FDA Approves Siliq (brodalumab) for Moderate to Severe Plaque Psoriasis
The FDA has approved Siliq (brodalumab), a human interleukin-17 receptor A antagonist, 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. The approval provides a new option for patients with inadequate response to prior treatments. In clinical trials, Siliq demonstrated significant improvements in psoriasis area and severity index scores and physician global assessments compared with placebo at 12 weeks. Clinicians should note that Siliq carries a boxed warning for suicidal ideation and behavior, and patients should be monitored accordingly.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Siliq (brodalumab) is a human interleukin-17 receptor A (IL-17RA) antagonist. It binds to IL-17RA and blocks the biologic activity of several IL-17 cytokines (IL-17A, IL-17F, IL-17A/F heterodimer, and IL-25).
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.
The recommended dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2, followed by 210 mg every 2 weeks. If an adequate response has not been achieved after 12 to 16 weeks, consider discontinuing therapy. Each prefilled syringe is for single dose only. Allow the syringe to reach room temperature (approximately 30 minutes) before injection. Do not inject into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.
Three multicenter, randomized, double-blind, controlled trials (Trials 1, 2, and 3) enrolled 4373 adults with moderate to severe plaque psoriasis. Co-primary endpoints at Week 12 were PASI 75 and sPGA 0/1 with at least 2-point improvement. In Trial 1, 83% of Siliq-treated patients achieved PASI 75 vs 3% for placebo; 76% achieved sPGA 0/1 vs 1% for placebo. In Trial 2, 86% achieved PASI 75 vs 7% for placebo; 80% achieved sPGA 0/1 vs 2% for placebo. In Trial 3, 85% achieved PASI 75 vs 6% for placebo; 79% achieved sPGA 0/1 vs 2% for placebo. Comparisons to ustekinumab were also made for PASI 100 at Week 12.
Not reported in label.
Siliq is indicated for patients who have failed or lost response to other systemic therapies. It is not a first-line option. Consider discontinuing if no adequate response by 12-16 weeks.
View Original Abstract ↓
Guselkumab Phase III trials validate 3VAS and 4VAS measures for psoriatic arthritis disease activity assessment
Study checks how well pain scores track joint damage in psoriatic arthritis patients
Related in Dermatology
From Other Specialties
