Author(s)
Reich K1, Puig L2, Luger T3, Lambert J4, Chimenti S5, Girolomoni G6, Nicolas JF7, Kragballe K8, Mistry S9, Bergmans P10, Thompson G9, Barker J11, Paul C121Georg-August University, Hamburg, Germany, 2Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, 3University of Münster, Münster, Germany, 4Ghent University Hospital, Ghent, Belgium, 5University of Rome, Rome, Italy, 6University of Verona, Verona, Italy, 7University of Lyon, Lyon, France, 8Århus University, Århus, Denmark, 9Janssen-Cilag Ltd., High Wycombe, United Kingdom, 10Janssen-Cilag BV, Tilburg, Netherlands, 11St John's Institute of Dermatology, King's College, London, United Kingdom, 12Larrey Hospital, Paul Sabatier University, Toulouse, France
OBJECTIVES: We describe Week 52 quality of life outcomes following immediate or gradual transition to ustekinumab in psoriasis patients with inadequate response to methotrexate in the Phase IV TRANSIT study (NCT01059773). METHODS: In this 52-week, open-label trial, 490 patients with moderate-to-severe plaque psoriasis despite treatment with methotrexate (10–25mg/week for ≥8 weeks) were randomised 1:1 to ustekinumab with immediate cessation of methotrexate (Arm1), or 4 weeks’ overlap with decreasing methotrexate dose (Arm2). Ustekinumab was administered according to label: 45mg in patients ≤100kg or 90mg if >100kg. Patients ≤100kg not achieving adequate response (Psoriasis Area Severity Index decrease from baseline ≥75% [PASI 75]) at Weeks 28 or 40 were dose escalated to 90mg. RESULTS: A total of 244 patients were treated in Arm1 and 245 in Arm2; 92% and 90%, respectively, completed 52 weeks’ therapy. Median baseline Dermatology Life Quality Index (DLQI) was 8 and 9 in Arms1 and 2, respectively, decreasing to 1 (both arms) at Weeks 16 and 52. At Week 52 in Arms1 and 2, respectively, 61% and 62% of patients had a DLQI reduction ≥5 points; 62% and 67% had DLQI 0 or 1. Median DLQI scores were low at Week 28 among patients who dose escalated; further improvements were seen by Week 52. Median EuroQOL-5D Visual Analogue Scale improved from baseline to Week 52, respectively: 70.0 (IQR 50.0–80.0) to 85.0 (IQR 70.0–95.0) in Arm1, and 70.0 (IQR 50.0–85.0) to 85.0 (IQR 79.5–95.0) in Arm2. Median Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression scores also improved from baseline to Week 52. CONCLUSIONS: In patients with moderate-to-severe psoriasis, ustekinumab use was associated with clinically relevant improvements in patient-reported outcomes, irrespective of whether patients were transitioned with immediate or gradual cessation of methotrexate. Improvements at Week 16 were sustained to 52 weeks of ustekinumab therapy.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PSS28
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Sensory System Disorders