{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T09:02:24Z","timestamp":1784624544414,"version":"3.55.0"},"reference-count":40,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n We report the first study of anumigilimab, a novel anti\u2010G\u2010CSFR antibody, in patients with neutrophil\u2010driven skin diseases [hidradenitis suppurativa (HS) and palmoplantar pustulosis (PPP)].<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This phase 1b, open\u2010label, repeat\u2010dose study (NCT03972280) comprised 15\u2010week treatment and 9\u2010week follow\u2010up periods. Enrolled patients had International HS Severity Score System (IHS4) score \u22654 or PPP Area and Severity Index (ppPASI) score \u226512. After \u226510 patients completed anumigilimab 0.3\u2009mg\/kg IV at 21\u2010day intervals (Cohort 1), pharmacokinetic\/pharmacodynamic modelling determined the Cohort 2 dose (0.6\u2009mg\/kg). Primary endpoints were treatment\u2010emergent adverse events (TEAEs). Secondary endpoints were pharmacokinetics and immunogenicity. Exploratory endpoints were pharmacodynamics and clinical response.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 39 patients (HS,\n n<\/jats:italic>\n \u2009=\u200922; PPP,\n n<\/jats:italic>\n \u2009=\u200917), 33 patients (84.6%) experienced 198 TEAEs. Sixteen patients (41.0%) experienced 70 anumigilimab\u2010related TEAEs; the most common were fatigue and neutropenia (both\n n<\/jats:italic>\n \u2009=\u20097), which resolved spontaneously, and no association between neutropenia and infections was observed. No deaths or serious treatment\u2010related TEAEs occurred. Presence of antidrug antibodies was negligible. Anumigilimab exposure and absolute neutrophil count reduction (pharmacodynamic endpoint) were dose dependent. In signal\u2010finding exploratory analyses, 57.9% of patients with HS (\n n<\/jats:italic>\n \u2009=\u200911\/19 with data at Week 15) achieved \u226550% HS Clinical Response, IHS4 score decreased by 40.3%, and patients with PPP experienced a 40.4% reduction in ppPASI score. These clinical responses were not dose dependent, possibly due to imbalanced baseline characteristics and small sample size.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Anumigilimab was generally well tolerated in patients with HS or PPP, with no serious treatment\u2010related safety concerns, and demonstrated dose\u2010dependent pharmacology. While clinical responses in HS and PPP were observed, it should be noted that these observations were exploratory and signal\u2010finding in nature. Importantly, the study was not powered to statistically confirm efficacy and lacked a placebo control, underscoring the need for future randomized, placebo\u2010controlled trials to validate these preliminary signal\u2010finding observations.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jdv.70594","type":"journal-article","created":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T08:12:34Z","timestamp":1784621554000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and pharmacokinetics of anumigilimab for hidradenitis suppurativa or palmoplantar pustulosis: A phase 1b study"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6372-8048","authenticated-orcid":false,"given":"Johannes S.","family":"Kern","sequence":"first","affiliation":[{"name":"Monash University School of Translational Medicine and Alfred Health Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4838-300X","authenticated-orcid":false,"given":"Simon Francis","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Bispebjerg Hospital, Department of Dermatology University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8042-7885","authenticated-orcid":false,"given":"Georgios","family":"Kokolakis","sequence":"additional","affiliation":[{"name":"Psoriasis Research and Treatment Center, Clinic of Dermatology, Venereology, and Allergology Charit\u00e9\u2010Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-8385-0623","authenticated-orcid":false,"given":"Maurizio","family":"Podda","sequence":"additional","affiliation":[{"name":"Department of Dermatology Medical Center Klinikum Darmstadt, Teaching Hospital Goethe\u2010University Frankfurt Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0712-2540","authenticated-orcid":false,"given":"Gregor B. E.","family":"Jemec","sequence":"additional","affiliation":[{"name":"Department of Dermatology Zealand University Hospital Roskilde Denmark"},{"name":"Faculty of Health and Medical Science University of Copenhagen Copenhagen Denmark"},{"name":"PHOENIX Center, Department of Allergy, Dermatology and Venereology Herlev\u2010Gentofte Hospital Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8594-243X","authenticated-orcid":false,"given":"Kurt","family":"Gebauer","sequence":"additional","affiliation":[{"name":"Fremantle Dermatology Fremantle Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5506-1319","authenticated-orcid":false,"given":"Claus","family":"Zachariae","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy University Hospital of Copenhagen Gentofte Hellerup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5042-3632","authenticated-orcid":false,"given":"John","family":"Frew","sequence":"additional","affiliation":[{"name":"Holdsworth House Research Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4882-1564","authenticated-orcid":false,"given":"Pablo","family":"Fernandez\u2010Pe\u00f1as","sequence":"additional","affiliation":[{"name":"Department of Dermatology The University of Sydney, Westmead Hospital Westmead New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0418-521X","authenticated-orcid":false,"given":"Falk G.","family":"Bechara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Venereology and Allergology, Ruhr\u2010University Bochum Germany"},{"name":"ICH \u2013 International Center for Hidradenitis Suppurativa\/Acne Inversa Ruhr\u2010University Bochum Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8327-8475","authenticated-orcid":false,"given":"Stefan","family":"Beissert","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Carl Gustav Carus, Technische Universit\u00e4t Dresden Dresden Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2585-1986","authenticated-orcid":false,"given":"Sourabh","family":"Malandkar","sequence":"additional","affiliation":[{"name":"CSL Behring Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3945-3133","authenticated-orcid":false,"given":"Karen","family":"Scalzo\u2010Inguanti","sequence":"additional","affiliation":[{"name":"CSL Behring Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0122-181X","authenticated-orcid":false,"given":"Partha","family":"Nandy","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6212-9058","authenticated-orcid":false,"given":"Selvakumar","family":"Sukumar","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"issue":"4","key":"e_1_2_13_2_1","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1002\/bjs.6569","article-title":"Hidradenitis suppurativa","volume":"96","author":"Buimer MG","year":"2009","journal-title":"Br J Surg"},{"issue":"2","key":"e_1_2_13_3_1","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1056\/NEJMcp1014163","article-title":"Clinical practice. 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