RESUMO
BACKGROUND: Dupilumab is a monoclonal antibody that targets the interleukin (IL)-4 receptor alpha subunit, thus blocking the effects of IL-4 and IL-13, and has shown efficacy in treating various conditions including asthma, atopic dermatitis, eosinophilic esophagitis, and others. Because of its immune modulatory effects, clinical trials that studied dupilumab did not allow patients to receive live vaccines during the clinical trials because of an abundance of caution, and thus package inserts recommend that patients who are being treated with dupilumab should avoid live vaccines. Because dupilumab is now approved for use in patients from 6 months of age for the treatment of atopic dermatitis, this reported contraindication is now posing a clinical dilemma for patients and clinicians. OBJECTIVE: To perform a systematic review of literature on the safety and efficacy of vaccinations in patients who are receiving dupilumab and to provide expert guidance on the use of vaccines in patients who are receiving dupilumab. METHODS: A systematic review of the literature was performed, and an expert Delphi Panel was assembled. RESULTS: The available literature on patients who received vaccinations while using dupilumab overall suggests that live vaccines are safe and that the vaccine efficacy, in general, is not affected by dupilumab. The expert Delphi panel agreed that the use of vaccines in patients receiving dupilumab was likely safe and effective. CONCLUSION: Vaccines (including live vaccines) can be administered to patients receiving dupilumab in a shared decision-making capacity.
RESUMO
BACKGROUND: Herpes zoster (HZ) is a painful condition caused by reactivation of the varicella-zoster virus. The objectives of this study were to compare HZ incidence in adults with asthma versus adults without asthma and to compare healthcare resource use as well as direct costs in adults with HZ and asthma versus adults with asthma alone in the USA. METHODS: This retrospective longitudinal cohort study included adults aged ≥18 years across the USA. Patients were identified from Optum's deidentified Clinformatics Data Mart Database, an administrative claims database, between 1 October 2015 and 28 February 2020, including commercially insured and Medicare Advantage with part D beneficiaries. Cohorts of patients with and without asthma, and separate cohorts of patients with asthma and HZ and with asthma but not HZ, were identified using International Classification of Diseases 10th Revision, Clinical Modification codes. HZ incidence, healthcare resource use and costs were compared, adjusting for baseline characteristics, between the relevant cohorts using generalised linear models. RESULTS: HZ incidence was higher in patients with asthma (11.59 per 1000 person-years) than patients without asthma (7.16 per 1000 person-years). The adjusted incidence rate ratio (aIRR) for HZ in patients with asthma, compared with patients without asthma, was 1.34 (95% CI 1.32 to 1.37). Over 12 months of follow-up, patients with asthma and HZ had more inpatient stays (aIRR 1.11; 95% CI 1.02 to 1.21), emergency department visits (aIRR 1.26; 95% CI 1.18 to 1.34) and outpatient visits (aIRR 1.19; 95% CI 1.16 to 1.22), and direct healthcare costs that were US dollars ($) 3058 (95% CI $1671 to $4492) higher than patients with asthma without HZ. CONCLUSION: Patients with asthma had a higher incidence of HZ than those without asthma, and among patients with asthma HZ added to their healthcare resource use and costs.
Assuntos
Asma , Custos de Cuidados de Saúde , Herpes Zoster , Humanos , Herpes Zoster/economia , Herpes Zoster/epidemiologia , Asma/economia , Asma/epidemiologia , Asma/terapia , Masculino , Feminino , Estudos Retrospectivos , Incidência , Pessoa de Meia-Idade , Adulto , Custos de Cuidados de Saúde/estatística & dados numéricos , Idoso , Estados Unidos/epidemiologia , Estudos Longitudinais , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Recursos em Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Adulto Jovem , Efeitos Psicossociais da Doença , Hospitalização/economia , Hospitalização/estatística & dados numéricos , AdolescenteRESUMO
There is a lack of consensus over the description and severity assignment of allergic adverse reactions to immunotherapy, although there seems to be a consensus at least in terms of using the World Allergy Organization (WAO) grading systems to describe local adverse events for Sublingual Immunotherapy (SLIT) and Systemic Allergic Reactions (SARs) to Subcutaneous Immunotherapy (SCIT) amongst the major national/regional allergy societies. In this manuscript, we propose a modification of the previous WAO Grading system for SARs, which aligns with the newly-proposed Consortium for Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions in Food Allergy (version 3.0). We hope this can facilitate a unified grading system appropriate to SARs due to allergen immunotherapy, independent of allergen and route of administration, and across clinical and research practice.