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

Summary

Background

Some plaque psoriasis patients 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 4, open-label, single-arm, estimation study (NCT01543204) enrolled patients on adalimumab who had achieved static physician 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. Anti-adalimumab antibodies (ADA) were measured at screening. Patients received etanercept 50mg twice weekly for 12 weeks followed by 50mg weekly. Primary endpoint was sPGA 0/1 at week 12 (intent-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 (DLQI), treatment satisfaction, and Work Productivity and Activity Impairment (WPAI).

Results

Sixty-four patients enrolled; 67% had ADA. Week 12 sPGA 0/1 rates (95% confidence interval) were 39.7% (27.6%-52.8%; primary endpoint); and 45.0% (29.3%–61.5%) for ADA-positive and 35.0% (15.4%–59.2%) for ADA-negative patients. Week 12 PASI 75 response rates (95% CI) were 47.5% (31.5%–63.9%) for ADA-positive and 50.0% (27.2%–72.8%) for ADA-negative patients. No new safety signals were observed. PROs of itch, pain, and flaking consistently improved at week 12 and were maintained through week 24.

Conclusions

Psoriasis patients with secondary failure of adalimumab achieved satisfactory response to etanercept regardless of ADA status.

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