An Open-Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab

April 2011 | Volume 10 | Issue 4 | Original Article | 396 | Copyright © 2011

Ronald Vender MD FRCPC

Dermatrials Research; McMaster University, Hamilton, ON, Canada

Abstract

Background: The past several years have seen the approval of five different biologic agents for the treatment of moderate to severe plaque psoriasis in the United States and Canada. Psoriasis has proven to be a difficult disease to treat and treatment failures, even with newer biologic therapies, are not uncommon. The vast majority of clinical data for these medications is derived from treatment of biologic-naïve patients, or patients who have not responded to, or lost response to, or not tolerated systemic therapy for psoriasis. There is currently little data available on therapeutic response of a second biologic therapy after loss of response, or no response, to the first biologic therapy initiated. It has become common clinical practice to switch medications that are structurally distinct but therapeutically similar in order to achieve an improved clinical outcome. Therapeutic interchange now is being applied to the biologic agents used to treat psoriasis.
Objectives: Using a proof of concept study, describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis.
Methods: A total of 10 biologically naïve patients with moderate to severe psoriasis who were initiated on adalimumab for at least 12 weeks but had a Physician’s Global Assessment (PGA) of mild or worse were transitioned to commercial etanercept 50 mg twice weekly (BIW) for 12 weeks followed by a dose reduction to 50 mg once weekly (OW) for an additional 12 weeks. Ethics approval was obtained and the study registered with ClinicalTrials.gov (NCT00833729). The primary outcome measured was the mean change in Physician’s Global Assessment (PGA) score (range 0-5) from baseline (when the first etanercept injection is given) to 12 weeks of etanercept therapy. The secondary outcomes measures included the mean change in Dermatology Quality of Life Index (DLQI), mean change in body surface area (BSA) covered in psoriasis, Subject’s Global Assessment of disease (SGA), proportion of patients achieving an improvement in PGA score from baseline to 12 weeks and again at 24 weeks and safety.
Results: Overall, there were significant favorable changes in all outcomes measured (PGA, SGA, BSA and DLQI) with respect to etanercept’s efficacy after an inadequate response to at least 12 weeks of adalimumab therapy. There were no significant safety issues noted especially during the transition period from adalimumab to etanercept. ClinicalTrials.gov identifier: NCT00833729.

J Drugs Dermatol. 2011;10(4):396-402.

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INTRODUCTION

Tumour necrosis factor-α (TNFα) inhibitors have changed the way we treat patients that suffer with moderate to severe chronic plaque psoriasis (PsO). Three TNF inhibitors have been approved by the FDA and Health Canada for the treatment of PsO: infliximab (Remicade,® Centocor, Malvern, PA, Schering-Plough/Merck Canada, Kirkland, QC); etanercept (Enbrel,® Amgen, Thousand Oaks, CA, Amgen Canada, Mississauga ON/Pfizer Canada, Montreal, PQ); and adalimumab (Humira,® Abbott Laboratories, Abbott Park, IL, & Ville St-Laurent, QC, Canada). A segment of patients may experience an inadequate response to one or more of these agents despite proven efficacy. Transitioning to another TNF inhibitor has become common practice after an inadequate or failed response, or intolerable adverse reactions to the initial TNFα inhibitor prescribed. There is currently little data available on therapeutic response of a second biologic therapy after loss of response, or no response, to the first biologic therapy initiated.1–3

MATERIALS AND METHODS

Study Design

A total of 10 patients with moderate to severe psoriasis who were currently using adalimumab for at least 12 weeks (range six months–three years) but had a PGA of mild (2) or worse

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