Gianni Turcato, Arian Zaboli, Lucia Filippi, Alessandro Cipriano, Marta Parodi, Serena Sibilio, Paolo Ferretto, Daniela Milazzo, Massimo Marchetti, Lorenzo Ghiadoni, Christian J Wiedermann
{"title":"Unveiling key predictors of sepsis mortality in intermediate care units: a decision tree study.","authors":"Gianni Turcato, Arian Zaboli, Lucia Filippi, Alessandro Cipriano, Marta Parodi, Serena Sibilio, Paolo Ferretto, Daniela Milazzo, Massimo Marchetti, Lorenzo Ghiadoni, Christian J Wiedermann","doi":"10.1080/03007995.2025.2466730","DOIUrl":"10.1080/03007995.2025.2466730","url":null,"abstract":"<p><strong>Background: </strong>Sepsis remains a leading cause of mortality, especially among patients admitted to non-ICU settings like intermediate care units (IMCUs). Current prognostic tools have limitations in predicting outcomes in these patients. This study aimed to identify key predictors of mortality using decision tree analysis.</p><p><strong>Methods: </strong>We conducted a prospective observational study from January 2023 to June 2024, enrolling 254 septic patients admitted to the IMCU of Santorso Hospital, Italy. Clinical, laboratory, and demographic data were collected, and decision tree analysis was performed to identify factors associated with 30-day mortality. Variables were compared using univariate and multivariate analyses, and significant predictors were incorporated into the decision tree model.</p><p><strong>Results: </strong>The 30-day mortality rate was 14.6%. Serum albumin was identified as the root node of the decision tree, with lower levels (≤2.3 g/dL) strongly associated with mortality. Additional predictors were identified as higher NEWS scores (OR 1.153, <i>p</i> = 0.002) and older age (OR 1.062, <i>p</i> = 0.021). Traditional scoring systems like SOFA and APACHE did not significantly predict outcomes in this setting.</p><p><strong>Conclusions: </strong>Serum albumin is a key prognostic marker in septic patients admitted to IMCUs, alongside NEWS and age. These findings suggest that albumin levels at admission may aid in early risk stratification and clinical decision-making in non-ICU environments. Future studies should validate these results across different healthcare settings to optimize sepsis management.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"199-207"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nanette Santoro, Genevieve Neal-Perry, Petra Stute, Martin Blogg, Shayna Mancuso, Antonia Morga, Faith D Ottery, Emad Siddiqui
{"title":"Fezolinetant effect on vasomotor symptoms due to menopause in women unsuitable for hormone therapy.","authors":"Nanette Santoro, Genevieve Neal-Perry, Petra Stute, Martin Blogg, Shayna Mancuso, Antonia Morga, Faith D Ottery, Emad Siddiqui","doi":"10.1080/03007995.2025.2470752","DOIUrl":"10.1080/03007995.2025.2470752","url":null,"abstract":"<p><strong>Objective: </strong>To assess efficacy and safety of fezolinetant in women unsuitable for hormone therapy (HT), using pooled SKYLIGHT 1 and 2 data.</p><p><strong>Methods: </strong>SKYLIGHT 1 and 2 were double-blind, placebo-controlled studies of once-daily placebo, fezolinetant 30 mg or 45 mg for 12 weeks in women aged ≥40-≤65 years with moderate to severe vasomotor symptoms (VMS; average ≥7 hot flashes/d), followed by a double-blind, non-controlled extension period for 40 weeks. The HT unsuitable group comprised 4 mutually exclusive subgroups, categorized using the following hierarchy: contraindicated; caution; stopper for medical concerns; averse.</p><p><strong>Results: </strong>A total of 1,022 participants received ≥1 dose of study medication (fezolinetant 30 mg, <i>n</i> = 339; fezolinetant 45 mg, <i>n</i> = 341). Improvement was seen for the HT unsuitable group in frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12 (mean difference [95% CI] fezolinetant 45 mg vs. placebo: -2.55; 95% CI, -3.29 to -1.80; <i>p</i> < .001 at week 12). Sleep disturbance, measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b (PROMIS-SD SF 8b) total score, improved by weeks 4 and 12 (mean difference [95% CI] fezolinetant 45 mg vs. placebo at week 12: -1.60; 95% CI, -2.71 to -0.49; <i>p</i> = .005). Fezolinetant was well tolerated in the HT unsuitable group, with treatment-emergent adverse events in 39.4% of participants receiving fezolinetant 45 mg vs. 41.3% receiving placebo.</p><p><strong>Conclusion: </strong>This pooled analysis demonstrated efficacy of fezolinetant vs. placebo in reducing frequency and severity of VMS due to menopause in participants unsuitable for HT.</p><p><strong>Clinical trial registration: </strong>SKYLIGHT 1 - ClinicalTrials.gov, NCT04003155; https://clinicaltrials.gov/ct2/show/NCT04003155 (conducted between July 2019 and August 2021); SKYLIGHT 2 - ClinicalTrials.gov, NCT04003142; https://clinicaltrials.gov/ct2/show/NCT04003142 (conducted between July 2019 and April 2021).</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"375-384"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Manish Jha, Amanda Teeple, Jason Shepherd, Alexander Gillespie, Nikisha Grant, Ashley Mortimer, Sophie Kirkman, Chloe Middleton-Dalby, Kruti Joshi
{"title":"Characteristics of patients with major depressive disorder eligible for and prescribed esketamine, treatment outcomes and physician experiences: a physician and patient survey in the United States.","authors":"Manish Jha, Amanda Teeple, Jason Shepherd, Alexander Gillespie, Nikisha Grant, Ashley Mortimer, Sophie Kirkman, Chloe Middleton-Dalby, Kruti Joshi","doi":"10.1080/03007995.2025.2463975","DOIUrl":"10.1080/03007995.2025.2463975","url":null,"abstract":"<p><strong>Objective: </strong>Esketamine is an FDA-approved treatment for treatment-resistant depression (TRD) or major depression with acute suicidal ideation or behavior (MDSI). This analysis addressed the lack of data on real-world characteristics of patients with TRD and MDSI or prescribed esketamine.</p><p><strong>Methods: </strong>Data were derived from the Adelphi Real World Depression Disease Specific Programme a cross-sectional survey of physicians and patients with TRD, MDSI, or those prescribed esketamine in the US (July 2022-February 2023). Physicians reported demographic and clinical characteristics, patients completed PHQ-9 and WPAI measures.</p><p><strong>Results: </strong>Of 914 patients enrolled in the survey, 66.2% had TRD and 33.8% MDSI. Mean (± standard deviation) PHQ-9 scores were 8.3 ± 6.3 (TRD) and 9.3 ± 6.3 (MDSI), with moderate-to-very severe depression reported by 36.5% (TRD) and 48.3% (MDSI) of patients. Mean work impairment was 26.0 ± 28.1% and overall impairment 34.7 ± 27.3%. No-to-mild impairment was reported for most patients in ability to meet basic needs, social functioning, work, overall quality of life and general health. Patients and physicians showed low levels of agreement on disease severity and trajectory. Patients prescribed esketamine (<i>n</i> = 94) were 43.3 ± 13.3 years old, diagnosed 5.7 ± 6.6 years before survey, sex was evenly split, and 64.8% were working full or part time. Most common diagnoses were TRD (38.3%), MDD (37.2%) or MDSI (17.0%). Patients showed improvements in CGI-S (64.6-77.8%) and activities of daily living (34-67%) following esketamine.</p><p><strong>Conclusions: </strong>The substantial impact of TRD and MDSI on daily life and unmet treatment need was underestimated by physicians. Patients treated with esketamine reported favorable outcomes.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"355-368"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anita H Clayton, Mousam Parikh, Tracy Yee, Daniel Mercer, Haiyan Sun, Nicholas Cummings, Andrew Rava, Oscar Hayes, Nadia Nabulsi
{"title":"Healthcare resource utilization with adjunctive cariprazine and other atypical antipsychotics in patients with major depressive disorder.","authors":"Anita H Clayton, Mousam Parikh, Tracy Yee, Daniel Mercer, Haiyan Sun, Nicholas Cummings, Andrew Rava, Oscar Hayes, Nadia Nabulsi","doi":"10.1080/03007995.2025.2465617","DOIUrl":"10.1080/03007995.2025.2465617","url":null,"abstract":"<p><strong>Objective: </strong>Little is known about the healthcare resource utilization (HRU) associated with different adjunctive atypical antipsychotics (AAs) for the treatment of major depressive disorder (MDD). This analysis evaluated HRU in patients with MDD treated adjunctively with cariprazine versus other AAs.</p><p><strong>Methods: </strong>Merative MarketScan databases were searched for claims made from 01/01/2018 to 12/31/2020 (Medicaid) or 3/31/2021 (commercial and Medicare). The study included adults with ≥1 inpatient MDD claim or ≥2 outpatient MDD claims >30 days apart and ≥1 claim for cariprazine, brexpiprazole, generic aripiprazole, or generic quetiapine adjunctive to an antidepressant (i.e. ≥14-day overlap between AA and antidepressant). Outcomes included all-cause and MDD-related inpatient stays and emergency department (ED), office, and psychiatric visits. Results were reported as estimated mean ratios, calculated <i>via</i> negative binomial regression, of the comparator AA to cariprazine with 95% CIs.</p><p><strong>Results: </strong>Analyses included 40,195 patients (cariprazine [<i>n</i> = 1,038], brexpiprazole [<i>n</i> = 3,221], generic aripiprazole [<i>n</i> = 20,601], generic quetiapine [<i>n</i> = 15,335]). The cariprazine cohort had significantly fewer all-cause and MDD-related inpatient stays relative to all other AA cohorts. All-cause ED visits were significantly lower in the cariprazine versus generic quetiapine cohort, and MDD-related ED visits were significantly lower in the cariprazine versus generic aripiprazole and generic quetiapine cohorts. ED visits were similar between cariprazine and all other cohorts. All-cause and MDD-related office and psychiatric visits were significantly lower in the cariprazine versus most other AA cohorts.</p><p><strong>Conclusion: </strong>Although causality cannot be determined from these real-world findings, results suggest that in patients with MDD, initiating adjunctive cariprazine is associated with significantly lower HRU for certain outcomes relative to other AAs.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"219-226"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Addendum.","authors":"","doi":"10.1080/03007995.2024.2445962","DOIUrl":"https://doi.org/10.1080/03007995.2024.2445962","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1"},"PeriodicalIF":2.4,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142920797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xuehua Ke, Helen Ding, Yezhou Sun, Daisuke Goto, Prajakta Waghmare, Mingyue Li
{"title":"Experiencing chronic cough symptoms for 3 years is associated with increased rates of healthcare resource use and higher healthcare costs in the United States compared to resolved chronic cough.","authors":"Xuehua Ke, Helen Ding, Yezhou Sun, Daisuke Goto, Prajakta Waghmare, Mingyue Li","doi":"10.1080/03007995.2024.2433252","DOIUrl":"10.1080/03007995.2024.2433252","url":null,"abstract":"<p><strong>Objective: </strong>Chronic cough (CC) symptoms can persist as refractory or unexplained CC (RCC). We sought to characterize the clinical and economic burden of RCC.</p><p><strong>Methods: </strong>In this retrospective US cohort study using data from Optum's de-identified CDM Database (01/2015-03/2022), CC was identified as ≥1 CC diagnosis or ≥3 cough events (with ≥8 weeks and ≤120 days between the first and third events and ≥3 weeks between any two events). The index date was set as the earliest date of meeting the CC definition. The baseline period was defined as the 364 days prior to and including the index date. Adults with CC at baseline who met CC requirements (≥1 CC diagnosis, or ≥2 cough events occurring ≥8 weeks but ≤120 days apart) in both follow-up year 2 and follow-up year 3 were defined as having \"3-year chronic cough\" (3YCC), a proxy measure of RCC, and compared to adults with CC at baseline who did not meet CC requirements in follow-up years 2 and 3 (non-3YCC). A propensity score weighting approach was used to adjust for baseline differences between the 3YCC and non-3YCC groups to compare clinical characteristics and healthcare resource use and costs in the two groups during the follow-up period.</p><p><strong>Results: </strong>At baseline, the 3YCC group (<i>N =</i> 3,338) had significantly more comorbidities and higher all-cause healthcare resource use and costs than the non-3YCC group (<i>N =</i> 43,122) in unweighted analyses. After weighting, the groups (<i>N =</i> 3,338 with 3YCC and <i>N =</i> 3,145 without) were compared during a 3-year follow-up period. The 3YCC group had significantly more comorbidities, higher levels of all-cause healthcare resource use, and higher all-cause healthcare costs during the follow-up period compared to the non-3YCC group, after adjusting for baseline differences. For example, the mean total healthcare costs (in 2022 US dollars) were significantly higher among the 3YCC group than the non-3YCC group in each follow-up year, at $49,454 versus $42,144 in follow-up year 1, $49,339 versus $36,939 in follow-up year 2, and $51,737 versus $36,503 in follow-up year 3 (<i>p <</i>.001 for each comparison).</p><p><strong>Conclusions: </strong>After adjusting for baseline differences, persistent symptoms of CC were associated with significantly higher comorbidity, healthcare resource use, and healthcare costs compared to CC that resolved. Effective treatments for RCC would thus be expected to result in improved health as well as substantial healthcare cost offsets.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"173-184"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Taha Koray Sahin, Yunus Kaygusuz, Mehmet Cihan İcli, Sercan Aksoy, Deniz Can Guven
{"title":"The perspectives and knowledge of patients with cancer on mpox and mpox vaccination: a cross-sectional study.","authors":"Taha Koray Sahin, Yunus Kaygusuz, Mehmet Cihan İcli, Sercan Aksoy, Deniz Can Guven","doi":"10.1080/03007995.2024.2445757","DOIUrl":"10.1080/03007995.2024.2445757","url":null,"abstract":"<p><strong>Objective: </strong>The recent outbreak of monkeypox (mpox) poses significant public health challenges, particularly for immunocompromised populations such as patients with cancer. However, misinformation poses a significant challenge during new outbreaks for patients with chronic diseases, as observed during the COVID-19 pandemic. Therefore, we aimed to assess perspectives and knowledge of patients with cancer on mpox and their willingness to receive mpox vaccination.</p><p><strong>Methods: </strong>A cross-sectional study was conducted among patients with cancer using a structured questionnaire. The survey encompassed sociodemographic data, mpox knowledge, attitudes towards vaccination, and willingness to mpox vaccination. Multivariate logistic regression analyses were performed to identify independent predictors of vaccination willingness.</p><p><strong>Results: </strong>A total of 275 patients were included. A significant majority (73.1%) of respondents wanted to learn more about mpox, and 33.8% were confident in global efforts to control the outbreak. 69.1% of the patients were unwilling to receive the mpox vaccine, mainly due to safety concerns and the interference with the anti-cancer treatment. In multivariable analysis, younger age (<65 years) (OR = 1.836, 95% CI:1.030-3.271, <i>p</i> = 0.039), information about mpox before (OR = 1.899, 95% CI:1.104-3.268, <i>p</i> = 0.021) and good knowledge about mpox (OR = 1.968, 95% CI:1.118-3.465, <i>p</i> = 0.019) were significant predictors of willingness to vaccinate against mpox.</p><p><strong>Conclusion: </strong>A substantial proportion of cancer patients in Turkey are hesitant to receive the mpox vaccine, primarily due to concerns about safety and its implications for cancer treatment. Targeted educational interventions that address these specific concerns and enhance understanding of the benefits of vaccination are critical to improving vaccine uptake in this vulnerable population.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"83-91"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142884998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lisa Dwyer Orr, Kay Sadik, Kathleen Beusterien, Stephanie Loomer, Kristen King-Concialdi, Kathryn Krupsky, Elizabeth Brighton, Lee Kirksey, Narjust Florez
{"title":"Drivers and barriers to health-seeking behaviors and interactions: a qualitative study of Black patients with lung cancer and with peripheral artery disease.","authors":"Lisa Dwyer Orr, Kay Sadik, Kathleen Beusterien, Stephanie Loomer, Kristen King-Concialdi, Kathryn Krupsky, Elizabeth Brighton, Lee Kirksey, Narjust Florez","doi":"10.1080/03007995.2024.2444420","DOIUrl":"10.1080/03007995.2024.2444420","url":null,"abstract":"<p><strong>Objective: </strong>To identify factors that may influence health-seeking behaviors and health system interactions from the perspective of Black patients with lung cancer (LC) or peripheral artery disease (PAD).</p><p><strong>Methods: </strong>Semi-structured interviews were conducted virtually with Black patients in the United States. Thematic analysis of interview transcripts was performed. The Sense-Think-ACT-Relate (STAR) behavioral framework was used to map emerging themes of drivers and barriers to health-seeking behaviors and health system interactions.</p><p><strong>Results: </strong>Thirty Black patients with LC (<i>n</i> = 15) and PAD (<i>n</i> = 15) participated in this study. The mean age of participants was 53.4 years, 22 were female, and half lived in an urban area or large city. Factors that shape health-seeking behaviors spanned several framework domains including Trust, Rational and Emotional Associations, Cultural, and Situational. Having a provider who was friendly, knowledgeable, and understood the patient's lived experience was a key driver to seeking care. Barriers to care included patients not recognizing disease symptoms, reservations about seeking care, having previous negative interactions with healthcare systems, and feeling stigmatized or excluded. Situational influences, such as financial cost of accessing and receiving healthcare, also acted as barriers. Similar themes emerged for the LC versus PAD cohorts.</p><p><strong>Conclusion: </strong>Multiple drivers and barriers to health-seeking behaviors exist for Black patients with LC versus PAD, including patients' perceptions of previous health system interactions. Because of known inequities experienced by Black patients, these results highlight the need for interventions that address more than just medical needs but that also encourage patients to seek care when they experience early symptoms and prioritize establishing patient-provider relationships built on trust, respect, and cultural understanding.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"135-143"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel J Moore, Natasha I Leibel, William Polonsky, Henry Rodriguez
{"title":"Understanding the different stages of type 1 diabetes and their management: a plain language summary.","authors":"Daniel J Moore, Natasha I Leibel, William Polonsky, Henry Rodriguez","doi":"10.1080/03007995.2024.2436984","DOIUrl":"10.1080/03007995.2024.2436984","url":null,"abstract":"","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"13-24"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142870834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara
{"title":"Dupilumab improves sense of smell and clinical outcomes in patients with severe chronic rhinosinusitis with nasal polyps with anosmia.","authors":"Andrew P Lane, Joaquim Mullol, Claire Hopkins, Wytske J Fokkens, Stella E Lee, Jerome Msihid, Scott Nash, Harry Sacks, Kinga Borsos, Siddhesh Kamat, Paul J Rowe, Yamo Deniz, Juby A Jacob-Nara","doi":"10.1080/03007995.2024.2434083","DOIUrl":"10.1080/03007995.2024.2434083","url":null,"abstract":"<p><strong>Objective: </strong>Loss of sense of smell is a cardinal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP) and significantly impacts health-related quality-of-life. Dupilumab significantly improved smell outcomes (loss of smell [LoS] score; University of Pennsylvania Smell Identification Test [UPSIT]) versus placebo in the phase 3 SINUS-24/-52 studies (clinicaltrials.gov, NCT02898454/NCT02912468) in patients with severe CRSwNP. This post hoc analysis investigated the effect of dupilumab on olfaction using UPSIT smell impairment categories.</p><p><strong>Methods: </strong>Patients with baseline smell impairment (UPSIT ≤34/≤33 [women/men; score range 0-40] AND LoS score ≥1 [0-3] AND smell/taste item of the 22-item Sinonasal Outcome Test >0 [SNOT-22; 0-5]) treated with dupilumab 300 mg or placebo once every 2 weeks on background intranasal corticosteroids were analyzed.</p><p><strong>Results: </strong>Of 724 patients, 665 (91.9%) had smell impairment at baseline; most had anosmia (UPSIT 0-18) (dupilumab/placebo: 80.9%/79.8%). At week 24, the proportion of dupilumab-treated patients with anosmia decreased to 28.5%, while 14.9% achieved normosmia; most placebo-group patients (79.2%) remained anosmic and only 1.2% achieved normosmia (odds ratio = 17.3; 95% confidence interval = 5.1-59.0; <i>p</i> <.0001); results were similar at week 52. Improvements in Nasal Polyp Score, nasal congestion, and SNOT-22 total score were moderately correlated with improvements in UPSIT at weeks 24 and 52 (r = -.38 to -.50).</p><p><strong>Conclusion: </strong>Most patients with severe CRSwNP had anosmia at baseline. Dupilumab treatment significantly improved smell versus placebo, with 14.9% achieving normosmia by week 24. There was a trend for better clinical outcomes in patients with greater smell improvement.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"53-59"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}