What You Need to Know about the FDA Approval of Ritlecitinib (LITFULO) for Alopecia Areata

***RECORDING FROM LIVE PUBLIC WEBINAR HELD BY DR DONOVAN ON WED JUN 28 2023******
On Jun 23, 2023 the US Food and Drug Administration approved Ritlecitinib (Litfulo) for the treatment of severe alopecia areata. This marks the second drug approved for severe forms of alopecia areata and comes just 12 months after the first drug (baricitinib) was FDA approved.
Ritlecitinib (now to be marketed as Litfulo) is approved for individuals 12 and over with severe alopecia. Similar to baricitinib, the drug does not help everyone but does help about 25 %-30% of patients achieve really good regrowth after six months of using the drug. Similar to baricitinib, many patients do not respond completely to the medication - for reasons that are not entirely clear. The drug will be needed lifelong for most patients.
On Wednesday June 28, 2023, Dr. Donovan hosted a public webinar discussing ritlecitinib in more depth. He reviewed how well the drug works, the potential side effects, the unknown issues that still exist with the drug and review how Ritlecitinib compares to baricitinib. This is a recording of the complete webinar.
TIMESTAMPS for RECORDING:
Introduction to the Baricitinib (Olumiant) "BRAVE-AA" Clinical Trials (starts at 6:48)
The Baricitinib (Olumiant) - 104 week data (starts at 15:11)
Introduction to the Ritlecitinib (Litfulo) "Allegro" Trials (starts at 19:01)
Comparing Baricitinib (Olumiant) and Ritlecitinib (Litfulo) Data (starts at 28:03)
Prescribing JAK Inhibitors in Real Practice (starts at 45:16)
Contraindications to using a JAK Inhibitor (starts at 48:02)
Do Patients on JAK Inhibitors maintain their nice results? (starts at 57:22)
Question and Answer Period (starts at 1:05:06)
REFERENCES
King B et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 Mar 26.
King B et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529.
Kwon O et al. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 Mar 1;1-9.
King B, Ohyama M, Senna M, et al. Outcomes of Down Titration in Patients with Severe Scalp Alopecia Areata Treated with Baricitinib 4 mg: Week 104 Data from BRAVE AA-2. Paper presented at the American Academy of Dermatology 2023 Annual Meeting, March 17-21, New Orleans, LA. Accessed May 1 2023.
Senna M et al. Long-Term Efficacy of Baricitinib in Alopecia Areata: 104-Week Results from BRAVE AA-1 and BRAVE AA-2. Paper presented at the AAD 2023 Annual Meeting, March 17-21, New Orleans, LA. Accessed May 1 2023.
Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7.
Donovan J. Pulmonary Embolism in Open Label Extension Trial of Deuruxolitinib Stops 12 mg BID Arm. donovanmedical.com/hair-blog/...
#alopeciaareata #jakinhibitors #ritlecitinib #alopecia #alopeciatreatment

Пікірлер: 36

  • @mohammedasaad1950
    @mohammedasaad195011 ай бұрын

    Thank u thank u very much for the wonderful explanation ❤

  • @donovanmedical9780

    @donovanmedical9780

    11 ай бұрын

    thank you.

  • @AF-yx3hh
    @AF-yx3hh8 ай бұрын

    Thank for such an amazing and informative lecture

  • @donovanmedical9780

    @donovanmedical9780

    8 ай бұрын

    thank you!

  • @MariaPerez-iy5pg
    @MariaPerez-iy5pg7 ай бұрын

    @Dovan medican Does the drug ritlecitinib in its metabolism give rise to active or inactive metabolites?

  • @Vaibhaw_Robo
    @Vaibhaw_Robo Жыл бұрын

    Wonderful explanation,, applaud 👏👏

  • @donovanmedical9780

    @donovanmedical9780

    Жыл бұрын

    Thank you! 😃

  • @NJGirl321
    @NJGirl3218 ай бұрын

    What a thorough informative video. I appreciate you expressing that in the second study the diverse make up if race. Which is important. It's disappointing that there were only 4% black. I wonder were they men or women

  • @donovanmedical9780

    @donovanmedical9780

    7 ай бұрын

    both males and females were included in the trials.

  • @copetillirope178
    @copetillirope17811 ай бұрын

    extraordinary content as always. Doctor i have a question is the treatment for lpp and ffa of the eyebrow basically the same and is isotretinoin and dutasteride helpfull in case of lpp of the eyebrows ? thanks with all my respect

  • @donovanmedical9780

    @donovanmedical9780

    11 ай бұрын

    Thanks for the great question. Optimal treatments for eyebrow loss have not been rigorously compared between classic LPP with eyebrow loss and classic FFA with eyebrow loss. Likely they are similar. topical steroids, steroid injections, calcineurin inhibitors, topical JAK inhibitors have a role as do the systemic agents you mention. It's not clear if dutasteride truly has the same role in classic LPP with eyebrow loss but it may. Certainly isotretinoin, hydroxychloroquine, mycophenolate, oral JAK inhibitors, doxycycline, methotrexate are on the list.

  • @copetillirope178

    @copetillirope178

    11 ай бұрын

    @@donovanmedical9780 i can’t thank you enough for your answer doc I’m extremelly gratefull. i have been watching all your videos and reading all your published study and as a 29 years old male i have eyebrows loss which definitely looks like ffa or lpp ( with the pinpoint dot and facial papules and isolated tiny hair on the now » bald area » ). The thing is that i thought i had a solid treatment plans after reading your « gold standard » list as i’m on dutasteride + isotretinoin + oral minoxidil 5 mg + steroid injection every 3 months as you advised and i also bought a small red light device but the loss keep and keep progressing. I’m now leaning toward more lpp ( even tho it really looks life ffa even thoyou said it was rare in males but i do got all the ffa signs ) because if i had ffa theorically with such a treatment plan it should have at least stopped . my question is what could i possibly add to stop the brows loss ? I’m not willing to use hydroxycloroquine or use oral immunosupressant /jak inhibitor and i already tried oral antibiotics without any success and i also won’t use topical steroid ( I’m already having injections anyway ) or bimatoprost ( due to the feat of pap ) . I was thinking of adding topical minoxidil and tacrolimus but are those even usefull for lpp and would those even make a difference in stopping the loss with what I’m already taking ? Do you have any idea of what i could take who wouldn’t be an oral systemic medication ? I know prp is useless but i was thinking of maybe trying exosome or stem cell ? I’ve been following you and watching your works for years and your truly an inspiration. With all my respect and consideration for your awesome work . Sorry for the long question

  • @restacks8777
    @restacks8777 Жыл бұрын

    Very interesting, do You thing it’s going to be available in Europe soon?

  • @donovanmedical9780

    @donovanmedical9780

    Жыл бұрын

    The European Medicines Agency (EMA) is expected to decide on approval by the end of the year. Stay tuned !

  • @nurDerHSV857
    @nurDerHSV857 Жыл бұрын

    Hi can you maybe link the paper which you referred to at 57:33

  • @donovanmedical9780

    @donovanmedical9780

    Жыл бұрын

    No paper yet! This was the wonderful data presented by Dr Senna at the AAD Meeting. Stay tuned for paper!

  • @WambierMD
    @WambierMD Жыл бұрын

    Dear Dr Donovan. Kenalog 10mg is actually FDA approved as injectable for AA. "The intralesional administration of Kenalog-10 Injection is indicated for alopecia areata; " on label. However, this was certainly "grandfathered". But yes, on-label.

  • @donovanmedical9780

    @donovanmedical9780

    Жыл бұрын

    True, true, my friend! True, true. These grandfathered indications stand. What my grandfather did not realize is that we - as a society - would demand so much more of the medication approval process for people. The approval process is just so different that they cannot be compared. Unfortunately, there have been no FDA approvals for alopecia areata prior to June 13, 2022 that stood the same rigorous approval that baricitinib and subsequently ritlecitinib have - namely having sufficient power to assess some kind of primary endpoint with no less than 90 % power to detect superiority over placebo. Fortunately (or unfortunately) that bar is so different now. The wishy washy indications from the past are problematic as they do not clearly identify the precise patient to receive the indicated medication - only the disease. Given that we treat patients with diseases rather than diseases alone - the distinction is so so important. The grandfathered indications do not indicate dosing in ways that are clinically meaningful. I don’t use Kenalog-10 for alopecia areata but rather 2.5 mg per mL and 5 mg per mL. Is this an off label? Sometimes I dilute in bacteriostatic saline and once in a blue moon in lidocaine. Compounding is not regulated at all by the FDA. Kenalog-10 x 2 mL in the scalp for alopecia areata is not unreasonable (although I never use this concentration). Kenalog-10 x 2 mL in the eyebrow for alopecia areata is likely to be considered malpractice. Kelalog-10 for patchy AA is reasonable. Kenalog-10 for longstanding alopecia universalis is inappropriate. The new approval process is so different and the grandfathering of Kenalog-10 can’t truly be considered to be the same as the newer drugs that we now welcome to market. My grandfather never would have imagined that a manuscript for a new alopecia areata drug would come complete with a “Bayesian 3- parameter E-max Exposure Response Model.” What a world, my friend! What a world!

  • @nurDerHSV857

    @nurDerHSV857

    Жыл бұрын

    @@donovanmedical9780 "Kenalog-10 x 2 mL in the eyebrow for alopecia areata is likely to be considered malpractice" ... why? sorry for asking :D i am only a layman ? just interested

  • @donovanmedical9780

    @donovanmedical9780

    Жыл бұрын

    @@nurDerHSV857 one of the side effects of steroid injections is “atrophy” or dramatic cessation of collagen and other substances in the skin. Small amounts are often fine for the eyebrow in the setting of alopecia areata. Large amounts (like 2 mL in my example) are not fine and carry a very high risk of “atrophy” and temporary disfigurement (and possibly other aide effects in the skin and eye too). Opening a bottle of Kenalog10 and injecting thoughtfully at appropriate doses and amounts can lead often to good outcomes. Injecting too much of a good concentration or too much of a high concentration can lead to problems.

  • @Anniesav15
    @Anniesav1511 ай бұрын

    Will it work for scarring alopecias? Will there be new advancements in treatments for scarring alopecia sufferers?

  • @donovanmedical9780

    @donovanmedical9780

    11 ай бұрын

    There are many advances weekly in the treatment of scarring alopecia. Be sure to follow the Evidence Based Hair podcast (youtube or wherever you get your podcasts) and you'll see the tremendous research. As for JAK inhibitors in scarring alopecia, ritlecitinib is too new to have been studied but JAK inhibitors have been studied. They don't help everyone with scarring alopecia, but they do help some patients. donovanmedical.com/hair-blog/baracitinib-lpp-ffa

  • @younisbhat6345
    @younisbhat63459 ай бұрын

    Sir ,can u tell me what should i do as i am suffering from alopecia arata since past 4 years .As i am using medicine as per dermatologist i saw very much improvement and when i left medicine , same condition happens again and this happens many times that after cutting off medicine , alopecia comes back after month or 2 months! Ur suggestion

  • @donovanmedical9780

    @donovanmedical9780

    9 ай бұрын

    be sure to follow the advice of your doctors. For some people, treatment is lifelong. I do not know enough about your story to know how best to treat you. But for many people treatment is lifelong for advanced alopecia areata.

  • @SAM-ro2tw
    @SAM-ro2tw10 ай бұрын

    How can i get this medicine? I’m form India

  • @donovanmedical9780

    @donovanmedical9780

    10 ай бұрын

    Many countries have not approved ritlecitinib yet. This is approved in the US right now. As time goes by, more and more countries will review if they consider it safe and effective and decide if approval is appropriate.

  • @johnwhitt9942
    @johnwhitt99428 ай бұрын

    Would this be effective for male pattern baldness?

  • @donovanmedical9780

    @donovanmedical9780

    8 ай бұрын

    This medication would not, no.

  • @Bullet-Tooth-Tony-

    @Bullet-Tooth-Tony-

    3 ай бұрын

    @@donovanmedical9780 Why not?

  • @tomo-lr6fc
    @tomo-lr6fc4 ай бұрын

    this medication is way too expensive for people who can't afford it or poor, once again the people with the money get all the toys

  • @tishafay
    @tishafay7 ай бұрын

    It probably should work for traction Alopecia as well ( that's what I have) but after doing some reading and looking at the website, the side effects aren't worth the risk. This medicine could potentially cause illnesses and even result in death.

  • @donovanmedical9780

    @donovanmedical9780

    7 ай бұрын

    there is no good evidence that Jak3/Tec activation in lymphocytes plays a critical role in traction nor is there evidence that blocking the pathway would have much in the way of benefit. Inhibitors of this nature would be relatively contraindicated. Evidence based approaches can be reviewed with a dermatologist including cessation of mechanical forces that contribute to traction as well as treatments such as triamcinolone acetonide, topical and oral minoxidil and PRP.

  • @calijay9805
    @calijay9805Ай бұрын

    I thought finasteride already took care of this problem for most people.

  • @donovanmedical9780

    @donovanmedical9780

    Ай бұрын

    Thank you for your comment. No, finasteride does not help alopecia areata. It is of no benefit for this autoimmune-mediated disease.

  • @TheByzantios10
    @TheByzantios108 ай бұрын

    What an amazing analysis. As a parent of a teenager with about 20% AA, that we are trying to decide, -after our dermatologist's recommendation to take litfulo-, whether to go ahead with this new treatment....I couldn't ask for more.... really really thank you... greetings from Greece... 🫶

  • @donovanmedical9780

    @donovanmedical9780

    8 ай бұрын

    thank you! I'm glad this video could be of some help to you

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