{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T12:18:15Z","timestamp":1788265095832,"version":"build-2803163510"},"reference-count":33,"publisher":"Becaris Publishing Limited","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:p>\n                    <jats:bold>Aim:<\/jats:bold>\n                    Primary biliary cholangitis (PBC) is a rare liver disease associated with high morbidity. This study assessed the burden of fatigue and\/or pruritus among patients with PBC in the US.\n                    <jats:bold>Materials &amp; methods:<\/jats:bold>\n                    This retrospective study used IQVIA PharMetrics\n                    <jats:sup>\u00ae<\/jats:sup>\n                    Plus data (2016\u20132022). Patients with PBC and fatigue and\/or pruritus were selected as cases. Controls were patients with PBC (no fatigue nor pruritus), matched 1:1 to cases by key characteristics. The index date for cases was a random symptom diagnosis date post-initial PBC diagnosis and for controls, a random medical visit date matching the time distribution from initial PBC diagnosis to index. Cumulative incidence of PBC comorbidities was described using Kaplan\u2013Meier analysis and compared via Cox Proportional hazard models. Generalized estimating equations compared healthcare resource use (HRU) and costs per-patient-per-year.\n                    <jats:bold>Results:<\/jats:bold>\n                    A total of 1839 fatigue cases\/controls (mean age [years]: 56.5; 88.7% female) and 760 pruritus cases\/controls were included (mean age [years]: 55.8; 90.8% female). Comorbidities at 1, 3 and 5-years post-index were higher for cases than controls (fatigue: 1.7 vs 0.7, 2.2 vs 0.9 and 2.5 vs 1.0; pruritus: 1.9 vs 0.8, 2.3 vs 1.0 and 2.7 vs 1.0; all p\u00a0&lt;\u00a00.001). Common comorbidities were anxiety, urinary tract infection, depression and sleep disorders (hazard ratios in cases vs controls: fatigue, 1.3\u20134.0; pruritus, 1.5\u20132.8; all p\u00a0&lt;\u00a00.01). One-year post-index, cases had higher rates of healthcare visits (incidence rate ratios: fatigue, 1.8\u20135.8; pruritus 1.6\u20136.1) and total healthcare costs (mean cost difference: fatigue, $42,515; pruritus $40,536).\n                    <jats:bold>Conclusion:<\/jats:bold>\n                    Patients with PBC who experience fatigue and\/or pruritus faced a greater clinical and economic burden compared with those without these symptoms, highlighting the need for effective treatments to alleviate PBC symptoms.\n                  <\/jats:p>","DOI":"10.57264\/cer-2025-0179","type":"journal-article","created":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T11:45:11Z","timestamp":1788263111000},"source":"Crossref","is-referenced-by-count":0,"title":["Burden of fatigue or pruritus in patients with primary biliary cholangitis: a United States matched case\u2013control study"],"prefix":"10.57264","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6873-6933","authenticated-orcid":false,"given":"Sonal","family":"Kumar","sequence":"first","affiliation":[{"name":"Weill Cornell Medical College, Cornell University, New York, NY 10065, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8068-7786","authenticated-orcid":false,"given":"Nisreen","family":"Shamseddine","sequence":"additional","affiliation":[{"name":"Ipsen, Cambridge, MA 02142, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2741-8418","authenticated-orcid":false,"given":"Hongbo","family":"Yang","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc., Boston, MA 02199, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2056-8838","authenticated-orcid":false,"given":"Su","family":"Zhang","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc., Boston, MA 02199, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-0141-2241","authenticated-orcid":false,"given":"Jingyi","family":"Chen","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc., Boston, MA 02199, US"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8553-3652","authenticated-orcid":false,"given":"Kris V","family":"Kowdley","sequence":"additional","affiliation":[{"name":"Liver Institute Northwest, Seattle, WA 98105, US"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"36897","reference":[{"issue":"1","key":"e_1_3_9_3_2","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1016\/j.jhep.2017.03.022","article-title":"EASL Clinical Practice Guidelines: the diagnosis and management of patients with primary biliary cholangitis","volume":"67","author":"European Association for the Study of the Liver","year":"2017","unstructured":"European Association for the Study of the Liver. EASL Clinical Practice Guidelines: the diagnosis and management of patients with primary biliary cholangitis. J. Hepatol. 67(1), 145\u2013172 (2017).","journal-title":"J. Hepatol."},{"issue":"6","key":"e_1_3_9_4_2","doi-asserted-by":"crossref","first-page":"1423","DOI":"10.1111\/jgh.15329","article-title":"Regional variation and temporal trend of primary biliary cholangitis epidemiology: a systematic review and meta-analysis","volume":"36","author":"Lv T","year":"2021","unstructured":"Lv T, Chen S, Li M Regional variation and temporal trend of primary biliary cholangitis epidemiology: a systematic review and meta-analysis. J. Gastroenterol. Hepatol. 36(6), 1423\u20131434 (2021).","journal-title":"J. Gastroenterol. Hepatol."},{"issue":"10457","key":"e_1_3_9_5_2","doi-asserted-by":"crossref","first-page":"1053","DOI":"10.1016\/S0140-6736(24)01303-5","article-title":"Primary biliary cholangitis","volume":"404","author":"Tanaka A","year":"2024","unstructured":"Tanaka A, Ma X, Takahashi A, Vierling JM. Primary biliary cholangitis. Lancet 404(10457), 1053\u20131066 (2024).","journal-title":"Lancet"},{"issue":"1","key":"e_1_3_9_6_2","first-page":"49","article-title":"Clinical updates in primary biliary cholangitis: trends, epidemiology, diagnostics, and new therapeutic approaches","volume":"8","author":"Galoosian A","year":"2020","unstructured":"Galoosian A, Hanlon C, Zhang J, Holt EW, Yimam KK. Clinical updates in primary biliary cholangitis: trends, epidemiology, diagnostics, and new therapeutic approaches. J. Clin. Transl. Hepatol. 8(1), 49\u201360 (2020).","journal-title":"J. Clin. Transl. Hepatol."},{"issue":"7","key":"e_1_3_9_7_2","doi-asserted-by":"crossref","first-page":"1379","DOI":"10.1016\/j.cgh.2018.12.007","article-title":"Pruritus is common and undertreated in patients with primary biliary cholangitis in the United Kingdom","volume":"17","author":"Hegade VS","year":"2019","unstructured":"Hegade VS, Mells GF, Fisher H Pruritus is common and undertreated in patients with primary biliary cholangitis in the United Kingdom. Clin. Gastroenterol. Hepatol. 17(7), 1379\u20131387 (2019).","journal-title":"Clin. Gastroenterol. Hepatol."},{"issue":"6","key":"e_1_3_9_8_2","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1159\/000506980","article-title":"Quality of life in patients with primary biliary cholangitis: a single-center experience in Serbia","volume":"38","author":"Milovanovic T","year":"2020","unstructured":"Milovanovic T, Popovic D, Stojkovic Lalosevic M Quality of life in patients with primary biliary cholangitis: a single-center experience in Serbia. Dig. Dis. 38(6), 515\u2013521 (2020).","journal-title":"Dig. Dis."},{"key":"e_1_3_9_9_2","first-page":"83","article-title":"Anxiety and depression in patients with primary biliary cholangitis: current insights and impact on quality of life","volume":"13","author":"Sivakumar T","year":"2021","unstructured":"Sivakumar T, Kowdley KV. Anxiety and depression in patients with primary biliary cholangitis: current insights and impact on quality of life. Hepat. Med. 13, 83\u201392 (2021).","journal-title":"Hepat. Med."},{"issue":"18","key":"e_1_3_9_10_2","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3390\/cells13181580","article-title":"Current landscape and evolving therapies for primary biliary cholangitis","volume":"13","author":"Fiorucci S","year":"2024","unstructured":"Fiorucci S, Urbani G, Di Giorgio C, Biagioli M, Distrutti E. Current landscape and evolving therapies for primary biliary cholangitis. Cells 13(18), 1\u201331 (2024).","journal-title":"Cells"},{"key":"e_1_3_9_11_2","unstructured":"US FDA. URSO 250\u00ae (ursodiol) tablets and URSO FORTE\u00ae (ursodiol) tablets prescribing information. (2023). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/020675s028lbl.pdf"},{"key":"e_1_3_9_12_2","unstructured":"US FDA. OCALIVA (obeticholic acid) prescribing information. Intercept Pharmaceuticals Inc. (2022). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/207999s008lbl.pdf"},{"key":"e_1_3_9_13_2","unstructured":"US FDA. IQIRVO (elafibranor) prescribing information. Ipsen Biopharmaceuticals Inc. (2024). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/218860s000lbl.pdf"},{"key":"e_1_3_9_14_2","unstructured":"US FDA. LIVDELZI (seladelpar) prescribing information. Gilead Sciences Inc. (2024). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/217899s000lbl.pdf"},{"key":"e_1_3_9_15_2","unstructured":"Satija B Singh P. US FDA declines full approval for Intercept's liver disease drug. Reuters. (2024). https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-declines-full-approval-intercepts-liver-disease-drug-2024-11-12\/"},{"key":"e_1_3_9_16_2","unstructured":"Intercept Pharmaceuticals Inc. Intercept Announces Voluntary Withdrawal of OCALIVA\u00ae for Primary Biliary Cholangitis (PBC) from the US Market; US Clinical Trials Involving Obeticholic Acid Placed on Clinical Hold. BioSpace. (2025). https:\/\/www.biospace.com\/press-releases\/intercept-announces-voluntary-withdrawal-of-ocaliva-for-primary-biliary-cholangitis-pbc-from-the-us-market-us-clinical-trials-involving-obeticholic-acid-placed-on-clinical-hold"},{"issue":"4","key":"e_1_3_9_17_2","doi-asserted-by":"crossref","first-page":"297","DOI":"10.1016\/S1542-3565(03)00134-4","article-title":"Natural history of pruritus in primary biliary cirrhosis","volume":"1","author":"Talwalkar JA","year":"2003","unstructured":"Talwalkar JA, Souto E, Jorgensen RA, Lindor KD. Natural history of pruritus in primary biliary cirrhosis. Clin. Gastroenterol. Hepatol. 1(4), 297\u2013302 (2003).","journal-title":"Clin. Gastroenterol. Hepatol."},{"issue":"5","key":"e_1_3_9_18_2","doi-asserted-by":"crossref","first-page":"1284","DOI":"10.1016\/0016-5085(94)90021-3","article-title":"Ursodeoxycholic acid in the treatment of primary biliary cirrhosis","volume":"106","author":"Lindor KD","year":"1994","unstructured":"Lindor KD, Dickson ER, Baldus WP Ursodeoxycholic acid in the treatment of primary biliary cirrhosis. Gastroenterology 106(5), 1284\u20131290 (1994).","journal-title":"Gastroenterology"},{"issue":"7","key":"e_1_3_9_19_2","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1056\/NEJMoa1509840","article-title":"A placebo-controlled trial of obeticholic acid in primary biliary cholangitis","volume":"375","author":"Nevens F","year":"2016","unstructured":"Nevens F, Andreone P, Mazzella G A placebo-controlled trial of obeticholic acid in primary biliary cholangitis. N. Engl. J. Med. 375(7), 631\u2013643 (2016).","journal-title":"N. Engl. J. Med."},{"issue":"9","key":"e_1_3_9_20_2","doi-asserted-by":"crossref","first-page":"795","DOI":"10.1056\/NEJMoa2306185","article-title":"Efficacy and safety of elafibranor in primary biliary cholangitis","volume":"390","author":"Kowdley KV","year":"2024","unstructured":"Kowdley KV, Bowlus CL, Levy C Efficacy and safety of elafibranor in primary biliary cholangitis. N. Engl. J. Med. 390(9), 795\u2013805 (2024).","journal-title":"N. Engl. J. Med."},{"issue":"9","key":"e_1_3_9_21_2","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1056\/NEJMoa2312100","article-title":"A phase 3 trial of seladelpar in primary biliary cholangitis","volume":"390","author":"Hirschfield GM","year":"2024","unstructured":"Hirschfield GM, Bowlus CL, Mayo MJ A phase 3 trial of seladelpar in primary biliary cholangitis. N. Engl. J. Med. 390(9), 783\u2013794 (2024).","journal-title":"N. Engl. J. Med."},{"issue":"1","key":"e_1_3_9_22_2","doi-asserted-by":"crossref","first-page":"e000857","DOI":"10.1136\/bmjgast-2021-000857","article-title":"Disease burden of primary biliary cholangitis and associated pruritus based on a cross-sectional US claims analysis","volume":"9","author":"Gungabissoon U","year":"2022","unstructured":"Gungabissoon U, Gibbons DC, Requena G, Ribeiro de Souza A, Smith H. Disease burden of primary biliary cholangitis and associated pruritus based on a cross-sectional US claims analysis. BMJ Open Gastroenterol. 9(1), e000857 (2022).","journal-title":"BMJ Open Gastroenterol."},{"issue":"9","key":"e_1_3_9_23_2","doi-asserted-by":"crossref","first-page":"1250","DOI":"10.1002\/hep4.1407","article-title":"A national hospital-based study of hospitalized patients with primary biliary cholangitis","volume":"3","author":"Manno V","year":"2019","unstructured":"Manno V, Gerussi A, Carbone M A national hospital-based study of hospitalized patients with primary biliary cholangitis. Hepatol. Commun. 3(9), 1250\u20131257 (2019).","journal-title":"Hepatol. Commun."},{"issue":"1","key":"e_1_3_9_24_2","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1002\/hep.30174","article-title":"Primary biliary cholangitis in Medicare population: the impact on mortality and resource use","volume":"69","author":"Sayiner M","year":"2019","unstructured":"Sayiner M, Golabi P, Stepanova M Primary biliary cholangitis in Medicare population: the impact on mortality and resource use. Hepatology 69(1), 237\u2013244 (2019).","journal-title":"Hepatology"},{"issue":"3","key":"e_1_3_9_25_2","doi-asserted-by":"crossref","first-page":"356","DOI":"10.1002\/hep4.1314","article-title":"Burden of primary biliary cholangitis among inpatient population in the United States","volume":"3","author":"Shahab O","year":"2019","unstructured":"Shahab O, Sayiner M, Paik J Burden of primary biliary cholangitis among inpatient population in the United States. Hepatol. Commun. 3(3), 356\u2013364 (2019).","journal-title":"Hepatol. Commun."},{"issue":"10","key":"e_1_3_9_26_2","doi-asserted-by":"crossref","first-page":"2751","DOI":"10.1007\/s10067-018-4187-y","article-title":"Direct healthcare costs and comorbidity burden among patients with psoriatic arthritis in the USA","volume":"37","author":"Merola JF","year":"2018","unstructured":"Merola JF, Herrera V, Palmer JB. Direct healthcare costs and comorbidity burden among patients with psoriatic arthritis in the USA. Clin. Rheumatol. 37(10), 2751\u20132761 (2018).","journal-title":"Clin. Rheumatol."},{"issue":"8","key":"e_1_3_9_27_2","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1080\/03007995.2020.1775072","article-title":"Prevalence and economic burden of hyperkalemia in the United States Medicare population","volume":"36","author":"Mu F","year":"2020","unstructured":"Mu F, Betts KA, Woolley JM Prevalence and economic burden of hyperkalemia in the United States Medicare population. Curr. Med. Res. Opin. 36(8), 1333\u20131341 (2020).","journal-title":"Curr. Med. Res. Opin."},{"issue":"10","key":"e_1_3_9_28_2","doi-asserted-by":"crossref","first-page":"1404","DOI":"10.1002\/hep4.1573","article-title":"Health care resource use and cost burden of chronic kidney disease in patients with chronic liver disease: a real-world claims analysis","volume":"4","author":"Rustgi VK","year":"2020","unstructured":"Rustgi VK, Li Y, John T, Catalano C, Elsaid MI. Health care resource use and cost burden of chronic kidney disease in patients with chronic liver disease: a real-world claims analysis. Hepatol. Commun. 4(10), 1404\u20131418 (2020).","journal-title":"Hepatol. Commun."},{"issue":"25","key":"e_1_3_9_29_2","doi-asserted-by":"crossref","first-page":"3083","DOI":"10.1002\/sim.3697","article-title":"Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples","volume":"28","author":"Austin PC","year":"2009","unstructured":"Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat. Med. 28(25), 3083\u20133107 (2009).","journal-title":"Stat. Med."},{"issue":"6","key":"e_1_3_9_30_2","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1093\/aje\/kwq433","article-title":"Updating and validating the Charlson Comorbidity Index and score for risk adjustment in hospital discharge abstracts using data from 6 countries","volume":"173","author":"Quan H","year":"2011","unstructured":"Quan H, Li B, Couris CM Updating and validating the Charlson Comorbidity Index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am. J. Epidemiol. 173(6), 676\u2013682 (2011).","journal-title":"Am. J. Epidemiol."},{"key":"e_1_3_9_31_2","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1186\/1471-230X-11-95","article-title":"An increased risk of urinary tract infection precedes development of primary biliary cirrhosis","volume":"11","author":"Varyani FK","year":"2011","unstructured":"Varyani FK, West J, Card TR. An increased risk of urinary tract infection precedes development of primary biliary cirrhosis. BMC Gastroenterol. 11, 95 (2011).","journal-title":"BMC Gastroenterol."},{"issue":"3","key":"e_1_3_9_32_2","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1111\/j.1572-0241.2000.01857.x","article-title":"Impact of fatigue on the quality of life of patients with primary biliary cirrhosis","volume":"95","author":"Huet PM","year":"2000","unstructured":"Huet PM, Deslauriers J, Tran A, Faucher C, Charbonneau J. Impact of fatigue on the quality of life of patients with primary biliary cirrhosis. Am. J. Gastroenterol. 95(3), 760\u2013767 (2000).","journal-title":"Am. J. Gastroenterol."},{"issue":"1","key":"e_1_3_9_33_2","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1002\/hep.26365","article-title":"Impact of primary biliary cirrhosis on perceived quality of life: The UK-PBC national study","volume":"58","author":"Mells GF","year":"2013","unstructured":"Mells GF, Pells G, Newton JL Impact of primary biliary cirrhosis on perceived quality of life: The UK-PBC national study. Hepatology 58(1), 273\u2013283 (2013).","journal-title":"Hepatology"},{"issue":"1","key":"e_1_3_9_34_2","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1053\/jhep.2001.21165","article-title":"Risk factors for primary biliary cirrhosis in a cohort of patients from the United States","volume":"33","author":"Parikh-Patel A","year":"2001","unstructured":"Parikh-Patel A, Gold EB, Worman H, Krivy KE, Gershwin ME. Risk factors for primary biliary cirrhosis in a cohort of patients from the United States. Hepatology 33(1), 16\u201321 (2001).","journal-title":"Hepatology"},{"issue":"5","key":"e_1_3_9_35_2","first-page":"2","article-title":"Primary Biliary Cholangitis: Clinical Insights Into Diagnosis and Staging","volume":"17","author":"Hirschfield GM","year":"2021","unstructured":"Hirschfield GM. Primary Biliary Cholangitis: Clinical Insights Into Diagnosis and Staging. Gastroenterol. Hepatol. (NY) 17(Suppl. 5), 2\u20135 (2021).","journal-title":"Gastroenterol. Hepatol. (NY)"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.57264\/cer-2025-0179","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T11:45:20Z","timestamp":1788263120000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.57264\/cer-2025-0179"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":33,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.57264\/cer-2025-0179"],"URL":"https:\/\/doi.org\/10.57264\/cer-2025-0179","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]},"article-number":"e250179"}}