Τετάρτη 28 Φεβρουαρίου 2018

Impact of Previous Biologic Use on Efficacy and Safety of Brodalumab and Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis: Integrated Analysis of AMAGINE-2 and AMAGINE-3

Abstract

Background

Biologics used increasingly used for treating moderate-to-severe psoriasis. Efficacy may differ in patients with previous biologics exposure.

Objective

To investigate the impact of previous biologic exposure on efficacy and safety of brodalumab and ustekinumab in moderate-to-severe plaque psoriasis.

Methods

Two placebo- and ustekinumab-controlled phase 3 clinical trials. Initial 12-week induction phase where patients were treated with brodalumab (210mg Q2W or 140mg Q2W), ustekinumab or placebo. Efficacy endpoints included: Psoriasis Area and Severity Index (PASI 75) and Physician's Global Assessment (sPGA 0/1) versus placebo, PASI 100 versus ustekinumab, Dermatology Life Quality Index (DLQI) and Psoriasis Symptom Inventory (PSI). Adverse events were monitored throughout.

Results

493 patients (334 [27%] brodalumab 210 mg Q2W and 159 [26%] ustekinumab) received prior biologics exposure; 150 (12%) and 62 (10%) reporting previously failed biologic. Brodalumab efficacy in patients with or without previous biologics exposure was statistically equivalent; 40.9% and 39.5% of bio-naïve and -experienced patients achieved PASI 100 at Week 12, compared with 21.1% and 17.0% with ustekinumab (both P<0.001). In patients where prior biologics had been successful or failed, 41.7% and 32.0% achieved PASI 100, compared with 21.1% and 11.3% with ustekinumab. Tolerability was similar, and did not appear to be influenced by previous biologic treatment.

Conclusions

Efficacy of brodalumab 210 mg Q2W was similar regardless of prior biologic therapy (P=0.31, 0.32 and 0.64 for PASI 75, 90, and 100 respectively). Almost twice as many patients achieved PASI 100 or complete clearance at Week 12 compared with ustekinumab; differences most noticeable where previous biologics had failed. Both treatments were well tolerated.

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