{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T03:28:20Z","timestamp":1776050900288,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,4,25]],"date-time":"2020-04-25T00:00:00Z","timestamp":1587772800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Teva Branded Pharmaceutical Products R&D Inc"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Reslizumab 3.0 mg\/kg has demonstrated efficacy in clinical studies of patients with eosinophilic asthma and a history of exacerbations. A population pharmacokinetic (PK) model was developed to determine whether 3.0 mg\/kg weight\u2010based dosing is appropriate to obtain consistent reslizumab exposures in all patients. PK data in healthy volunteers and patients \u226512 years with moderate to severe asthma, eosinophilic asthma, or nasal polyposis were analyzed from 4 phase 1, 2 phase 2, and 2 phase 3 studies of intravenous (IV) reslizumab (N = 804). Covariates evaluated included age, race, sex, baseline weight, renal and liver function, concomitant medications, and antidrug antibody status. Exposure\u2010response models were developed to characterize key efficacy (blood eosinophil levels, forced expiratory volume in 1 second [FEV<jats:sub>1<\/jats:sub>], Asthma Control Questionnaire [ACQ\u20107] scores), and safety end points (muscle disorder adverse events [AEs]). Vial\u2010based dosing was evaluated as an alternative to weight\u2010based dosing. IV reslizumab PK was accurately described by a 2\u2010compartment PK model with 0\u2010order input and first\u2010order elimination. Body weight was the only covariate that significantly influenced PK parameters. However, with weight\u2010based dosing, comparable steady\u2010state exposures were observed across high and low body weights. Greater eosinophil lowering and longer response duration were observed with increasing dose; exposure\u2010related effects on FEV<jats:sub>1<\/jats:sub> and ACQ\u20107 were also seen, demonstrating the clinical importance of a dosing regimen to optimize reslizumab exposure. The probability of a muscle disorder AE appeared to increase with increasing exposure. Steady\u2010state exposure measures were similar for both dosing regimens, showing vial\u2010based dosing as an alternative method of achieving the benefits of weight\u2010based dosing.<\/jats:p>","DOI":"10.1002\/jcph.1609","type":"journal-article","created":{"date-parts":[[2020,4,25]],"date-time":"2020-04-25T14:05:10Z","timestamp":1587823510000},"page":"1039-1050","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Population Pharmacokinetic and Pharmacokinetic\/Pharmacodynamic Modeling of Weight\u2010Based Intravenous Reslizumab Dosing"],"prefix":"10.1002","volume":"60","author":[{"given":"Julie","family":"Passarell","sequence":"first","affiliation":[{"name":"Cognigen Corporation a Simulations Plus company  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Jaworowicz","sequence":"additional","affiliation":[{"name":"Cognigen Corporation a Simulations Plus company  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Ludwig","sequence":"additional","affiliation":[{"name":"Cognigen Corporation a Simulations Plus company  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Rabinovich\u2010Guilatt","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D Inc  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donna S.","family":"Cox","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D Inc  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Micha","family":"Levi","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D Inc  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Garin","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D Inc  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jill","family":"Fiedler\u2010Kelly","sequence":"additional","affiliation":[{"name":"Cognigen Corporation a Simulations Plus company  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Bond","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D Inc  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,4,25]]},"reference":[{"key":"e_1_2_10_2_1","first-page":"205","volume-title":"Samters Immunologic Diseases","author":"Gleich GJ","year":"1995"},{"key":"e_1_2_10_3_1","first-page":"7","article-title":"Profile of reslizumab in eosinophilic disease and its potential in the treatment of poorly controlled eosinophilic asthma","volume":"7","author":"Walsh GM","year":"2013","journal-title":"Biologics"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201103-0396OC"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.4168\/aair.2018.10.5.428"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(15)00042-9"},{"key":"e_1_2_10_7_1","unstructured":"CINQAIR (reslizumab) US Prescribing Information.https:\/\/www.cinqair.com\/globalassets\/cinqair\/prescribinginformation.pdf. 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