{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T15:19:31Z","timestamp":1747149571877,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"S2","license":[{"start":{"date-parts":[[2023,11,9]],"date-time":"2023-11-09T00:00:00Z","timestamp":1699488000000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The current dosing strategy of immune globulin products for the treatment of primary immunodeficiency diseases (PIDDs) in the USA is based on total body weight (BW). The aim of our study was to assess the relationship between dose and trough level, and to determine whether an alternative dosing strategy should be considered for patients who are overweight or obese. We analyzed data in a total of 533 patients from 11 studies. We modeled the relationship between trough level and dose per week using a linear mixed model. We used an over\u2010dispersed Poisson model to model the relationship between infection and trough level. In these analyses, we then combined the study\u2010specific treatment effects using a random\u2010effect or fixed\u2010effect model. The mean administered dose per week was 9.77, 14.00, or 18.17\u00a0g in patients who were normal weight, overweight, or obese, respectively. Compared with a patient of normal weight, a 1\u00a0g increase in dose per week in a patient who was overweight was associated with a smaller increase in the trough level, 0.08\u00a0g\/L less (95%CI \u20130.14 to \u20130.03\u00a0g\/L), and a 1\u00a0g increase in dose per week in a patient who was obese was associated with a much smaller increase in trough level, 0.01\u00a0g\/L less (95%\u00a0CI \u20130.07 to 0.06\u00a0g\/L). Last, for a 1\u00a0unit (g\/L) increase in trough level, the expected number of infections remained the same, with a multiplicative factor of 1.01 (95%CI 0.98\u20101.04). Overall, we found no compelling evidence to justify a reconsideration of the current dosing strategy based on total BW for patients with PIDDs who are overweight or obese.<\/jats:p>","DOI":"10.1002\/jcph.2368","type":"journal-article","created":{"date-parts":[[2023,11,9]],"date-time":"2023-11-09T12:34:41Z","timestamp":1699533281000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Dosing Strategy of Immunoglobulin (IgG) Replacement Therapies in Obese and Overweight Patients with Primary Immunodeficiency Diseases (PIDDs): A Meta\u2010Analysis of Clinical Trials"],"prefix":"10.1002","volume":"63","author":[{"given":"Tingting","family":"Zhou","sequence":"first","affiliation":[{"name":"Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2904-6574","authenticated-orcid":false,"given":"Million A.","family":"Tegenge","sequence":"additional","affiliation":[{"name":"Office of Clinical Evaluation Office of Therapeutic Products Center for Biologics Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Basil","family":"Golding","sequence":"additional","affiliation":[{"name":"Office of Plasma Protein Therapeutics Office of Therapeutic Products Center for Biologics Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Scott","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research US Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,11,9]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.2146\/ajhp140171"},{"key":"e_1_2_6_3_1","unstructured":"Ontario Regional Blood Coordinating Network (ORBCON).Ideal body weight calculator with IVIg dosing 2023.\u00a0https:\/\/ivig.transfusionontario.org\/dose\/"},{"key":"e_1_2_6_4_1","unstructured":"National Blood Authority (Australia).BloodSTAR calculator for adjusting Ig dose for ideal body weight 2023.https:\/\/www.blood.gov.au\/bloodstar\u2010calculator\u2010adjusting\u2010ig\u2010dose\u2010ideal\u2010body\u2010weight"},{"key":"e_1_2_6_5_1","unstructured":"Commissioning Criteria Policy for the use of therapeutic immunoglobulin (Ig) 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2019.https:\/\/aspe.hhs.gov\/sites\/default\/files\/migrated_legacy_files\/\/189281\/IGIV_Market_Update.pdf."},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.28260"},{"issue":"4","key":"e_1_2_6_12_1","doi-asserted-by":"crossref","first-page":"S102","DOI":"10.1093\/ajhp\/zxz233","article-title":"Optimization of intravenous immune globulin use at a comprehensive cancer center","volume":"76","author":"Figgins BS","year":"2019","journal-title":"Am J Health Syst Pharm"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"e_1_2_6_14_1","unstructured":"FDA guidance for industry\u2010safety efficacy and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency 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