Long term efficacy of TREMFYA [transcript] [audio]

Guest: Dr. Bhaskar Srivastava

Presenter: Neal Howard

Guest Bio: Dr. Srivastava is the Director of Medical Affairs in Dermatology at Janssen Pharmaceuticals. He was the US medical lead for Janssen’s recent launch of TREMFYA® (guselkumab). Prior to his role at Janssen Pharmaceuticals, Dr. Srivastava was the Dermatology Director of Clinical Innovation at Reliant Medical Group,  and an Assistant Clinical Professor of Dermatology at Yale University School of Medicine. Dr. Srivastava received his MD and PhD in Immunology from University of Pennsylvania of School of Medicine.

Segment Overview: Dr. Bhaskar Srivastava, Director of Medical Affairs in Dermatology at Janssen Pharmaceuticals discusses abstracts being presented at the American Acadamy of Dermatology (AAD) Feb 2018 on the long term efficacy of TREMFYA that resulted in clear or almost clear skin (at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90)) through 72 weeks. These results were not achieved with any other competitor treatments.    Also, a presentation that showed efficacy of TREMFYA demonstrated across all predefined weight quartiles and high efficacy responses were observed in psoriasis patients without regard to weight. This is especially important since obesity is one of the main comorbidities of psoriasis. Read more.


Neal Howard: Glad that you could join us here today. Our guest today is Dr. Bhaskar Srivastava and he’s joining us today as Director of Medical Affair and Dermatology at Janssen Pharmaceuticals. He’s going to discuss some abstracts that are being presented at the American Academy of Dermatology. Welcome doctor. How are you today?

Bhaskar Srivastava: Thank you. I’m great. How are you?

N: Great. A bit of background about yourself for our listeners and then we’ll jump right into this brand new development called “TREMFYA”.

B: I can give you some background about myself. So I’m a dermatologist and immunologist by training. I did my MD and PhD at University of Pennsylvania and my clinical training at Yale university. I finished up there in 2011 and stayed on faculty for a few years. I was in practice for few years after that and then joined Janssen about two years ago, around the time that we were gearing up to launch TREMFYA and it’s been an exciting ride.

N: Now, talk about this long-term drug, why it is so much better than what’s already out there?

B: The data speak to various strengths of TREMFYA. The first point that comes out is that you see superiority to HUMIRA at all tested secondary endpoints. And so I think this gives very valuable information to healthcare providers and patients regarding the superiority of Trial 2 HUMIRA which would be a very commonly used and well-known drug. So I think that, that is .1 in comparison to what else is out there.

N: How many people are we talking about that were involved in the trials?

B: The total number of TREMFYA patients in VOYAGE 1, if we’re talking about the trials where we compared to HUMIRA, the total number of patients and I’m sort of going off the top of my head here, to give you the exact number but it was around 330 in VOYAGE 1 and almost 500 in VOYAGE 2. So let’s say we’re talking about 800+ patients on TREMFYA and then I think it was around 330 patients in HUMIRA for VOYAGE 1 and, absolutely which 2 numbers exactly. So compairing over 800 TREMFYA patients to 700 HUMIRA patients.

N: Is there any a significant change into how TREMFYA is administered as opposed to HUMIRA or any other type drug for plaque psoriasis?

B: There are various drugs both oral and injectable that are FDA approved for even to moderate plaque psoriasis and the range is from oral to intravenous to subcutaneous administration. TREMFYA is administered subcutaneously at weeks. It’s 100 milligrams, one injection a week, 0 for in every 8 weeks thereafter.

N: It’s basically a relief of symptoms that will occur but not as frequently based on being injected every 8 weeks after we stood 4 and 8.

B: Yes, so the injections are weeks 0, 4 and then every 8 weeks thereafter, so 12, 20, 28. I think in terms of relief from symptoms, patients have different degrees. The primary endpoint was PASI 90 or as co-primary endpoints, PASI 90 or IgA 01. So PASI 90 is a 90 percent improvement in your psoriasis and IgA 01 is clear or almost clear of psoriasis. And so 7 out of 10 to 8 out of 10 patients achieved that 700 PASI 90, 8 out of 10 or more actually for IgA 01, achieved those endpoints in the trials. So those patients would expect that those high degrees of clearance and we also tracked the degree of improvement in patient reported outcomes, right?, which included signs and symptoms of psoriasis and pinned those excellent responses in those domains. Among those patients, there were patients whose skin was completely clear of psoriasis and patients who achieved, patient reported outcome measures that were also showing no impact on the quality of life. Not necessarily all of those data are not necessarily in our label but they are available in different abstracts and scientific conferences. So to answer your question there, some patients can expect complete resolution of their psoriasis and their symptoms. And if our primary endpoint, many patients can expect 90% or clear resolution of their psoriasis.

N: Are there any limitations as to the availability of TREMFYA?

B: So I can only really speak to the United States and Janssen is committed to ensuring excellent matters for TREMFYA. There are programs in place to help ensure that to patients.

N: Now where can we go online and learn some more about TREMFYA and about Janssen Pharmaceuticals?

B: You can go to tremfya.com.

N: Alright. Well, thank you so much. It’s been a pleasure. I hope you come back and talk with us in the future, okay?

B: Absolutely, thank you so much.

N: You’ve been listening to Health Professional Radio. I’m your host Neal Howard. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm. Subscribe to the podcast on iTunes and be sure to check out our affiliates page at hpr.fm.


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