Crohn’s Disease Phase 3 Study Findings [Interview][Transcript]

Dr_John_Popp_Crohns_DiseaseGuest: Dr. John Popp
Presenter: Neal Howard
Guest Bio: John W. Popp, Jr.joined a private practice in Columbia, South Carolina where he also maintained a position as Clinical Professor of Medicine at the University of South Carolina and chaired the Division of Digestive Diseases and Nutrition. He retired from private practice in June of 2006 and joined Centocor as a Medical Director in the Medical Affairs Department In July of 2006.

Segment overview: In this segment, Dr. John (Jay) Popp discusses the Phase 3 Study Findings for Crohn’s Disease.

Health Professional Radio – Crohn’s Disease

Neal Howard: Hello and welcome to the program today. I’m your host Neal Howard, thank you so much for joining us here on Health Professional Radio. Our guest in studio is Dr. John Popp, Dr. Popp completed medical school at Yale University, completed a Fellowship in Gastroenterology at Mass General. Now he retired from private practice back in 2006 and joined Janssen as Medical Director in the Medical Affairs Department. And he’s joining us here in Health Professional Radio today to discuss the Phase 3 Study findings for Crohn’s disease. Welcome to Health Professional Radio Dr. Popp.

Dr. John Popp: Hi Neal. Just a slight correction, I was at the University of South Carolina, not Southern California.

N: Okay. We know that for a fact.

P: That’s okay just different…

N: Two great Universities anyway, right?

P: Absolutely.

N: So Crohn’s disease, let’s talk first what is exactly is Crohn’s disease and what type of misconceptions surround Crohn’s disease?

P: Well Neal, Crohn’s disease is one of the two major diseases we put in the category of inflammatory bowel disease. So when we talk about inflammatory bowel disease there are primarily two diseases, one being Crohn’s disease and the other being ulcerative colitis. Ulcerative colitis involves the colon while Crohn’s disease can involve any portion of the digestive tract literally from the mouth to the anus and anywhere in between and what it is Neal is an inflammation of the digestive tract, we’re not exactly sure what causes it, we do think that there is a genetic basis coupled with immunologic basis and maybe something in the environment that triggers that combination to produce this ongoing inflammation. I think maybe you asked about misconceptions, people don’t know a lot about inflammatory bowel disease, they tend to think of it as something that they may be settled with for life that there are no effect to treatments and although especially Crohn’s disease maybe with you for the rest of your life, there are now an increase in number of treatments that make people able to live a very normal life.

N: A recent study was conducted concerning Crohn’s disease called The Phase 3 Study. Who conducted this study and why and what were the findings?

P: Well this study was performed by Janssen and it was looking at a drug called Ustekinumab, the tradename is Stelara and this is a drug that’s been out there since 2009 for the treatment of psoriasis and psoriatic arthritis but the development program for Crohn’s disease has gone on for more than a decade. The scientists at Janssen really felt that this mechanism of action which we can certainly talk about later might prove useful in the management of Crohn’s disease. So this study was divided into two portions, there was an induction study to see how well we could get patients well initially and then a maintenance study to see how well we could keep them there. So the first induction studies were called the UNITI studies, one was called UNITI-1 and the other was called UNITI-2 and people who responded were enrolled over into the maintenance study which was called IM-UNITI. I’d like to give you a few details if I could Neal because there’s an important distinction in these two trials. So UNITI-1 included patients who had failed TNF inhibitors. So TNF inhibitors of which there are several on the market for Crohn’s disease, Remicade, Rumera and Cimzia are all tradenames for inhibitors of tumor necrosis factor alpha that are FDA approved to the management of Crohn’s disease. One of the hardest to treat population as you might imagine are individuals who have failed one or more of these products because generally people are not treated with TNF inhibitors until they have failed conventional therapy including antibiotics, drugs called Mesalamines, steroids, corticosteroids and then a classic drugs called immuno-modulators, so these are historically the most difficult patients to treat. IM-UNITI-2 that population was different, these were patients who failed conventional therapy. They had not failed TNF inhibitors and the research scientists at Janssen designed the trial this way so that it would encompass all of the patients’ kind of a community of Crohn’s disease patients, those who had failed TNF inhibitors and those who had failed conventional Therapy. So that was the kind of the demographic profile of the patients who entered the study. These patients were given either a placebo, it’s a placebo controlled trial or they received 130mg intravenously, so it’s an IV therapy induction, or approximately 6 mg/kg intravenously. And Neal I think it’s important to make this distinction because in psoriasis and psoriatic arthritis patients are not treated with intravenous therapy, they’re treated with subcutaneous therapy. They may even study, which again consisted of patients who responded in the induction studies, these patients were treated with subcutaneous therapy at the same type of dosage that we use for psoriasis.

N: How many subjects are we talking about between the two classes?

P: Well we’re talking well over 600-800 patients, actually a thousand patients, well a more than a thousand all together were enrolled in these trials. So as I said when we look back at the therapy that this has gone on for a long period of time but just to give you more precise numbers, in UNITI-1, so the TNF failure trial there were around 740, in UNITI-2 trial there were around 630, so slightly over 13,000 patients altogether.

N: Were there any age findings, does Crohn’s disease manifests at any age or is there an age at which you find it more often?

P: Sure, that’s an important question because Crohn’s disease can affect any age, any age at all Neal and in this population, this was an adult’s trial, so patients 18 years or older and the way pharmacology works now, our pharmaceutical development is you must prove efficacy and importantly safety in the adult population before you study it in the pediatric population. So this was a trial of eligible adult patients.

N: Do you see in the near future a trial that will focus on pediatrics?

P: Well ultimately all of these drugs we hope to use in pediatric patients because after all they can sometimes be our sickest patients and typically pediatric patients may present with more profound disease, more serious disease than adults. So it’s a little bit of catch-22, we know that these drugs work like the TNF inhibitors work very well in children and in many cases better than they do in adults but we can’t use them until we proved safety and efficacy in adults. So I think somewhere down the road we might see there is a trial to hopefully get the drug approved for pediatric population.

N: Do you foresee a widespread acceptance of these findings or as sometimes as the case is facilitating change sometimes a challenge especially if we’ve been treating and managing Crohn’s disease in a way having not known these findings?

P: Well you’re right Neal, anytime we have a new drug on the market you have to ask yourself that question “How well will this data be received?” And what I can tell you is that as we have presented this data at major GI meetings, so this has been rolled out over the past basically year almost, it has been very well received. People were very excited about this and this drug. I should also mention that this drug has been used off label by gastroenterologists for a number of years and its important distinction to make Neal, the FDA approval is obviously mandatory before a company can market a drug. But there’re a lot of drugs out there that we use that do not really subscribe to the label precisely and because of the expected ability of this drug to treat Crohn’s disease people have tried it in situations where there were no options and if this worked really very well. So people are excited about this Neal, the data has been very well received and to be honest I think people can’t wait for this drug to come to market.

N: It’s been great having you here with us in studio today Dr. Popp.

P: Thank you so much Neal.

N: Thank you. Transcripts and audio of this program are available at, also at and be sure to subscribe to this podcast on iTunes.