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Background: Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics., Objective: This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study., Methods: The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60-<190, 190-<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL)., Results: Overall, 822 patients were included. CSEs occurred in 760 (93%) patients pre-treatment and 398 (49%) during follow-up. CSE rate (RR[95% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n=173]: 0.31[0.25, 0.37]; 60-<190 [n=176]: 0.30[0.25, 0.36]; 190-<550 [n=170]: 0.26[0.20, 0.33]; ≥550 kU/L [n=155]: 0.28[0.23, 0.35]) and irrespective of atopic status (yes [n=422]: 0.29[0.26, 0.33]; no [n=52]: 0.33[0.23, 0.47]; unknown [n=348]: 0.28[0.24, 0.32]), prior omalizumab use (yes [n=151]: 0.37[0.30, 0.45]; no [n=671]: 0.27[0.24, 0.30]) or eligibility (eligible (n=349): 0.29[0.25, 0.34]; non-eligible [n=191]: 0.32[0.27, 0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and BEC (cells/µL) combinations (<81/<300 [n=53]: 0.34[0.24, 0.47], <81/≥300 [n=103]: 0.33[0.26, 0.41], ≥81/<300 [n=98]: 0.36[0.28, 0.47], ≥81/≥300 [n=249]: 0.26[0.22, 0.31])., Conclusion: Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype., (Copyright © 2025. Published by Elsevier Inc.)

Objectives: The healthcare burden of moderate asthma is not as well studied as severe asthma. This study used 2019 US claims data to characterize patients in Global Initiative for Asthma (GINA) steps 3 to 5 (moderate to severe) during the first 90 days of 2019., Methods: Patient characteristics, healthcare resource utilization and costs were described for all patients and GINA groups. Patients in GINA 3 accounting for the top 10% and 20% of asthma-related total costs were also analyzed., Results: In the overall asthma population ( N  = 337 015), mean asthma-related healthcare cost per patient was $12 560; for GINA 3, 4 and 5, costs were $10 265, $12 923, and $22 601, respectively. For the GINA 3 top 10% and 20% cost subgroups, these expenditures were higher than for GINA 5 ($54 549 and $94 386, respectively), driven by outpatient and inpatient costs. The high-cost GINA 3 subgroups were older, more often female and had a higher comorbidity burden versus GINA 4 or 5. An exploratory analysis suggested that biologic initiation significantly increased costs in patients initially in GINA 3 ( p  < 0.0001), but significantly reduced costs in GINA 3 top 10% and 20% cost subgroups (both p  < 0.01)., Conclusion: Results indicate patients receiving GINA 3 treatment can have a high disease burden and may benefit from treatment with a biologic.

Background: PRO measures of symptoms in clinical trials have historically utilized visual and numerical scales but verbal descriptors may make it easier for patients to clearly differentiate between response options. This study assessed content validity and meaningful change in five verbal response scales (VRSs) used to assess chronic rhinosinusitis with nasal polyp (CRSwNP) symptom severity., Methodology: This qualitative, semi-structured interview study recruited adults from the US, Germany, and China with confirmed moderate-to-severe CRSwNP. Interviews included a concept elicitation section, where participants were asked about their experience of living with CRSwNP including symptoms and health-related quality-of-life impacts, and a cognitive debriefing section, where participants were debriefed and participant understanding and real-life relevance of the CRSwNP symptom VRS content were assessed. Interview transcripts were qualitatively analyzed using thematic analysis methods., Results: Among the 24 participants interviewed, the most frequently reported CRSwNP symptoms were nasal obstruction, runny nose, mucus in the throat, loss of smell and facial pain/pressure. Participants demonstrated good understanding of the CRSwNP symptom VRS instructions, items, recall period, and response options. The five CRSwNP symptom VRS items were relevant to the majority of participants' experience of CRSwNP. At the item level, a one-category within-person improvement was the level most frequently reported by participants to be a meaningful change., Conclusion: The CRSwNP symptom VRSs assess relevant and bothersome symptoms experienced by patients with moderate-to-severe CRSwNP, supporting content validity of this measure. The findings of this study provided preliminary insights into meaningful change in the VRS. Further quantitative assessment of meaningful change is needed, and psychometric evaluation of the CRSwNP symptom VRSs will be required to evaluate their appropriateness for assessment of clinical trial endpoints in patients with CRSwNP., Competing Interests: Declarations. Ethics approval and consent to participate: The study was conducted according to the principles outlined in the Declaration of Helsinki, and according to guidelines published by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Additionally, all data was handled in accordance with the European General Data Protection Regulation (GDPR), and data from China was handled in accordance with the PIPL and Data Security Law (DSL). Ethical approval was obtained from Salus Institutional Review Board (IRB), a centralized IRB that provides ethical oversight to research conducted globally for multi-country studies, prior to the collection or processing of participant data (Salus IRB: C218108 GK9381A). Each participant provided written and verbal consent via the informed consent form before their interview was conducted. Consent for publication: Not applicable. Competing interests: TK, NG, WA, RA-C and ARS are employed by GSK and hold financial equities in GSK; KF, RS, SW and AG are employees of Adelphi Values, a consulting company that received funds from GSK to conduct this study but did not receive payment for manuscript development., (© 2024. The Author(s).)

Objectives: To provide long-term, real-world safety and effectiveness data for mepolizumab treatment in eosinophilic granulomatosis with polyangiitis in Japan., Methods: MARS (NCT04551989) was a real-world, observational study of patients who had previously completed the PMS study (NCT03557060; ≥96 weeks of mepolizumab treatment before study entry [baseline]) and continued receiving four-weekly mepolizumab 300 mg subcutaneously for a further 96 weeks. Safety outcomes were assessed from baseline to Week 96 (observation period); clinical outcomes were assessed pre-mepolizumab initiation (retrospective period) and during the observation period., Results: Of 118 patients enrolled in the study, 58% (69/118) experienced adverse events and 22% (26/118) experienced serious adverse events over the observation period; none were mepolizumab-related. Over the study (pre-mepolizumab period; baseline; end of observation period) the proportion of patients with no clinical symptoms increased (6%, to 27%, to 32%, respectively), median oral glucocorticoid dose decreased (6.9, to 3.0, to 2.0 mg/day, respectively) and the proportion of oral glucocorticoid-free patients increased (8%, to 31%, to 36%, respectively)., Conclusions: Long-term MARS study data are consistent with the known safety profile of mepolizumab. Over 192 weeks (pre-mepolizumab-observation), mepolizumab was well tolerated, with improvements in eosinophilic granulomatosis with polyangiitis disease control and reductions in oral glucocorticoid use., (© Japan College of Rheumatology 2024. Published by Oxford University Press.)

Purpose: To inform effective management strategies for severe asthma in China, this study aimed to comprehensively characterize clinical characteristics, treatment patterns, disease control status, and healthcare resource utilization among patients on GINA Step 4/5 therapies by analyzing data from the Adelphi Asthma Disease Specific Program conducted in China., Patients and Methods: All information was retrieved from medical records or collected from physicians and patients on the survey date (August-December 2018); no follow-up was conducted. Results were summarized descriptively for patients on GINA Step 4/5 therapies, who were pooled from a consecutive sample (comprising three or more consecutive patients with physician-diagnosed asthma from each participating physician) and an oversample (comprising the next two patients with physician-perceived severe asthma from each participating physician)., Results: Of the included patients (n=754), 51.5% had ever had a blood eosinophil measurement taken, 22.1% had available records for their most recent blood eosinophil measurements (68.9% of them had an elevated level ≥150 cells/µL), 39.9% had ever been tested for specific immunoglobulin E or radioallergosorbent, and 8.0% were prescribed maintenance oral corticosteroids. Asthma was not well controlled in 69.2% of patients. In the prior year, 27.1% experienced at least one severe exacerbation and 22.8% experienced at least one hospitalization (emergency visit or overnight stay) due to asthma., Conclusion: In Chinese patients with asthma on GINA Step 4/5 therapies, biomarker testing was underutilized, asthma was not well controlled, and severe exacerbations were not infrequent. These findings highlight the urgent need for optimized asthma management for patients on GINA Step 4/5 therapies in China., Competing Interests: VB, ZT, TY, PH, AR, and RAC are employees of GSK. VB, ZT, PH, AR, and RAC hold stocks and shares of GSK. JS was an employee of Adelphi Real World at the time of the study conduct, and AH and MS are employees of Adelphi Real World. The authors report no other conflicts of interest in this work., (© 2024 Benson et al.)

Purpose: To inform better asthma management in China, this study aimed to comprehensively investigate clinical characteristics, treatment patterns, asthma control status, exacerbations, and humanistic burden among adult patients seeking hospital-based asthma care by analyzing data from Adelphi Asthma Disease Specific Program conducted in China., Patients and Methods: All information was collected on survey date (August-December 2018) from medical records, physicians, or patients, without follow-up being conducted. Results are summarized descriptively for the overall population as well as subgroups defined by GINA 2018 treatment step., Results: Of the included 765 patients, 46.0%, 40.4%, and 29.2% had undergone lung function, blood eosinophil count, and specific immunoglobulin E/radioallergosorbent testing, and 17.2%, 24.1%, and 58.7% were managed at GINA Steps 1-2, 3, and 4-5, respectively. Asthma was not well controlled in 57.3% of patients based on definitions adapted from the ERS/ATS and 10.7% of patients had experienced ≥1 severe exacerbation in the preceding year. According to patient self-reporting (n=603), the mean (SD) was 0.9 (0.1) for utility on EQ-5D-3L and was 7.8% (10.4%), 36.9% (20.0%), 40.8% (22.2%), and 37.9% (22.3%) for absenteeism, presenteeism, work productivity loss, and activity impairment, respectively, on WPAI. Both asthma control and humanistic burden worsened with progressive GINA treatment steps., Conclusion: In patients seeking hospital-based asthma care in China, lung function and biomarker tests were underutilized, impairment in productivity and quality of life was observed, and more than half did not achieve well-controlled asthma despite approximately 60% being managed at GINA treatment Steps 4-5. These findings highlight the urgent need for optimizing asthma management in China., Competing Interests: V.B., R.AC., Z.T., P.H., A.R., and T.Y. are employees of GSK. V.B., R.AC., Z.T., P.H., and A.R. hold GSK stocks and shares. J.S. was an employee of Adelphi Real World at the time the study was conducted, and A.H. and M.S. are employees of Adelphi Real World. The authors report no other conflicts of interest in this work., (© 2024 Benson et al.)

Background: Several biologics for the treatment of severe asthma are available as self-administration devices., Objective: We performed a systematic literature review to understand the use, benefits, and challenges of these self-administration devices., Methods: Electronic databases and conference proceedings were searched using terms for asthma, biologic treatment, and at-home/self-administration (GSK study 213094). Publications were scanned for relevance using prespecified Population, Intervention, Comparison, Outcomes, Study Design (PICOS) criteria. Data on efficacy, safety, patient experience, and economic outcomes were extracted; study quality was assessed. A firsthand patient perspective was obtained., Results: Thirty-five of 504 records met the inclusion criteria. Across four phase 3 studies, ≥95% of biologic self-administrations were successful on the basis of predefined criteria. At-home self-administration was preferred over in-clinic administration by 43-96% of patients across 5 studies. Most patients (≥89%) in two phase 3 studies reported completing self-administration easily without repeated reference to instructions; high proportions of patients (≥98%) were confident in their ability to self-administer their biologic, and ≥96% rated it as extremely, very or moderately easy to self-administer. Across 16 studies reporting efficacy data, there was evidence of reduced blood eosinophil counts and improved asthma control with biologic self-administration, with improved health-related quality of life shown across 6 studies. Economic outcomes data were limited. From a patient perspective, autonomy is the major benefit of self-administration., Conclusion: Although more evidence is needed, this systematic literature review provides consistent evidence of high injection success rates and, supported by a patient perspective, preference for self-administration of biologics among patients with severe asthma., Competing Interests: Funded by GSK (study 213094). Disclosure of potential conflict of interest: S. Boccaletti at the time of the study was a GSK employee. R. Alfonso-Cristancho and W. Ahmed are employees of GSK and hold stocks and shares. A. Eze, L. Badgujar, N. Halfpenny, and D. Heldt are employees of OPEN Health which received payment from GSK to conduct this study. P. Auti and C. Alleman at the time of the study were employees of OPEN 10.13039/100018696Health who received funding from GSK to conduct this study. L. Sergison declares no relevant conflicts of interest., (© 2024 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.)

Objectives: We report the prevalence of eosinophilic granulomatosis with polyangiitis (EGPA) and describe oral corticosteroid (OCS) use and disease burden before and after the mepolizumab approval in 2018 for EGPA in Japan., Methods: Two retrospective studies (GSK IDs: 218083 and 218084) used two databases: (1) the JMDC insurer database (Japanese health insurer claims) was used to report annual EGPA prevalence and OCS use in mepolizumab-treated patients and (2) Medical Data Vision database was used to report annual treatment use, OCS dose, relapses, and healthcare resource utilization in patients with EGPA., Results: EGPA prevalence (95% confidence interval) increased from 4.2 (0.1, 23.4) in 2005 to 58.6 (53.2, 64.5) per 1,000,000 in 2020. Median OCS dose (mg/day) decreased from a range of 4.8-7.7 during 2010-2017 to 4.5-4.8 during 2018-2020 (lowest dose in 2020). The proportion of patients with prednisolone-equivalent daily OCS dose >10 mg decreased from 2017 (11.9%) to 2020 (10.3%), while the median dose halved. The proportion of patients with EGPA relapses (64.3% to 41.6%) and hospitalization (27.8% to 23.6%) decreased from 2010 to 2020., Conclusions: EGPA prevalence increased between 2005 and 2020. With the introduction of mepolizumab for EGPA in 2018, real-world OCS use, relapses, and healthcare resource utilization decreased., (© Japan College of Rheumatology 2023. Published by Oxford University Press.)

Objectives: The objective of the study is to assess real-world, long-term safety/effectiveness of mepolizumab for eosinophilic granulomatosis with polyangiitis (EGPA) in Japan., Methods: The Mepolizumab long-term study to Assess Real-world Safety and effectiveness of EGPA in Japan (MARS) (GSK ID: 213684/NCT04551989) is an ongoing 96-week study of patients with EGPA who received four-weekly mepolizumab 300 mg subcutaneously for ≥96 weeks before study entry (baseline) and continued treatment. This interim analysis included safety from baseline to Week 48 (observation period) and clinical outcomes before mepolizumab and during the observation period., Results: Of 118 patients enrolled, 29% (34/118) experienced adverse events (AEs), of which 13% (15/118) experienced serious AEs; none were considered mepolizumab related. The median oral corticosteroid (OCS) dose decreased from 6.9 (pre-mepolizumab) to 3.0 (baseline) and 2.0 mg/day (Weeks 45-48); the proportion of patients receiving no OCS increased from 8% to 32% and 38%, respectively. Patients experiencing clinical symptoms decreased from 94% (pre-mepolizumab) to 73% (baseline) and 67% (Week 48). During the observation period, 5% of patients experienced EGPA relapse; the rates of EGPA-related hospitalisations, EGPA-related emergency room/unscheduled visits, and asthma exacerbations were 0.05, 0.09, and 0.08 event/person-year, respectively., Conclusions: The results of mepolizumab treatment for ≥144 weeks (before baseline plus observation) were consistent with the known safety profile and allowed OCS dose reduction while improving disease control versus pre-treatment among patients with EGPA., (© Japan College of Rheumatology 2023. Published by Oxford University Press.)