Equivalent to etanercept alone twice weekly, Canadian study finds
Psoriasis Area and Severity Index (PASI) score response and measures of health-related quality of life (HRQoL) appear to be numerically similar in psoriasis patients on either etanercept 50 mg twice weekly or in psoriasis patients receiving etanercept 50 mg once weekly plus as-needed topical therapy, according to Canadian researchers who published two reports related to the REFINE study.
The REFINE study was a Randomized, blinded assessor study to Evaluate the efFIcacy and safety of etanercept 50 mg once weekly (QW) plus as Needed topical agent versus Etanercept 50 mg twice weekly (BIW) in patients with moderate to severe plaque psoriasis, researchers reported in the Feb. 2015 issue of the Journal of the European Academy of Dermatology and Venereology (29(2):361–366).
“The aim of the first published report based on the REFINE study was to assess the effect of adding topical steroids to a regimen of etanercept 50 mg,” said Dr. Marc Bourcier, adermatologistfrom Moncton, N.B., and an assistant professor at the University of Sherbrooke. “Stepping down etanercept from the initial dose to the maintenance dose and also adding as needed topical corticosteroids therapy into the treatment is not something new. We commonly do this in our practice already, but the problem is that we had not conducted studies to confirm that the strategy worked.”
He said there was a similar report published two years ago by European colleagues, but this is the first time a study like this has been done in Canada, and involving strictly Canadian patients.
According to the investigators, the study participants were primarily Caucasian (87.7%); most patients were men (64.5%) and the overall mean age was 45.3 years.The authors added that the demographic and clinical characteristics were similar across treatment arms.
Over the course of this phase 3b, multicentre, randomized,open-label study, the authors reported that patients with moderate-to-severe plaque psoriasis received etanercept 50 mg twice weekly for 12 weeks, and then were randomized to etanercept 50 mg twice weekly or 50 mg once weekly plus a topical agent as needed to achieve static physician global assessment (sPGA) status of clear for 12 weeks.
The study endpoints included percentage change in PASI score from week 12 to week 24; proportion of patients achieving 50% improvement in PASI 50, PASI 75 and PASI 90; patients achieving sPGA of clear/almost clear; and change in affected body surface area (BSA).
The findings revealed that the mean difference between the etanercept arm (n=140) and the etanercept plus topical arm (n=142) in change in PASI score from week 12 to week 24 was 16.2% (-3.5%, 35.8%).
Data also revealed that PASI response rates were similar between groups. In addition, the percentage of patients achieving sPGA status of clear/almost clear was 40.6% (32.5%, 48.6%) and 45.8% (37.6%, 54.0%) at week 12 for patients in etanercept and etanercept plus topical arms, respectively, and 53.5% (45.3%, 61.7%) and 45.4% (37.2%, 53.6%) at week 24.
“We were impressed with the findings that showed that patients who continued receiving twice weekly etanercept had exactly about the same efficacy as those who added topical corticosteroid therapy regimen and stepped down to a maintenance dose of etanercept,” said Dr.Bourcier.
HRQoL similar in both groups
At week 24 of the REFINE study, the measures of HRQoL were numerically similar in patients who stayed on etanercept 50 mg twice weekly and for patients who received etanercept 50 mg once weekly plus topical therapy through to week 24, researchers reported in the second report published in the Aug. 2015 issue of the Journal of the European Academy of Dermatology and Venerology (29(8):1555–1561).
“Awareness about the impact that treatment has on a patient’s QoL is important and that is why when we conduct these studies we often have questionnaires about health-related QoL issues,” Dr. Bourcier said.
The HRQoL measures used in the REFINE study included the Dermatology Life Quality Index (DLQI), Treatment Satisfaction Questionnaire for Medication (TSQM) and the Economic Implications of Psoriasis Patient Questionnaire.
“For the purpose of this part of the analysis, what we wanted to do was compare both groups to see if people who remained on etanercept 50mg twice weekly would answer the same or differently on those three questionnaires compared to patients who received etanercept 50mg once weekly plus topical therapy,” said Dr.Bourcier.
Important economic implications
Data from the study revealed that the mean change in DLQI from baseline to week 24 was 10.7 (7.8) for the etanercept 50 mg twice weekly arm and 9.9 (6.9) for the etanercept plus topical corticosteroid arm.
Findings also showed that the mean change in TSQM effectiveness, convenience, side-effects and global satisfaction was 27.1 (36.1), 14.8 (25.9), -0.7 (22.0) and 26.7 (32.5) for the etanercept arm and 32.5 (40.3), 18.5 (29.0), 1.3 (19.4) and 28.4 (35.9) for the etanercept plus topical corticosteroid arm.
The researchers also reported that economic implications, including healthcare visits, employment status, work productivity, ability to perform daily activities and out-of pocket expenses, were similar between treatment arms.
“We are pleased about the results of the REFINE study. It is nice to know that stepping down to an once weekly injection of etanercept and adding some form of cortisone cream can be beneficial and be just as effective as patients continuing to take etanercept twice weekly,” Dr. Bourcier concluded.
“I think this has important economic implications, because we can now potentially cut the cost of treatment and maintain the same clinical efficacy.”
This article originally published in The Chronicle of Skin & Allergy (Sept. 2015; 21(6):1,22,29).