USTEKINUMAB REDUCES ITCH, BODILY PAIN, AND FATIGUE IN PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS
Author(s)
C Han, PhD, Assistant Director1, Mark Lebwohl, MD, Department of Dermatology Chair2, Kim A. Papp, MD, PhD, President3, Bradley Schenkel, MS, Director Health Economics1, Newman Yeilding, MD, Senior Director, Clinical Research4, Yonghui Wang, PhD, Research Scientist4, Gerald G. Krueger, MD, Professor of Dermatology51Johnson & Johnson Pharmaceutical Services LLC, Malvern, PA, USA; 2 Mount Sinai School of Medicine, New York, NY, USA; 3 Probity Medical Research, Waterloo, ON, Canada; 4 Centocor Research and Development, Inc, Malvern, PA, USA; 5 University of Utah Health Sciences Center, Salt Lake City, UT, USA
OBJECTIVES This analysis examines the impact of ustekinumab on symptoms commonly associated with moderate-to-severe psoriasis, including itch, bodily pain, and fatigue, using data from a Phase 3 clinical trial. METHODS In PHOENIX I trial, 766 patients were randomized to ustekinumab 45mg or 90mg at weeks 0 and 4 and every 12 weeks thereafter, or placebo at weeks 0 and 4 with crossover to ustekinumab at week 12. Assessments included the Itch visual analogue scale (VAS) (0 [no itch] to 10 [severe itch]) and for pain and fatigue the SF-36 bodily pain and vitality scales (0 to 100 [higher scores indicate greater impact of pain and fatigue on quality of life]). RESULTS At baseline, mean (SD) itch score was 6.8 (2.7), and mean (SD) bodily pain and vitality scores were 45.5 (11.4) and 49.7 (10.0), respectively. At week 12, average change in itch score from baseline was –4.9, -5.1, and –0.8 in the ustekinumab 45mg, 90mg, and placebo group, respectively, representing a median reduction of 86% in itch in the ustekinumab-treated patients compared to a 4% reduction in placebo-treated patients (p<0.001 for each ustekinumab group vs. placebo). Mean change in pain score from baseline to week 12 was 4.4, 5.8, and 0.2 in the ustekinumab 45mg, 90mg, and placebo group, respectively (p<0.005 for each ustekinumab group vs. placebo). Specifically, 37% of patients reported moderate or more severe bodily pain at baseline. At week 12, 17% of ustekinumab-treated patients vs. 38% of placebo-treated patients reported moderate or severe bodily pain (p<0.01). Similarly, ustekinumab-treated patients demonstrated a greater improvement in vitality score (1.5 in the ustekinumab 45mg group and 1.6 in the 90mg group) than the placebo group (-1.6) (p<0.005 for each ustekinumab group vs. placebo). CONCLUSIONS Ustekinumab improves itch, pain, and fatigue in patients with moderate-to-severe psoriasis.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PSY42
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Sensory System Disorders, Systemic Disorders/Conditions
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