title: Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice.
abstract: BACKGROUND
  Tumour necrosis factor-α inhibitors, including infliximab (IFX), can improve disease control of plaque-type psoriasis.
  
  
  OBJECTIVE
  The Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis (REALITY) study evaluated the efficacy and safety of maintenance IFX therapy in typical clinical settings.
  
  
  METHODS
  In this prospective, observational, open-label, multicentre study in patients with plaque-type psoriasis, IFX 5 mg kg was infused at weeks 0, 2 and 6, and every 8 weeks thereafter during a 50-week treatment phase. The primary outcome was ≥ 75% Psoriasis Area and Severity Index (PASI) improvement from baseline to week 50. Patients with ≥ 25% PASI improvement from baseline to the end of the treatment phase were potentially eligible to enter a 48-week extended treatment phase. Response maintenance and other efficacy measures were evaluated. Adverse events (AEs) were collected.
  
  
  RESULTS
  In total 660 patients enrolled. Of 521 efficacy-evaluable treatment phase patients (66% male, mean age 46·5 years, mean PASI 18·1), 56·8% achieved PASI 75 at the end of the treatment phase. Response was maintained at week 50 by 64·7% (205/317) of patients who achieved PASI 75 at week 14. During extended treatment, 66·3% (112/169) of patients attained PASI 75 at week 98; response was maintained at week 98 by 71·6% (101/141) of those who achieved PASI 75 at week 50. IFX was generally well tolerated. During treatment, 7·6% (50/659) of patients had serious AEs. During extended treatment, 4·1% (eight of 193) of patients had serious AEs.
  
  
  CONCLUSIONS
  PASI 75 response was achieved by 56·8% and 66·3% of patients at weeks 50 and 98, respectively. The AE pattern was consistent with previous reports.
authors.affiliation: University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Ave. Room M1-737, Toronto, ON, Canada, M4N 3M5.
authors.forename: N H
authors.initials: NH
authors.lastname: Shear
authors.forename: M
authors.initials: M
authors.lastname: Hartmann
authors.forename: M
authors.initials: M
authors.lastname: Toledo-Bahena
authors.forename: A
authors.initials: A
authors.lastname: Katsambas
authors.forename: L
authors.initials: L
authors.lastname: Connors
authors.forename: Q
authors.initials: Q
authors.lastname: Chang
authors.forename: R
authors.initials: R
authors.lastname: Yao
authors.forename: K
authors.initials: K
authors.lastname: Nograles
authors.forename: Z
authors.initials: Z
authors.lastname: Popmihajlov
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D003879:Dermatologic Agents; D000069285:Infliximab