Fall Newsletter 2021 | Vitiligo Support International

I started this message to announce the good news that on September 21, 2021, the JAK inhibitor, ruxolitinib cream (Opzelura™), was approved by the FDA for the treatment of atopic dermatitis! VSI has been following the progress of and reporting on ruxolitinib cream through the various vitiligo clinical trials for several years.

You can read more about the potential positive impact this has for vitiligo in the ruxolitinib cream update further down in this newsletter.

However, almost simultaneously with the Opzelura news, we began receiving phone calls and emails from concerned members who had seen ominous-sounding media announcements regarding the safety of tofacitinib, another Jak inhibitor we’ve been reporting on since 2015, which has also produced very positive results with vitiligo.

Click here to read VSI's original newsletter article on tofacitinib.

Once I began delving deeper into the information, it quickly became clear this was not going to be an easy topic to cover. Not only was the news just breaking, meaning there were daily updates resulting in almost seemingly endless revisions, but the material is complicated and deeply scientific.

We spent a great deal of time reaching out to the medical experts in our network seeking clarification, but encountered roadblocks because so many of the specialists we collaborate with are also involved in the clinical trials and were hesitant to comment.

In the end, I believe the article below was able to successfully drill down to the core of the subject, find reputable experts to provide professional statements, and still cover the material in a patient-friendly format. I also feel that in spite of the initial cloud of uncertainty, the situation continues to provide very positive news and a bright future for vitiligo treatments!

VSI Advocating For You!

VSI Director Jackie Gardner recently participated in the American Academy of Dermatology Association’s (AADA) 2021 Legislative Conference which took place September 23-28. With 220 participants from 38 states, for the second year due to COVID-19, the conference was held virtually.

Ms. Gardner, the patient advocate in the VA delegation also consisting of 2 dermatologists and 1 dermatology resident, made virtual calls on the offices of 2 senators and 3 congressmen.

Ms. Gardner discussed the “Safe Step Act” (House Resolution (H.R.) 2163 - Senate (S.) 464, addressing the current step therapy protocols, also known as “fail first” strategies. This practice requires that patients first try (and fail) one or more prescription drugs before coverage is provided for the medication selected by the patient’s physician.

These methods not only negatively impact patients’ health and quality of life, but, as in the case of vitiligo, patients are left struggling to consistently use an ineffective medication as prescribed, for months at a time, all the while watching the vitiligo continue to consume their bodies.

Below: Gardner Meeting with
Congressman Morgan Griffith VA. 9th District

Legislative Ask:

Take action to ensure that physicians remain the clinical authority over a patient’s care and lessen the burden on patients required to go through step therapy protocols instituted by insurance companies.

Cosponsor and support passage of the Safe Step Act (H.R. 2163/S. 464), which would ensure that step therapy protocols used by health plans will preserve the physician’s right to make treatment decisions in the best interest of the patient.

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If it's important that VSI continues its efforts on your behalf to:

Advocate Nationally;

Making sure the voice of the vitiligo patient is heard and understood;

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The most current, relevant vitiligo information available,

Please consider a donation, large or small, to sustain this vital work.

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Sincerely,

Jackie Gardner
Executive Director

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What Does a Black Box Warning Mean?
How Will it Affect Future Vitiligo Treatments?

"If You Take This Popular Medication, Talk to Your Doctor Now, FDA Says."

These headlines regarding the drugs Xeljanz® and Xeljanz® XR, (the oral formulation of the JAK Inhibitor generically known as tofacitinib), have created quite a stir in the vitiligo community!

After a recent safety review, the FDA made the decision to place “black box warnings” on several JAK inhibitors, finding them to be “associated with an excess risk for serious heart-related events, cancer, blood clots and death.”

Black Box Warning

A black box warning, or “boxed warning,” is an FDA warning to alert consumers about serious or life-threatening side effects the drug may have. Found on the package insert for prescription drugs, this is the most serious warning given by the FDA.

The findings are somewhat controversial for a variety reasons, not the least of which is the fact that all of the warnings have been based solely on interim and preliminary results from a post-marketing safety clinical trial ordered by the FDA when it first approved tofacitinib for rheumatoid arthritis (RA) in 2012. This trial compared tofacitinib with TNF blockers in patients with RA.

TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Source: FDA

Although the clinical trial concluded in July 2020, the full results have not yet been published, and the topline results that have been released have been made available only through alerts and press releases from the FDA and Pfizer.

Requirements for inclusion criteria for that clinical trial included:

Participants must be 50 years of age and older
Have moderate to severe rheumatoid arthritis
Have at least one cardiovascular risk factor (e.g., current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

According to the Cleveland Heart Lab, in general “people with rheumatoid arthritis have a 50 percent higher risk of experiencing a heart attack, twice the rate of heart failure and more peripheral vascular disease than those without the condition.”

The fact that some of these JAK inhibitors seem to be associated with serious heart-related events is definitely concerning. The question is, does the increased risk apply to the general population, or primarily to individuals who are predisposed to cardiovascular events by virtue of their underlying conditions?

According to Kevin Winthrop, MD, MPH
Director of the Center for Infectious Disease Studies at Oregon Health & Science University

Other studies have yet to find higher rates of either major cardiovascular events or malignancy with tofacitinib, compared with other treatments. He went on to say, “When you look at the real-world data, we have not seen those signals. The rates for major adverse cardiovascular events (MACE) and malignancy are no different in tofacitinib than in anything else. Even looking at people with cardiovascular risk factors, we have not seen a difference in MACE between people on tofacitinib and people on TNF blockers.”

Clearly these are very serious warnings that are not to be taken lightly. However, they need to be reviewed in context, carefully weighing all the information.

The FDA issued boxed warnings for 2 other arthritis JAK inhibitors, baricitinib and upadacitinib, not because they have demonstrated the same health and safety risks as tofacitinib, but because they share the same mechanisms of action, but have not yet been subjected to the large safety trials like tofacitinib, so the potential for risks has not been adequately evaluated.

An additional two oral (systemic) JAK inhibitors, ruxolitinib (Jakafi®) and fedratinib (Inrebic®) were not included in boxed warning update requirements as they are not indicated for the treatment of arthritis and other inflammatory conditions.

Somewhat ironically, as noted above, the oral version of ruxolitinib, (Jakafi), did not incur the new boxed warning, yet, the recently-FDA approved ruxolitinib cream, Opzelura will. However, the warning on Opzelura references the risks of serious side effects with oral JAK inhibitors.

Click Here to Read Full Prescribing Information

Above language located on page 2

VSI reached out to Brett King, MD, PhD, one of the nation’s leading experts in the use of JAK inhibitors for the treatment of many dermatologic conditions, including vitiligo, for his thoughts regarding the black box warning on ruxolitinib cream.

Dr. King was kind enough to provide the following statement:

Dr. Brett King

"The warnings regarding ruxolitinib cream, recently approved for atopic dermatitis (ie. eczema) and in clinical trials for vitiligo, should be regarded as a point of discussion between physicians and their patients. They emerge from data regarding this class of medicine (JAK inhibitors) when given orally, that is when people take the medicines by mouth. Because there is some systemic absorption of ruxolitinib cream, the potential risks of this class of medicines, when given orally, should be considered in patients using ruxolitinib cream. Therefore, it is critically important to know the details of the warnings."

"To my knowledge, the safety profile of ruxolitinib cream is excellent. I commonly prescribe JAK inhibitors, and I have always spent a lot of time explaining the known risks of these medicines to patients, and the vast majority of them have felt that the potential benefits outweighed the potential risks. While there is some small risk of these medicines, the opportunity for people to experience wellness and normalcy again is enormous. Of course we want to be cautious, but in our caution we must not forget that people are suffering and that we have medicines to make it better or even go away. Equipped with actual data and knowledge about the risks of ruxolitinib cream (or any other medicine, for that matter), patients can make educated decisions that are good for them. We must not get stuck in the warnings about ruxolitinib cream but instead educate ourselves about them and celebrate the possibility of wellness that the medicine provides."

Brett King, MD, PhD
Associate Professor of Dermatology
Yale School of Medicine

VSI would also like to extend our gratitude to doctors Nanette Silverberg and Stanley Cohen
for sharing their time, comments, and professional insight on this topic.

Nanette B. Silverberg, M.D., FAAD, FAAP
Clinical Professor of Dermatology
Columbia University College of Physicians and Surgeons
Board-certified in Dermatology and Pediatric Dermatology
VSI Medical and Scientific Advisory Committee

Stanley Cohen, M.D., Clinical Professor
Department of Internal Medicine
UT SW Medical Center and
Co-Director of the Division of Rheumatology
Presbyterian Hospital, Dallas

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If a medication you’re taking carries risk that warrants a black box warning, that doesn’t
necessarily mean that you shouldn’t take it. But the risks and benefits of a medication
are something your healthcare provider should discuss with you.

---------------------------

Medical Disclaimer:
The content of this newsletter is provided for informational purposes only, and does not
constitute or intend to substitute for professional medical advice, diagnosis, or treatment.

Calling all Medicare Vitiligo Patients!

VSI regularly hears from patients from all over the United States who have been denied insurance coverage for their vitiligo treatment. VSI has been fighting this battle on a national level for several years. While we are definitely making progress, it’s been a slow road.

Part of the problem is that currently there is no accepted standard for coverage of vitiligo treatments. Each company has their own policies and guidelines, many times based on outdated and incorrect information.

What most people may not realize is just how much private insurance coverage can be affected by Medicare policies. Over 55 million Americans are now covered by Medicare or Medicare Advantage, making it the nation’s largest health insurance program Consequently, many, if not most, insurance providers establish their baseline standards and procedures to follow the Medicare model.

Medicare has agreed to meet with us – but requires that we bring Medicare letters of denial for a vitiligo treatment.

If you are reading this newsletter and you, or someone you know, was denied coverage for a vitiligo treatment by Medicare, please contact VSI immediately. You could help make a difference for future insurance coverage for ALL vitiligo patients! Click Here to Contact VSI

What's On Your Mind?

Q. Can Hand Sanitizers Cause Vitiligo?

My 5 year old daughter has vitiligo and I have some concerns regarding hand sanitizers. She is fortunate to have the opportunity to be in the classroom full time, but the increased focus on germs has also increased the use of hand sanitizers. The dispensers are placed in several areas of their classroom, as well as at all of the school entrances, on the playground, the lunchroom, and even on the buses.

I didn’t realize until I asked her teacher, but apparently (several years ago) due to the risks of alcohol poisoning to young children, many schools, including ours, switched from alcohol-based sanitizers, to those with benzalkonium chloride as the active ingredient. I was surprised at how many brand-name hand sanitizing products also use this ingredient.

I’ve really started reading the labels of the sanitizing products for our home as well. I recently purchased a gallon of hand sanitizer advertising the active ingredient as “Ethanol Alcohol 70%.” However, when I got it home and looked more closely, I was shocked to see that the inactive ingredients included hydrogen peroxide!

My questions are:

1. Are hand sanitizers using benzalkonium chloride safe for use for those with vitiligo?

2. Is hydrogen peroxide* safe for use with vitiligo, if listed only as an inactive ingredient?

VSI posed the above questions to one of the
nation’s foremost authorities on chemical-induced vitiligo:

Dr. John Harris MD, PhD
Associate Professor and Chair
Department of Dermatology
University of Massachusetts Medical School (UMMS)
Worcester, MA

Below Are His Responses:

Benzalkonium chloride is not a phenol. While it has a benzene ring, it has no hydroxyl group on it, rather a carbon chain, so I don’t anticipate problems for vitiligo.

Hydrogen peroxide as described here as an inactive ingredient should not be a problem for vitiligo.

* We know from research that hydrogen peroxide is produced by inflammatory cells, and contributes to the development of oxidative stress.

We also know that those with vitiligo not only have excessive levels of hydrogen peroxide in their skin, they have reduced levels of catalase, the enzyme that neutralizes hydrogen peroxide in the skin of those without vitiligo.

Because the melanocytes (pigment-making cells) of those with vitiligo are very sensitive to cell damage from oxidative stress in the skin, the over-abundance of hydrogen peroxide in the skin of those with vitiligo has been recognized as one of the precipitating/triggering factors in the onset and/or development of vitiligo.

Click here to read more about the dangers
of alcohol-based hand sanitizers in children

Medical News Updates

Highlights of recently-published medical
articles on vitiligo and its treatments

Incyte Ruxolitinib

Ruxolitinib Cream
Receives FDA Approval!

On September 21, 2021, the FDA approved Incyte’s ruxolitinib cream (Opzelura™) for the treatment of mild to moderate atopic dermatitis (AD). Opzelura is the first and only topical JAK inhibitor approved in the United States.

Opzelura™

Research has shown that when the JAK signaling pathway becomes over-active, it drives the inflammation associated with triggering both the onset and subsequent progression of vitiligo. The goal of the ruxolitinib cream (a topical, nonsteroidal, anti-inflammatory JAK inhibitor) is to reduce or block this process.

What Does this Mean for Vitiligo?

In our two previous newsletters, we reported on the very positive results of Incyte’s Phase 2 and Phase 3 vitiligo clinical trials for this medication.

As noted in the previous report, Incyte was planning to submit the vitiligo/ruxolitinib cream marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the second half of 2021.

How Long Will it Take for Vitiligo Approval?

It took about 9 months from the time the AD marketing applications were submitted to receive FDA approval.

The vitiligo clinical trials have continued to show “significant improvements in facial and total body repigmentation,” with no new safety-related problems.

Keeping in mind that nothing is ever carved in stone with the FDA, if Incyte remains on schedule and files the marketing application for vitiligo before the end of 2021, and if vitiligo approval follows a timeline similar to that of AD, Opzelura cream could be approved for vitiligo in 2022!

VSI will continue to provide updates on this promising information.
For additional information, see VSI's Summer Newsletter.

Research & Clinical Trials

Vitiligo Treatment Clinical Trial
Irvine, California

Phase 2 Clinical Trial Evaluating
AMG 714 Treatment for Vitiligo

Study Location:

UCI Health Beckman Laser Institute and
Medical Center, Suite 222
Irvine, California, 92697

As VSI has previously reported, many times when a person experiences a vitiligo relapse, they lose pigment in the exact same location as a previous lesion, due to the discovery of autoimmune memory T cells. This new therapy targets and blocks the memory signaling and also removes these memory T cells, which is showing long-term improvement from short-term therapy.

Participants will be randomized into one of two groups for a 24 week, double blind period.

Each group will receive 300 mg of AMG 714, or, placebo for AMG 714, subcutaneously
on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

At week 24, all participants who have not shown at least 25% improvement,
will begin NB-UVB phototherapy 3 times per week for a total of 24 weeks.

Key Inclusion Criteria:

Clinical diagnosis of active or stable non-segmental vitiligo
At least 0.25% facial depigmentation
At least 3% depigmentation on the body
Must be willing to undergo narrow band ultraviolet B (nbUVB) phototherapy
Must discontinue all vitiligo treatments from screening through the final safety follow-up visit at week 48

Key Exclusion Criteria:

More than 33% pigment loss on the face or on the total body
Previous or current diagnosis of other cancer
May never have used any depigmentation treatments

To participate, or for more information:
Contact: Laura Ortiz - Phone: 949-824-6483 - Email: [email protected]

RECELL Clinical Trial
Irvine, California

RECELL Clinical Trial
for Stable Vitiligo

Study Location:

UCI Health Beckman Laser Institute and
Medical Center, Suite 222
Irvine, California, 92697

The purpose of this study is to evaluate the application of Spray-On Skin™ Cells, prepared using the RECELL Device, for safe and effective repigmentation of stable vitiligo.

At the initial visit, a thin shave of normal skin is obtained (using lidocaine). The healthy melanocytes are extracted and mixed with a solution, which is then applied to the prepared depigmented area, and covered with a dressing.

After 1 week, participants will return for dressing removal and to begin NB-UVB light therapy.

Phototherapy will continue 3 times each week for 1 month, then 2 times each week for another 2 months, using a provided home phototherapy device.

After the dressing is removed, participants will return for a total of 5 more visits,
at or around the following schedule: Week 4; Week 12; Week 24; Week 36; and Week 52.

Key Inclusion Criteria:

Must be at least 18 years of age
Must have focal, segmental or generalized (i.e., nonsegmental) vitiligo
Vitiligo must have been stable (no change) over previous 12 months

Key Exclusion Criteria:

May not be pregnant
May not have depigmented fingertips
May not have greater than 30% total body pigmentation
May not be using anticoagulant medications (such as heparin or warfarin)

To participate, or for more information:
Contact: Laura Ortiz - Phone: 949-824-6483 - Email: [email protected]

Continued Online Depigmentation Survey

Have you Ever Considered Depigmentation Therapy?

Depigmentation Experts

VSI is assisting Simi Cadmus, MD, Pooja Reddy, MD, and Ammar Ahmed, MD, from Dell Medical School, at the University of Texas at Austin, who are seeking feedback from those with any type of vitiligo who have considered depigmentation, but have never undergone the therapy.

We need you to help physicians better understand
the first-hand insight into the patient perspective!

This group will represent a comparison group to those
who may have signed up previously who were
undergoing or had completed depigmentation therapy.

Participation involves:
Completing a brief online survey

Qualifications:

Must have considered, but not undergone depigmentation therapy
May have completed any type of vitiligo treatment except depigmentation

If you qualify; have not previously participated;
and would be willing to complete a brief survey click here.

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Amazon Shopping for VSI

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Tobi Cares Donation Program

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iGIVE SHOPPING

iGive.com offers access to free shipping deals and exclusive coupons, on top of the great deals you'll find every day through its network of 1,000+ stores, including Pottery Barn, REI, Staples, Petco, Expedia, Best Buy, QVC and many more. Best of all, up to 26% of your purchase at each store is donated to VSI at no cost to you! Let friends and family know so they can support VSI, too. Click register for iGive to get started today, and download the iGive button to automatically benefit VSI whenever you go to an included store.

GOODSEARCH SHOPPING AND DINING!

GoodSearch and Goodshop, like iGive, offers coupons, discounts, and donations to VSI through its network of over 5,000 stores. Just click the link above to get the savings started and the donations flowing!

* Vitiligo Support International Inc. (VSI) is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.

Earn Funding for VSI with eBay

Support VSI with eBay!

Do you sell items on eBay, or want to hold an online garage sale? If so, consider donating a percentage of your proceeds to VSI through eBay’s Giving Works program! It’s easy – when you list an item through a Giving Works listing, choose to send 10-100% of the final sale price to VSI. Your listing will have a special placement and designation. You’ll receive a proportional fee credit from eBay, and will also receive a tax donation receipt when the donation is deducted from your funds received. It’s a great opportunity to make some money for yourself and for VSI, so clean out those closets and garages and get selling!

To Learn More About VSI's Giving Works: Click here

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