title: Quality of life and patient benefit following transition from methotrexate to ustekinumab in psoriasis.
abstract: BACKGROUND
  TRANSIT (NCT01059773) compared immediate and gradual transition from methotrexate to ustekinumab in psoriasis patients via multiple measures, including patient-reported outcomes.
  
  
  OBJECTIVE
  To evaluate patient perception of treatment benefits in TRANSIT.
  
  
  METHODS
  A total of 489 psoriasis patients received ustekinumab, with immediate cessation of methotrexate (Arm 1) or 4 weeks' overlap with decreasing methotrexate dose (Arm 2). Ustekinumab was administered at weeks 0, 4, 16, 28 and 40. Dermatology Life Quality Index (DLQI), EuroQol 5-item (EQ-5D), visual analogue scale (VAS) valuation technique and patient benefit index (PBI) were employed. Mean global PBI and sub-scores were calculated from the sum of the benefit items weighted by their respective relevance at baseline. Patient-relevant benefit was defined as PBI ≥1 (scale: 0 [no benefit] to 4 [maximum benefit]). Correlations of global PBI with Psoriasis Area and Severity Index (PASI) and DLQI were examined.
  
  
  RESULTS
  Relationships between PBI and clinical data were evaluable in 340 patients. The most important treatment goals at baseline included: 'be healed of all skin defects', 'have confidence in therapy', 'get better skin quickly' and 'regain control of the disease'. Benefit in PBI global score was achieved at week 4 by 93% of patients in Arm 1 and 91% in Arm 2. Global PBI scores increased in both Arms between weeks 4 and 52. Global PBI correlated weakly with PASI change from baseline (correlation coefficient range: -0.22 to -0.40), and moderately with DLQI (-0.29 to -0.54). Overall DLQI score was lower than baseline at all times; and the percentage of patients with an overall score of 0 or 1 increased with time. Correspondingly, EQ VAS scores increased with time. DLQI and EQ VAS results were similar between arms.
  
  
  CONCLUSIONS
  Regardless of the strategy for transitioning from methotrexate, ustekinumab was associated with rapid and sustained improvement in patient-reported outcomes. PBI appears a suitable tool for assessing patient-relevant treatment benefits in psoriasis patients.
authors: Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
authors: M
authors: M
authors: Augustin
authors: Institute for Health Services Research in Dermatology and Nursing (IVDP), German Center for Health Services Research in Dermatology (CVderm), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
authors: C
authors: C
authors: Blome
authors: Department of Dermatology, Paul Sabatier University, Toulouse, France.
authors: C
authors: C
authors: Paul
authors: Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: L
authors: L
authors: Puig
authors: University of Münster, Münster, Germany.
authors: T
authors: T
authors: Luger
authors: Department of Dermatology, Ghent University Hospital, Ghent, Belgium.
authors: J
authors: J
authors: Lambert
authors: University of Rome, Rome, Italy.
authors: S
authors: S
authors: Chimenti
authors: Department of Dermatology, University of Verona, Verona, Italy.
authors: G
authors: G
authors: Girolomoni
authors: Århus University, Århus, Denmark.
authors: K
authors: K
authors: Kragballe
authors: Janssen Cilag NV, Beerse, Belgium.
authors: D
authors: D
authors: Naessens
authors: Janssen-Cilag BV, Tilburg, The Netherlands.
authors: P
authors: P
authors: Bergmans
authors: Janssen Pharmaceutica NV, Moscow, Russia.
authors: P
authors: P
authors: Smirnov
authors: St John's Institute of Dermatology, King's College, London, UK.
authors: J
authors: J
authors: Barker
authors: Dermatologikum, Hamburg, Germany.
authors: K
authors: K
authors: Reich
mesh_terms: D003879:Dermatologic Agents / Q000627:therapeutic use*; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D000069549:Ustekinumab / Q000627:therapeutic use*
chemical_list: D003879:Dermatologic Agents; D000069549:Ustekinumab; D008727:Methotrexate