STELARA for Adolescents [transcript][audio]

Guest: Dr. Andrew Greenspan, M.D.

Presenter: Neal Howard

Guest Bio: Andrew Greenspan, MD is the Vice President for U.S. Medical Affairs, Janssen Immunology. based in Horsham, Pennsylvania. He is responsible for overseeing the Medical Affairs activities supporting REMICADE®, SIMPONI®, SIMPONI ARIA®, STELARA®, and TREMFYA®, including the execution of all Post-Marketing Requirements and Post-Marketing Commitments.
Andy joined Johnson & Johnson in 2003 with progressively increasing responsibilities, working across both Medical Affairs and R&D in Neuroscience, Immunology, and Oncology.
He has led Phase 1 through 4 clinical studies and has co-authored over 30 peer-reviewed journal articles.
Andy graduated Magna Cum Laude from Columbia University, where he studied Psychology and earned his medical degree from Harvard Medical School. He completed his residency training in internal medicine at New York Hospital/Weill Cornell Medical College.

Segment Overview: Dr. Andrew Greenspan discusses the recent FDA approval of STELARA® (ustekinumab) for adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

TRANSCRIPT – STELARA

Neal Howard: Welcome to the program. I’m your host Neal Howard here on Health Professional Radio. Thank you so much for joining us today. Our guest is Dr. Andrew Greenspan. He’s here as Vice-President of Medical Affairs for Janssen Biotech Incorporated. He’s joined us here on the program to talk about the recent FDA approval of STELARA for adolescents. Welcome to the program Dr. Greenspan.

Dr. Andrew Greenspan: Thank you very much Neal.

N: Now, the recent FDA approval of STELARA is very important as it relates to adolescents 12 years of age or a bit older. Before we jump right into that, give us just a bit of a brief, brief background about yourself prior to Janssen Biotech.

G: Sure. I am an internal medicine physician. I practiced in New Jersey for a few years and for the past 15 years, I’ve been an employee of Johnson & Johnson and I’m currently in the Janssen Biotech Division. For about half of my career, I’ve worked in research and development with Immunology. And for the past 4 years, I’ve been leading the Immunology Medical Affairs team.

N: We’re here to talk about STELARA, the recent FDA approval of STELARA. First of all, give our listeners a bit of background about plaque psoriasis. What is it and how severe can it get?

G: Sure. Well, there’s many forms of psoriasis. The indication that STELARA was approved for was specifically and the most common type of psoriasis called ‘Plaque Psoriasis’. And it manifests in elevated plaques on the skin. They can often be on extensor surfaces such as the knees or the elbows but they can really affect any part of the body and it can range the gamut from mild disease all the way to severe disease where patients can have up to, I’ve seen 75% of the body covered in these plaque psoriasis. So as you can imagine, it can have significant impact on these patients’ quality of life.

N: What causes this?

G: Once a chronic inflammatory condition and it leads to a hyper activation of the immune system. So our immune system is critical for us to and fight invading microbes such as bacteria, viruses but in many patients with inflammatory immune diseases, the immune system is inappropriately activated and it can lead to a wide variety of immune disorders and in this case, it leads to a proliferation of keratinocytes in the skin which leads to the increased thickness and scalingness of the skin.

N: What type of person is a candidate for plaque psoriasis? Are there certain groups that are more susceptible to it?

G: Yes. So really anyone can get it. There are certain races that are more susceptible to it. There’s some patient types that are more susceptible to it, based on their genetic predisposition or their family risk, family history but really, it can affect anyone.

N: Talk about this recent approval and why is it so important to this particular group of patients?

G: Well, we’re very excited about this approval and one of the reasons is because we’re always looking to develop new medicines or new uses of our drugs that are already on the market where we see there is significant unmet need for patients and adolescents psoriasis is just a terrific example of that. So in general, patients with psoriasis are often unfortunately under treated. For whatever reason, physicians and patients are not fully embracing the available biologics that work very effectively today. And it’s even more true for adolescents, in fact one study showed that less than half of the patients are receiving appropriate therapy such as phototherapy or other oral medications. And in fact, only 10% of adolescent patients with plaque psoriasis have received a prior biologic.

N: Now, is that based on a lack of awareness or the fact that research has been a little bit slow? What do you attribute that to?

G: Well, one of the reasons is up until very recently, there were no biologics approved for this population. The first drug that was approved was ‘Enbrel’ fairly recently and STELARA represents the second biologic approved. So one of the reasons is the lack of availability of effective therapies and that’s why we’re so pleased that’s the recently gained FDA approval.

N: How does it work to alleviate or treat this condition in adolescents?

G: Well, the mechanism of action for STELARA is it blocks two inflammatory proteins called ‘Cytokines’ and in this case, it blocks ‘IL-12’ or ‘Interleukin 12’ and ‘IL-23’. And by blocking those, it deactivates some of those inflammatory cells that I talked about earlier so that the keratinocyte overproduction is minimized and the plaque psoriasis don’t develop quite as significantly.

N: Are there any significant side effects that one would I guess be surprised at based on the other plaque psoriasis, the nature of that and the nature of the drugs that treat it?

G: Well in general, what we’ve seen in our clinical trials, STELARA works very effectively in clearing the skin and often the case in pediatric trials, the results we see in terms of efficacy is even slightly better than what we see in adults. You ask me about safety, there are warnings and precautions in our FDA approval that we observed with the STELARA Adult Psoriasis Program and the safety findings we see and adolescents really are no different from the adult population. In general, it’s well tolerated but there are warnings that the physicians should be careful to instruct their patients on.

N: Is this the first of its kind to effect to this specific group as far as you’re aware of?

G: Yes, well this is a second biologic for this population but this is the first IL 12, 23 inhibitor. It’s actually the only drug on the market that blocks those specific cytokines that’s ever been approved so it’s the first of its kind for this patient population.

N: And where can we go online and get some more information about STELARA and about Janssen Biotech as well?

G: Well, we have a web page and I’m going to actually look it up in one second, I want to make sure I give you the right web address but it is stelarahcp.com. And on that page, you can learn everything you need to know about STELARA , for its indications in adolescent psoriasis but it’s also approved in adult psoriasis as well as Crohn’s disease and psoriatic arthritis.

N: Well, I appreciate you coming in today Dr. Greenspan. Hoping you’ll come back and give us some updates as STELARA progresses.

G: Thank you Neal. We’re pleased with this recent approval and we hope to hear from patients and physicians to see how their experience has been.

N: Excellent. You’ve been listening to Health Professional Radio. I’m your host Neal Howard. Transcripts and audio of the program are available at healthprofessionalradio.com.au and also at hpr.fm. Subscribe to this podcast on iTunes, listen in and download at SoundCloud and be sure and visit our affiliates page when you visit us at hpr.fm and healthprofessionalradio.com.au.

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