title: The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study.
abstract: BACKGROUND
  In patients with psoriasis and inadequate response (IR) to tumor necrosis factor-α antagonist treatment, the incremental benefit of switching to another tumor necrosis factor-α antagonist is unknown.
  
  
  OBJECTIVE
  We sought to evaluate the clinical response to an etanercept-to-infliximab switch in patients with psoriasis and IR to etanercept.
  
  
  METHODS
  Adults with moderate-to-severe plaque psoriasis and IR to etanercept (≥ 4 months) were eligible for this open-label study (called PSUNRISE). Patients had a Physician Global Assessment (PGA) score of at least 2 (mild) on a 5-point scale with etanercept, with or without concomitant oral systemic methotrexate or cyclosporine at baseline and during the study. Patients received intravenous infusions of infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22. PGA was used to evaluate efficacy at week 10 (primary end point) and week 26 (durability). Safety was evaluated through the end of the study.
  
  
  RESULTS
  Of 215 patients, only 10 received concomitant immunomodulators. At week 10, 65.4% of patients (138 of 211; 95% confidence interval 58.6%-71.8%) achieved a PGA score of clear (0) or minimal (1) (primary end point). This response was durable through week 26, at which time 61.3% (122 of 199; 95% confidence interval 54.2%-68.1%) achieved a PGA score of clear (0) or minimal (1). There were no unexpected side effects or safety concerns.
  
  
  CONCLUSIONS
  This was an open-label, 26-week study; an incremental change of 1 PGA point, even mild to minimal, was considered clinically significant, as most psoriasis practitioners seek to achieve minimal psoriasis or clear skin.
  
  
  CONCLUSIONS
  After switching to infliximab, a substantial proportion of patients with psoriasis and IR to etanercept experienced rapid and durable improvement.
authors.affiliation: Department of Dermatology, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts, USA.
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Robert E
authors.initials: RE
authors.lastname: Kalb
authors.forename: Andrew
authors.initials: A
authors.lastname: Blauvelt
authors.forename: Michael P
authors.initials: MP
authors.lastname: Heffernan
authors.forename: Howard L
authors.initials: HL
authors.lastname: Sofen
authors.forename: Laura Korb
authors.initials: LK
authors.lastname: Ferris
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Kerdel
authors.forename: Stephen
authors.initials: S
authors.lastname: Calabro
authors.forename: Jim
authors.initials: J
authors.lastname: Wang
authors.forename: Urs
authors.initials: U
authors.lastname: Kerkmann
authors.forename: Marc
authors.initials: M
authors.lastname: Chevrier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D004351:Drug Resistance; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage; D012867:Skin / Q000473:pathology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D003879:Dermatologic Agents; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068800:Etanercept