Effect of Infliximab on Health-Related Quality of Life and Disease Activity by Body Region in Patients With Moderate-to-Severe Psoriasis and Inadequate Response to Etanercept: Results from the PSUNRISE Trial
August 2013 | Volume 12 | Issue 8 | Original Article | 874 | Copyright © 2013
Robert E. Kalb MD,a Andrew Blauvelt MD,b Howard L. Sofen MD,c Marc Chevrier MD,d David Amato DO,d
Stephen Calabro MS,d Jim Wang PhD,e Brad Schenkel MS,f and Alice B. Gottlieb MD PhDg
aSUNY at Buffalo School of Medicine and Biomedical Sciences, Department of Dermatology, Buffalo, NY
bOregon Medical Research Center, Portland, OR
cUCLA School of Medicine, Department of Medicine/Dermatology, Los Angeles, CA
dJanssen Biotech, Inc., Horsham, PA
eJohnson & Johnson Research & Development, LLC, Raritan, NJ
fJanssen Scientific Affairs, LLC, Horsham, PA
gTufts Medical Center and Tufts University School of Medicine, Boston, MA
BACKGROUND: Treatment with tumor necrosis factor (TNF)-α antagonists is effective in patients with moderate-to-severe plaque psoriasis,
including those with impaired health-related quality of life (HRQoL).
METHODS: PSUNRISE is a multicenter, open-label, prospective study evaluating the efficacy and safety of switching from etanercept to infliximab in psoriasis patients with an inadequate response to etanercept. Patients received intravenous infusions of infliximab 5 mg/ kg at weeks 0, 2, 6, 14, and 22. HRQoL was assessed using the Dermatology Life Quality Index (DLQI), the 36-item Short-Form Health Survey (SF-36), and the EuroQoL (EQ-5D) index and EQ-5D visual analog scale (VAS; 0-100 cm) among patients receiving at least one infliximab infusion. Subgroup analyses (t- test) were performed to compare mean DLQI improvement between patients who achieved and did not achieve clinical response (Physician’s Global Assessment [PGA] 0/1 and at least a 75% improvement in the Psoriasis Area and Severity Index [PASI 75]) at weeks 10 and 26.
RESULTS: A total of 215 patients received at least one infliximab infusion. A DLQI score of 0 or 1 (no negative effect on HRQoL) was achieved by 3.7%, 44.2%, and 41.4% of patients at weeks 0, 10 and 26, respectively. Mean changes in SF-36 Physical Component Summary scores were 1.8 (week 10) and 2.4 (week 26); corresponding changes in Mental Component Summary scores were 4.5 and 5.0. The mean change in EQ-5D index score was 0.08 at week 10 and 0.09 at week 26; respective mean changes in EQ-5D VAS score were 7.73 and 9.49. Mean improvements in DLQI were significantly higher for patients achieving versus those not achieving PGA 0/1 (P=0.0193 [week 10] and P=0.0010 [week 26]) and PASI 75 response (P<0.0001 [week 10]; P=0.0012 [week 26]).
CONCLUSION: Psoriasis patients with prior inadequate response to etanercept demonstrated sustained improvements in HRQoL after switching to infliximab, and HRQoL improvements were associated with clinical responses.
J Drugs Dermatol. 2013;12(8):874-880.
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Psoriasis patients may experience a significantly impaired health-related quality of life (HRQoL),1,2 causing negative psychosocial effects such as feelings of stress, stigmatization, embarrassment, and self-consciousness.3,4 Active disease is also associated with an increased risk of suicidal ideation and high levels of depression and anxiety,4,5 and the impact of psoriasis on HRQoL is similar to that of other major medical conditions, such as cancer, heart disease, depression, and diabetes.2
Psoriasis of the scalp, face, palms/soles, and nails presents unique challenges and may be more difficult to treat compared with other areas of the body.6-8 Facial and scalp involvement have a highly adverse impact on HRQoL due to the visible lesions and inconvenient treatments.8,9 Patients with palmoplantar psoriasis suffer from functional disability and physical discomfort,10 and the majority of those with significant nail psoriasis report restricted activities.11 Data regarding regional symptoms and their impact on HRQoL are needed to identify appropriate treatment for these challenging presentations of psoriasis.
Tumor necrosis factor-α (TNF-α) antagonists, such as infliximab and etanercept, effectively treat skin symptoms12-14 and improve HRQoL in patients with psoriasis.15-17 In the PSUNRISE (Prospective Study Using Remicade in Psoriasis Patients with an