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WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.
Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”
The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.
In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.
The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.
According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.
Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.
On Twitter @whitneymcknight
WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.
Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”
The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.
In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.
The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.
According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.
Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.
On Twitter @whitneymcknight
WASHINGTON – After 60 weeks of continuous therapy with the investigational drug ixekizumab, 722 patients who initially had moderate to severe plaque psoriasis had Psoriasis Area Severity Index (PASI) 75, 90, and 100 response rates of 87%, 78%, and 57%, respectively, based on study results presented by Dr. Andrew Blauvelt at the annual meeting of the American Academy of Dermatology.
Additionally, the rate of complete clearance or mild severity of plaque psoriasis based on the Physician Global Assessment measure was 79% in the study patients. Dr. Blauvelt said “these were tremendous results over time.”
The findings come from the open-label continuation study of ixekizumab in UNCOVER-3. At week 12 of that study, 722 ixekizumab-treated patients were continued on or converted to a regimen of 80 mg ixekizumab every 4 weeks.
In UNCOVER-3, all study participants initially received induction therapy with ixekizumab and then were randomized to placebo (193 patients), etanercept 50 mg twice weekly (382 patients), 80 mg ixekizumab every 4 weeks (386 patients) after a 160 mg starting dose, or 80 mg ixekizumab every 2 weeks (385 patients) after an initial 160 mg starting dose. After 12 weeks, patients entered open-label treatment with the study drug once every 4 weeks.
The long-term safety and tolerability profile was similar to the one seen during the induction period and cited in previously published data. Dr. Blauvelt, President of the Oregon Medical Research Center, said the finding was “good news, in that there were no unexpected safety signals [not already] seen with initial therapy.”
Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokines, inhibiting interaction with the IL-17 receptor.
According to a spokesperson from Eli Lilly, sponsor of the UNCOVER trial and maker of ixekizumab, a decision from the U.S. Food and Drug Administration on whether to approve ixekizumab for use in psoriasis is expected during the first quarter of 2016.
Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.
On Twitter @whitneymcknight
AT AAD 2016
Key clinical point: Continuous therapy with the investigational drug ixekizumab appears to be safe and effective for long-term use.
Major finding: At Week 60, the PASI 75, 90, and 100 response rates were 87%, 78%, and 57%, respectively.
Data source: Phase 3 UNCOVER-3 trial of 1,346 patients randomized to placebo, active control, or ixekizumab at every 4 weeks or every 2 weeks after induction.
Disclosures: This trial was sponsored by Eli Lilly, maker of ixekizumab. Dr. Blauvelt is an advisor or consultant for and has received research grants from a wide variety of drug companies including Eli Lilly.
