence: Katy Gallop, Acaster Lloyd Consulting, 84 Theobalds Road, London, WC1X 8NL, UK, Tel +44 203 9781686, Email [email protected] Robert Ryan, Aimmune Therapeutics, 10 Eastbourne Terrace, London, W2 6LG, UK, Email [email protected] Purpose: This study aimed to estimate utility values for health states relating to oral immunotherapy (OIT) for peanut allergy (PA), for children with PA and their caregivers. Patients and Methods: Two methods were used: an online survey and structured interviews. Both methods assessed current utility/untreated PA (health-related quality of life, HRQoL) and HRQoL in different health states: "up-dosing phase of treatment", "maintenance phase" and "able to tolerate 6– 8 peanuts if accidentally ingested". The survey was conducted in individuals with and without experience of OIT; data collected included the EQ-5D-Y (child states) and EQ-5D-5L (caregiver states). Results: In total, 100 caregivers and 38 adolescents completed the treatment-naïve survey, a separate sample of 50 caregivers participated in structured interviews. Seven caregivers and two adolescents with experience of OIT for PA completed the survey. Data from the three samples were pooled, the mean utility values were untreated PA: 0.796 (child), 0.855 (caregiver); up-dosing: 0.711 (child), 0.806 (caregiver); maintenance: 0.821 (child), 0.849 (caregiver), tolerate 6– 8 peanuts: 0.859 (child), 0.884 (caregiver). The results show a gain in utility of 0.063 for children and 0.029 for caregivers between the untreated and tolerate 6– 8 peanuts health states. Conclusion: This study is the first to assess utilities relating to OIT for PA. The results show the potential benefit of OIT for individuals with PA and their caregivers and provide values for use in cost-effectiveness evaluation. [ABSTRACT FROM AUTHOR]

Aims: To describe the epidemiology of peanut allergy (PA) in the UK over the last three decades. Methods: PA patients were identified from the Clinical Practice Research Datalink between 1987 and 2015. Incidence and prevalence of PA were compared between 2000 and 2015. Prevalence and relative risk (RR) of atopic comorbidities, anaphylaxis, adrenaline prescriptions versus matched controls were calculated. Results: Point prevalence of PA in the entire population and those <18 years increased from 31 to 202 and 116 to 635 per 100,000, respectively, between 2000 and 2015. Incidence increased from 8.6 to 18.2 per 100,000. Incidence in 2015 was 105 cases per 100,000 aged 0–4 years versus 13.4 per 100,000 aged 5+ years. Anaphylactic events affected 1.2% of the cases and 0.007% of the controls. The rate of adrenaline prescriptions was 5,910 per 100,000 person-years for PA patients. RRs for asthma, eczema and allergic rhinitis in PA patients versus controls were 4.5 (95% CI 4.2–4.8), 3.2 (3.1–3.4) and 2.6 (2.4–3.0), respectively. Conclusions: The prevalence and incidence of PA increased markedly over the study period. PA was associated with atopic conditions and anaphylaxis. PA patients had increased adrenaline prescriptions. [ABSTRACT FROM AUTHOR]

Aims: We aimed to estimate the resource use and associated costs for patients with peanut allergy (PA) compared to matched controls. Methods: This was a retrospective cohort study using data from the UK Clinical Practice Research Datalink and Hospital Episode Statistics. PA patients were matched to two control cohorts: the first (simple-matched) were matched 1:1 on year of birth, general practice, gender and registration year. The second (atopy-matched) were matched on the same characteristics plus presence/absence of an atopic condition. Prescriptions and primary and secondary care contacts were compared between cases and controls. Results: 15,483 peanut-allergic patients were identified: 13,609 (87.9%) were simple-matched and 9,320 (60.2%) atopy-matched. The total per person annual incremental health-care costs associated with PA were £253 (atopy-matched) and £333 (simple-matched). For those with PA and a prior anaphylaxis incremental costs were £662, for those prescribed an epinephrine autoinjector incremental costs were £392. Extrapolated to the U.K. population, total excess costs of PA were between £33 and 44 million in 2015. Conclusions: Patients with PA had increased health-care contacts and consequently increased associated costs compared to controls. Observation bias should be considered in interpretation, but this study suggests that PA presents significant burden to health-care systems. [ABSTRACT FROM AUTHOR]

Background: Oral glucocorticoids (steroids) are the mainstay of treatment for systemic lupus erythematosus (SLE), but their use is often associated with short- and long-term side effects. Following a literature review and discussions with patients with SLE, clinicians, and payers, a need was identified for a comprehensive SLE-specific tool that can be used to evaluate the side effects and benefits of steroids over time from a patient perspective. The objective of this study was to develop a patient-reported outcome (PRO) measure to assess general impact (baseline burden), benefits, side effects, and impacts associated with the use of oral steroids in patients with SLE.Methods: A qualitative research protocol was developed in which adults with SLE currently receiving or who had received steroids in the past year were recruited from six US rheumatology practices to participate in concept elicitation (CE) interviews. The SLE Steroid Questionnaire (SSQ) was developed based on CE interview results and clinical input. Cognitive debriefing interviews with a second group of patients with SLE evaluated the content, clarity, and relevance of the items. The SSQ was refined using patient feedback, clinician review, and a translatability assessment. The protocol received central independent review board approval.Results: Thirty-three patients (52% moderate disease severity; 58% currently receiving steroids, mean dose 8.7 mg/day) completed CE interviews. Patients reported benefits, side effects, and impacts from steroids. The refined SSQ contains 50 items assessing steroid dose/duration (4 items), general impact (baseline burden; 19 items), benefits (7 items), work/productivity (3 items), side effects (10 items), emotions (6 items), and overall satisfaction (1 item).Conclusion: The SSQ is a unique PRO, developed using robust scientific methodology in accordance with the Food and Drug Administration PRO Guidance. It was designed to comprehensively assess the patient experience with steroid therapy and better understand the benefits and burden of steroids for patients with SLE. [ABSTRACT FROM AUTHOR]

Background: Limited research has examined the impact of peanut allergy (PA) on children using validated instruments to assess psychosocial burden and the factors influencing burden., Objective: The PAPRIQUA study aimed to assess the caregiver-reported impact of living with PA on children's health-related quality of life (HRQL), correlations between PA severity and child's sex, and associations of caregivers' sex and anxiety with the proxy report of their child's HRQL and to identify significant predictors of a child's HRQL., Methods: A cross-sectional survey of caregivers of children with mild, moderate and severe PA, based on caregiver perception, was conducted in the United Kingdom. Participants were recruited through a survey recruitment panel; a maximum quota of 20% who rated their child's PA as mild was set to ensure population diversity; however, the quota was not required as few participants considered their child's PA mild. The survey, funded by Aimmune Therapeutics, included sociodemographic and clinical questions, the EQ-5D-Y, Hospital Anxiety and Depression Scale, Food Allergy Quality of Life Questionnaire-Parent Form (FAQLQ-PF) and Food Allergy Independent Measure (FAIM)., Results: One hundred caregivers of children with PA (aged 4-15 years) completed the survey. Child's sex was not associated with proxy-reported burden. For younger children (aged 4-10 years), there was no effect of PA severity; parents of older children (aged 11-15 years) reported low to higher burden for their child on the EQ-5D-Y and FAQLQ-PF dependent upon PA severity. For all measures of child burden except the EQ-5D-Y, two or more reactions in the past 12 months and parental anxiety significantly predicted higher levels of burden for the child (P < .05-P < .001). Experiencing a life-threatening event in the past 12 months significantly predicted EQ-5D-Y proxy utility (P < .01)., Conclusions and Clinical Relevance: Caregivers report that children with PA experience high levels of psychosocial burden, particularly those with more severe PA and a reaction history. Interventions to decrease caregiver anxiety and reaction frequency may help reduce the child's burden. Self-report studies in children with PA would help confirm these findings., (© 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.)

Objective: The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care., Methods: Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ). A second cohort of patients with SLE participated in combined concept elicitation/cognitive debriefing interviews, after which the LSQ was revised., Results: Fourteen patients completed concept elicitation interviews: 93% were female, 57% were white, and 85% had moderate/severe SLE. Current treatments included hydroxychloroquine (93%), steroids (79%), and belimumab (57%), and 43% were biologic naive. Patients were generally satisfied with their treatment and medical care; however, they were dissatisfied with treatment adverse effects and the number of available treatment options. Cognitive debriefing interviews (n = 8) demonstrated that the LSQ was comprehensive, clear, and relevant; therefore, only minor revisions were made to the questionnaire. The LSQ assesses satisfaction with current SLE treatments (25 items), medical care (11 items), and insurance coverage (3 items). The draft LSQ was evaluated in 195 adults with SLE. Fifty-eight percent of patients reported that they were "somewhat satisfied" with their SLE treatment., Conclusions: The LSQ has been developed to assess treatment satisfaction among patients with SLE. Following further testing to support its validity and reliability, it will provide a useful tool to facilitate assessment of satisfaction with treatments for SLE and help inform treatment decisions.