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Ixekizumab has maintained or has achieved high levels of skin clearance for patients with moderate-to-severe plaque psoriasis


The New England Journal of Medicine ( NEJM ) has published detailed results from three pivotal phase 3 studies, UNCOVER-1, UNCOVER-2 and UNCOVER-3, that have demonstrated the efficacy and safety of Ixekizumab ( Taltz ) through 60 weeks in patients with moderate-to-severe plaque psoriasis.
This publication also detailed 12-week efficacy data for patients treated with Ixekizumab in UNCOVER-1.
In all three studies, responders to Ixekizumab through 12 weeks demonstrated high levels of skin clearance through 60 weeks.

All three studies evaluated the safety and efficacy of Ixekizumab ( 80 mg every two weeks, following a 160-mg starting dose ) compared to placebo after 12 weeks.
UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received Etanercept ( 50 mg twice a week ) for 12 weeks.
All three studies also evaluated response rates with Ixekizumab every four weeks through 60 weeks.
In UNCOVER-1 and UNCOVER-2, patients treated with Ixekizumab who achieved clinical response ( static Physician's Global Assessment score [ sPGA ] 0 or 1 ) at 12 weeks were re-randomized to receive Ixekizumab ( 80 mg every four weeks ) or placebo through 60 weeks.
In UNCOVER-3, all patients completing 12 weeks continued the study receiving Ixekizumab ( 80 mg every four weeks ) through 60 weeks.

In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score ( PASI ) 75 and sPGA 0 or 1.
PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions ( each graded on a zero to four scale ), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a recommended measure the FDA uses to evaluate effectiveness.
In all three studies, sPGA and PASI were also assessed through 60 weeks.

In UNCOVER-1, Ixekizumab given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Ixekizumab, the majority of whom achieved virtually clear ( PASI 90 ) or completely clear skin ( PASI 100, sPGA 0 ).
81.8% of patients treated with Ixekizumab has achieved sPGA 0 or 1 compared to 3.2% of those treated with placebo ( p less than 0.001 ); 89.1% of patients treated with Ixekizumab has achieved PASI 75 compared to 3.9% of patients treated with placebo ( p less than 0.001 ); 70.9% of patients treated with Ixekizumab has achieved PASI 90 compared to 0.5% treated with placebo ( p less than 0.001 ); 35.3% of patients treated with Ixekizumab has achieved complete resolution of psoriasis plaques ( PASI 100 ) compared to zero patients treated with placebo ( p less than 0.001 ).

In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Ixekizumab every two weeks who achieved clinically meaningful response ( sPGA 0 or 1 ) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Ixekizumab every four weeks.
In UNCOVER-1 and UNCOVER-2 through 60 weeks: 78.3% of patients has maintained sPGA 0 or 1; 83.3% of patients achieved PASI 75; 76.5% of patients has achieved PASI 90.
More than half of patients ( 57.5% ) has achieved complete resolution of skin plaques ( PASI 100 ).

In UNCOVER-3, high levels of clearance were also achieved with Ixekizumab given every four weeks through 60 weeks among patients initially treated with Ixekizumab every two weeks: 74.5% of patients has achieved sPGA 0 or 1; 83.4% of patients has achieved PASI 75; 73.2% of patients has achieved PASI 90.
More than half of patients ( 55.3% ) has achieved complete resolution of skin plaques ( PASI 100 ).

Ixekizumab may increase the risk of infection. Patients treated with Ixekizumab had a higher rate of infections than patients treated with placebo ( 27 versus 23% ). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Ixekizumab compared to placebo.
Serious infections have occurred. ( Xagena )

Source: Eli Lilly, 2016

XagenaMedicine_2016



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