Allergy and Asthma Medical Group and Research Center

Introduction Despite recent advances in the management of atopic dermatitis (AD), patients continue to face significant burden and diminished quality of life1. Real-world studies are essential to understand patient needs and evaluate long-term effectiveness and safety of current therapies. Here, we present the design of ARMADA-AD disease registry that aims to collect real-world data to characterize unmet needs in AD, patient journey, and long-term outcomes of various AD treatment options. Procedure/Study ARMADA-AD, a global, multicenter, longitudinal, prospective, observational, real-world study, plans to recruit atleast 1000 patients aged ≥12 years with confirmed diagnosis of AD and follow them for 5 years. Patients initiating or switching a systemic therapy for AD (including, but not limited to biologics, oral JAKi, and immunosuppressive/immunomodulatory therapies) will be included. Patients concurrently participating in interventional clinical trials will be excluded. Primary objectives are to comprehensively document patients’ unmet needs, describe patient characteristics and treatment patterns, and characterize real-world safety, effectiveness, and patient satisfaction with systemic treatment options for AD. Key secondary objectives include evaluation of longitudinal course of AD and selected atopic and non-atopic comorbidities, long-term safety and effectiveness of systemic AD therapies, impact of AD treatment across relevant sub-groups, general healthcare practices, and comprehensive patient experiences. Results ARMADA-AD is expected to begin enrollment in H1 2025. Conclusion Data collected from the ARMADA-AD registry will address existing gaps and serve as a valuable resource to further our understanding of unmet needs and burden of AD, and real-world safety and effectiveness of systemic therapies, compared to other registries.

DOI: 10.20452/pamw.17068, Published online: July 24, 2025, Authors: Dominika Ochab-Krupnik^1,2, Piotr Lacwik^1,2, Anna Mościcka^1,2, Beata Kręcisz¹, Maciej Kupczyk³, Cezary Pałczyński^1,2

Introduction/Background Patients with antibody deficiency commonly receive immunoglobulin replacement therapy (IgRT), but markers for disease control vary. The normal range for IgG ranges from 600 to 1700 mg/dL, with providers commonly aiming for a lower threshold of at least 550 mg/dL in these patients. A case series of two patients suggested that levels >800 mg/dL could provide significantly increased protection against infection and advocated tailoring IgRT doses based on specific patient outcomes (1). Methods Data collection was completed for 75 antibody-deficiency patients receiving subcutaneous immunoglobulin (SCIG) or intravenous immunoglobulin (IVIG). Of 75 patients, 13 were adults and all had CVID. Among pediatric patients, 55 had primary immunodeficiencies (PID): 9 CVID, 29 hypogammaglobulinemia, 7 Bruton’s agammaglobulinemia, 3 STAT-1 gain-of-function (GOF) mutation, 3 autoimmune lymphoproliferative syndrome (ALPS), and 4 specific antibody deficiency (SAD) with normal immunoglobulins and B cells. Seven remaining pediatric patients had secondary immunodeficiencies (SID) caused by end-stage renal disease or lymphoma. Data were annualized and patients were divided into “well-controlled” and “uncontrolled” disease. Lack of disease control was defined as greater than three courses of oral antibiotics or steroids yearly and >1 ED/ICU admission annually. Data/Results On average, well-controlled patients had three to four infections per year, while uncontrolled patients had six despite consistent IgRT treatment. The upper limit of IgG levels for any patient in this study did not exceed 1,394 mg/dL. The calculated average steady state IgG levels across the key subgroups are as follows: Well-controlled CVID: 844 mg/dL Well-controlled hypogammaglobulinemia: 899 mg/dL Suboptimally-controlled CVID: 635 mg/dL Suboptimally-controlled hypogammaglobulinemia: 606 mg/dL Bruton’s patients had no fewer than 4 infections annually, and an average IgG level of 637 mg/dL. Patients with SAD and ALPS had better disease control with an average steady-state IgG of 1,012 mg/dL. Patients with STAT-1 GOF had the highest steady-state IgG levels (988 mg/dL). In SID, IgG levels were difficult to capture due to inconsistent therapy use. There was no statistically significant difference between the adult and pediatric cohorts. Conclusion These results indicate the optimal IgG level for treatment should change based on diagnosis, but likely begins at least 800 mg/dL.

Introduction: Allergic rhinitis (AR) is a common type 2/Th2 comorbidity in asthma patients (pts). Besides having higher exacerbation rates and health-care costs, asthma pts with AR (vs those without AR) have worse asthma disease control, symptoms, and quality of life (QoL). In a pivotal phase 2b study (NCT01854047), dupilumab (DPL), a fully human anti-IL-4Rα monoclonal antibody that inhibits IL-4 and IL-13 signaling, improved lung function and QoL measures, reduced severe asthma exacerbations, and was generally well tolerated in adults with uncontrolled persistent asthma on medium-to-high-dose ICS+LABA. Aims: This post hoc analysis assessed efficacy findings in asthma pts with self-reported ongoing comorbid AR. Methods: Pts received DPL 200/300 mg every 2 weeks (q2w; currently investigated in phase 3 [NCT02414854]) or q4w, or placebo (PBO). Change from baseline to Weeks 12 and 24 in FEV 1 (L and %) and annualized severe asthma exacerbation rate over the 24-week treatment period are reported. Results: DPL 200 and 300 mg q2w improved FEV 1 (L) ( P P Table ). Conclusions: In asthma patients with ongoing AR, DPL added to ICS+LABA improved FEV 1 and reduced severe asthma exacerbations. Future studies are required to investigate the benefit of DPL in this subgroup.

Background: Poor pMDI technique remains common despite training, instruction leaflets (IfU), and re-assessments, with poor technique impacting disease control and absorbing healthcare budget. A drug- and excipient-free, repeat use, pMDI-facsimile training tool is available (Trainhaler® plus Flo-Tone® [T+F], Clement Clarke). Aims: To extend our knowledge of the T+F training tool and test the hypothesis that the T+F training tool is superior to IfU in teaching inhaler technique. Methods: Prior to their demonstration of placebo pMDI use, three groups, each of 15 inhaler-naive volunteers aged ≥12 years, were randomised to training with T+F, salbutamol HFA IfU (ProAir® Teva) or no training (Control). A study-blind expert scored video-taped pMDI use from a 14-Step checklist to a maximum of 22 points. Adequate or fail was scored 2 or 0 (8 major Steps) or 1 or 0 (6 minor Steps). Data were analysed using a two-tailed test. Results: The overall mean T+F score of 17.3 out of 22 was significantly higher than IfU (P 0.05). Breathe out fully (S6), start to inhale gently (S10) and breathe in slowly and deeply for 5 seconds (S12) were the main Step differences. Conclusion: The study has shown that T+F is the better technique training tool compared with IfU or no training in volunteers unfamiliar with pMDIs. We await the data from an on-going study in asthma and COPD patients.