Biologic Therapy for Crohn’s Disease [Interview][Transcript]

Dr_John_Popp_Crohns_disease_Biologic_TherapyGuest: 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 a biologic therapy for the treatment of Crohn’s disease that is currently under review for approval in the U.S. and Europe.

Transcription
Health Professional Radio – Biologic Therapy

Neal Howard: Hello I’m your host Neal Howard, thank you for joining us in the program today. Our guest in studio today here on Health Professional Radio is Dr. J. Popp. After retiring from private practice in 2006, he joined Janssen as a Medical Director in the Medical Affairs Department. And he’s here with us today returning to talk with us about some brand new developments in the treatment of Crohn’s disease. Good afternoon Dr. Popp.

Dr. John Popp: Hi Neal, thanks for having me.

N: Thanks for coming back. New treatments for Crohn’s disease, first let’s talk about what Crohn’s disease is.

P: Well Crohn’s disease is an inflammatory condition of the digestive tract and one of the problems with it Neal is that it can involve any part of the digestive tract literally from the mouth to the anus and anywhere in between. It’s a chronic condition for which there is no known cure so even by removing the portion of disease you cannot say that a patient is cured because a lot of them will get the disease once again. So it’s a condition that really has to be reckoned.

N: Now no known cure, is there a known cause or causes of Crohn’s disease?

P: Well we don’t know the specific cause, we’re getting closer Neal and we think that you have to have some genetic susceptibility. We can’t identify precisely which gene or genes are involved, we’ve identified many different genes that may play a role. We then think that there’s some malfunction or dysfunction of the immune system. In the gut, the GI tract has a very extensive immune system and then we think that there may be some type of trigger, we don’t know what it could be, it may be a bacteria, may be a virus. Who knows? But those combination of things kind of collide to produce inflammation of the digestive tract.

N: Have you noticed some age at which people seem to be suffering from Crohn’s either in a more severe way, does it affect anybody and any age group?

P: Well it really can, so nobody is spared. So this commonly presents in childhood and youngsters probably a real spot where we see a lot of it is teenagers and young adults. So one of the problems Neal especially if it affects children before they’ve developed puberty or reached puberty is it can have profound effects on their growth and just by itself can produce growth retardation as the primary manifestation of the disease. So once again you have to be very tuned in to the possibility of Crohn’s disease being present even if typical gastrointestinal symptoms are not.

N: Now is this growth inhibiting factor found in other diseases of irritable bowel syndrome or colitis, is that something if developed in an early age can affect a child’s growth?

P: So irritable bowel syndrome is an extremely common condition and the most common condition that a gastro-neurologist sees. This is very different that’s called IBS, irritable bowel syndrome, very different from IBD, inflammatory bowel disease which Crohn’s is one type. There’s no growth retardation with irritable bowel syndrome, don’t get me wrong Neal, symptoms can be very, very severe and disabling for people with irritable bowel but it is not due to the kind of inflammation we see with Crohn’s disease.

N: Now talking about the treatment and management of Crohn’s disease, I know each patient is different, each situation is different, but let us know briefly how to treat Crohn’s disease.

P: Well you’re right in that each patient is different and what we really are after Neal is personalized medicine. We want to find the right therapy for the right patient at the right dose, at the right time and it’s critical that we do that and what we hoped to have happen in the future is to have better tools to allow us to predict which drug or drugs or combination of drugs will work for a specific patient. There’s some tests we can do now, there’s some genetic tests, there’s some serologic tests that we can sort of predict the disease’s course, in other words how serious it will be, how likely a patient might be to require surgery and we can adjust their therapy accordingly but what we need is better tools to be able to manage specific patients in a very precise personalized way.

N: Now speaking of these tools, you do have knowledge of some new therapies that are up for approval in the United States and in Europe as well. Based on your knowledge, could you talk about some of these therapies?

P: Yeah, we do Neal and there is a drug called Ustekinumab, the tradename is Stelara and it’s not a new drug. It’s been out and approved for psoriasis since 2009, so it’s a drug that the medical community is quite familiar with especially dermatologists and rheumatologists. But it’s a new drug for Crohn’s disease, we anticipate it will be released and approved by the FDA later this year sometime this fall and what makes it different Neal is that it affects one of the pathways of inflammation. So it blocks one of the things that cause, two of the things actually that causes inflammation and there are no drugs out there like it now. What we know about Crohn’s is there are many different ways that inflammation may occur. We’ve used TNF inhibitors for a number of years since 1998, very effectively in a large percentage of patients but not in all patients, so we’re very excited about having a drug that has a different mechanism of action to allow us to provide more directed therapy for our Crohn’s disease patients.

N: Now what was it based on your knowledge, you say it affects certain areas, it affects inflammation. What was it specifically about the drug other than its effect on inflammation, I guess in general that peaked interest in it as an effective treatment for Crohn’s disease when it was for psoriasis? Sort of like a Viagra being for the heart and then all of a sudden being for male enhancement. What was it about the drug that peaked the interest to start the study?

P: Well we know that there are many diseases out there that we put into a category of immune mediated diseases. Psoriasis is one, psoriatic arthritis is another, rheumatoid arthritis, inflammatory bowel disease, there seems to be some commonality with the way these diseases happen. So in knowing the mechanism of how this drug treats psoriasis and psoriatic arthritis the presumption was made that it would be beneficial for Crohn’s disease. And this is a drug that has been exhaustively studied, the most recent trial, the Phase 3 Trial had over thirteen hundred patients in it but we’ve been at this for well over a decade trying to pinpoint the right way to manage patients with this drug. So there’s a lot of excitement out there about it because it does give us, again a different target that we can try to effect in patients who have this potentially disabling disease.

N: Is there any information that talks about whether or not an immunity to this drug, for instance if the person is managing for a year, is there a point where the efficacy is going to drop off and another therapy will have to take over? Or is this something that can be used long term based on the studies?

P: Well what we’ve learned with the use of TNF inhibitors which really have been the mainstay of biologic therapies since 1998. These patients, some patients do lose response, so we can start the drug, it can be very effective, it might work for year, two years, five years, ten years and then stop working. We don’t have enough experience Neal with Stelara, we know that people who were in remission tended to stay there for a year. We know with psoriasis that the remissions tend to be very durable. So that’s what’s we’re hoping, when we think about and we talk about unmet needs in an earlier segment, we need drugs that not only work initially but has staying power and what we think may happen Neal is that the body experiences a change in the way inflammation occurs. So it might be due to one inflammatory cytokine for example, TNF-alpha for a while and then suddenly it’s something else. So that’s why we have to be prepared to change therapy in patients when they lose response to whatever we have treating their disease with.

N: You’ve been listening to Health Professional Radio, my your host Neal Howard and we’ve been in studio today talking with Dr. Jay Popp. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm and you can subscribe to this podcast on iTunes.

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