{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:51:53Z","timestamp":1787500313122,"version":"build-2736575974"},"reference-count":49,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2017,6,20]],"date-time":"2017-06-20T00:00:00Z","timestamp":1497916800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["1R01CA165609\u201001A1"],"award-info":[{"award-number":["1R01CA165609\u201001A1"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000048","name":"American Cancer Society","doi-asserted-by":"publisher","award":["IRG\u201013\u2010043\u201001"],"award-info":[{"award-number":["IRG\u201013\u2010043\u201001"]}],"id":[{"id":"10.13039\/100000048","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2017,7]]},"abstract":"Abstract<\/jats:title>\n \n A 43\u2010year\u2010old female with multiple sclerosis developed urethral melanoma. The only potential risk factor was treatment with natalizumab, a humanized monoclonal antibody against\n \u03b1<\/jats:italic>\n 4 integrins. To investigate the risk\u2010exposure relationship, we reviewed this case, all other published cases, and cases of natalizumab\u2010associated melanoma reported to regulatory agencies. Data sources included the Food and Drug Administration's (\n FDA<\/jats:styled-content>\n ) Adverse Event Reporting System (\n FAERS<\/jats:styled-content>\n ) (2004\u20132014), a\n FDA<\/jats:styled-content>\n Advisory Committee Meeting Report, and peer\u2010reviewed publications. In the United States, the manufacturer maintains an\n FDA<\/jats:styled-content>\n \u2010mandated Tysabri Safety Surveillance Program (part of the Tysabri Outcomes Unified Commitment to Health (\n TOUCH<\/jats:styled-content>\n )) of natalizumab\u2010treated patients. We statistically compared reporting completeness for natalizumab\u2010associated melanoma cases in\n FAER<\/jats:styled-content>\n s for which information was obtained entirely from the\n TOUCH<\/jats:styled-content>\n program versus cases where\n FAERS<\/jats:styled-content>\n information was supplemented by\n TOUCH<\/jats:styled-content>\n program information.\n FAERS<\/jats:styled-content>\n included 137 natalizumab\u2010associated melanoma reports in patients with multiple sclerosis. Median age at melanoma diagnosis was 45\u00a0years (range: 21\u201374\u00a0years). Changes in preexisting nevi occurred in 16%, history of cutaneous nevi occurred in 22%, diagnosis within 2\u00a0years of beginning natalizumab occurred in 34%, and 74% had primary surgical treatment. Among seven natalizumab\u2010treated\n MS<\/jats:styled-content>\n patients who developed biopsy\u2010confirmed melanoma on treatment and reported in the literature, median age at diagnosis was 41\u00a0years (range: 38\u201348\u00a0years); and the melanoma diagnosis occurred following a median of 12 natalizumab doses (range: 1\u201377 doses). A history of mole or nevi was noted in four patients and a history of prior melanoma was noted in one patient. Completeness scores for reports were significantly lower for\n FAERS<\/jats:styled-content>\n cases reported from the\n TOUCH<\/jats:styled-content>\n program versus\n FAERS<\/jats:styled-content>\n cases supplemented by\n TOUCH<\/jats:styled-content>\n information (median score of 2 vs. 4 items out of 8\u2010possible items,\n P<\/jats:italic>\n \u00a0<\u00a00.0007). Clinicians should monitor existing nevi and maintain suspicion for melanoma developing in natalizumab\u2010treated patients. The\n TOUCH<\/jats:styled-content>\n Safety Surveillance Program, currently focused on progressive multifocal leukoencephalopathy, should be expanded to include information on other serious complications including malignancies, particularly if they are immunologic in nature.\n <\/jats:p>","DOI":"10.1002\/cam4.1098","type":"journal-article","created":{"date-parts":[[2017,6,21]],"date-time":"2017-06-21T00:08:43Z","timestamp":1498003723000},"page":"1541-1551","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions (SONAR)"],"prefix":"10.1002","volume":"6","author":[{"given":"Rachel A.","family":"Sabol","sequence":"first","affiliation":[{"name":"Tulane University School of Medicine New Orleans Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Noxon","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Sartor","sequence":"additional","affiliation":[{"name":"Tulane University School of Medicine New Orleans Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph R.","family":"Berger","sequence":"additional","affiliation":[{"name":"Department of Neurology Perelman School of Medicine Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zaina","family":"Qureshi","sequence":"additional","affiliation":[{"name":"The Arnold School of Public Health University of South Carolina Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis W.","family":"Raisch","sequence":"additional","affiliation":[{"name":"University of New Mexico College of Pharmacy Albuquerque New Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LeAnn B.","family":"Norris","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul R.","family":"Yarnold","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Georgantopoulos","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William J.","family":"Hrushesky","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Bobolts","sequence":"additional","affiliation":[{"name":"Oncology Analytics Plantation Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Ray","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akida","family":"Lebby","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Kane","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8645-5705","authenticated-orcid":false,"given":"Charles L.","family":"Bennett","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR) program University of South Carolina College of Pharmacy Columbia South Carolina"},{"name":"The Medical University of South Carolina Hollings Cancer Center Charleston South Carolina"},{"name":"William Jennings Bryan Dorn Veterans Administration Medical Center Columbia South 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