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Dermatology Xagena

Initial data from pivotal phase-3 trial evaluating the efficacy and safety of Adalimumab for moderate to severe fingernail psoriasis in adult patients


Findings of a phase 3 study of patients with moderate to severe psoriasis demonstrating that nearly half of adult patients treated with Adalimumab ( Humira ) has achieved at least a 75% improvement in their moderate to severe fingernail psoriasis compared to patients receiving placebo, were presented at Psoriasis 2016 - 5th Congress of the Psoriasis International Network taking place July 7 - 9 in Paris.

Fingernail psoriasis occurs in up to 55% of people living with psoriasis and up to 70% of people living with psoriatic arthritis. It is associated with pitting, deformation, thickening, discoloration and separation of the nail from the nail bed.

In this study, Adalimumab treated patients met primary endpoints at week 26.

The 46.6% achieved at least a 75% improvement in modified Nail Psoriasis Severity Index ( mNAPSI ) versus 3.4% for placebo ( p less than 0.001 ).

The 48.9% achieved Physician's Global Assessment-fingernail-psoriasis of 0 ( clear ) or 1 ( minimal ) with at least a 2-point improvement from baseline versus 6.9% for placebo ( p less than 0.001 ).

This phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study evaluated the safety and efficacy of Adalimumab in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis.
During the first 26-weeks ( Period A ), enrolled patients ( n=217 ) were randomized to receive Adalimumab 40 mg every other week ( n=109 ) following an initial 80 mg dose or matching placebo ( n=108 ).
After week 16 in Period A, if psoriasis-affected body surface area increased by 25% or more from baseline, patients could transition to receive open label Adalimumab for 26 weeks ( Period B ).

Period A analysis identified no new safety signals with Adalimumab every other week dosing through 26 weeks. Adverse events were reported by 56.9% of Adalimumab-treated patients and 55.6% of placebo-treated patients. Serious adverse effects were reported by 7.3% and 4.6%, respectively, including serious infections in 3.7% of those treated with Adalimumab compared to 1.9% on placebo. ( Xagena )

Source: AbbVie, 2016

XagenaMedicine_2016



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