{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T20:27:12Z","timestamp":1773692832435,"version":"3.50.1"},"reference-count":27,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2023,1,10]],"date-time":"2023-01-10T00:00:00Z","timestamp":1673308800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Revance Therapeutics, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A product containing daxibotulinumtoxinA with a stabilizing excipient peptide (RTP004). DAXI immunogenicity was assessed in three phase 3 glabellar line studies (two placebo-controlled, single-dose studies and an open-label repeat-dose safety study). Binding antibodies to daxibotulinumtoxinA and RTP004 were detected by validated ELISAs. Samples positive for daxibotulinumtoxinA-binding antibodies were evaluated further for titer and neutralizing antibodies by mouse protection assay. Overall, 2786 subjects received DAXI and 2823 subjects were exposed to RTP004 as DAXI (n = 2786) or placebo (n = 37). Treatment-related anti-daxibotulinumtoxinA binding antibodies were detected in 21 of 2737 evaluable subjects (0.8%). No subject developed neutralizing antibodies. Treatment-related anti-RTP004 binding antibodies were detected in 35 (1.3%) of 2772 evaluable subjects. Binding antibodies were generally transient, of low titer (&lt;1:200), and no subject had binding antibodies to both daxibotulinumtoxinA and RTP004. All subjects with treatment-induced binding antibodies to daxibotulinumtoxinA or RTP004 achieved none or mild glabellar line severity at Week 4 following each DAXI cycle, indicating no impact on DAXI efficacy. No subjects with binding antibodies to daxibotulinumtoxinA or RTP004 reported immune-related adverse events. This evaluation of anti-drug antibody formation with DAXI shows low rates of antibody formation to both daxibotulinumtoxinA and RTP004.<\/jats:p>","DOI":"10.3390\/toxins15010060","type":"journal-article","created":{"date-parts":[[2023,1,11]],"date-time":"2023-01-11T04:45:58Z","timestamp":1673412358000},"page":"60","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials"],"prefix":"10.3390","volume":"15","author":[{"given":"Conor J.","family":"Gallagher","sequence":"first","affiliation":[{"name":"Revance Therapeutics, Inc., Nashville, TN 37203, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3137-2478","authenticated-orcid":false,"given":"Ronald R.","family":"Bowsher","sequence":"additional","affiliation":[{"name":"B2S Life Sciences, Franklin, IN 46131, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Clancy","sequence":"additional","affiliation":[{"name":"B2S Life Sciences, Franklin, IN 46131, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3667-0842","authenticated-orcid":false,"given":"Jeffrey S.","family":"Dover","sequence":"additional","affiliation":[{"name":"SkinCare Physicians, Chestnut Hill, MA 02467, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7734-3146","authenticated-orcid":false,"given":"Shannon","family":"Humphrey","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Skin Science, University of British Columbia and Humphrey Cosmetic Dermatology, Vancouver, BC V5Z 4E1, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Liu","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Nashville, TN 37203, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregg","family":"Prawdzik","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Nashville, TN 37203, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,1,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1017\/cts.2020.493","article-title":"Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs","volume":"4","author":"Vandivort","year":"2020","journal-title":"J. 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