{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T18:24:49Z","timestamp":1791915889791,"version":"4.3.4"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100008792","name":"Novartis Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J Dermatology"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Secukinumab, a fully human, monoclonal antibody targeting interleukin\u201017A, is approved for moderate\u2010to\u2010severe HS in adults. This study evaluated pharmacokinetics (PK), high\u2010sensitivity C\u2010reactive protein (hsCRP) changes, and safety of secukinumab over 52\u2009weeks in SUNSHINE and SUNRISE Phase 3 trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An exploratory analysis of pooled Phase\u20103 trials evaluated serum PK and safety of secukinumab 300\u2009mg every 2 (SECQ2W) or 4\u2009weeks (SECQ4W). A population PK model assessed the effects of body weight, disease severity, and baseline hsCRP on secukinumab serum concentration. Exposure\u2013response analysis assessed the relationship between predicted PK and HS clinical response [HiSCR]. No confirmatory statistical testing was performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Mean serum trough concentration at Weeks 16, 24, and 52 was ~2\u2010fold higher with SECQ2W vs. SECQ4W. At Week 16, exposure overlap was high, with an estimated numerical increase in HiSCR of ~3% for SECQ2W over SECQ4W. At Week 52, HiSCR levels plateaued. At Week 16, hsCRP decreased from 18.6\u2009\u00b1\u200926.3\u2009mg\/L to 12.8\u2009\u00b1\u200918.0\u2009mg\/L (SECQ2W), 15.9\u2009\u00b1\u200927.6\u2009mg\/L to 11.5\u2009\u00b1\u200918.4\u2009mg\/L (SECQ4W), and remained unchanged with placebo (14.4\u2009\u00b1\u200922.5\u2009mg\/L to 14.7\u2009\u00b1\u200923.8\u2009mg\/L); reductions were sustained through Week 52. Higher body weight, disease severity, and baseline hsCRP were associated with lower secukinumab serum concentrations. Secukinumab immunogenicity was low (&lt;\u20091%), with no new safety signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Secukinumab serum concentrations in patients with HS varied with body weight, disease severity, and baseline hsCRP. SECQ2W may benefit certain patients. Secukinumab reduced hsCRP through Week 52. The safety profile of secukinumab was consistent with other approved indications, with no apparent dose\u2013response relationship observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302)<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/ijd.70025","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T12:23:52Z","timestamp":1755779032000},"page":"289-298","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Secukinumab in the Treatment of Moderate\u2010to\u2010Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the\n                    <scp>SUNSHINE<\/scp>\n                    and\n                    <scp>SUNRISE<\/scp>\n                    Phase 3 Studies"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1171-4917","authenticated-orcid":false,"given":"Afsaneh","family":"Alavi","sequence":"first","affiliation":[{"name":"Department of Dermatology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4844-3559","authenticated-orcid":false,"given":"Ziad","family":"Reguiai","sequence":"additional","affiliation":[{"name":"Dermatology Department Polyclinique Courlancy\u2010Bezannes  Reims France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor B. E.","family":"Jemec","sequence":"additional","affiliation":[{"name":"Department of Dermatology Zealand University Hospital  Roskilde Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice B.","family":"Gottlieb","sequence":"additional","affiliation":[{"name":"Department of Dermatology UT Southwestern Medical Center  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena B.","family":"Wozniak","sequence":"additional","affiliation":[{"name":"Novartis Ireland Limited  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenz","family":"Uhlmann","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heng","family":"Fan","sequence":"additional","affiliation":[{"name":"Shanghai Novartis Trading Limited  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Llobet Martinez","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard","family":"Bruin","sequence":"additional","affiliation":[{"name":"Novartis, Biomedical Research  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Thomas","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivette","family":"Alarcon","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Bieth","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoba","family":"Ravichandran","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexa B.","family":"Kimball","sequence":"additional","affiliation":[{"name":"Harvard Medical School and Clinical Laboratory for Epidemiology and Applied Research in Skin (CLEARS), Department of Dermatology Beth Israel Deaconess Medical Center  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-020-0149-1"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-3083.2001.00303.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2019.08.090"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph18136709"},{"key":"e_1_2_10_6_1","first-page":"1","article-title":"Pain, Psychological Comorbidities, Disability, and Impaired Qualify of Life in Hidradenitis Suppurativa","volume":"21","author":"Patel Z. 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