ORIGINAL ARTICLE
Quality of life and patient benefit following transition from
methotrexate to ustekinumab in psoriasis
M. Augustin,
1,
* C. Blome,
1
C. Paul,
2
L. Puig,
3
T. Luger,
4
J. Lambert,
5
S. Chimenti,
6
G. Girolomoni,
7
K. Kragballe,
8
D. Naessens,
9
P. Bergmans,
10
P. Smirnov,
11
J. Barker,
12
K. Reich
13
1
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
2
Department of Dermatology, Paul Sabatier University, Toulouse, France
3
Hospital de la Santa Creu i Sant Pau, Universitat Aut onoma de Barcelona, Barcelona, Spain
4
University of M€ unster, M€ unster, Germany
5
Department of Dermatology, Ghent University Hospital, Ghent, Belgium
6
University of Rome, Rome, Italy
7
Department of Dermatology, University of Verona, Verona, Italy
8
Arhus University,
Arhus, Denmark
9
Janssen Cilag NV, Beerse, Belgium
10
Janssen-Cilag BV, Tilburg, The Netherlands
11
Janssen Pharmaceutica NV, Moscow, Russia
12
St John’s Institute of Dermatology, King’s College, London, UK
13
Dermatologikum, Hamburg, Germany
*Correspondence: M. Augustin. E-mail: m.augustin@uke.de
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: À0.22 to À0.40), and moderately with DLQI (À0.29 to À0.54). 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.
Received: 25 November 2015; Accepted: 18 May 2016
Previous publication of data
e-poster at the 21st European Academy of Dermatology and Venereology (EADV) Congress, Prague, Czech Republic, September 2012 (Reich K, Puig L, Luger T,
et al. Long-term improvement in patient-reported outcomes after transition from methotrexate to ustekinumab in moderate to severe psoriasis: TRANSIT Week 52
results); oral presentation at the 22nd EADV Congress, Istanbul, Turkey, October 2013 (Augustin M, Blome C, Paul C, et al. Assessment of patient benefit following
transition from methotrexate to ustekinumab in psoriasis patients: a sub-analysis of the TRANSIT study).
© 2016 European Academy of Dermatology and Venereology JEADV 2017, 31, 294–303
DOI: 10.1111/jdv.13823 JEADV