FDA Approves New Drug, Olumiant, for Alopecia Areata

I recently came across an article that mentioned a new pill for alopecia. 

"FDA greenlights 1st treatment for sudden hair loss caused by autoimmune disease"

"The drug — part of a class of medicines known as JAK inhibitors — is the first approved treatment for alopecia areata.
Two Phase 3 Trials of Baricitinib for Alopecia Areata.

People suffering from a rare autoimmune disorder that causes their hair to suddenly fall out, often in clumps, now have a treatment option for the first time.

On Monday, the Food and Drug Administration approved baricitinib, a once-a-day pill developed by the drugmaker Eli Lilly to treat alopecia areata, an autoimmune disease that triggers sudden hair loss. The drug was originally approved by the FDA in 2018 to treat rheumatoid arthritis.

The drug — part of a class of medicines known as JAK inhibitors — is the first approved treatment in the United States for the condition, which affects more than 300,000 people in the country each year, according to the FDA.

People with the autoimmune disease can experience hair loss anywhere on their body, including around the scalp, eyebrows and eyelashes, according to the American Academy of Dermatology. The condition can develop at any age, though most people develop it during childhood or during their teenage years, according to the organization.

Alopecia recently gained national attention after actor Will Smith infamously slapped Chris Rock at the Oscars after the comedian made a joke about actor Jada Pinkett Smith, Smith's wife, who suffers from a different form of the condition than the one treated by Eli Lilly's drug.

Baricitinib helps regrow hair by preventing the body’s immune system from attacking hair follicles.

Two phase 3 clinical trials, involving a total of 1,200 patients with severe alopecia areata, found that about 40 percent of people who received a daily 4-milligram dose of the drug regrew all or almost all of their hair after 36 weeks.

That compares to the about 20 percent of people who received a lower 2-milligram dose of the drug and less than 6 percent of the people in the placebo group.

People in the trials had lost at least 50 percent of hair from their scalp before taking the drug.

The drug is a breakthrough for people with the autoimmune disorder, said Dr. Brett King, a Yale dermatologist who was the principal investigator for the two trials. Many use wigs or scarves to hide their condition.

My question is, would your try it? Or are some things better left alone?

SOURCE: NBC News:  FDA greenlights 1st treatment for sudden hair loss caused by autoim...

FDA's News Release: FDA Approves First Systemic Treatment for Alopecia Areata

 

Views: 1862

Comment by Horacio on June 16, 2022 at 7:01pm

Good news. But, this drug has to be taken forever? What happens after discontinuing the drug?

Comment by Patricia Kay Penton on June 16, 2022 at 7:11pm

This drug is a potent immune suppressant, which means it can put you at risk for all sorts of infections, including tuberculosis. I would not take it. That being said, I still have most of my hair and I respond well to cortisone injections. If I was completely bald, I might reconsider. But anyone who is thinking of taking this should thoroughly research the potential side effects. 

Comment by dreamscometrue on June 16, 2022 at 7:17pm

To me, its just another RA drug used to treat AA off label.  Nothing to see here. Xeljanz is also a JAK inhibitor. They're not coming up with anything new, just another drug in the same class as their competitor, same risk involved.  No one seems to want to find the root cause of AA.  The circular patches it starts out with in my opinion is the clue and key to solving this disorder.

Comment by ButterflyV on June 16, 2022 at 8:13pm

Too many side effects!!

Comment by Adnan Shah on June 17, 2022 at 1:59am

Guys and Girls don't try any immuno suppressants, It will effect us adversely in one way or other and above all it is temporary treatment.
Make routine of exercise (whichever you like, i love cycling) and keep yourself healthy. I have AU since 1998 (age 17 years). Accept whatever was/is in your fate and be happy with it. 
My only hope is Stem Cell treatment, if it can reboot my Immune system and fix miscalculations by immune system to allow hair growth. 

Comment by Michael Leigh on June 17, 2022 at 10:26am

Hi to our extended Joli family. This is Michael from Joli Caméléon. I felt compelled to share my thoughts on this latest "magic cure".  The results of the Olumiant (Baricitinib) by Ely Lilly trial in restoring hair were the most effective of any so far. BUT . . . please do your own research first and read the fine print (and Black Box warning) from Eli Lilly and ask your Doctor what this might mean to you. The full clinical trial results document is subject to the the United States Freedom of Information Act, Exemption 4.

In reading it, I was surprised by the number of reported adverse thrombotic events in the original  RA trial. But the FDA apparently thinks the benefits outweigh the risks and certified it.  As many of the prior posts discuss, the drug is a JAK inhibitor and works by suppressing certain aspects of the immune system response.  I am NOT a medical practitioner.  For most of my life I have researched and  - when personally necessary - pursued homeopathic medicine as a pathway to treating the underlying causes rather than symptoms. I grew up in England and suffered as a teenager from another auto-immune condition, Psoriasis. It was really bad, with crusty legions all over my body. After 3 years of being prodded and poked and injected and "anti-sensitized", at the same time as using Dermovate (R), a strong steroid cream, and numerous coal tar treatments, I was ready to give up.  That was until I was introduced to the homeopathic practice of the late (great) Dr. Margery Grace Blackie.  She was a British Doctor of Medicine who was appointed as the first woman royal physician to Queen Elizabeth II.  Her practice also included Dr. Anita Davies, a renowned homeopath. If you are not familiar with Homeopathy, know that it almost universally has a very bad rap in the traditional medical and scientific field where it is scoffed at as having no scientific provability, in spite of tens of thousands of documented case studies that demonstrate its efficacy. Homeopathy's biggest strength is also its biggest weakness: there is little money to be made in pursuing homeopathic remedies so big-pharma doesn't pursue it and seemingly does everything it can not to legitimize it. In the US, the FDA, as well as other medical bodies around the world continually work on trying to control and eliminate homeopathy and/or the advertising of homeopathic products, amid significant government lobbying by big-pharma supported and compensated lobbyists.  I get it, I really do.  It is really difficult to find a good homeopathic doctor (because there is little money in it and everyone has to make a living).  

Nevertheless, homeopathy has worked for me for over 50 years.  In the seventies, while still suffering from chronic psoriais, I was fortunate enough to be introduced to the late, great Dr. Davies (passed away in 2018).  She treated many notable people including The Queen, The Queen Mother and Princess Alice, Duchess of Gloucester.  And she treated me.  My psoriasis has been in remission since 1974 after she and Dr. Max Deacon treated me over a period of 18 months.  It is said that Queen Elizabeth, at 96 years old, still travels with her homeopathic medicine kit.  She is my role model for the efficacy of homeopathy.  The point is that there are alternatives that are not designed to suppress the immune system.  If you want to know more about homeopathy, check out my own site, MyHomeopath.com. I created it out of frustration with the one-sided data out in the netisphere. Nothing is for sale on the site, it is information only.  But if it intrigues you, there are plenty of sites that do.  Because there are also so many charlatans out there selling homeopathic remedies, I suggest you look at Boiron (USA and Franc), Hyland's (USA), Nelson's and Ainsworth (UK) as sources of legitimate homeopathic remedies and for much information. I am sure there are others so apologies if I left them out.  For instance, I use homeopathic eye drops from Simulsan of Switzerland, who also make ear drops. I take homeopathic cell salts from Hyland's for my immune system support (there are 12 primary cell salts in the body).    

You may or may not share my personal belief that many auto-immune conditions we are subject to have common underlying causes.  For instance, according to NAAF, approx. 60% of Alopecians also suffer from a co-condition. My new personal challenge is yet another auto-immune condition - (sudden onset) Vitiligo.  Out of nowhere.  I'll let you know how that goes in due course.Anyway, stay healthy out there. With or without hair, our mantra, whatever the world throws at you,  #AdaptBeautifully.  Best,  Michael.       

     

Comment by Michael Leigh on June 17, 2022 at 10:34am

PS:  personal disclosure, I have androgenetic alopecia, not areata.  But several of our own reps and ambassador teams do. I have met or spoken with thousands of alopecians over the past 16 years and I am always looking for better ways to help.  Please let me know if I can.  Best,  Michael.  

Comment by LeslieAnn Butler on June 17, 2022 at 3:08pm

I am wondering if this would work for someone who has had alopecia for most of their life. I've had universalis since 1984.

Comment by dreamscometrue on June 17, 2022 at 3:16pm

Same for me @LeslieAnn Butler I've had it since 1989, AU.  But I dont think it will work nor do I think its a permanent cure.  Im sure anyone who had success with this has to take these pills for the rest of their life.  Its the same thing as Xeljanz but with a twist Im sure.  

Comment by TurboK on June 18, 2022 at 7:15pm

I would try it, but I want a permanent cure, Besides, my primary care doctor is already pissed off that I am seeing a specialist and am currently taking LDN (Low Dose Naltrexone). She is one of those that believes that if God gives you an autoimmune disease, you should be rejoicing in it.
I have no idea how others are able to "just live with it." I used to suffer from AA, but when my body built up a tolerance to Cortisone, I went full AU in a matter of a few weeks, which was almost 17 years ago, and I still can't "just live with it."

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