Ilumya is now available!

Ilumya(TM) (tildrakizumab-asmn) is a new medication recently approved by the F.D.A. for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

We’ve partnered with patients for nearly 6 years on studies that have helped provide the data to show the outstanding results for patients on this treatment. We are happy to help bring another option to people who live with psoriasis.


New treatment approved for excessive sweating!

dermira-FDAWe are excited to announce that one of the clinical studies that we and our patients participated in met its ultimate goal: approval by the Federal Drug Administration (FDA). Qbrexza cloths will be available as a prescription beginning in October 2018.

Qbrexza cloths are the first new treatment for hyperhidrosis (excessive sweating) since 2011 and are approved for use in adults and children ages 9 and above. 

To learn more, visit https://sweathelp.org/sweatsolutions-newsletter/news-blog/413-finally-new-hyperhidrosis-treatment-fda-approved.html


Heart Attacks and Psoriasis

If you have psoriasis, it places you at a higher risk for having a heart attack when compared to someone who doesn’t have psoriasis. The old saying from a 1970’s TV commercial, “the heartbreak of psoriasis,” is true! If you have a little bit of psoriasis, then the risk is a little bit. If you have a medium amount of psoriasis, then the risk is medium, and if you have a lot of psoriasis, your risk for a heart attack is high. Why is this the case? The amount of inflamed skin due to psoriasis that we can see with our eyes is directly correlated with the amount of inflamed tissue that occurs on the inside of the body. More specifically, inflammation from the skin spills into the bloodstream and causes the inner linings of arteries to become inflamed. This, in turn, makes the arteries more likely to become blocked, which can then lead to things like heart attacks and strokes. Emerging new evidence suggests that treatments for psoriasis, like the biologics Stelara and Cosentyx, improve the skin and are then likely to decrease the risk of heart attacks. This makes psoriasis much more than a cosmetic skin disease, and more of a general health issue, for those who suffer from it. Get your psoriasis cleared up and improve your overall health.Publications


Dupixent

In a December 2016 issue of New England Journal of Medicine, and a May 2017 issue of Lancet, two of the world’s most prominent medical journals, OMRC’s Dr. Andrew Blauvelt and colleagues reported the results of phase 3 studies using dupilumab (also known as Dupixent) for the treatment of moderate-to-severe atopic dermatitis (also known as eczema).  Dupilumab was shown to be safe and highly effective for this disabling disease.  Most patients had significant improvement in their itch and chronic skin disease.  Eye dryness and redness was the most common side effect.  Importantly, dupilumab was not associated with an increased risk of infections or cancers and did not cause any laboratory abnormalities.  These studies led to the FDA approval of dupilumab/Dupixent in March of 2017.  Dr. Blauvelt, a leading authority on this new drug, was a top enroller in these studies and has served as a key scientific advisor for Regeneron, the makers of dupilumab and the pharmaceutical company that sponsored these clinical studies.  New dupilumab studies are now underway in children with moderate-to-severe atopic dermatitis. 

Part One (.PDF)
Part Two (.PDF)


Biosimilars

Biosimilars are biologic medications that are near identical, or similar, copies of original FDA-approved biologic medications. Some people view them as “generic biologics,” although technically they are not generic drugs, since generics are 100% identical to original medications. In this article published in the magazine Dermatology World, the current state of biosimilars is discussed, especially as it relates to biosimilars of Enbrel, Humira, and Remicade, well-known and popular originator biologics used to treat psoriasis. Dr. Andrew Blauvelt of OMRC has been involved in the testing of biosimilars for psoriasis, has been the leader of the Biosimilars Working Group of the International Psoriasis Council, has advised pharmaceutical companies on the development of biosimilars, and has spoken widely to general dermatology audiences on this area. He is frequently quoted throughout the attached biosimilar update, an article that would serve as a good introduction for those interested in learning more about this hot topic in dermatology.

Read More (.PDF)


Immunodermatology: Part 2: Practical Immunology

Andrew Blauvelt, MD, MBA

Practical immunology is important for dermatologists to understand as it relates to a wide variety of pipeline drugs currently under investigation. In Dr Blauvelt’s view, there are three major cell types involved in psoriasis pathogenesis: 1) dendritic cells (upstream/initiating immune responses); 2) T cells (making pro-inflammatory cytokines); and 3) keratinocytes. Targeting IL-23, which is made by dendritic cells, leads to reductions in Th17 cells, since IL-23 is the major survival and growth factor for this type of T cell. Thus, ustekinumab is an indirect T-cell targeting agent. The main cytokine that is being made by the Th17 cells is IL-17A, which leads to activation and growth of keratinocytes. IL-17A is now considered the main effector cytokine of psoriasis. So, by targeting IL-17, downstream function of keratinocytes can be normalized.

A recent study looked at patients on either etanercept or ixekizumab (an anti IL-17A antibody currently under investigation for the treatment of psoriasis). Within two weeks of initiation of therapy, ixekizumab led to the down-modulation of psoriasis-related gene expression to a much greater extent when compared to etanercept. Of the 959 genes up-regulated with psoriasis, 559 were turned off within two weeks of ixekizumab therapy versus 84 with etanercept therapy. This proof-of-concept translational study supports the idea that IL-17A is a key cytokine involved in the pathogenesis of psoriasis.

Pipeline products that specifically block IL-23

These products are unlike ustekinumab in that they do not block IL-12.

MK-3222, an anti-p19 monoclonal antibody (mAb), from Merck
Phase 3 studies underway
CNTO1959, an anti-p19 mAb, from Janssen
Phase 2 studies completed
AMG139, an anti-p19 mAb, from Amgen
Phase 1 studies completed
Pipeline products that block IL-17A function

Secukinumab, a fully human anti-IL-17A mAb, from Novartis
In Phase 3 studies, phase 2 studies published in 2012 (Br J Dermatol)
Ixekizumab, a humanized anti-IL-17A mAb, from Lilly
In Phase 3 studies, phase 2 studies published in 2012 (N Engl J Med)
Brodalumab, a fully human anti-IL-17RA receptor mAb, from Amgen
In Phase 3, phase 2 studies published in 2012 (N Engl J Med)
According to Dr. Blauvelt, all three of the IL-17 blockers look incredibly good from published results and the safety signals, thus far, also look good. If Phase 3 studies confirm these initial results, clinicians will soon have a variety of new promising agents to treat psoriasis patients.

Acquired T-cell Immunity

Regarding the normal function of Th17 cells, individuals who have impaired Th17 responses develop chronic mucocutaneous infections, especially with Candida albicans and Staphylococcus aureus (e.g., Job’s syndrome); these patients also do not develop psoriasis. Normal Th17 responses lead to healing of acute infections with these organisms and no psoriasis (e.g., healthy individuals). Exaggerated Th17 responses lead to healing of acute infections, but eventual development of psoriasis. Of importance, the IL-23/Th17 pathway seems to be less important to systemic immunity when compared to skin and mucosal immunity.

Interestingly, there is also emerging literature regarding the role of IL-17A in the pathogenesis of atherosclerosis. This may mean that targeting of IL-17A may not only treat psoriasis, but also improve atherosclerosis. This, in turn, may decrease the risk of cardiovascular disease associated with psoriasis.

Looking into the Future

As dermatologists, it is important to consider whether drugs that inhibit IL-23 or IL-17 cause or worsen skin or mucosal infections, such as those caused by S. aureus and Candida. Based upon the normal function of this immune pathway, it is unlikely that these drugs will cause or worsen systemic infections. Lastly, it remains to be determined whether they will impact systemic anti-inflammatory activity, including atherosclerosis. Obviously, this latter point will be very important when choosing the proper therapy for patients with moderate-to-severe psoriasis.