Biofailure Data
Primary Efficacy
Post-hoc analysis at 52 weeks
This was a 16-week open label study. Failure was defined as treatment for at least 3 months without achieving PASI 75 response or 50% loss of original improvement.
This chart shows pooled data from Studies 2 and 3 in which patients who failed on Stelara were switched to SILIQ at 16 weeks.
Failure was defined as an sPGA score ≥3, or persistent sPGA score ≥2 over a 4-week period.
Post-hoc analysis
Data pooled from two multicenter, randomized, controlled, phase 3 studies in the subgroup of patients who previously failed on Humira, Enbrel, or Remicade.
Failure was classified as a primary or secondary failure, intolerance or other specified reason. p-values are for patients who failed on prior biologics treated with SILIQ vs patients who failed on prior biologics and were treated with Stelera.
*Rescue is defined as treatment with SILIQ after failure with another/other treatment(s) and is the term used in the SILIQ clinical studies.
Primary endpoint | NRI analysis
Post-hoc analysis | NRI analysis
In Study 1, 68% of patients who received SILIQ from baseline through Week 52 attained PASI 100 by Week 52 (p<.001)
In Study 1, 69% of patients who received SILIQ from baseline through week 108 attained PASI 100 by Week 108 (N=83)
See how SILIQ could save their day — even if the day is just spent relaxing at the pool with their kids.
We're helping more patients go for total clearance with Siliq Solutions™.
It’s simple. Enrolling through the REMS portal takes just a few minutes.
Important Safety Information for SILIQ (brodalumab) Injection
INDICATION
SILIQ® injection 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.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes [see Warnings and Precautions (5.1) in the full Prescribing Information]. Because of the observed suicidal behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program [see Warnings and Precautions (5.2) in the full Prescribing Information].
Crohn’s Disease
SILIQ is contraindicated in patients with Crohn’s disease. In clinical trials, which excluded Crohn’s patients, one SILIQ patient was withdrawn after developing Crohn’s disease.
SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program
SILIQ is available only through a restricted program called the SILIQ REMS because of observed suicidal ideation and behavior in patients treated with SILIQ. Before prescribing SILIQ, prescribers must be certified with the program, have each patient sign a Patient-Prescriber Agreement Form, and provide the patient a Wallet Card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available at SILIQREMS.com
Infections
SILIQ may increase the risk of infections. Serious infections and fungal infections were observed at a higher rate in patients treated with SILIQ than placebo-treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy.
Risk for Latent Tuberculosis (TB) Reactivation
Evaluate patients for TB prior to initiating treatment with SILIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SILIQ and consider anti-TB therapy prior to initiation in patients with history of latent TB if adequate treatment cannot be confirmed. Monitor closely for symptoms of active TB during and after treatment.
Immunizations
Avoid use of live vaccines in patients treated with SILIQ.
Adverse Reactions
The most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
To report SUSPECTED ADVERSE REACTIONS, contact Customer Service at 1-800-321-4576 or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
Please click here for full Prescribing Information, including Boxed Warning about suicidal ideation and behavior.
You are now entering a site that is for US healthcare professionals only. By selecting YES below, you certify that you are a US healthcare professional and wish to proceed to this section of the site. Products or treatments described on this site are available in the United States but may not be available in all other countries. I certify that I am a licensed US healthcare professional and wish to proceed to the healthcare professional section of this site.
Thank you for visiting www.siliq.com. By clicking continue, you will be taken to a website or sites to which our Privacy Policy and other rules do not apply. Ortho Dermatologics does not possess editorial control over the content of the information provided in such website(s) and therefore does not warrant their accuracy and completeness. You are solely responsible for interactions with such website(s).
SILIQ was evaluated in 3 similarly designed phase 3 studies. Study 1 included 661 adult patients with a diagnosis of plaque psoriasis for ≥6 months involving ≥10% body surface area (BSA), PASI score ≥12, and sPGA score ≥3. Study 2 included 1831 patients with similar eligibility criteria and Study 3 included 1881 patients with similar eligibility criteria. Study 1 was a placebo-controlled study, while studies 2 and 3 were placebo- and active (Stelara)-controlled studies.1,3
You are now leaving a promotional website and entering a Risk Evaluation and Mitigation Strategy (REMS) site. Do you want to leave?
WARNING: SUICIDAL IDEATION AND BEHAVIOR
Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. Prior to prescribing SILIQ, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health