title: Melanoma and non-melanoma skin cancer in inflammatory bowel disease patients following tumor necrosis factor-α inhibitor monotherapy and in combination with thiopurines: analysis of the Food and Drug Administration Adverse Event Reporting System.
abstract: OBJECTIVE
  Reports have shown an increased risk of melanoma skin cancer (MSC) with exposure to tumor necrosis factor alpha (TNF-α) inhibitors and non-melanoma skin cancer (NMSC) with thiopurine exposure in inflammatory bowel disease (IBD) patients. Using the Food and Drug Administration Adverse Event Reporting System (FAERS) we sought to evaluate the odds of developing MSC and NMSC for patients on TNF-α inhibitors as monotherapy and in combination therapy with thiopurines and/or steroids.
  
  
  METHODS
  The FAERS was queried for reports between January 2003 and June 2012. A proportional reporting ratio (PRR) metric analyses was performed on the data to determine the odds of developing MSC and NMSC.
  
  
  RESULTS
  The PRR analysis showed increased odds of developing MSC and NMSC for patients on a TNF-α inhibitor (p-value = 0.035 and p-value = 0.03, respectively) and those on a TNF-α inhibitor in combination with a thiopurine (p-value < 0.001 and p-value < 0.001).
  
  
  CONCLUSIONS
  TNF-α inhibitor monotherapy or use with concomitant thiopurines in patients with IBD is associated with higher odds of developing MSC and NMSC.
authors.affiliation: Research Institute, NorthShore University HealthSystem, Evanston, IL, 60201, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: McKenna
authors.affiliation: Research Institute, NorthShore University HealthSystem, Evanston, IL, 60201, USA.
authors.forename: Derrick J
authors.initials: DJ
authors.lastname: Stobaugh
authors.affiliation: Department of Gastroenterology, Mayo Clinic, Rochester, MN, 55905, USA. deepak.parakkal@mayo.edu.
authors.forename: Parakkal
authors.initials: P
authors.lastname: Deepak
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D016208:Databases, Factual; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008545:Melanoma / Q000139:chemically induced*; D008875:Middle Aged; D016017:Odds Ratio; D011687:Purines / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D012878:Skin Neoplasms / Q000139:chemically induced*; D013256:Steroids / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D011687:Purines; D013256:Steroids; D014409:Tumor Necrosis Factor-alpha; C030985:purine