{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T10:52:47Z","timestamp":1781952767268,"version":"3.54.5"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T00:00:00Z","timestamp":1774310400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T00:00:00Z","timestamp":1774310400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Pharmacokinet Pharmacodyn"],"published-print":{"date-parts":[[2026,6]]},"DOI":"10.1007\/s10928-026-10022-1","type":"journal-article","created":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T14:12:03Z","timestamp":1774361523000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis"],"prefix":"10.1007","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5802-0539","authenticated-orcid":false,"given":"John P.","family":"Prybylski","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7234-9701","authenticated-orcid":false,"given":"Jing \u2018Daisy\u2019","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6321-5792","authenticated-orcid":false,"given":"Christopher","family":"Banfield","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4221-8115","authenticated-orcid":false,"given":"Arnab","family":"Mukherjee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9019-0789","authenticated-orcid":false,"given":"Vivek","family":"Purohit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,24]]},"reference":[{"issue":"5","key":"10022_CR1","doi-asserted-by":"publisher","first-page":"898","DOI":"10.1002\/art.40064","volume":"69","author":"R Aggarwal","year":"2017","unstructured":"Aggarwal R, Rider LG, Ruperto N et al (2017) 2016 American College of Rheumatology\/European League against rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: an international myositis assessment and clinical studies group\/paediatric rheumatology international trials organisation collaborative initiative. Arthritis Rheum 69(5):898\u2013910","journal-title":"Arthritis Rheum"},{"issue":"18","key":"10022_CR2","doi-asserted-by":"publisher","first-page":"1734","DOI":"10.1056\/NEJMra1402225","volume":"372","author":"MC Dalakas","year":"2015","unstructured":"Dalakas MC (2015) Inflammatory muscle diseases. N Engl J Med 372(18):1734\u20131747","journal-title":"N Engl J Med"},{"issue":"7","key":"10022_CR3","doi-asserted-by":"publisher","first-page":"1192","DOI":"10.1136\/ard.2008.093161","volume":"68","author":"S Bernatsky","year":"2009","unstructured":"Bernatsky S, Joseph L, Pineau C et al (2009) Estimating the prevalence of polymyositis and dermatomyositis from administrative data: age, sex and regional differences. Ann Rheum Dis 68(7):1192\u20131196","journal-title":"Ann Rheum Dis"},{"key":"10022_CR4","doi-asserted-by":"publisher","DOI":"10.1097\/md.0000000000023677","author":"R Aggarwal","year":"2021","unstructured":"Aggarwal R, Charles-Schoeman C, Schessl J, Dimachkie MM, Beckmann I, Levine T (2021) Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis (\u201cProDERM study\u201d). Med. https:\/\/doi.org\/10.1097\/md.0000000000023677","journal-title":"Med"},{"issue":"5","key":"10022_CR5","doi-asserted-by":"publisher","first-page":"1224","DOI":"10.1111\/bjd.15006","volume":"176","author":"C Huard","year":"2017","unstructured":"Huard C, Gull\u00e0 S, Bennett D, Coyle A, Vleugels R, Greenberg S (2017) Correlation of cutaneous disease activity with type 1 interferon gene signature and interferon. Br J Dermatol 176(5):1224\u20131230","journal-title":"Br J Dermatol"},{"issue":"3","key":"10022_CR6","doi-asserted-by":"publisher","first-page":"339","DOI":"10.1007\/s40257-020-00502-6","volume":"21","author":"GA Cobos","year":"2020","unstructured":"Cobos GA, Femia A, Vleugels RA (2020) Dermatomyositis: an update on diagnosis and treatment. Am J Clin Dermatol 21(3):339\u2013353","journal-title":"Am J Clin Dermatol"},{"key":"10022_CR7","doi-asserted-by":"crossref","unstructured":"Higgs BW, Zhu W, Morehouse C et al (2014) A phase 1b clinical trial evaluating sifalimumab, an anti-IFN-$$\\:\\alpha\\:$$ monoclonal antibody, shows target neutralisation of a type i IFN signature in blood of dermatomyositis and polymyositis patients. Ann Rheum Dis 73(1):256\u2013262","DOI":"10.1136\/annrheumdis-2012-202794"},{"key":"10022_CR8","doi-asserted-by":"crossref","unstructured":"Chen P, Vu T, Narayanan A et al (2015) Pharmacokinetic and pharmacodynamic relationship of AMG 811, an anti-IFN-$$\\:\\gamma\\:$$ IgG1 monoclonal antibody, in patients with systemic lupus erythematosus. Pharm Res 32(2):640\u2013653","DOI":"10.1007\/s11095-014-1492-2"},{"issue":"1","key":"10022_CR9","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1001\/archdermatol.2009.328","volume":"146","author":"MJ Bendewald","year":"2010","unstructured":"Bendewald MJ, Wetter DA, Li X, Davis MD (2010) Incidence of dermatomyositis and clinically amyopathic dermatomyositis: a population-based study in olmsted County, Minnesota. Arch Dermatol 146(1):26\u201330","journal-title":"Arch Dermatol"},{"key":"10022_CR10","first-page":"S118","volume":"63 Suppl 11","author":"LG Rider","year":"2011","unstructured":"Rider LG, Werth VP, Huber AM et al (2011) Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: physician and Patient\/Parent global activity, manual muscle testing (MMT), health assessment questionnaire (HAQ)\/Childhood health assessment questionnaire (C-HAQ), childhood myositis assessment scale (CMAS), myositis disease activity assessment tool (MDAAT), disease activity score (DAS), short form 36 (SF-36), child health questionnaire (CHQ), physician global damage, myositis damage index (MDI), quantitative muscle testing (QMT), myositis functional index-2 (FI-2), myositis activities profile (MAP), inclusion body myositis functional rating scale (IBMFRS), cutaneous dermatomyositis disease area and severity index (CDASI), cutaneous assessment tool (CAT), dermatomyositis skin severity index (DSSI), skindex, and dermatology life quality index (DLQI). Arthritis Care Res 63 Suppl 11:S118\u2013S157","journal-title":"Arthritis Care Res"},{"issue":"1","key":"10022_CR11","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1007\/s12016-020-08814-5","volume":"60","author":"T Vojinovic","year":"2021","unstructured":"Vojinovic T, Cavazzana I, Ceruti P et al (2021) Predictive features and clinical presentation of interstitial lung disease in inflammatory myositis. Clinical Reviews Allergy Immunology 60(1):87\u201394","journal-title":"Clinical Reviews Allergy Immunology"},{"issue":"9","key":"10022_CR12","first-page":"576","volume":"6","author":"JT Ryman","year":"2017","unstructured":"Ryman JT, Meibohm B (2017) Pharmacokinetics of monoclonal antibodies. CPT: Pharmacometrics Systems Pharmacology 6(9):576\u2013588","journal-title":"CPT: Pharmacometrics Systems Pharmacology"},{"issue":"5","key":"10022_CR13","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1007\/s10928-008-9102-8","volume":"35","author":"L Gibiansky","year":"2008","unstructured":"Gibiansky L, Gibiansky E, Kakkar T, Ma P (2008) Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn 35(5):573\u2013591","journal-title":"J Pharmacokinet Pharmacodyn"},{"issue":"6","key":"10022_CR14","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1023\/b:jopa.0000012999.36063.4e","volume":"30","author":"L Zhang","year":"2003","unstructured":"Zhang L, Beal SL, Sheinerz LB (2003) Simultaneous vs. sequential analysis for population PK\/PD data II: robustness of methods. J Pharmacokinet Pharmacodyn 30(6):405\u2013416. https:\/\/doi.org\/10.1023\/b:jopa.0000012999.36063.4e","journal-title":"J Pharmacokinet Pharmacodyn"},{"issue":"4","key":"10022_CR15","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1007\/BF01061691","volume":"21","author":"NL Dayneka","year":"1993","unstructured":"Dayneka NL, Garg V, Jusko WJ (1993) Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokinet Biopharm 21(4):457\u2013478","journal-title":"J Pharmacokinet Biopharm"},{"issue":"6","key":"10022_CR16","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1007\/s10928-017-9542-0","volume":"44","author":"AG Dosne","year":"2017","unstructured":"Dosne AG, Bergstrand M, Karlsson MO (2017) An automated sampling importance resampling procedure for estimating parameter uncertainty. J Pharmacokinet Pharmacodyn 44(6):509\u2013520","journal-title":"J Pharmacokinet Pharmacodyn"},{"key":"10022_CR17","volume-title":"NONMEM Users Guides","author":"SL Beal","year":"1992","unstructured":"Beal SL, Sheiner LB, Boeckmann A, Bauer RJ (1992) NONMEM Users Guides. NONMEM Project Group, University of California"},{"issue":"2","key":"10022_CR18","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1016\/j.cmpb.2003.11.003","volume":"75","author":"L Lindbom","year":"2004","unstructured":"Lindbom L, Ribbing J, Jonsson EN (2004) Perl-speaks-NONMEM (PsN): a Perl module for NONMEM related programming. Comput Methods Programs Biomed 75(2):85\u201394. https:\/\/doi.org\/10.1016\/j.cmpb.2003.11.003","journal-title":"Comput Methods Programs Biomed"},{"key":"10022_CR19","unstructured":"R Core Team (2022) R: A Language and environment for statistical computing. R Foundation for Statistical Computing. https:\/\/www.R-project.org\/"},{"key":"10022_CR20","unstructured":"Baron KT (2022) Mrgsolve: Simulate from ODE-Based Models.; https:\/\/github.com\/metrumresearchgroup\/mrgsolve"},{"issue":"2","key":"10022_CR21","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1007\/s40262-023-01343-2","volume":"63","author":"JP Prybylski","year":"2024","unstructured":"Prybylski JP (2024) Reporting coefficient of variation for logit, Box-Cox and other non-log-normal parameters. Clin Pharmacokinet 63(2):133\u2013135. https:\/\/doi.org\/10.1007\/s40262-023-01343-2","journal-title":"Clin Pharmacokinet"},{"issue":"102234","key":"10022_CR22","doi-asserted-by":"publisher","first-page":"102234","DOI":"10.1016\/j.eclinm.2023.102234","volume":"64","author":"VP Werth","year":"2023","unstructured":"Werth VP, Aggarwal R, Charles-Schoeman C et al (2023) Efficacy of intravenous Immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: A post-hoc analysis of the proderm study. EClinicalMedicine 64(102234):102234","journal-title":"EClinicalMedicine"},{"issue":"12","key":"10022_CR23","doi-asserted-by":"publisher","first-page":"2378","DOI":"10.1016\/j.jid.2023.05.025","volume":"143","author":"R Pandya","year":"2023","unstructured":"Pandya R, Dan J, Kleitsch J, White B, Werth VP (2023) Validation of Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score and other efficacy outcomes as measures of skin disease in dermatomyositis in the Lenabasum Phase 3 Trial. J Invest Dermatol 143(12):2378-2385.e7","journal-title":"J Invest Dermatol"},{"issue":"4","key":"10022_CR24","first-page":"205","volume":"7","author":"S Ueckert","year":"2018","unstructured":"Ueckert S (2018) Modeling composite assessment data using item response theory. CPT: Pharmacometrics Systems Pharmacology 7(4):205\u2013218s","journal-title":"CPT: Pharmacometrics Systems Pharmacology"},{"issue":"2","key":"10022_CR25","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1007\/s10928-007-9080-2","volume":"35","author":"MM Hutmacher","year":"2008","unstructured":"Hutmacher MM, Krishnaswami S, Kowalski KG (2008) Exposure-response modeling using latent variables for the efficacy of a JAK3 inhibitor administered to rheumatoid arthritis patients. J Pharmacokinet Pharmacodyn 35(2):139\u201357. https:\/\/doi.org\/10.1007\/s10928-007-9080-2","journal-title":"J Pharmacokinet Pharmacodyn"},{"issue":"2","key":"10022_CR26","doi-asserted-by":"publisher","first-page":"180","DOI":"10.1002\/psp4.12888","volume":"12","author":"K Goteti","year":"2023","unstructured":"Goteti K, French J, Garcia R, Li Y, Casset-Semanaz F, Aydemir A, Townsend R, Mateo CV, Studham M, Guenther O, Kao A, Gastonguay M, Girard P, Benincosa L, Venkatakrishnan K (2023) Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development. CPT Pharmacometrics Syst Pharmacol 12(2):180\u2013195. https:\/\/doi.org\/10.1002\/psp4.12888","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"issue":"5","key":"10022_CR27","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-020-00478-5","volume":"22","author":"C Hu","year":"2020","unstructured":"Hu C, Zhou H, Sharma A (2020) Application of beta-distribution and combined uniform and binomial methods in longitudinal modeling of bounded outcome score data. AAPS J 22(5):95. https:\/\/doi.org\/10.1208\/s12248-020-00478-5","journal-title":"AAPS J"},{"issue":"4","key":"10022_CR28","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-019-0343-9","volume":"21","author":"GJ Wellhagen","year":"2019","unstructured":"Wellhagen GJ, Kjellsson MC, Karlsson MO (2019) A bounded integer model for rating and composite scale data. AAPS J 21(4):74. https:\/\/doi.org\/10.1208\/s12248-019-0343-9","journal-title":"AAPS J"},{"key":"10022_CR29","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13219","author":"JP Prybylski","year":"2024","unstructured":"Prybylski JP (2024) Indirect modeling of derived outcomes: are minor prediction discrepancies a cause for concern? CPT: Pharmacometrics & Systems Pharmacology. https:\/\/doi.org\/10.1002\/psp4.13219","journal-title":"CPT: Pharmacometrics & Systems Pharmacology"}],"container-title":["Journal of Pharmacokinetics and Pharmacodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10928-026-10022-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10928-026-10022-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10928-026-10022-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T10:41:46Z","timestamp":1781952106000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10928-026-10022-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,24]]},"references-count":29,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10022"],"URL":"https:\/\/doi.org\/10.1007\/s10928-026-10022-1","relation":{},"ISSN":["1567-567X","1573-8744"],"issn-type":[{"value":"1567-567X","type":"print"},{"value":"1573-8744","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,24]]},"assertion":[{"value":"29 October 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors are current or former employees of Pfizer and own stock in the company. Pfizer supported the study and the reported analysis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Statements and declarations"}},{"value":"All authors are current or former employees of Pfizer and may own stock in the company. Pfizer supported the study and the reported analysis.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"17"}}