POS0858 HOW SYMPTOMS AND TREATMENTS IMPACT THE EXPERIENCES OF PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS PARTICIPATING IN A CLINICAL TRIAL
Authors: P. A. Merkel, B. Hellmich, C. Pagnoux, U. Specks, M. Wechsler, V. H. Shih, L. Börjesson Sjö, S. Necander, C. Roberts, J. Hanlon, C. N. Ho
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Eosinophilic granulomatosis with polyangiitis (EGPA) causes considerable multi-organ damage and disability. Greater insight into patient experiences with the disease and how these experiences change with treatment could support shared treatment decision-making. <h3>Objectives:</h3> To contextualize the experience of living with EGPA and the definition of treatment success from the perspective of patients participating in a clinical trial. <h3>Methods:</h3> MANDARA (NCT04157348) was a randomized, double-blind, Phase 3, head-to-head, non-inferiority study comparing the efficacy and safety of benralizumab 30 mg vs mepolizumab 300 mg every 4 weeks for 52 weeks in patients with relapsing/refractory EGPA taking oral glucocorticoids ± other stable immunosuppressants. Patients enrolled in MANDARA from the US, UK, Canada, Germany, or Belgium were invited to take part in a sub-study during the double-blind period, consisting of two 60-minute, 1:1, semi-structured telephone interviews with interviewers experienced in qualitative research. Interview 1 occurred between 7 and ≤21 days after initiation of treatment, and focused on patients' reports of symptoms and the impacts of EGPA on their daily life. Interview 2 occurred between 7 and ≤21 days after the final dose of blinded treatment (week 48) and focused on patients' experiences with the clinical trial and study treatment, personal definitions of treatment success, and changes in symptoms and impacts since interview 1. <h3>Results:</h3> In total, 38 patients consented to participate; 35 (92.1%) completed interview 1, 32 (84.2%) completed interview 2, and 29 (76.3%) completed both interviews. Of the 38 participants, 27 (71.0%) were female; median (range) age was 55 (25‒75) years, and participants were predominantly White (34 [89.5%]; 3 [7.9%] reported 'Other'; and 1 [2.6%] Asian). There was a broad geographical distribution: 15 (39.0%) UK, 11 (29.0%) Germany, 6 (16.0%) Canada, and 3 (8.0%) from each of Belgium and the US. Median (range) time since diagnosis was 42.0 (3.6–240) months. 24 (63.0%) of the participants were from the mepolizumab arm. At interview 1, the most frequently reported symptoms were difficulty breathing/shortness of breath, nasal congestion/discharge, fatigue, neuropathy/numbness/tingling, and coughing (<b>Table 1</b>); the most frequently reported impacts were on ability to exercise or engage in strenuous activities, quality and quantity of sleep, and ability to work (<b>Table 2</b>). Systematic comparison of interviews from the two timepoints suggests that during the trial there was an improvement in symptoms and impacts. The most frequently reported improved symptoms were in difficulty breathing/shortness of breath, nasal congestion/discharge, and fatigue (<b>Table 1</b>), and the most frequently reported improved impacts were in physical function, social function, and sleep (<b>Table 2</b>). 26 participants described their experience of the clinical trial: most participants across both treatment groups described the treatment as successful (benralizumab, n=6 [66.7%]; mepolizumab, n=17 [73.9%]), and two participants in the mepolizumab group vs. zero in the benralizumab group reported perceiving the treatment as unsuccessful; one patient (mepolizumab group) could not make conclusive statements about treatment success. The most common reason participants considered treatment successful was the ability to stop or reduce glucocorticoid use (n=8 [25.0%]). Across both groups participants reported improved quality of life and reductions in side effects from glucocorticoids, with some describing improvements in breathing, weight stabilization and energy/ability to exercise. <h3>Conclusion:</h3> These results provide insight into patients' perspectives of living with EGPA and their perceptions and experiences with an anti-interleukin-5 treatment, highlighting the need for effective treatments that allow patients to reduce the use of glucocorticoids, and helping to guide the choice of outcomes for future clinical trials.<b>REFERENCES: NIL.</b> <h3>Acknowledgements:</h3> Robert Walsh of inScience Communications, Springer Healthcare Ltd, UK, provided medical writing support, which was funded by AstraZeneca in accordance with Good Publication Practice 2022 guidelines. <h3>Disclosure of Interests:</h3> Peter A Merkel Consulting and stock options for Kyverna, Q32, and Sparrow, Consulting fees for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, InflaRx, and Takeda. ArGenx, Cabaletta, CSL Behring, Dynacure, HiBio, Janssen, Novartis, NS Pharma, Regeneron Pharmaceuticals, and Vistera. Kyverna, Q32, and Sparrow. Royalties from UpToDate, Research support for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, InflaRx, and Takeda. Eicos, Electra, Forbius, Genentech/Roche, Genzyme/Sanofi, and Neutrolis, Bernhard Hellmich Speakers fees for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Chugai, GlaxoSmithKline, InflaRx, Janssen, MSD, Pfizer, Novartis, Phadia, and Roche, Consulting fees for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Chugai, GlaxoSmithKline, InflaRx, Janssen, MSD, Pfizer, Novartis, Phadia, and Roche, Christian Pagnoux Speaker fees for GlaxoSmithKline, Otsuka, Pfizer, and Roche, Consulting fees for GlaxoSmithKline, Otsuka, Pfizer, and Roche. Advisory boards for AstraZeneca, GlaxoSmithKline, and Otsuka, Research support for Roche. Educational grants from GlaxoSmithKline, Otsuka, and Pfizer, Ulrich Specks Consulting fees for Amgen, Argenix, AstraZeneca, Boehringer Ingelheim, and CSL Vifor, Research support for AstraZeneca, Bristol-Myers Squibb, Genentech, GSK, NorthStar Radioisotopes, and Syneos, Michael Wechsler Consulting fees for AstraZeneca, Boehringer Ingelheim, Cohero Health, Equillium, Genentech, GlaxoSmithKline, Novartis, Regeneron, Sanofi–Genzyme, Sentien Biotechnologies, Teva, and Amgen, Vivian H Shih May own stock/stock options in AstraZeneca, Employee at AstraZeneca at the time the work was conducted, Lena Börjesson Sjö May own stock/stock options in AstraZeneca, Employee at AstraZeneca at the time the work was conducted, Sofia Necander May own stock/stock options in AstraZeneca, Employee at AstraZeneca at the time the work was conducted, Caroline Roberts Employee at IQVIA, which received funding from AstraZeneca for this research, Jennifer Hanlon Employee at IQVIA, which received funding from AstraZeneca for this research, Calvin N Ho May own stock/stock options in AstraZeneca, Employee at AstraZeneca at the time the work was conducted.