Dermatologia Newsy Obok slidera

FDA zatwierdza dwa leki w leczeniu atopowego zapalenia skóry

Ten tekst przeczytasz w 3 min.

Amerykańska Agencja ds. Żywności i Leków (FDA) zatwierdziła dwa doustne leki w leczeniu atopowego zapalenia skóry: Rinvoq (upadacytynib; AbbVie) oraz Cibinqo (abrocitinib; Pfizer). Obydwa preparaty są inhibitorami kinaz janusowych JAK-1 i mogą być stosowane w leczeniu umiarkowanego do ciężkiego przebiegu atopowego zapalenia skóry (AZS).

Rinvoq i Cibinqo są pierwszymi doustnymi  inhibitorami kinaz janusowych (JAK) dostępnymi w Stanach Zjednoczonych do leczenia AZS. Zdaniem prof. Emmy Guttman-Yassky, z w Icahn School Medicine w Mount Sinai w Nowym Jorku, to wielka wiadomość, ponieważ od kilku lat w USA nie było żadnej terapii ogólnoustrojowej w leczeniu AZS, która byłaby bezpieczniejsza niż klasyczne immunosupresanty, takie jak cyklosporyna i metotreksat.

Rinvoq może być stosowany u dorosłych i dzieci od 12. roku życia

Terapia upadacytynibem skierowana jest do pacjentów w wieku od 12 lat z umiarkowanym i ciężkim przebiegiem AZS, którzy są oporni na inne metody leczenia. Preparat został zatwierdzony w dwóch mocach dawek – 15 mg i 30 mg.

Badanie dotyczące bezpieczeństwa i skuteczności Rinvoqu zostały przeprowadzone w trzech etapach z udziałem ponad 2,5 tys. pacjentów w wieku od 12 lat i starszych z umiarkowanym lub ciężkim przebiegiem atopowego zapalenia skóry. Około 52 proc. uczestników było wcześniej poddanych leczeniu układowemu. Pacjenci otrzymywali raz dziennie doustną tabletkę Rinvoqu w dawce 15 mg lub 30 mg. Po 16. tygodniu badania eksperci zauważyli odpowiedź kliniczną na leczenie, m.in. ustępowanie zmian skórnych i świądu. We wszystkich trzech etapach badania zaobserwowano znaczną poprawę w zakresie świądu już po pierwszym tygodniu leczenia. Badanie wykazało również, że lek jest na ogół bezpieczny. Niepożądane objawy najczęściej dotyczyły wyprysku opryszczkowego lub wykwitu ospowego Kaposiego. Rinvoq może również powodować inne skutki uboczne, np.:

  • osłabienie odporności organizmu i jego zdolności do zwalczania infekcji;
  • zwiększone ryzyko zgonu u osób w wieku 50 lat i starszych z co najmniej jednym czynnikiem wystąpienia chorób sercowo-naczyniowych;
  • zwiększenie ryzyka wystąpienia niektórych nowotworów np. chłoniaka, skóry, płuc (zwłaszcza u osób palących);
  • zwiększenie ryzyka poważnych zdarzeń sercowo-naczyniowych, takich jak zawał serca, zgon, szczególnie u osób w wieku 50 lat i starszych z co najmniej jednym czynnikiem ryzyka wystąpienia chorób serca, a także obecnych i byłych palaczy;
  • zakrzepy krwi w żyłach kończyn dolnych, płucach lub tętnicach, zwłaszcza u osób powyżej 50. roku życia.

Leku Rinvoq nie należy przyjmować w przypadku uczulenia na upadacytynib lub któregokolwiek ze składników leku, a  także w przypadku czynnej infekcji.

Cibinqo znacznie łagodzi i ogranicza zmiany skórne oraz świąd

Cibinqo przeznaczony jest do leczenia osób dorosłych z opornym na leczenie, umiarkowanym do ciężkiego atopowego zapalenia skóry. Lek został zatwierdzony w dwóch dawkach – 100 mg i 200 mg.

W trzyetapowym badaniu klinicznym udział wzięło 1,6 tys. pacjentów. We wszystkich analizach Cibinqo wykazał spójny profil bezpieczeństwa oraz znaczną skuteczność w łagodzeniu i ograniczaniu zmian skórnych oraz świądu. Już po dwóch tygodniach obserwowano zmniejszenia nasilenia swędzenia.  Najczęstsze niepożądane działania leku dotyczyły zapalenia nosogardzieli, nudności, bólu głowy. Producenci podkreślają również możliwość wystąpienia niektórych skutków ubocznych, m.in.:

  • zwiększonego ryzyka wystąpienia poważnych infekcji (opryszczka, półpasiec, zapalenie płuc);
  • zwiększonego ryzyka śmiertelności u osób powyżej 50. roku życia z co najmniej jednym czynnikiem ryzyka chorób sercowo-naczyniowych;
  • zwiększonego ryzyka zachorowania na nowotwór złośliwy chłoniaka, skóry, raka płuc (zwłaszcza u obecnych lub byłych palaczy);
  • zdarzeń sercowo-naczyniowych, szczególnie u osób powyżej 50. roku życia z co najmniej jednym czynnikiem wystąpienia chorób sercowo-naczyniowych;
  •  

Cibinqo nie należy stosować w przypadku aktywnej infekcji lub alergii na którykolwiek ze składników leku.

Źródła: Pfizer, AbbVie, Medscape

 

Przeczytaj także: Upadacitinib skuteczny w leczeniu atopowego zapalenia skóry

Biblioteka Faktów

Przeczytaj bezpłatnie pokrewny artykuł w czasopiśmie „Pielęgniarstwo w Anestezjologii i Intensywnej Opiece”:

Rany nowotworowe skóry – objawy i postępowanie miejscowe

256 thoughts on “FDA zatwierdza dwa leki w leczeniu atopowego zapalenia skóry

  1. Hi there! Thank you for podcasting these interviews with Yoav, Sid, and Josh. Just noticed a small error on the screen of your audio player– “Institute” is missing its first “t.”We are putting out three social media posts for each of the researchers interviewed. Thanks again for the coverage!Cheers,Jenna MarshallSFI CommunicationsOY about #Mastodon – I got the app.; tried to figure it out. And perhaps it’s year end mishegas that is making it more difficult. I’ll read your posts more carefully and see what I think. Many of those I follow in and outside our industry are still on Twitter. Maybe we hope he can be moved out. Tho’ Jeff Bezos is not a saint (at all!) he has let the Wash Post run well since purchasing. It’s whether Musk goes through with stepping down because the polls said so AND then what!hi clark, thanks so much for your comment, sounds like we’re definitely on the same page about this stuff! looking forward to exploring what you’ve been writing lately. in the meantime, the Milosz piece, Creating the World, is available on my 2006 New World Records release,Tell the Birds. Go here for more info.

  2. Thanks for sharing superb informations. Your site is so cool. I am impressed by the details that you have on this web site. It reveals how nicely you understand this subject. Bookmarked this website page, will come back for more articles. You, my friend, ROCK! I found simply the info I already searched all over the place and simply couldn’t come across. What an ideal site.

  3. Throughout this great pattern of things you actually secure a B- just for effort. Where you actually lost us was on your details. As people say, details make or break the argument.. And it could not be much more accurate here. Having said that, allow me tell you what exactly did do the job. Your authoring is certainly highly persuasive which is probably why I am making an effort to opine. I do not make it a regular habit of doing that. 2nd, whilst I can see a jumps in logic you make, I am definitely not sure of how you seem to connect the details which inturn produce the actual conclusion. For the moment I will, no doubt subscribe to your position however wish in the foreseeable future you link the facts better.

  4. You actually make it appear so easy with your presentation but I in finding this matter to be really one thing that I feel I might by no means understand. It seems too complex and very wide for me. I’m having a look forward on your subsequent post, I will attempt to get the hang of it!

  5. An impressive share, I just given this onto a colleague who was doing a little analysis on this. And he in fact bought me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! But yeah Thnkx for spending the time to discuss this, I feel strongly about it and love reading more on this topic. If possible, as you become expertise, would you mind updating your blog with more details? It is highly helpful for me. Big thumb up for this blog post!

  6. Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.

  7. Great V I should definitely pronounce, impressed with your website. I had no trouble navigating through all the tabs and related info ended up being truly simple to do to access. I recently found what I hoped for before you know it at all. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, site theme . a tones way for your client to communicate. Excellent task..

  8. Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.

  9. Nice post. I learn something more challenging on different blogs everyday. It will always be stimulating to read content from other writers and practice a little something from their store. I’d prefer to use some with the content on my blog whether you don’t mind. Natually I’ll give you a link on your web blog. Thanks for sharing.

  10. Have you ever thought about creating an e-book or guest authoring on other sites? I have a blog centered on the same ideas you discuss and would love to have you share some stories/information. I know my subscribers would appreciate your work. If you’re even remotely interested, feel free to shoot me an email.

  11. I’m impressed, I must say. Actually hardly ever do I encounter a weblog that’s both educative and entertaining, and let me tell you, you might have hit the nail on the head. Your concept is excellent; the difficulty is something that not enough persons are speaking intelligently about. I am very joyful that I stumbled throughout this in my search for something relating to this.

  12. I’m really loving the theme/design of your blog. Do you ever run into any web browser compatibility problems? A handful of my blog audience have complained about my website not operating correctly in Explorer but looks great in Firefox. Do you have any solutions to help fix this issue?

  13. When I originally commented I clicked the -Notify me when new feedback are added- checkbox and now every time a remark is added I get 4 emails with the same comment. Is there any means you may take away me from that service? Thanks!

  14. of course like your web-site but you have to check the spelling on quite a few of your posts. A number of them are rife with spelling issues and I find it very bothersome to tell the truth nevertheless I will definitely come back again.

  15. Please let me know if you’re looking for a writer for your weblog. You have some really great articles and I believe I would be a good asset. If you ever want to take some of the load off, I’d really like to write some content for your blog in exchange for a link back to mine. Please blast me an email if interested. Thank you!

  16. I’m impressed, I have to say. Really not often do I encounter a blog that’s each educative and entertaining, and let me let you know, you have got hit the nail on the head. Your concept is excellent; the difficulty is one thing that not enough people are speaking intelligently about. I’m very completely satisfied that I stumbled across this in my search for one thing referring to this.

  17. Do you mind if I quote a few of your articles as long as I provide credit and sources back to your webpage? My website is in the very same niche as yours and my users would certainly benefit from a lot of the information you provide here. Please let me know if this okay with you. Thanks!

  18. I’m not sure the place you are getting your information, however good topic. I needs to spend some time learning more or understanding more. Thank you for magnificent info I used to be searching for this information for my mission.

  19. I’m still learning from you, but I’m trying to reach my goals. I definitely love reading everything that is written on your website.Keep the information coming. I enjoyed it!

  20. Howdy! Would you mind if I share your blog with my myspace group? There’s a lot of people that I think would really enjoy your content. Please let me know. Many thanks

  21. I do not even know how I ended up here, but I thought this post was good. I don’t know who you are but definitely you are going to a famous blogger if you aren’t already 😉 Cheers!

  22. Hey there! I just wanted to ask if you ever have any problems with hackers? My last blog (wordpress) was hacked and I ended up losing a few months of hard work due to no back up. Do you have any solutions to protect against hackers?

  23. Sight Care is a daily supplement proven in clinical trials and conclusive science to improve vision by nourishing the body from within. The Sight Care formula claims to reverse issues in eyesight, and every ingredient is completely natural.

  24. Cortexi is a completely natural product that promotes healthy hearing, improves memory, and sharpens mental clarity. Cortexi hearing support formula is a combination of high-quality natural components that work together to offer you with a variety of health advantages, particularly for persons in their middle and late years. Cortex not only improves hearing but also decreases inflammation, eliminates brain fog, and gives natural memory protection.

  25. Boostaro increases blood flow to the reproductive organs, leading to stronger and more vibrant erections. It provides a powerful boost that can make you feel like you’ve unlocked the secret to firm erections

  26. Puravive introduced an innovative approach to weight loss and management that set it apart from other supplements. It enhances the production and storage of brown fat in the body, a stark contrast to the unhealthy white fat that contributes to obesity.

  27. Cortexi is an effective hearing health support formula that has gained positive user feedback for its ability to improve hearing ability and memory. This supplement contains natural ingredients and has undergone evaluation to ensure its efficacy and safety. Manufactured in an FDA-registered and GMP-certified facility, Cortexi promotes healthy hearing, enhances mental acuity, and sharpens memory.

  28. FitSpresso stands out as a remarkable dietary supplement designed to facilitate effective weight loss. Its unique blend incorporates a selection of natural elements including green tea extract, milk thistle, and other components with presumed weight loss benefits.

  29. Prostadine is a dietary supplement meticulously formulated to support prostate health, enhance bladder function, and promote overall urinary system well-being. Crafted from a blend of entirely natural ingredients, Prostadine draws upon a recent groundbreaking discovery by Harvard scientists. This discovery identified toxic minerals present in hard water as a key contributor to prostate issues.

  30. Dentitox Pro is a liquid dietary solution created as a serum to support healthy gums and teeth. Dentitox Pro formula is made in the best natural way with unique, powerful botanical ingredients that can support healthy teeth.

  31. Gorilla Flow is a non-toxic supplement that was developed by experts to boost prostate health for men. It’s a blend of all-natural nutrients, including Pumpkin Seed Extract Stinging Nettle Extract, Gorilla Cherry and Saw Palmetto, Boron, and Lycopene.

  32. TerraCalm is an antifungal mineral clay that may support the health of your toenails. It is for those who struggle with brittle, weak, and discoloured nails. It has a unique blend of natural ingredients that may work to nourish and strengthen your toenails.

  33. Endo Pump Male Enhancement is a dietary supplement designed to assist men improve their sexual performance. This natural formula contains a potent blend of herbs and nutrients that work together to improve blood flow

  34. SonoVive™ is an all-natural supplement made to address the root cause of tinnitus and other inflammatory effects on the brain and promises to reduce tinnitus, improve hearing, and provide peace of mind.

  35. Introducing FlowForce Max, a solution designed with a single purpose: to provide men with an affordable and safe way to address BPH and other prostate concerns. Unlike many costly supplements or those with risky stimulants, we’ve crafted FlowForce Max with your well-being in mind. Don’t compromise your health or budget – choose FlowForce Max for effective prostate support today!

  36. Claritox Pro™ is a natural dietary supplement that is formulated to support brain health and promote a healthy balance system to prevent dizziness, risk injuries, and disability. This formulation is made using naturally sourced and effective ingredients that are mixed in the right way and in the right amounts to deliver effective results.

  37. Glucofort Blood Sugar Support is an all-natural dietary formula that works to support healthy blood sugar levels. It also supports glucose metabolism. According to the manufacturer, this supplement can help users keep their blood sugar levels healthy and within a normal range with herbs, vitamins, plant extracts, and other natural ingredients.

  38. TropiSlim is a unique dietary supplement designed to address specific health concerns, primarily focusing on weight management and related issues in women, particularly those over the age of 40. TropiSlim targets a unique concept it refers to as the „menopause parasite” or K-40 compound, which is purported to be the root cause of several health problems, including unexplained weight gain, slow metabolism, and hormonal imbalances in this demographic.

  39. EyeFortin is a natural vision support formula crafted with a blend of plant-based compounds and essential minerals. It aims to enhance vision clarity, focus, and moisture balance.

  40. Sight Care is a daily supplement proven in clinical trials and conclusive science to improve vision by nourishing the body from within. The Sight Care formula claims to reverse issues in eyesight, and every ingredient is completely natural.

  41. Kerassentials are natural skin care products with ingredients such as vitamins and plants that help support good health and prevent the appearance of aging skin. They’re also 100% natural and safe to use. The manufacturer states that the product has no negative side effects and is safe to take on a daily basis. Kerassentials is a convenient, easy-to-use formula.

  42. AquaPeace is the most in-demand ear health supplement on the market. Owing to its natural deep-sea formula and nutritious nature, it has become an instant favorite of everyone who is struggling with degraded or damaged ear health.

  43. Glucofort Blood Sugar Support is an all-natural dietary formula that works to support healthy blood sugar levels. It also supports glucose metabolism. According to the manufacturer, this supplement can help users keep their blood sugar levels healthy and within a normal range with herbs, vitamins, plant extracts, and other natural ingredients. https://glucofortbuynow.us/

  44. I just wanted to type a comment to express gratitude to you for the superb pointers you are writing on this site. My extended internet search has at the end been paid with good strategies to share with my partners. I would declare that most of us visitors actually are extremely fortunate to exist in a great network with so many perfect individuals with great pointers. I feel very grateful to have discovered your web site and look forward to many more amazing times reading here. Thank you again for a lot of things.

  45. Hi, I think your blog might be having browser compatibility issues. When I look at your website in Firefox, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, great blog!

  46. Island Post is the website for a chain of six weekly newspapers that serve the North Shore of Nassau County, Long Island published by Alb Media. The newspapers are comprised of the Great Neck News, Manhasset Times, Roslyn Times, Port Washington Times, New Hyde Park Herald Courier and the Williston Times. Their coverage includes village governments, the towns of Hempstead and North Hempstead, schools, business, entertainment and lifestyle. https://islandpost.us/

  47. Have you ever considered creating an e-book or guest authoring on other sites? I have a blog centered on the same ideas you discuss and would really like to have you share some stories/information. I know my audience would value your work. If you are even remotely interested, feel free to send me an e mail.

  48. I will right away grasp your rss feed as I can not to find your email subscription hyperlink or e-newsletter service. Do you’ve any? Kindly allow me know in order that I may subscribe. Thanks.

  49. I found your weblog web site on google and examine just a few of your early posts. Continue to keep up the excellent operate. I just additional up your RSS feed to my MSN News Reader. Searching for forward to reading more from you later on!…

  50. Thank you for another informative site. Where else could I get that kind of info written in such a perfect way? I’ve a project that I am just now working on, and I have been on the look out for such information.

  51. I haven’t checked in here for some time as I thought it was getting boring, but the last several posts are great quality so I guess I will add you back to my everyday bloglist. You deserve it my friend 🙂

  52. Hey are using WordPress for your blog platform? I’m new to the blog world but I’m trying to get started and set up my own. Do you need any coding knowledge to make your own blog? Any help would be greatly appreciated!

  53. Hello there, I discovered your site by the use of Google at the same time as looking for a similar topic, your website came up, it seems great. I’ve bookmarked it in my google bookmarks.

  54. I haven’t checked in here for some time because I thought it was getting boring, but the last several posts are good quality so I guess I’ll add you back to my daily bloglist. You deserve it my friend 🙂

  55. I have been browsing on-line greater than three hours these days, yet I never found any interesting article like yours. It is beautiful value enough for me. In my opinion, if all web owners and bloggers made excellent content as you did, the internet might be much more useful than ever before.

  56. Thanks for sharing excellent informations. Your site is so cool. I am impressed by the details that you have on this blog. It reveals how nicely you understand this subject. Bookmarked this web page, will come back for extra articles. You, my friend, ROCK! I found just the information I already searched all over the place and simply couldn’t come across. What an ideal web site.

  57. Have you ever thought about creating an e-book or guest authoring on other blogs? I have a blog centered on the same information you discuss and would love to have you share some stories/information. I know my readers would value your work. If you’re even remotely interested, feel free to send me an e mail.

  58. Great V I should certainly pronounce, impressed with your site. I had no trouble navigating through all the tabs and related information ended up being truly easy to do to access. I recently found what I hoped for before you know it at all. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, site theme . a tones way for your client to communicate. Excellent task..

  59. Thanks , I have recently been looking for information approximately this topic for a while and yours is the best I have came upon so far. But, what concerning the conclusion? Are you certain in regards to the source?

  60. Good website! I truly love how it is easy on my eyes and the data are well written. I am wondering how I could be notified when a new post has been made. I have subscribed to your feed which must do the trick! Have a great day!

  61. Thank you for some other informative site. The place else could I get that type of information written in such a perfect means? I have a project that I’m simply now operating on, and I have been at the look out for such info.

  62. Magnificent goods from you, man. I have understand your stuff previous to and you are just too fantastic. I actually like what you’ve acquired here, really like what you are saying and the way in which you say it. You make it enjoyable and you still take care of to keep it smart. I can’t wait to read much more from you. This is actually a tremendous website.

  63. I’ve been browsing online more than 3 hours lately, yet I never discovered any attention-grabbing article like yours. It’s beautiful worth enough for me. Personally, if all site owners and bloggers made good content as you probably did, the net will likely be a lot more helpful than ever before.

  64. Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point. You definitely know what youre talking about, why waste your intelligence on just posting videos to your site when you could be giving us something informative to read?

  65. Pingback: best eft cheats
  66. obviously like your web site however you have to take a look at the spelling on quite a few of your posts. Several of them are rife with spelling problems and I to find it very troublesome to inform the reality then again I’ll surely come back again.

  67. Hello There. I found your weblog using msn. This is a very smartly written article. I’ll be sure to bookmark it and come back to learn more of your helpful info. Thanks for the post. I will definitely comeback.

  68. Wonderful goods from you, man. I have understand your stuff previous to and you are just too magnificent. I really like what you’ve acquired here, certainly like what you’re stating and the way in which you say it. You make it enjoyable and you still care for to keep it smart. I can not wait to read much more from you. This is really a wonderful web site.

  69. Someone essentially help to make seriously posts I would state. This is the very first time I frequented your web page and thus far? I surprised with the research you made to make this particular publish amazing. Excellent job!

  70. Hiya very cool web site!! Man .. Beautiful .. Wonderful .. I’ll bookmark your web site and take the feeds additionally…I’m satisfied to seek out a lot of helpful info here in the post, we’d like work out more strategies in this regard, thank you for sharing.

  71. It?¦s actually a great and useful piece of info. I am satisfied that you shared this helpful information with us. Please keep us informed like this. Thanks for sharing.

  72. Do you mind if I quote a couple of your articles as long as I provide credit and sources back to your webpage? My website is in the very same area of interest as yours and my users would genuinely benefit from a lot of the information you present here. Please let me know if this ok with you. Cheers!

  73. Good web site! I truly love how it is simple on my eyes and the data are well written. I’m wondering how I might be notified whenever a new post has been made. I’ve subscribed to your feed which must do the trick! Have a nice day!

  74. I’m delighted by your post and its celebration of this wonderful Monday. The content is both insightful and uplifting. Adding more visuals could make it even more engaging for a wider audience.

  75. The next time I read a blog, I hope that it doesnt disappoint me as much as this one. I mean, I know it was my choice to read, but I actually thought youd have something interesting to say. All I hear is a bunch of whining about something that you could fix if you werent too busy looking for attention.

  76. We’re a group of volunteers and opening a brand new scheme in our community. Your website provided us with useful information to paintings on. You have done a formidable task and our whole neighborhood shall be grateful to you.

  77. Wow that was odd. I just wrote an very long comment but after I clicked submit my comment didn’t appear. Grrrr… well I’m not writing all that over again. Anyhow, just wanted to say great blog!

  78. Good blog! I really love how it is easy on my eyes and the data are well written. I am wondering how I might be notified when a new post has been made. I’ve subscribed to your RSS feed which must do the trick! Have a nice day!

  79. Right now it sounds like WordPress is the best blogging platform out there right now. (from what I’ve read) Is that what you’re using on your blog?

  80. Hi there! I know this is kinda off topic however I’d figured I’d ask. Would you be interested in exchanging links or maybe guest writing a blog article or vice-versa? My website addresses a lot of the same subjects as yours and I feel we could greatly benefit from each other. If you happen to be interested feel free to send me an email. I look forward to hearing from you! Excellent blog by the way!

  81. Today, I went to the beach with my kids. I found a sea shell and gave it to my 4 year old daughter and said „You can hear the ocean if you put this to your ear.” She put the shell to her ear and screamed. There was a hermit crab inside and it pinched her ear. She never wants to go back! LoL I know this is entirely off topic but I had to tell someone!

Dodaj komentarz

Twój adres e-mail nie zostanie opublikowany.