Join leading dermatology experts as they review the SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program!See Full Prescribing Information for SILIQ, including BOXED WARNING about suicidal ideation and behavior, <a target="_blank" rel="noopener noreferrer" href="https://pi.bauschhealth.com/globalassets/BHC/PI/Siliq-pi.pdf">here</a>.

The SILIQ REMS Process: A Worthwhile and Uncomplicated Conversation

Approaching the Conversation

The following are opinions of Dr. Mark Lebwohl and not intended to replace the informed consent process between a doctor and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REMS requirements. More information will be discussed later in this video. Hello, I'm Dr. Mark Lebwohl, dean for clinical therapeutics at the Icon School of Medicine at Mount Sinai in New York and chairman emeritus of the Department of Dermatology. I have been practicing dermatology for over four decades and I was the principal investigator in the clinical trials for SILIQ (brodalumab). Today I'd like to talk to you about SILIQ and the SILIQ Risk Evaluation and Mitigation Strategy, or REMS program. 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. I choose SILIQ when an adult patient has failed on a biologic, so it is usually my second choice. That means we're dealing with a more difficult to treat patient. Individual results may vary, but in my experience we have had good results and PASI 100 is not out of the question. To put patients on SILIQ, they have to enroll in the REMS program and doctors must be certified in the program. SILIQ has a boxed warning and the full prescribing information because there were four suicides among more than 4400 patients with psoriasis treated with SILIQ in the clinical trials. Although there is no causal relationship to SILIQ established, it is still a worthwhile and simple conversation to have with your patients. Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ in the clinical trials. The REMS program helps ensure that patients are informed about the risks of suicidal ideation and behavior so that they keep this in mind to help detect and get medical attention to manage any such issues that arise. We'll also cover more details about the SILIQ boxed warning and other important safety information in this video. You know, we're talking about a condition where patients are normally depressed, but we did see those four cases in the trials, and to be careful, the FDA instituted the REMS program. And that's fine. It's necessary and it's simple to do. So here's how I handle it with my patients. The conversation is actually fairly easy, especially because it's not the first drug they're using and it takes me less than a minute and I say to them, this is what we saw in the clinical trials about how effective it was. The trials had over 4400 patients in them. And we talk about what they can expect in terms of efficacy and safety. And I say, but also in those trials, there were four patients who committed suicide. And I tell them what's happened there and what the experience has been since the drug was approved. And I say, so we have this REMS program we have to do at that point. I will take them through the patient enrollment form, which you see here. And as it says in the form, I explain to them, I have to go through this with you, and I've already discussed with you that suicides and suicidal thoughts can occur if you feel worsening feelings or withdrawal, depression, anxiety, helplessness, or other mood changes. I want you to contact either me or the National Suicide Prevention Hotline. And if you're thinking of hurting or killing yourself, you have to call me or the National Suicide Prevention Hotline. If you are imminently at the point of harming yourself, you must immediately call 911. Here's the card you should keep in your wallet. The card covers what we just talked about and has the phone numbers you need. You should understand that someone from the SILIQ REMS program may contact me or may contact you. And at that point, I ask them if they agree to using SILIQ, which the vast majority do, and if so, to sign the form. And then I just cut off the bottom of the sheet at the dotted line and give it to them. My staff actually fills out all of their data and all of my data beforehand. So all patients have to do is agree and sign. So the whole thing that I do with patients takes as much time as it just took me to go through it with you. And that's how I make sure I follow the REMS program requirements with my patients who need SILIQ. The form can be done electronically now, too. Providers have to register at SILIQREMS.com but once you've done that, you can log in and enroll patients quite easily that way. And I say you. But it can be done by, say, your bio coordinator. As I said at the beginning, patients I consider for SILIQ have psoriasis that hasn't responded to other treatments, so they're more difficult to treat. When I review the efficacy and safety of SILIQ with patients and then go over the REMS program information with them, very few of them hesitate to go on it. And most of those who hesitate do end up going on it anyway. They need what the drug can offer for patients who fail to respond to other drugs. SILIQ may be the answer they're looking for. The REMS program helps ensure patients are informed about the risks and helps doctors document that conversation. We owe it to our patients to enroll them so they can get SILIQ when they need it. Before closing, please take a moment to listen to some additional information about the SILIQ REMS program and important safety information for SILIQ. The SILIQ REMS program physicians must register for the SILIQ REMS program@SILIQREMS.com. Discontinuation or transfer of care must be reported to the SILIQ REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SILIQ REMS are available at SILIQREMS.com. 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 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 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. Discontinue SILIQ if a patient develops 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 dispensed to patients authorized to receive SILIQ. More information is available at SILIQREMS.com or by calling the SILIQ REMS program call center at 855-11-6135 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. Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. 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 tinia infections. To report suspected adverse reactions, contact Bauch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA gov medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior at SILIQ.com.

Mark Lebwohl - An Introduction to the REMS Program for Psoriasis and Beginning the Patient Conversation

Join Mark Lebwohl, MD, as he provides an introduction and overview of the SILIQ® (brodalumab) injection Risk Evaluation and Mitigation Strategy (REMS) Program for patients undergoing treatment for moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.Dr. Lebwohl discusses the background and rationale of the SILIQ REMS Program, the program requirements, and how he counsels his patients on utilizing the program to ensure their well-being.See the Full Prescribing Information for SILIQ, including BOXED WARNING about suicidal ideation and behavior, <a target="_blank" rel="noopener noreferrer" href="https://pi.bauschhealth.com/globalassets/BHC/PI/Siliq-pi.pdf">here</a>. &nbsp;