title: Characteristics and Medication Use of Psoriasis Patients Who May or May Not Qualify for Randomized Controlled Trials.
abstract: BACKGROUND
  Clinical trials impose exclusion criteria that may limit the generalizability of results.
  
  
  OBJECTIVE
  To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns.
  
  
  METHODS
  Moderate-to-severe psoriasis patients were identified from the U.S. Department of Defense health care database from January 1, 2008, to October 31, 2013. Eligibility classification for psoriasis trials was based on common trial exclusion criteria involving medical conditions and recent treatment history. Patient characteristics and treatment patterns of 4 biologics (adalimumab, etanercept, infliximab, and ustekinumab) were compared between groups. Adherence was measured by medication possession ratio and persistence as continuous time on drug with ≤ 90-day gap between supply times.
  
  
  RESULTS
  Among 16,284 qualifying psoriasis patients, 4,677 (28.7%) were medically ineligible, and 8,466 (52.0%) had ineligibility-related treatments that could be stopped prior to trial entry; the latter patients were considered potentially eligible for psoriasis trials. Common reasons for medical ineligibility included malignancies and hematologic disorders; treatment ineligibilities included use of topical corticosteroids and phototherapy. Medically ineligible patients were older and had more comorbidities, while potentially eligible patients were younger and healthier than trial-eligible patients. Most treatment patterns were similar across groups, except that, compared with the trial-eligible group, medically ineligible patients had greater adherence to infliximab and potentially trial-eligible patients had greater adherence and persistence to adalimumab.
  
  
  CONCLUSIONS
  This large real-world study found that patients who may be ineligible for psoriasis trials differ in important respects (e.g., comorbidities, prior treatments) from their trial-eligible counterparts. Regardless of their differences at baseline, adherence, persistence, and switching of biologic medications are largely similar, with few differences noted among groups.
  
  
  BACKGROUND
  Financial support for this study was provided by Lilly USA. Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries, and he is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Malatestinic, Goldblum, Solotkin, Lin, Johnston, and Araujo are employees and/or stock owners of Lilly. Nordstrom, Kistler, and Fraeman are employees of Evidera, which received funding from Lilly to conduct this study. LCDR Hawley is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that "copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a U.S. government work as a work prepared by a military service member or employee of the U.S. government as part of that person's official duties. Research data were derived from an approved Naval Medical Center, Portsmouth, Virginia, institutional review board protocol. The views expressed in this work are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government. Study concept and design were contributed by Malatestinic and Araujo, along with the other authors. Nordstrom, Kistler, Fraeman, and Sicignano collected the data, and data interpretation was performed by Wu, Lin, and Hawley, along with Malatestinic, Nordstrom, Solotkin, and Araujo. The manuscript was written by Johnston, Malatestinic, Kistler, Wu, and Araujo, along with Nordstrom, Goldblum, Solotkin, Hawley, and Sicignano, and revised by Goldblum, Solotkin, Malatestinic, and Araujo, along with Nordstrom, Wu, Fraeman, Johnston, Hawley, and Sicignano.
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: William
authors.initials: W
authors.lastname: Malatestinic
authors.affiliation: 2 Evidera, Waltham, Massachusetts.
authors.forename: Beth
authors.initials: B
authors.lastname: Nordstrom
authors.affiliation: 3 Kaiser Permanente Los Angeles Medical Center, Los Angeles, California.
authors.forename: Jashin J
authors.initials: JJ
authors.lastname: Wu
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: Orin
authors.initials: O
authors.lastname: Goldblum
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Solotkin
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: Chen-Yen
authors.initials: CY
authors.lastname: Lin
authors.affiliation: 2 Evidera, Waltham, Massachusetts.
authors.forename: Kristin
authors.initials: K
authors.lastname: Kistler
authors.affiliation: 2 Evidera, Waltham, Massachusetts.
authors.forename: Kathy
authors.initials: K
authors.lastname: Fraeman
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: Joseph
authors.initials: J
authors.lastname: Johnston
authors.affiliation: 4 Naval Medical Center, Portsmouth, Virginia.
authors.forename: Lcdr Lesley
authors.initials: LL
authors.lastname: Hawley
authors.affiliation: 5 Health ResearchTx, Trevose, Pennsylvania.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Sicignano
authors.affiliation: 1 Lilly USA, Indianapolis, Indiana.
authors.forename: Andre
authors.initials: A
authors.lastname: Araujo
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use*; D016208:Databases, Factual; D003879:Dermatologic Agents / Q000627:therapeutic use; D004608:Eligibility Determination / Q000379:methods; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D014481:United States; D000069549:Ustekinumab / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D001688:Biological Products; D003879:Dermatologic Agents; D000069285:Infliximab; D000069549:Ustekinumab; D000068879:Adalimumab; D000068800:Etanercept