Ortho Dermatologics: Long-term Efficacy Data for Siliq

Monday, October 16, 2017 | Psoriasis , Research and Publications


Siliq™ (brodalumab) injection provided sustained high levels of skin clearance (PASI 100) over more than two years in patients with moderate-to-severe psoriasis, according to data presented at the 2017 Fall Clinical Dermatology Conference in Las Vegas and reported by Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc.

SILIQ is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ has a Boxed Warning and a Risk Evaluation and Mitigation Strategy (REMS) due to observed suicidal ideation and behavior in clinical trials. SILIQ is contraindicated in patients with Crohn's disease. Serious infections have occurred; therefore caution should be exercised when considering the use of SILIQ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment and avoid use of live vaccines.

Results from the long-term extension study (AMAGINE-2) found that SILIQ provided sustained high levels of skin clearance (PASI 100) over more than two years in those with moderate-to-severe psoriasis. Further, a sub-analysis group of patients who received any dose of brodalumab in the induction phase and SILIQ during the maintenance and long-term extension (LTE) phases demonstrated similar response rates. Patients who received either study dose of brodalumab in the induction phase and SILIQ throughout the maintenance and LTE phases at week 120, had a PASI 100 response rate of 59.0% (N=178), and PASI 90 response rate of 76.4% (N=178). At week 52, the same set of patients had a PASI 100 response rate of 63.4% (N=290) and PASI 90 response rate of 85.9% (N=290). At week 120, SILIQ continued to be generally well-tolerated with a safety profile comparable to that observed in the 52-week period.

Results of a Phase 3, multicenter, randomized, double-blind, placebo-controlled study (AMAGINE-1) of the efficacy of brodalumab in a subset of patients with prior exposure to ustekinumab, demonstrated that SILIQ was similarly efficacious with improved skin clearance in patients both with and without prior ustekinumab exposure.  Among patients receiving continuous SILIQ, rates of 100% reduction in PASI score (PASI 100) was 65.2% (43 of 66) and 76.5% (n=13 of 17) in ustekinumab-naive and -experienced patients at week 52, respectively. PASI 90 were 75.8% (50 of 66) in ustekinumab-naive and 88.2% (15 of 17), in ustekinumab-experienced patients.

Siliq™ (brodalumab) injection provided sustained high levels of skin clearance (PASI 100) over more than two years in patients with moderate-to-severe psoriasis, according to data presented at the 2017 Fall Clinical Dermatology Conference in Las Vegas and reported by Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc.

Results from the long-term extension study (AMAGINE-2) found that SILIQ provided sustained high levels of skin clearance (PASI 100) over more than two years in those with moderate-to-severe psoriasis. Further, a sub-analysis group of patients who received any dose of brodalumab in the induction phase and SILIQ during the maintenance and long-term extension (LTE) phases demonstrated similar response rates. Patients who received either study dose of brodalumab in the induction phase and SILIQ throughout the maintenance and LTE phases at week 120, had a PASI 100 response rate of 59.0% (N=178), and PASI 90 response rate of 76.4% (N=178). At week 52, the same set of patients had a PASI 100 response rate of 63.4% (N=290) and PASI 90 response rate of 85.9% (N=290). At week 120, SILIQ continued to be generally well-tolerated with a safety profile comparable to that observed in the 52-week period.

Results of a phase III, multicenter, randomized, double-blind, placebo-controlled study (AMAGINE-1) of the efficacy of brodalumab in a subset of patients with prior exposure to ustekinumab, demonstrated that SILIQ was similarly efficacious with improved skin clearance in patients both with and without prior ustekinumab exposure.  Among patients receiving continuous SILIQ, rates of 100% reduction in PASI score (PASI 100) was 65.2% (43 of 66) and 76.5% (n=13 of 17) in ustekinumab-naive and -experienced patients at week 52, respectively. PASI 90 were 75.8% (50 of 66) in ustekinumab-naive and 88.2% (15 of 17), in ustekinumab-experienced patients.

SILIQ is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ has a Boxed Warning and a Risk Evaluation and Mitigation Strategy (REMS) due to observed suicidal ideation and behavior in clinical trials. SILIQ is contraindicated in patients with Crohn's disease. Serious infections have occurred; therefore caution should be exercised when considering the use of SILIQ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment and avoid use of live vaccines.

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