Chat
Transcript: Research chat, Feb. 13, 2007

Liz Horn, Ph.D.

Members of the National Psoriasis Foundation learned about psoriasis and psoriatic arthritis treatments in this online chat with Liz Horn, Ph.D., director of research for the Psoriasis Foundation. Dr. Horn answered questions about treatments in development and shared research news from the American Academy of Dermatology meeting.

Online chat is available exclusively to Psoriasis Foundation members. To become a member, click here.

Chat transcript

Liz_H: Welcome! I am excited to be leading this research chat. I have just returned from the winter AAD where I learned about some exciting data on psoriasis. We also have some exciting updates about the BioBank.

Liz_H: Karen will be sending me your questions but I just wanted to tell you about the AAD meeting. The Phase III data for Humira in psoriasis was presented.

Liz_H: Phase III data was released for adalimumab (Humira) showing adalimumab was effective and well tolerated for patients with psoriasis. They had endpoints at weeks 16 and 52.

Karen_M: A reminder - this chat is moderated, so your questions and comments won't be seen by the whole room until I've approved them.

Liz_H: At week 16, a 75% improvement in psoriasis severity scores was achieved by 71% of participants receiving 40 mg of adalimumab every other week compared to 7% of those receiving placebo.

Liz_H: Those that achieved a 75% improvement continued with adalimumab treatment every other week until week 33, and their improvement was maintained. Adulimumab was well tolerated, as adverse events were low during the 52 week study.

Liz_H: This is very exciting as this is the latest of the 3 TNF inhibitors to release their phase III data. Enbrel and Remicade are already approved for psoriasis.

Liz_H: There is a new TNF inhibitor on the block - Certolizumab Pegol or Cimzia.

Liz_H: This TNF inhibitor is conjugated (attached) to a molecule that makes it stay around longer (decreases its half life).

Liz_H: Participants in the trial received placebo or one of two doses of Certolizumab pegol, 200 mg or 400 mg every two weeks for twelve weeks.

Karen_M: OK, folks, we're going to start answering some questions here in a moment.

Liz_H: At week 12, a 75% improvement in psoriasis severity scores was achieved by 75% (200 mg dose) and 83% (400 mg dose) of participants, respectively, compared to 7% of those on placebo.

Liz_H: The drug was well tolerated and the overall safety profile was similar to other drugs in this class.

nesielheum: So fewer injections or lower dosages of Certolizumab Pegol? can be expected?

Liz_H: Exactly - that is the idea - if you have something that stays around longer you need fewer doses (injections) to keep the same level.

Liz_H: This is Phase II data - and we need to wait for the Phase III trial results - but it is very exciting.

lehrschallbrian: Can you talk about the genetics aspect of research?

Liz_H: Moving on to genetics - genetics are an important area of psoriasis research.

Liz_H: Scientists know that there is a genetic component to psoriasis. Psoriasis is a complex genetic disease.

Liz_H: Scientists don't know how many genes or which combination of genes are involved - but they continue to work on it.

Liz_H: PSORS1 is the region on chromosome 6 that has the greatest link to psoriasis susceptibility. Scientists keep working to narrow this region.

Liz_H: A group of scientists that are funded by the Psoriasis Foundation have narrowed the region below what has previously been shown. We hope that work will be published soon.

Liz_H: A question was asked about whether the AAD has presentations on psoriatic arthritis.

Liz_H: Really, the focus of the AAD is dermatology/skin.

Liz_H: There is another group - the ACR - American College of Rheumatology - that has an annual meeting where they cover more PsA.

ouchyk: yes, they had their meeting recently...I was wondering if any of the newer medications are for PsA as well

nesielheum: Is there an expected timeline for when Humira might be approved for PS?

Liz_H: For Humira, Abbott has finished its phase III studies.

Liz_H: The FDA often requires 2 Phase IIIs. The first study released its data in October.

Liz_H: So hopefully within the next year. Abbott will likely release a press release when they file.

alli: Can you quickly explain the differences in the TNF inhibitors?

Liz_H: Currently there are 3 TNF inhibitors used for psoriasis.

Liz_H: 2 are approved - Enbrel and Remicade.

Liz_H: Humira is approved for PsA (like Enbrel and Remicade) and is in trials for Ps.

Liz_H: Enbrel and Humira are given by injection.

Liz_H: Enbrel is typically given twice a week (and there are 2 different doses for psoriasis and psa)

Liz_H: Humira is typically given every other week.

Liz_H: Remicade is an infusion given in a doctor's office on a regular schedule.

Liz_H: They all differ in how they are made up - and their scientific names indicate what kind of molecule they are.

nesielheum: We have been hearing very good things regarding CNTO 1275 can you offer any professional opinions regarding this developing drug?

Liz_H: CNTO 1275 -

Liz_H: it's a drug that's generated a lot of buzz.

Liz_H: It targets different molecules of the immune system.

Liz_H: Cytokines called IL-12 and IL-23. (IL stands for interleukin).

Liz_H: CNTO1275 targets a molecule called p40 - a component of both IL-12 and IL-23.

Liz_H: Individuals in the trial have seen results for 6 months with just one injection.

Liz_H: However, they have also dosed individuals with a weekly dose for 4 weeks in the Phase II trials.

Liz_H: The Phase II trial data was released at the Society of Investigative Dermatology in 2005.

Liz_H: It was just published in the New England Journal of Medicine this past week.

Liz_H: CNTO 1275 is also in phase III trials for psoriatic arthritis.

Karen_M: we're ready for some more questions - if you have one, please enter it and i'll pass it on to liz

Kimbercat: why the 2 different dosages with cnto1275, and what are they hoping to show?

Liz_H: Well they actually used 4 different doses in the phase II trial.

Liz_H: Phase II trials are designed to test if a drug is effective.

Liz_H: And they weren't quite sure how to dose it.

rosy3939: beside research where there any presentations on treatment options. I.E. Such as dosage, timing, etc?

Liz_H: The American Academy of Dermatology also trains and educated doctors in treating psoriasis.

Liz_H: There was a whole psoriasis symposium (3 hrs) on Sat afternoon discussing the different treatment options and how to use them.

Liz_H: I even got to speak and present the data at this meeting.

nesielheum: Is it safe to say that as new drugs are developed they are targeting much more specific molecules, as opposed to simply repressing the immune system in general?

Liz_H: Cyclosporine gave the first hint that psoriasis was a disease of the immune system in the 1970s.

Liz_H: Transplant patients who had psoriasis saw their psoriasis go away on cyclosporine.

Liz_H: Scientists are trying to find the cells of the immune system that are working overtime in psoriasis.

Liz_H: They are working on targeting their drugs.

Liz_H: This means that we should get more specific drugs with fewer side effects.

Catie_C: How long does it typically take for a drug to get from Phase III to market?

Liz_H: It typically takes 3-5 years.

Liz_H: But a lot can happen in that time.

alli: I'm interested in the reports that people who have used raptiva for psoriasis have developed signs of PA. Any study's on this?

Liz_H: There are no studies on this.

Liz_H: Raptiva did a phase IV trial on hand and foot psoriasis.

Liz_H: At week 12, approximately 46% of patients receiving 1 mg/kg of efalizumab were rated as clear, almost clear or mild compared to 18% of those receiving placebo. Efalizumab was well tolerated during the study.

Liz_H: This suggests it is an effective option for this difficult to treat patient subpopulation.

nesielheum: i mg per kg body weight?

Liz_H: Raptiva is based on weight.

Liz_H: Not all drugs are based on body weight.

nesielheum: Adverse side effects are always a concern, can you expand on how these new biologic drugs have increased, or decreased the potential for adverse side effects?

Liz_H: That is a good question.

Liz_H: Clinical trials have a very rigorous reporting mechanisms.

Liz_H: Anything that happens to you is an adverse event. There are adverse events and serious adverse events

Liz_H: AEs vs SAEs

Liz_H: Someone who falls off ladder while in a trial and breaks their arm is considered an AE.

Liz_H: Someone who gets in a car accident is an SAE.

Liz_H: I'm not trying to make light of this - but it is really important to examine the AEs and SAEs with the control group.

Liz_H: Some events are caused by the drug and others aren't.

Kimbercat: is there some point where they try to break out things like that?

Liz_H: Sometimes we need a large number to see a rare event.

Liz_H: They really break those things out in the PHase IV monitoring studies that companies are required to do.

Liz_H: Doctors are required to report SAEs to get this data.

nesielheum: I would think that it would be important to monitor AE and SAEs for the entire lifetime of a drugs usage

Liz_H: Many companies have registries to monitor the safety of their drugs. They spend millions do this.

Catie_C: Did you notice there was more interest in and focus on psoriasis this year @ AAD?

Liz_H: There were fewer posters on psoriasis this year.

Liz_H: The Psoriasis Foundation released data at the AAD which was very well received.

Liz_H: The National Psoriasis Foundation examined 3 years of patient survey data and reported that nearly 40% of patients were not currently receiving any treatment.

Liz_H: Of those with severe psoriasis in treatment, 57% were on topical treatment alone. The American Academy of Dermatology recommends that patients with moderate-to-severe psoriasis are treated with systemic and/or phototherapy.

Liz_H: Despite the increased number of psoriasis treatment options, there were no significant change in treatment patterns across three survey years.

Catie_C: That's shocking! How did you collect the data?

Liz_H: We collected our data from our community.

Liz_H: We have a survey panel program where we survey our constituency twice each year.

Liz_H: Surveys occur by phone or email.

Liz_H: Some of you may have participated in one of these surveys.

alli: Is that due to the cost of the new drugs or the side effects of the new drugs or that people just weren't bothered by their psoriasis enough?

nesielheum: any conclusions on why folks are not being treated? $$$$

Liz_H: There are probably a lot of reasons.

Liz_H: Some people might not perceive psoriasis is serious enough for something more than topicals.

Liz_H: Some doctors might not prescribe anything other than a topical.

Kimbercat: I know that some in my support group just got tired of drugs working for a while, and then stopping.....and they claim they would end up in worse shape after stopping the treatment

Liz_H: Money might be a factor in some cases. We know income predicts whether someone is in treatment.

Liz_H: I think people are frustrated, too.

alli: Kim, that can be very true with raptiva

Liz_H: But we have more treatments than we ever have - and some really exciting ones coming down the pipeline like CNTO1275 and others.

SandraJean: I've known people here who will only use vaseline or not

Catie_C: Does vaseline count as a treatment?

SandraJean: I wondered too

Liz_H: In our study - a treatment was a prescription.

Liz_H: Either a topical, phototherapy, systemic or a biologic.

Kimbercat: I was initially very excited about Raptiva, and was even set as an alternate to go before the FDA for approval, but I've since heard of too many problems after treatment to be comfortable with it.

Liz_H: Raptiva actually has 3 year safety and efficacy data.

Liz_H: Showing that it worked for people for 3 years and was well tolerated.

Liz_H: This was presented last year at the AAD.

Spotsworth: I know in my case money for treatment is an issue but also the "passive" attitude of doctors who don't want to do anything.

Liz_H: We know that there are really great doctors out there who are compassionate and help treat psoriasis.

Liz_H: We just need to figure out how to get people to the right doctor to help them.

Spotsworth: Yes, that is true that GREAT doctors are out there. But, many of us are in a situation where our HMO doesn't provide us these choices.

rosy3939: what about rebound data with Raptiva. ANd are there any new treatment option to help mitigate the possibility of it occuring?

Kimbercat: do you know if there's any explanation of the adverse events some patients seem to experience with Raptiva, or is that not being seen?

Liz_H: So - Raptiva works by keeping T cells in the blood.

Liz_H: Our T cells circulate through our body and move from the blood to the tissue.

Liz_H: It's called extravasation - I like that word.

alli: there's a sexy word for you on valentines day!!! LOL

Liz_H: In people with psoriasis, there are too many t cells in skin.

Liz_H: Raptiva blocks them from entering the skin and keeps the t cells in the blood.

Liz_H: In some people, when Raptiva isn't working, and they stop taking it, they get rebound.

Liz_H: Rebound means that you are much worse off than when you started -

Liz_H: There's a technical definition - but that's the gist of it.

Catie_C: Can doctors predict rebound?

Liz_H: They can't predict it. So what doctors recommend, is that if Raptiva isn't working and you go off of it, start taking something else.

Liz_H: This way it keeps the psoriasis under control.

Liz_H: What we really lack is the knowledge of what treatments will work for which individuals.

Liz_H: This is pharmacogenomics.

Liz_H: It is the study of how our genes predict how we respond to drugs - from both and efficacy and safety standpoint.

Catie_C: Will genetic research help figure this puzzle out?

Liz_H: We hope genetic research will help figure this out -and we're doing something about it.

Liz_H: Have you heard of the National Psoriasis Victor Henschel BioBank?

Liz_H: A resource for scientists to study the genetics of psoriasis.

Liz_H: We are collecting samples from our community for this important project.

Karen_M: i want to make sure we get to everyone's questions - liz, here's one ouchyk sent through earlier: Any new treatments for pustular psoriasis?

Liz_H: Sorry ouchyk

Liz_H: Raptiva worked well for pustular psoriasis of the hands. But there were no other studies on pustular psoriasis.

Karen_M: here's another one from earlier: Was there anything new regarding the safety profile of the biologics; any trends being seen with regard to long term usage?

Liz_H: There was no new long term data.

Liz_H: But, Raptiva released 3 year data last year.

Liz_H: Enbrel released 6 year data in rheumatoid arthritis last year.

Liz_H: It's not quite the same - but it is long term data on a drug.

Spotsworth: What about Remicade?

Alesis: Perhaps a good idea is to try and market the biobank study to dermatologists? My derm never mentioned it to me

Liz_H: We just announced the BioBank to the medical professional community at AAD.

Liz_H: And we're doing a big mailing on it to let them know about it.

Alesis: great!

Liz_H: There is data on remicade but not as long as Raptiva and Enbrel.

Kimbercat: do most drug companies continue to compile long term data?

Liz_H: Did I answer your remicade question?

Liz_H: Most companies continue to compile long term data.

Liz_H: Remicade has a huge registry in Crohn's disease called the TREAT registry. They are likely doing something similar in psoriasis.

Catie_C: Three years of data is considered long term? Or is it five?

Liz_H: Three years of continuous data is the longest we have in psoriasis.

Liz_H: The primary endpoint of most trials is 12 weeks.

Karen_M: here's another question - probably the last one we'll have time for: Is there any research being funded for alternative and or herbal treatments?

Liz_H: There is not a lot of alternative research.

Liz_H: We funded a study on dermal advantage and are awaiting the results.

Liz_H: There is one more important thing I want to share from the AAD.

Liz_H: The first data on children treated with a biologic was released.

Liz_H: Data was presented on the first Phase III trial of etanercept (Enbrel) in children age four to seventeen years old.

Spotsworth: What does AAD stand for?

Liz_H: American Academy of Dermatology.

Liz_H: Scientists love their acronyms - sorry.

Liz_H: Did I get everyone's questions?

Photochick66: do u know if there are any other biologics considering letting teens and children use them?

Liz_H: Sometimes they are used off label.

Liz_H: Enbrel is the only one to have a clinical trial in children.

Liz_H: Enbrel is approved for rheumatoid arthritis in children as young as 4.

Photochick66: oh okay cool thanks :)

ouchyk: will a transcript of this chat be available for viewing?

Karen_M: Great chat, everyone! Yes, we'll be posting a transcript

Alesis: Great!

Kimbercat: thanks for sharing your information and knowledge with us

Spotsworth: Thanks for the information!

alli: Thank-you for doing this chat!!!

dmedonis: Thanks Liz & Karen

Liz_H: Anytime! Thanks for letting me babble about science.

SandraJean: Thanks

Alesis: Yes, thank you

nesielheum: Thank You Karen, Liz and the NPF

Liz_H: I love science and sharing my information with you.

Christy_L: If you have topic ideas for other chats, please send them to getinfo@psoriasis.org

Catie_C: Thanks, I learned a lot!

Photochick66: Thanks :)

Liz_H: We have just updated our research pipeline and it will be in the next issue of the Advance.

ouchyk: oh good can that be found on line as well?

Alesis: Great.

Karen_M: thanks again, all

Karen_M: yes, the pipeline is online - and it will be updated in march, too

ouchyk: thanks liz & co.

Christy_L: We are working on a regular chat schedule. The next one is in April.

Karen_M: good night, everyone!