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• W2895876140 abstract "Cholinergic urticaria (CholU) is a frequent form of inducible urticaria, characterized by small itchy wheals induced by physical activity or passive warming. The underlying pathomechanisms of CholU are not completely understood. Several recent studies have provided evidence that IgE-mediated mast cell activation is of major importance in the pathogenesis of CholU.1Hiragun M. Hiragun T. Ishii K. Suzuki H. Tanaka A. Yanase Y. et al.Elevated serum IgE against MGL_1304 in patients with atopic dermatitis and cholinergic urticaria.Allergol Int. 2014; 63: 83-93Abstract Full Text PDF PubMed Scopus (51) Google Scholar, 2Metz M. Altrichter S. Ardelean E. Kessler B. Krause K. Magerl M. et al.Anti-immunoglobulin E treatment of patients with recalcitrant physical urticaria.Int Arch Allergy Immunol. 2011; 154: 177-180Crossref PubMed Scopus (120) Google Scholar, 3Metz M. Bergmann P. Zuberbier T. Maurer M. Successful treatment of cholinergic urticaria with anti-immunoglobulin E therapy.Allergy. 2008; 63: 247-249Crossref PubMed Scopus (121) Google Scholar In line with this theory are observations, mostly from case reports, that patients with CholU can benefit from omalizumab (anti-IgE) treatment.4Maurer M. Metz M. Brehler R. Hillen U. Jakob T. Mahler V. et al.Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence.J Allergy Clin Immunol. 2018; 141: 638-649Abstract Full Text Full Text PDF PubMed Scopus (142) Google Scholar Until now, no reports of larger CholU patient cohorts treated with omalizumab have been published. To address this gap of knowledge, we retrospectively analyzed treatment responses of patients with CholU treated with omalizumab at our urticaria center of reference and excellence over the last 10 years and assessed clinical outcome measures for links to clinical characteristics of patients with CholU (for detailed information, see the Methods section in this article's Online Repository at www.jacionline.org). Files of 16 patients with CholU treated with omalizumab contained sufficient data for the analysis of treatment response. Demographic, clinical, and laboratory characteristics of the patients are presented in Table E1 and diagnostic workup in Table E2 in this article's Online Repository at www.jacionline.org. Clinical responses were grouped into complete, major, partial, or no response and correlated with clinical characteristics, such as sex, age, duration of disease, and total IgE level, using IBM SPSS Statistics version 23 (Armonk, NY) and GraphPad Prism Version 6.0 (La Jolla, Calif). Of the 16 analyzed patients with CholU treated with omalizumab, 6 (37%) patients had a complete and 5 (31%) patients had an overall major treatment response (Fig 1, A). Detailed descriptions of all individual patients are presented in Table I. Fifteen of the 16 patients received omalizumab 300 mg monthly in at least 1 period of their treatment course, and 9 patients (60%) achieved complete or major response with this dose (see Fig E1 in this article's Online Repository at www.jacionline.org). The 6 patients, who reported only partial or no response to standard-dose omalizumab, were updosed (Fig 1, B), and 4 of these patients achieved major or complete response. Two patients did not show an improvement upon omalizumab updosing to up to 450 mg omalizumab every 2 weeks.Table IIndividual patients and their treatment outcome with the final dose of omalizumabIDSexAge (y)Disease duration (y)Concomitant urticariaTotal IgE (KU/L)Final dose (mg/every x wk)Treatment duration (mo)Effective#1F175ColdU792300/4 wk∗Final dose is the same dose as the initial one.3CR#2F5317None42.3150/4 wk∗Final dose is the same dose as the initial one.10CR#3M232CSUND300/4 wk∗Final dose is the same dose as the initial one.8CR∗Final dose is the same dose as the initial one.#4M3010CSU954300/3 wk15CR#5M3013None270450/2 wk21CR#6F3515None167450/3-4 wk18CR†Patients with complete response for 3 wk and major response in the last week before next dosing.#7F329None94.7300/4 wk∗Final dose is the same dose as the initial one.6MR#8F5313None66.7300/4 wk∗Final dose is the same dose as the initial one.26MR#9F359CSU173300/4 wk∗Final dose is the same dose as the initial one.4MR#10F394CSU289300/4 wk∗Final dose is the same dose as the initial one.9MR#11M402CSU328450/4 wk4MR#12M3715None102300/4 wk∗Final dose is the same dose as the initial one.3PR#13M3116ColdU678300/4 wk∗Final dose is the same dose as the initial one.6PR#14M339None387150/2 wk∗Final dose is the same dose as the initial one.3NR#15M258None884300/2 wk2NR#16M236None41.4450/2 wk0.5NRCR, Complete response; F, female; M, male; MR, major response; NR, no response; PR, partial response.∗ Final dose is the same dose as the initial one.† Patients with complete response for 3 wk and major response in the last week before next dosing. Open table in a new tab CR, Complete response; F, female; M, male; MR, major response; NR, no response; PR, partial response. Considering only patients with CholU (no comorbid urticarias), 5 of 9 (56%) had a complete or major response to omalizumab, whereas 4 (44%) had only a partial or no response (Table I). Whether CholU responses to treatment may be different/better in patients with CholU with comorbid urticarias versus CholU-only patients should be assessed in future studies, because previous studies showed that CholU and other forms of chronic urticaria are not uncommon together.5Sigler R.W. Levinson A.I. Evans III, R. Horakova Z. Kaplan A.P. Evaluation of a patient with cold and cholinergic urticaria.J Allergy Clin Immunol. 1979; 63: 35-38Abstract Full Text PDF PubMed Scopus (41) Google Scholar Most patients with complete or major response (ie, 8 of 9 patients for which this information was available) achieved this response within 6 weeks after the first application of the final effective dose. Concomitant other forms of urticaria were frequent in our patient cohort, namely, chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) (Table I). Previous studies showed that CSU or ColdU and CholU are not uncommon together; for example, about 25% of patients with CholU had CSU.6Asady A. Ruft J. Ellrich A. Hawro T. Maurer M. Altrichter S. Cholinergic urticaria patients of different age groups have distinct features.Clin Exp Allergy. 2017; 47: 1609-1614Crossref PubMed Scopus (16) Google Scholar All 5 patients with CholU with comorbid CSU showed major or complete response to omalizumab with a similar time to onset of both of their urticarias, except for 1 patient whose CSU took longer to respond. Of our 2 patients with CholU and concomitant ColdU, one had partial improvement and the other had complete response of both of the urticarias, again, with similar time to response. All of our female patients with CholU treated with omalizumab (n = 7) had a major or complete response when treated with omalizumab. In contrast, only 4 male patients (of 9) had a major or complete response. This difference was statistically significant (P = .036; see Fig E2 in this article's Online Repository at www.jacionline.org). Interestingly, the 2 patients who did not respond to omalizumab updosing were both male (Fig 1, B). In contrast, omalizumab treatment effects were not linked to the age of patients, their age at onset of disease, the duration of disease, or total IgE serum levels (see Fig E3, A-D, in this article's Online Repository at www.jacionline.org). In summary, we report the largest CholU patient cohort treated with omalizumab, as of today. Our findings demonstrate that most patients with CholU experience substantial and rapid benefit in response to omalizumab treatment. Female patients appear to respond better than male patients, insufficient responses can be improved by updosing of omalizumab, and concomitant chronic urticaria forms show similar responses in effect size and time to response. Previous case reports suggest that 3 of 4 patients with CholU exhibit the response to omalizumab treatment.7Ghazanfar M.N. Sand C. Thomsen S.F. Effectiveness and safety of omalizumab in chronic spontaneous or inducible urticaria: evaluation of 154 patients.Br J Dermatol. 2016; 175: 404-406Crossref PubMed Scopus (43) Google Scholar, 8Metz M. Ohanyan T. Church M.K. Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis.J Dermatol Sci. 2014; 73: 57-62Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar This is comparable to the results of our study. CholU, therefore, appears to be similar to other forms of urticarias, where responder rates range from 60% to 90%.4Maurer M. Metz M. Brehler R. Hillen U. Jakob T. Mahler V. et al.Omalizumab treatment in patients with chronic inducible urticaria: a systematic review of published evidence.J Allergy Clin Immunol. 2018; 141: 638-649Abstract Full Text Full Text PDF PubMed Scopus (142) Google Scholar, 8Metz M. Ohanyan T. Church M.K. Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis.J Dermatol Sci. 2014; 73: 57-62Abstract Full Text Full Text PDF PubMed Scopus (198) Google Scholar In comparison to other forms of urticaria, higher doses appear to be needed to achieve improvement in CholU, especially in male patients. The onset of treatment effect in CholU was comparable to that in CSU, and patients with CholU with concomitant other urticaria experienced similar responses to both their urticaria forms. In our study, female patients with CholU had a significantly better response to omalizumab treatment compared with male patients. In contrast, most studies reported similar response rates of omalizumab treatment in female and male patients with CSU and CIndU. A detailed summary of these studies is presented in Table E3 in this article's Online Repository at www.jacionline.org. We can, at this time, only speculate why female patients with CholU show higher rates of response as compared with male patients with CholU. In some subjects, CholU has been linked, predominantly in male patients, to sweat gland obstruction/destruction and hypohydrosis/anhydrosis, a pathomechanism unlikely to involve IgE-mediated mast cell activation. In this subtype of CholU, mast cell degranulation is held to be due to increased levels of acetylcholine due to decreased expression levels of cholinergic M3 receptors on eccrine sweat gland epithelial cells.9Fukunaga A. Washio K. Hatakeyama M. Oda Y. Ogura K. Horikawa T. et al.Cholinergic urticaria: epidemiology, physiopathology, new categorization, and management.Clin Auton Res. 2018; 28: 103-113Crossref PubMed Scopus (32) Google Scholar Interestingly, we did not find that failure to respond to omalizumab was linked to low IgE levels. Previous studies in CSU found low levels of IgE in nonresponders to omalizumab. However, the patient number in our study may have been too small to detect a relevant link between IgE levels and response to omalizumab; none of our patients had IgE levels of less than 40 IU/mL. Histamine release assays should be further investigated in the nonresponder group, which could provide some evidence for or against mast cell involvement in this subpopulation of patients. In conclusion, our findings suggest that omalizumab is an effective treatment for patients with CholU and call for a controlled prospective study to confirm the efficacy and safety of this treatment and other IgE-targeted therapies. In this retrospective study, 16 patients with CholU treated with omalizumab at the UCARE 19 of the Department of Dermatology and Allergy, Charité - Universitätsmedizin, Berlin, between January of 2007 and May 2017 were analyzed for treatment responses and clinical features. Patients with CholU were selected for this study only if their files included documentation that (1) CholU was physician-diagnosed, based on a clear patient history, photo documentation of CholU whealing, and/or provocation testing results, (2) omalizumab was applied at least once, and (3) the treatment response to omalizumab was assessed by 1 of our UCARE physicians. Demographic, clinical, and laboratory characteristics of the patients included on the basis of these criteria are presented in Table E1.Table E1Clinical characteristics of study participantsCharacteristicPatients with CholU (n = 16)Age (y), median (range)33 (17-53)Age at disease onset (y), median (range)21 (12-40)Duration of disease (y), median (range)9 (2-17)Sex: M:F9:7Other form of urticaria (% patients) CSU31.25 ColdU12.5Total IgE (kU/L) (n = 15), median (range)270 (41.4-954)Treatment duration of final dose (mo), median (range)5 (2-26) Open table in a new tab Patients had been diagnosed using patient anamneses, photo documentation, pulse-controlled ergometry,E1Altrichter S. Salow J. Ardelean E. Church M.K. Werner A. Maurer M. Development of a standardized pulse-controlled ergometry test for diagnosing and investigating cholinergic urticaria.J Dermatol Sci. 2014; 75: 88-93Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar Sauna provocation, and daily symptom dairy. For differential diagnosis in some patients, Cold-Warm contact test (TempTestE2Magerl M. Abajian M. Krause K. Altrichter S. Siebenhaar F. Church M.K. An improved Peltier effect-based instrument for critical temperature threshold measurement in cold- and heat-induced urticaria.J Eur Acad Dermatol Venereol. 2015; 29: 2043-2045Crossref PubMed Scopus (31) Google Scholar) had been performed. A detailed description of the individual patients is given in Table E2.Table E2Diagnostic workup of study participantsIDCholU triggerProvocation test/DocumentationComorbid urticariaComorbid urticaria triggerProvocation test/DocumentationTrigger factorsSymptomsTrigger factorsSymptoms#1ExerciseExercise in the coldPin-point sized wheals on trunk and armsPCE before and during omalizumab treatment, Cold-Warm contact test result negativeDaily diaryCold urticariaExercise in cold aggravates the symptomsEnlargement and confluency of the small whealsPCE followed by cold air exposition#2ExerciseExercise in the coldPassive warming (hot climate)Hot foodPin-point sized wheals on the whole bodyPhoto documentationCSUSpontaneousBigger whealsSeparate documentation of spontaneous and exercise-induced symptoms#3ExerciseChange from cold to warm environmentPassive warming (hot climate)Pin-point sized wheals on trunk and armsPCE, Cold-Warm contact test result negativeNone———#4ExerciseExercise in the coldPassive warming (hot climate)Emotional stressAlmost daily, small, maximum 1-h lasting wheals on the whole bodyCold-Warm contact test result negativeDaily dairyCSURarely (maximum once per week) spontaneousWheals long lasting (>2 h)Daily dairy, separate documentation of spontaneous and exercise-induced symptoms#5ExerciseChange from cold to warm environmentPassive warming (hot climate)Emotional stressPin-point sized wheals on upper trunk and armsCold-Warm contact test result negativeDaily dairyNone———#6ExercisePin-point sized wheals on the whole body, mild angioedema of the eyelidsCold-Warm contact test result negativeDaily dairyNone———#7ExercisePassive warming (bath, hot shower, sauna)Emotional stressPin-point sized wheals on the whole bodyPCE, Sauna provocation, Photo documentationNone———#8ExercisePassive warming (sauna)Emotional stressPin-point sized wheals on the whole bodyPCE, daily dairyCSUSpontaneousBigger whealsDaily dairy, separate documentation of spontaneous and exercise-induced symptoms#9ExercisePassive warming (bath, sauna)Emotional stressPin-point sized wheals on the whole bodyPCE, Sauna, Photo documentation, daily dairyCSUSpontaneousBigger whealsDaily dairy, separate documentation of spontaneous and exercise-induced symptoms#10ExerciseChange from cold to warm environmentSmall, maximum 1-h lasting wheals on the whole bodyCold-Warm contact test result negativeDaily dairyCSUSpontaneousBigger wheals, long lastingDaily dairy, separate documentation of spontaneous and exercise-induced symptoms#11ExercisePassive warming (bath, hot showers, sauna)Hot foodEmotional stressPin-point sized wheals on the whole bodyPCE, Sauna, Photo documentationNone———#12ExercisePassive warming (bath, hot showers)Hot foodEmotional stressPin-point sized wheals on the whole bodyPCE, Photo documentationNone———#13ExercisePassive warming (bath, hot showers)Hot foodPin-point sized wheals on the whole bodyPCE, Photo documentationCold urticariaExercise in cold aggravates the symptomsEnlargement and confluency of the small whealsPCE followed by cold air exposition#14ExercisePassive warming (bath, hot showers, sauna)Pin-point sized wheals on the whole bodyPCE, SaunaNone———#15ExercisePassive warming (bath, hot showers, sauna)Hot foodEmotional stressPin-point sized wheals on the whole bodyPCE, Sauna, Photo documentationNone———#16ExercisePassive warming (bath)Emotional stressPin-point sized wheals on the upper trunk and armsPCE, Photo documentationNone———#17ExercisePassive warming (bath, sauna)Emotional stressPin-point sized wheals on the whole bodyPCE, Sauna, Photo documentationNone———PCE, Pulse-controlled ergometry. Open table in a new tab Table E3Summary of the studies on omalizumab response in chronic urticaria (CU) analyzed for differences between female (F) and male (M) patientsStudynResultUrticaria typeComparison between responder and nonresponder Ghazanfar et alE3Ghazanfar M.N. Sand C. Thomsen S.F. Effectiveness and safety of omalizumab in chronic spontaneous or inducible urticaria: evaluation of 154 patients.Br J Dermatol. 2016; 175: 404-406Crossref PubMed Scopus (69) Google Scholar154M = FCSU and CIndU Viswanathan et alE4Viswanathan R.K. Moss M.H. Mathur S.K. Retrospective analysis of the efficacy of omalizumab in chronic refractory urticaria.Allergy Asthma Proc. 2013; 34: 446-452Crossref PubMed Scopus (50) Google Scholar19M = FCU Pinto Gouveia et alE5Pinto Gouveia M. Gameiro A. Pinho A. Goncalo M. Long-term management of chronic spontaneous urticaria with omalizumab.Clin Exp Dermatol. 2017; 42: 735-742Crossref PubMed Scopus (30) Google Scholar13M = FCSU Ertas et alE6Ertas R. Ozyurt K. Ozlu E. Ulas Y. Avci A. Atasoy M. et al.Increased IgE levels are linked to faster relapse in patients with omalizumab-discontinued chronic spontaneous urticaria.J Allergy Clin Immunol. 2017; 140: 1749-1751Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar93Nonresponders are F>MCSUComparison between fast and slow responder Gericke et alE7Gericke J. Metz M. Ohanyan T. Weller K. Altrichter S. Skov P.S. et al.Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria.J Allergy Clin Immunol. 2017; 139: 1059-1061.e1Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar56M = FCSU Open table in a new tab PCE, Pulse-controlled ergometry. All the patients had been treated, before omalizumab therapy, with 2 or more second-generation antihistamines, of which 1 or more had been used daily at 4-fold standard dose for 2 weeks or longer without significant clinical benefit. Omalizumab treatment was provided as off-label treatment after obtaining informed consent and a cost coverage waiver by patients and their health insurers, respectively. This study was approved by the Ethics Committee of the Charité - Universitätsmedizin Berlin (#EA1/241/15) and registered in the German Clinical Trials Register (DRKS-ID: DRKS00012387). Each patient file was analyzed for omalizumab dose, dosing interval, and treatment duration. Documentation of CholU disease activity (whealing, itch) of patients before and during omalizumab treatment at each visit was extracted from the clinical chart for subsequent analyses. The clinical responses were grouped into 4 categories: (1) complete response: patients had no or almost no symptoms; (2) major response: patients had a large benefit from the therapy, and symptoms occurred only rarely and/or were very mild; (3) partial response: patients had some symptom reduction and benefit, but stayed symptomatic, yet to a lesser extent; (4) no response: patients had no significant symptom improvement. Total IgE levels before treatment were measured (Immuno CAP System Phadia Laboratory Systems, Thermo Fisher Scientific Inc, Uppsala, Sweden) in most patients. Total IgE levels greater than 100 kU/L were considered as elevated. Statistical analyses were performed using IBM SPSS Statistics version 23 and GraphPad Prism Version 6.0. Binominal variables were analyzed using the chi-square test. Nonparametric continuous variables were compared using Kruskal-Wallis test. P value less than .05 was considered to indicate statistical significance.Fig E2Display of response rates to the final omalizumab dose, separated by sex. Response groups are depicted in different colors. CR, Complete response; MR, major response; NR, no response; PR, partial response.View Large Image Figure ViewerDownload Hi-res image Download (PPT)Fig E3A-D, Correlation of the clinical response to the final omalizumab dose and patient age (Fig E3, A), age at onset (Fig E3, B), duration of disease (Fig E3, C), and total IgE level (Fig E3, D). None of the response groups were significantly different in any figure. CR, Complete response; MR, major response; NR, no response; PR, partial response.View Large Image Figure ViewerDownload Hi-res image Download (PPT)" @default.
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• W2895876140 title "Real-life treatment of cholinergic urticaria with omalizumab" @default.
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