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The REMS Process for Psoriasis

Ortho Siliq REMS 2023

Important and Easy Conversations

Psoriasis

The following are opinions of Dr. Scott Drew and are 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. Hi there. I'm Dr. Scott Drew, a medical and surgical dermatologist at Dermatology Associates of mid Ohio. I've been practicing dermatology for over 30 years, and I've been using SiLIQ extensively since it was approved in 2017. I'd like to share with you my approach to discussing Siliq with my patients, and in particular the Siliq Risk Evaluation and mitigation strategy, or REMS program. This video will cover the Siliq boxed warning and other important safety information. 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. Let me start by saying I choose siliq because it has a unique mechanism of action. It acts as a cell membrane and binds to the IL 17 receptor, so it blocks the whole IL 17 family, not just the IL 17 a homodimers, but also the IL 17 af heterodymers. It's an important drug for many of my adult patients with psoriasis. We have a unique practice in that we're often a referral center for psoriasis. Some patients who come to us have had Pasi 20 or 30 or 40 on other systemic treatments or light therapy, including other biologics. This is when we think about Celik. But to use SilIQ, patients have to enroll in the REMS program. As dermatologists, we are familiar with this sort of program, especially for patients with serious skin diseases and the kind of treatments that we use. We do it for those products. We need to do it for Salik, too. And the reason for the Salik REMS program is that, sadly, there were four suicides in the phase three trials for Salik out of over 4400 patients. For this reason, Salik has a box warning in the full prescribing information. So we need to disclose that suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq in the clinical trials. The REMS program helps ensure that we, patients and doctors, both keep this in mind and detect and deal with any concerns that arise. And I explain that to patients. And to put it in perspective, we have not seen any suicides since the drug has been approved. Nevertheless, it is important that we talk to our patients about the risk of suicidal behavior. I think the management of psoriasis or any other disease really depends upon the trust our patients put in us to make them feel that they are part of the human continuum, even though they have psoriasis and that we have tools to help them. And when you earn that trust from a patient, they look to you not just for choices, but they also look to you for guidance. So I say something like this. I know that psoriasis is quite bothersome to you, and you've had many other therapies. I would like to talk to you about a drug called siliq, and I explain what they can expect in terms of efficacy and safety. Then I say, now I have to tell you that there were a few people who were in the trials who had some depression before they enrolled. And during the trial, sadly, four people committed suicide. The investigators didn't find a causal connection to the drug. But as a result of that, I need to go over this form with you, and I show them the form. It's pretty straightforward. And there's a hotline number on this wallet card. I ask them to carry it and call the number and seek immediate attention should they have any thoughts of self harm. While on Salik, I cover all the information that's here and fill it in. Name, address, all of that. We specifically ask if the patient has history of depression or suicide, suicidal thoughts or behavior. And I say, this is all about you having more information, helping you get the medicine you need, increasing your safety during treatment. And then we sign the form and send it in. It can be done electronically, too@salerems.com. I will say that when Siliq first came out, I was skeptical. I was a big biologic writer, and I thought I would never, ever write that drug because of this issue. And I believe that may still be a very common misconception among some dermatologists. And my advice is to register@salikrems.com and give Siliq a try for your appropriate patients. My first patients were those who didn't get better on all of the best stuff we had at the time. And all I will say is, it's worth it. Your patients are worth it. And now, before we close, I want to be sure you get a chance to hear 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@salehrems.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@salikrems.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 Soleik 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 dispense to patients authorized to receive SILIQ. More information is available@saliquerems.com or by calling the SILIQ REMS program call center at 855-511-6135 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 placebotreated 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 slash Medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior@siliq.com. Premiumpeed.com.

Scott Drew - Important and Easy Conversations

<p>Join Scott Drew, MD, as he shares his approach to discussing the REMS program with his patients. Dr Drew details how he offers guidance to his patients undergoing treatment for moderate-to-severe-plaque psoriasis, the importance of discussing the patient’s mental health history, and how he explains and contextualizes important information for patients participating in the REMS program.</p>

Important and Easy Conversations

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