FDA approved Siliq (brodalumab) for Moderate to Severe Plaque PsoriasisFDA approved new drug Siliq for adults with plaque psoriasis

FDA From the archive Source published February 15, 2017 Summary added May 14, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Siliq for adults with moderate to severe plaque psoriasis who have failed or lost response to other systemic therapies.

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)

Mechanism of Action

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).

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

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.

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The FDA has approved a new drug called Siliq (brodalumab) for adults with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. Siliq is for patients who have tried other treatments like systemic therapy or phototherapy but did not get enough relief or stopped responding.

Siliq works by blocking a protein in the body that causes inflammation. In clinical studies, patients taking Siliq had clearer skin and fewer psoriasis symptoms after 12 weeks compared to those on a placebo. This approval provides a new option for people who have not had success with other medicines.

However, Siliq has a boxed warning about an increased risk of suicidal thoughts and behavior. Patients and doctors should watch for any changes in mood or behavior. It is important to discuss your medical history and any mental health concerns with your healthcare provider before starting Siliq.

This approval does not mean Siliq is right for everyone. Talk to your doctor to see if Siliq could be a good choice for you. Your doctor can help you weigh the benefits and risks based on your personal health situation.

What this means for you:

Siliq is a new option for plaque psoriasis, but talk to your doctor about risks like suicidal thoughts.

Study Details

Study typeFda approval

PublishedFeb 2017

View Original Abstract ↓

1 INDICATIONS AND USAGE SILIQ ® (brodalumab) 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 is a human interleukin-17 receptor A (IL-17RA) antagonist 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. ( 1 )

FDA approved Siliq (brodalumab) for Moderate to Severe Plaque PsoriasisFDA approved new drug Siliq for adults with plaque psoriasis

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FDA approved Siliq (brodalumab) for Moderate to Severe Plaque PsoriasisFDA approved new drug Siliq for adults with plaque psoriasis

Study Details

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

Clinical research that matters. Delivered to your inbox.

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