Real-world evidence of reported symptoms and quality of life burden associated with chronic rhinosinusitis with nasal polyposis and comorbid asthma status

2021 ◽  
Author(s):  
Benjamin Emmanuel ◽  
Mousumi Biswas ◽  
Megan Scott ◽  
Mark Small ◽  
Lauren Lee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Real World ◽  
Nasal Polyposis ◽  
Real World Evidence ◽  
Asthma Status

scholarly journals Mucosal Eosinophilia and Neutrophilia Are Not Associated With QOL or Olfactory Function in Chronic Rhinosinusitis

2021 ◽  
pp. 194589242098743
Author(s):  
Nyssa F. Farrell ◽  
Jess C. Mace ◽  
David A. Sauer ◽  
Andrew J. Thomas ◽  
Mathew Geltzeiler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyposis ◽  
Cross Sectional Study ◽  
Olfactory Function ◽  
Sinus Surgery ◽  
Small Subset ◽  
Cross Sectional ◽  
Snot 22

Background Chronic rhinosinusitis (CRS) is often differentiated by histopathologic phenotypes (eosinophilic versus neutrophilic), which may impact disease severity measures and outcomes. As such, it has been suggested that counts of cellular elements be included as part of a standard pathological report following endoscopic sinus surgery (ESS). Objectives This cross-sectional study evaluated associations of mucosal eosinophilia and neutrophilia with measures of quality-of-life (QoL) and olfactory function. Methods Patients with medically refractory CRS completed the SNOT-22 survey and Brief Smell Identification Test (BSIT) at enrollment. In addition, baseline Lund-Mackay computed tomography (CT) and Lund-Kennedy endoscopy scores were collected. Ethmoid mucosa was biopsied during ESS and reviewed using microscopy to quantify densest infiltrate of eosinophils or neutrophils per high-powered-field (HPF). Eosinophilic CRS (eCRS) and neutrophilic CRS (nCRS), both with and without nasal polyposis (NP), were compared across SNOT-22 and BSIT scores. Results 77/168 patients demonstrated mucosal eosinophilia (eCRS) while a total of 42/168 patients demonstrated mucosal neutrophilia (nCRS). After adjusting for polyp status, 35/168 had eCRSsNP, 42/168 eCRSwNP, 75/168 non-eCRSsNP, 16/168 non-eCRSwNP. Additionally, 22/161 were noted to have nCRSsNP, 20/161 nCRSwNP, 84/161 non-nCRSwNP, and 35/161 non-nCRSsNP. A small subset of patients demonstrated both eosinophilia and neutrophilia: 14 CRSwNP and 7 CRSsNP. When evaluating average Lund-Mackay Scores (LMS), significant differences existed between non-eCRSsNP and eCRSsNP (p = 0.006). However, after controlling for nasal polyps, eosinophilia did not significantly associate with differences in the Lund-Kennedy Score. Neutrophilia did not significantly associate with any changes in LMS or LKS after controlling for NP. Eosinophilic and neutrophilic histopathologic subtypes did not significantly associate with differences in baseline SNOT-22 or BSIT measures after controlling for NP. Conclusion Neither the presence of mucosal eosinophilia nor mucosal neutrophilia demonstrated significant associations with SNOT-22 quality-of-life or BSIT olfactory function scores when controlling for comorbid nasal polyposis.

scholarly journals Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Andreas Straube ◽  
Philipp Stude ◽  
Charly Gaul ◽  
Katrin Schuh ◽  
Mirja Koch
Keyword(s):  
Quality Of Life ◽  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Real World ◽  
Treatment Patterns ◽  
Patient Profile ◽  
Real World Evidence ◽  
Patient Profiles ◽  
Treatment Responses

Abstract Background Erenumab, the first-in-class fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor, was shown to be efficacious and safe for the prophylactic treatment of migraine in adults in randomized clinical trials. Large-scale, real-world evidence in multi-centre settings is still needed to confirm these results. Erenumab patient profiles outside clinical trials and physicians’ treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet. Methods TELESCOPE was a multi-centre survey gathering real-world data from 45 German headache centres between July 2019 and December 2019. The project consisted of two parts. In the first part, treating physicians shared their experiences on current erenumab treatment with regard to patient profiles, treatment patterns and treatment responses. In the second part, a retrospective chart review was conducted of 542 migraine patients treated with erenumab for at least three months. Treatment responses focused on various aspects of patients’ quality of life. Results The analysis of 542 patients’ charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medication days. Furthermore, headache intensity and frequency were reduced in over 75 % and accompanying aura in 35 % of patients. The clinical global impression scale revealed a general improvement in 91 % of patients. According to the treating physicians’ professional judgement, 83 % of patients responded to erenumab and 80 % were satisfied with the treatment. Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients. Based on the assessment of physicians, erenumab reduced migraine symptoms in 65 % and increased quality of life in more than 75 % of their patients. Conclusions TELESCOPE confirms positive treatment responses with erenumab shown in clinical trials in a real-world multi-centre setting. The results show consistently positive experiences of physicians utilizing erenumab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophylactic therapies.

Dupilumab as Add-on Therapy for Chronic Rhinosinusitis With Nasal Polyposis in Aspirin Exacerbated Respiratory Disease

2020 ◽  
pp. 194589242096196
Author(s):  
S. Shahzad Mustafa ◽  
Karthik Vadamalai ◽  
Bryan Scott ◽  
Allison Ramsey
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Respiratory Disease ◽  
Nasal Polyposis ◽  
Total Serum ◽  
Life Questionnaire ◽  
Median Baseline ◽  
Aspirin Exacerbated Respiratory Disease ◽  
Snot 22

Background Aspirin-exacerbated respiratory disease (AERD) affects 7% of asthmatics. Usual therapies are inadequate for asthma and/or nasal polyposis, leading to decreased quality of life. Objective Our objective was to evaluate the efficacy of dupilumab in AERD patients with uncontrolled, chronic rhinosinusitis with nasal polyposis (CRSwNP). Methods Patients 18 years and older with a physician diagnosis of AERD and sino-nasal outcome test 22 (SNOT 22) score ≥19 despite standard medical therapy were eligible for the study. Patients received one month of placebo dosing, followed by 6 months of dupilumab. Patients were blinded to the order of therapy. Wilcoxon-paired rank sum test was used to compare study outcomes at baseline and the completion of the study. Results Ten patients completed the study. The median baseline SNOT 22 score improved from 46 [IQR: 34 to 64.8] to 9.5 [IQR: 2.5 to 19] after 6 months of therapy (p = 0.0050). The median baseline Lund MacKay score improved from 21.5 [IQR: 17 to 23.3] to 4 [IQR: 1.2 to 6] after 6 months of therapy (p = 0.0050). There was also improvement in the following secondary outcomes: asthma control test (ACT), mini asthma quality of life questionnaire (AQLQ), and University of Pennsylvania Smell Identification test (UPSIT). Exhaled nitric oxide (FeNO), total serum IgE, 24-hour urinary leukotriene E4, and serum thymus and activation regulated cytokine (TARC) also decreased. There were no significant study-related adverse events. Conclusion Dupilumab was highly effective as add-on therapy for CRSwNP in AERD, improving patient-reported outcomes, sinus opacification, and markers of T2 inflammation.

scholarly journals Quality of life after functional endoscopic sinus surgery

2020 ◽  
Vol 6 (6) ◽  
pp. 1049
Author(s):  
Raies Ahmad Begh ◽  
Aditiya Saraf ◽  
Kamal Kishore ◽  
Parmod Kalsotra
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Endoscopic Sinus Surgery ◽  
Nasal Polyposis ◽  
Surgical Intervention ◽  
Functional Endoscopic Sinus Surgery ◽  
Sinus Surgery ◽  
Time Period ◽  
Snot 22

<p class="abstract"><strong>Background:</strong> This paper aims to assess improvement in quality of life (QOL) after functional endoscopic sinus surgery through questionnaire sino-nasal outcome test (SNOT)-22.</p><p class="abstract"><strong>Methods:</strong> The present study was conducted on 50 patients in Department of ENT and HNS, SMGS Hospital, GMC Jammu during a time period of July 2017 to September 2019. All the patients with age ≥18 years who failed to respond to medical therapy (3 months) and underwent functional endoscopic sinus surgery (FESS) were included in the study. SNOT-22 questionnaire was used to assess the improvement.  </p><p class="abstract"><strong>Results:</strong> In our study, preoperative SNOT scores were higher (54±8.05) but after FESS they reduced significantly at 1st (16.47±5.51), 3rd (13.86±4.19), 6th months (12.9±8.05) post operatively. Chronic rhinosinusitis (CRS) with nasal polyposis group had greater mean difference of SNOT-22 scores (43.93) between preoperative period and 3 months postoperative period than patients grouped as CRS without nasal polyposis (41.47).</p><p class="abstract"><strong>Conclusions:</strong> We concluded that FESS is the best surgical intervention for chronic rhinosinusitis. It significantly improves the quality of life of patients of chronic rhinosinusitis.</p>

scholarly journals Long-Term Clinical Follow-Up of Patients With Chronic Rhinosinusitis

2020 ◽  
pp. 000348942096282
Author(s):  
Ulrica Thunberg ◽  
Amanj Saber ◽  
Bo Söderquist ◽  
Svante Hugosson
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyposis ◽  
Nasal Congestion ◽  
Symptom Relief ◽  
Nasal Discharge ◽  
Long Term Follow Up

Objective: This study comprised a long-term follow-up of a cohort of patients with chronic rhinosinusitis (CRS) regarding clinical features and symptomatology. Methods: Data from 42 patients with CRS were available from a previous study. Forty of these patients were alive and were contacted for inclusion after approximately 10 years. Patients completed a questionnaire about disease and symptoms, and underwent a clinical examination. Results: Thirty-four patients (85%) responded and could be included and evaluated. For the participants in this follow-up study median length of time between initial inclusion (C1) and follow-up (C2) was 11 years (range: 8-15). In some patients the CRS shifted phenotype over time, from CRS with nasal polyposis to CRS without nasal polyposis or vice versa. The median total visual analogue score for combined sinonasal symptoms for all patients was statistically significantly reduced at follow-up. For individual patients, scores for nasal congestion, nasal discharge, facial pressure, and hyposmia were also statistically significantly reduced. The most frequently reported symptom-relieving treatments were nasal steroids and saline rinsing of the nose. Self-reported general quality of life was statistically significantly improved at C2 compared to C1. Conclusion: At long-term follow-up, symptoms were generally reduced and patients reported an improved quality of life. Patients can be given hope for eventual symptom relief. CRS is a chronic condition that seems to harbor the ability to alter its phenotype after several years. Topical corticosteroids and saline rinsing of the nose should be emphasized, since patients consider these treatments to be of high value.

IMPACT OF CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS ON QUALITY OF LIFE BY SINO-NASAL SURGERY HISTORY

2018 ◽  
Vol 121 (5) ◽  
pp. S20 ◽  
Author(s):  
A. Khan ◽  
T. Huynh ◽  
S. Kamat ◽  
L. Mannent ◽  
P. Tomassen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyposis ◽  
Nasal Surgery

scholarly journals In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alicia Alpuente ◽  
Victor J Gallardo ◽  
Edoardo Caronna ◽  
Marta Torres-Ferrus ◽  
Patricia Pozo-Rosich
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Real World ◽  
Medical Decision ◽  
Stepwise Logistic Regression ◽  
Primary Efficacy ◽  
Patient’S Perspective ◽  
Real World Evidence ◽  
Patient Reported

Abstract Background Patient-Reported Outcomes (PROs) have been developed to numerically quantify disability, impact and quality of life. They have been widely used in migraine clinical trials. However, we still do not know which PRO more accurately reflects preventive treatment response from a patient’s perspective or which one may help us with treatment decisions in clinical practice. They have been used to enforce the efficacy results in clinical trials and real-world evidence so far. The aim of this study was to analyze which PROM is (1) better correlated with all primary efficacy endpoints and (2) which one is better associated with treatment continuation with CGRP-mAbs at week-12, which is usually the moment when this decision is made. Methods Patients with migraine who had received 3 administrations of CGRP-mAbs were evaluated in this prospective cohort study. Primary efficacy outcomes considered: a change in migraine days (MMD), headache days (MHD), pain intensity (INT), acute medication days (AMD) and 50% responder rate. The Spearman coefficient (rs) was the measure used for quantify the strength of the correlation between PROMs and treatment efficacy outcomes changes. A stepwise logistic regression identified which PROM was independently associated with treatment continuation at week-12. Results 263 patients completed 12 weeks of treatment. The efficacy outcomes and PROMs scores were statistically significantly reduced at week-12 for all patients. The role function-restrictive (RFR) domain of the Migraine-Specific Quality of Life (MSQ) questionnaire was statistically significantly correlated with all primary efficacy outcomes. Relative changes in MSQ total score (OR[95%]: 0.840[0.619-0.973]; p=0.037) and Patient Global Impression of Change (PGIC) scale (OR[95%]: 15.569[6.254-31.533]; p<0.001) were the PROMs associated with treatment continuation as independent factors at week-12. Conclusions Changes in MSQ questionnaire and PGIC scale at week-12 were the PROMs with higher association with CGRP-mAbs response from a patient’s perspective and medical decision-taking.

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