Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab

Abstract

SummaryBackground Some patients with plaque psoriasis experience secondary failure of tumour necrosis factor inhibitor therapy. Objectives To evaluate efficacy, safety and patient-reported outcomes (PROs) with etanercept in patients with secondary adalimumab failure. Methods This phase IV open-label single-arm estimation study (NCT01543204) enrolled patients on adalimumab who had achieved static Physician's Global Assessment (sPGA) score 0/1 (clear/almost clear). Patients subsequently lost response, defined as sPGA ≥ 3 or loss of 50% improvement in Psoriasis Area and Severity Index (PASI 50). At baseline, patients had involved body surface area ≥ 10%, sPGA ≥ 3 and PASI ≥ 10. Antiadalimumab antibodies (ADAs) were measured at screening. Patients received etanercept 50 mg twice weekly for 12 weeks, followed by 50 mg weekly. The primary end point was sPGA 0/1 at week 12 (intention-to-treat analysis; no hypothesis tested). Additional outcomes included rates of sPGA 0/1, PASI responses, safety, PROs of itch, pain and flaking, Dermatology Life Quality Index, treatment satisfaction and Work Productivity and Activity Impairment questionnaire. Results Sixty-four patients enrolled; 67% had ADAs. sPGA 0/1 rates at week 12 were 39Á7% [95% confidence interval (CI) 27Á6-52Á8; primary end point] and 45% (95% CI 29Á3-61Á5) for patients positive for ADAs and 35% (95% CI 15Á4-59Á2) for patients negative for ADAs. PASI 75 response rates at week 12 were 47Á5% (95% CI 31Á5-63Á9) for patients who were positive for ADAs and 50% (95% CI 27Á2-72Á8) for patients negative for ADAs. No new safety signals were observed. PROs of itch, pain and flaking consistently improved at week 12 and were maintained through week 24. Conclusions Patients with psoriasis who experienced secondary failure of adalimumab achieved satisfactory response to etanercept regardless of ADA status.

The Cytokine Mediated Molecular Pathophysiology of Psoriasis and Its Clinical Implications

“…A phase IV, open-label, single-arm estimation study evaluated the efficacy of etanercept therapy in patients who previously failed adalimumab. Both patients positive for anti-adalimumab antibodies (ADAs) (47.5% (95% CI: 31.5–63.9)) and patients negative for ADAs (50% (95% CI: 27.2–72.8) achieved PASI-75 after 12 weeks of treatment with etanercept [ 58 ]. The results supported etanercept as a satisfactory treatment for patients with secondary failure to adalimumab, regardless of ADA status [ 58 ].…”

Switching expensive drugs with frequently diminishing value

“…Given the high price of biologics, the pharmacoeconomic models and payments should be adjusted to take diminished value into consideration. After all, in the current study, six out of 10 patients were very dissatisfied with a treatment that used to work …”

“…It is rare that we welcome an imperfect study on a not very hot topic that is paid for by the pharmaceutical industry. In this issue of the BJD , Bagel et al . present the findings of their open‐label study of etanercept treatment in patients no longer responding satisfactorily to adalimumab.…”

“…Probably less desired by the sponsor of this study is the documentation of diminished treatment response over time . This is important because the pharmacoeconomic justification for the drug price is often largely based on quality of life data.…”

Impact of fixed‐dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52‐week randomized, double‐blind, PSO‐LONG trial

“…21 Topicals are the most commonly used medication for managing plaque psoriasis; up to 97.5% of psoriasis patients are reported to use topicals. 22 Despite this and the fact that numerous studies have reported the significant positive impact of biologics on work productivity, 15,20,[23][24][25][26][27][28][29][30][31][32][33][34][35][36] to the best of our knowledge, there are no studies that have investigated the impact of topicals on work productivity. Fixed-dose combination calcipotriol 50 µg/g/betamethasone dipropionate 0.5 mg/g (Cal/ BD) aerosol foam (Enstilarâ; LEO Pharma A/S, Ballerup, Denmark) is a topical approved for 4 weeks of treatment for psoriasis vulgaris in the United States 37 (for adults and adolescents) and the EU 38 (for adults only).…”