Etanercept may represent an effective therapeutic option in patients with moderate to severe plaque psoriasis who have failed to respond to treatment with apremilast, according to a recent open-label study published in the Journal of Drugs in Dermatology.
The 24-week, single-arm, phase 4 estimation study was conducted at 22 centers in the United States (ClinicalTrials.gov identifier: NCT02749370). There were 80 participants enrolled in the study: 20 people had intolerability to apremilast, 45 people had failed to achieve adequate clinical response to apremilast, and 15 people lost adequate clinical response to apremilast. Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks, followed by an additional 12 weeks of once-weekly subcutaneous etanercept 50 mg. Safety was evaluated in a 30-day follow-up period at the conclusion of the 24 weeks.
The primary end point of the study was Psoriasis Area and Severity Index (PASI) 75 at week 12, with secondary end points of PASI 75 at week 24 and PASI 90 at weeks 12 and 24. The effect of treatment on the participant’s quality of life was also measured, using Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI), and Patient Recorded Outcomes (PRO) at baseline and weeks 12 and 24 to determine satisfaction with treatment.
After 12 weeks, 41.6% of participants (95% CI, 30.4%-53.4%) achieved PASI 75. By week 24, the percentage of participants who had achieved PASI 75 increased to 45.5% (95% CI, 34.1%-57.2%). Also at week 12, 13.0% of participants (95% CI, 6.4%-22.6%) achieved PASI 90, followed by 22.1% of participants (95% CI, 13.4%-33.0%) at week 24. The PSI score improved from 16.6 (95% CI, 15.1-18.0) at baseline to 8.4 (95% CI, 6.9–9.9) at week 12 and to 8.1 (95% CI, 6.5-9.7) at week 24. By weeks 12 and 24, 66.2% of participants (95% CI, 54.3%-76.8%) and 57.3% of participants (95% CI, 45.4%-68.7%) were DLQI responders, respectively.
Participant satisfaction improved from 41.3% “very dissatisfied”, 16.3% “dissatisfied”, 5.0% “satisfied”, and 0% “very satisfied” at baseline to 60.8% either “satisfied” or “very satisfied” at week 12 and 53.3% either “satisfied” or “very satisfied” at week 24.
Of the 80 participants, 19 (23.8%) reported a treatment-emergent adverse event; 2 participants (2.5%) reported a serious adverse event (both drug eruptions, 1 resulting in injection site reaction and participant withdrawal from the study). The investigators did not consider either drug eruption to be related to the investigational product.
Interpretations are limited by the study design (single-arm, open-label). The investigators were unable to stratify data by subgroups (efficacy failure vs intolerability) because of the relatively small sample size.
These findings suggest that etanercept may be a viable treatment for patients with intolerability to or prior unsuccessful treatment with apremilast.
Disclosures: This study was sponsored by Amgen Inc. Jerry Bagel, MD, has served as an investigator, speaker, advisor, or consultant for Amgen Inc. and Celgene. Ahmed S. Samad, MD, Bradley S. Stolshek, PharmD, James B. Chung, MD, PhD, and Gregory Kricorian, MD, are employees and stockholders of Amgen Inc. Giresh A. Aras, PhD, is a former employee and stockholder of Amgen Inc. Leon H. Kircik, MD, has served as an investigator, speaker, advisor, or consultant for Amgen Inc. and Celgene.
Bagel J, Samad AS, Stolshek BS, et al. Open-label study to evaluate the efficacy of etanercept treatment in subjects with moderate to severe plaque psoriasis who have failed therapy with apremilast. J Drugs Dermatol. 2018;17(10):1078-1082