A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.

Start Date01 Apr 2024

Sponsor / Collaborator

Innovaderm Research, Inc.

NCT05650736 / Active, not recruitingPhase 2IIT

JAK1 Inhibition in Granuloma Annulare: an Opportunity for Pathogenesis Directed Therapy

The primary objective is to determine if JAK1 specific inhibition is effective in treating granuloma annulare (GA), a problematic inflammatory skin disease without an FDA approved treatment. The primary outcome will be the percentage change in the body surface area (BSA) involvement by GA after 6 months of treatment with abrocitinib 200 mg daily in 10 patients with moderate to severe GA affecting at least 5% body surface area (BSA).

Start Date27 Oct 2023

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT05743244 / RecruitingPhase 2IIT

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subtype-Selective JAK Inhibitors for Preservation of Pancreatic β Cell Function in Newly Diagnosed Type 1 Diabetes Mellitus

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Start Date19 Oct 2023

Sponsor / Collaborator

National Institute of Diabetes & Digestive & Kidney Diseases

[+1]

100 Clinical Results associated with Abrocitinib

100 Translational Medicine associated with Abrocitinib

100 Patents (Medical) associated with Abrocitinib

191

Literatures (Medical) associated with Abrocitinib

01 Feb 2024·Journal of the American Academy of Dermatology

Executive summary: Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Review

Author: Davis, Dawn M R ; Darr, Jennifer M ; Alikhan, Ali ; Schwarzenberger, Kathryn ; Cohen, David E ; Frazer-Green, Lindsy ; Silverberg, Jonathan I ; Eichenfield, Lawrence F ; Singh, Anne Marie ; Paller, Amy S ; Bercovitch, Lionel ; Sidbury, Robert ; Drucker, Aaron M ; Wu, Peggy A

BACKGROUND:

The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies.

METHODS:

A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations.

RESULTS:

The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications.

CONCLUSIONS:

The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.

01 Feb 2024·Rheumatology (Oxford, England)

Differential properties of Janus kinase inhibitors in the treatment of immune-mediated inflammatory diseases

Review

Author: Parmentier, Julie M ; Strengholt, Sander ; Lippe, Ralph ; Taylor, Peter C ; Xavier, Ricardo M ; Baraliakos, Xenofon ; Choy, Ernest ; Isaacs, John D ; Tanaka, Yoshiya ; Szekanecz, Zoltan

Abstract:

Janus kinases (JAKs) are a family of cytosolic tyrosine kinases that regulate cytokine signal transduction, including cytokines involved in a range of inflammatory diseases, such as RA, psoriasis, atopic dermatitis and IBD. Several small-molecule JAK inhibitors (JAKis) are now approved for the treatment of various immune-mediated inflammatory diseases. There are, however, key differences between these agents that could potentially translate into unique clinical profiles. Each JAKi has a unique chemical structure, resulting in a distinctive mode of binding within the catalytic cleft of the target JAK, and giving rise to distinct pharmacological characteristics. In addition, the available agents have differing selectivity for JAK isoforms, as well as off-target effects against non-JAKs. Other differences include effects on haematological parameters, DNA damage repair, reproductive toxicity and metabolism/elimination. Here we review the pharmacological profiles of the JAKis abrocitinib, baricitinib, filgotinib, peficitinib, tofacitinib and upadacitinib.

01 Feb 2024·Pharmacological research

Properties of FDA-approved small molecule protein kinase inhibitors: A 2024 update

Review

Author: Roskoski, Robert

Owing to the dysregulation of protein kinase activity in many diseases including cancer, this enzyme family has become one of the most important drug targets in the 21st century. There are 80 FDA-approved therapeutic agents that target about two dozen different protein kinases and seven of these drugs were approved in 2023. Of the approved drugs, thirteen target protein-serine/threonine protein kinases, four are directed against dual specificity protein kinases (MEK1/2), twenty block nonreceptor protein-tyrosine kinases, and 43 inhibit receptor protein-tyrosine kinases. The data indicate that 69 of these drugs are prescribed for the treatment of neoplasms. Six drugs (abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, upadacitinib) are used for the treatment of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 80 approved drugs, nearly two dozen are used in the treatment of multiple diseases. The following seven drugs received FDA approval in 2023: capivasertib (HER2-positive breast cancer), fruquintinib (metastatic colorectal cancer), momelotinib (myelofibrosis), pirtobrutinib (mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma), quizartinib (Flt3-mutant acute myelogenous leukemia), repotrectinib (ROS1-positive lung cancer), and ritlecitinib (alopecia areata). All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and trilaciclib. This review summarizes the physicochemical properties of all 80 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, polar surface area, potency, solubility, lipophilic efficiency, and ligand efficiency.

News (Medical) associated with Abrocitinib

06 Jun 2024

·www.sciencedaily.com

Drug used to treat eczema may provide relief for patients with intensely itchy skin diseases

A drug approved to treat eczema provided significant improvement in the symptoms of patients with severe itching diseases that currently have no targeted treatments, according to a new study. The drug, abrocitinib, was found to cause minimal side effects during a small 12-week study. It was beneficial for those with an itching disease called prurigo nodularis as well as for those with chronic pruritus of unknown origin, a condition that causes chronic unexplainable itching symptoms. A drug approved to treat eczema provided significant improvement in the symptoms of patients with severe itching diseases that currently have no targeted treatments, according to a new study published in JAMA Dermatology. The drug, abrocitinib, was found to cause minimal side effects during a small 12-week study led by University of Maryland School of Medicine (UMSOM) researchers. It was beneficial for those with an itching disease called prurigo nodularis as well as for those with chronic pruritus of unknown origin, a condition that causes chronic unexplainable itching symptoms. "Very few treatments exist for prurigo nodularis and chronic pruritus of unknown origin; patients often suffer for years in horrible discomfort, which can lead to anxiety and depression, severely impacting their quality of life," said Shawn Kwatra, MD, the Joseph W. Burnett Endowed Professor and Chair of Dermatology at UMSOM and Chief of Service Dermatology at the University of Maryland Medical Center (UMMC). "The rationale for this study came from my laboratory's studies findings of altered inflammatory mediators in these conditions that all function through JAK1. Through this trial, we hope to continue to move the needle toward personalized therapies that can provide sustainable relief for coping with these debilitating conditions." Affecting at least 130,000 Americans, prurigo nodularis causes dozens of extremely itchy and disfiguring bumps, usually on the chest, arms, and legs. Dr. Kwatra's previous research indicates that prurigo nodularis occurs more than 3 times as frequently in Black patients than white patients, tends to be more common in women, and is associated with depression, diabetes, chronic kidney disease, and HIV. Chronic pruritus of unknown origin is most prevalent among older adults and causes severe itching lasting longer than six weeks. Current therapies used to help manage symptoms include over-the-counter and prescription itch relief ointments and anti-inflammatory drugs such as antihistamines and corticosteroids. None of these medications, however, provide sustained relief. The study involved a total of 20 patients, half of whom had prurigo nodularis and half of whom had chronic pruritus of unknown origin. They were all given a 200-milligram pill of abrocitinib once a day for 12 weeks; the patients knew they were being given an experimental treatment, and the study did not include a placebo group. Abrocitinib was found to reduce itching and pain symptoms by 78 percent in the prurigo nodularis patients. Patients with chronic pruritus of unknown origin experienced a 54 percent reduction in itching and pain symptoms. Patients in both groups also reported an improvement in their quality of life and in their sleep habits. None of the patients experienced serious adverse events. The most common side effect, in 10 percent of patients, was small acne-like bumps. Abrocitinib is a JAK1 inhibitor drug that works to suppress inflammation, specifically pro-inflammatory chemicals called cytokines that are involved in an overactive immune system. The drugs appear to slow down immune activity by suppressing intracellular signaling of these cytokines. "This is not only an encouraging study but also sets the stage for a Phase 3 clinical trial," said Mark T. Gladwin, MD, who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of UMSOM, and Vice President for Medical Affairs at University of Maryland, Baltimore. "It holds promise for introducing a novel treatment to patients in underserved communities disproportionately affected by prurigo nodularis, a condition historically overlooked by dermatology." Since beginning his position at UMSOM, Dr. Kwatra has created the Maryland Itch Center at UMMC and is currently continuing his research there.

Clinical ResultPhase 3

20 Mar 2024

·www.fiercepharma.com

#FierceMadness is back: Get voting in the 2024 drug name tournament

This year we’re taking the branded drug names that were officially approved by the FDA in 2022 and 2023 - now it's your turn to vote for your winner. LAUNCHED: Wednesday, March 20, 7:00 a.m. ET It’s March, so it’s time for some #FierceMadness. Last year, we channeled the NCAA tournament for the best pharma ad campaigns, but, this year, we’re looking for the best of the best in drug names. Here’s how it works. We’ve chosen 64 of the most distinctive drug names to come out of the FDA’s 2022 and 2023 crop of new approvals. Whittling down to 64 from the 92 drug names available was our staff challenge, but now it’s up to you, readers, to deliberate and vote down to the final winner. Remember, this isn’t about the drugs themselves—neither how well they may work (or not) nor any controversies in how they may have been approved. Our goal is to assess their marketing suitability, considering how well they perform in their respective field and against competitors. Ready to play? Check out the bracket here (PDF) and see the full Madness 64 list below. Then vote is via our poll here. You can vote from now until Friday, March 22, at 6 p.m. ET. Check back here Monday, March 25, for your results, and the chance to vote in the next round. After that, we’ll be back with a new round each Wednesday and Monday through Monday, April 8, when you can vote for your championship winner. Any remote robo-voting will be noted, and those votes will be discarded. Please play fair. Don’t forget to tell us why you picked what you picked in the voting poll comments section—and what you think each drug name really sounds like. We’ll include the funniest and most out-of-the-box comments in our recaps every round, so make 'em good! New this year: Our sister publication Fierce Biotech is also running its own Madness tournament for the best of the best in biotech company names. Check out and vote in its championship here. Good luck, and happy Madness! #FierceMadness 2024: The full bracket of 64 Jesduvroq vs. Lamzede Jesduvroq Maker: GSK Indication: Anemia due to chronic kidney disease Sounds like: When you hit your finger with a hammer, but it’s in front of your children so you’re trying not to swear Lamzede Maker: Chiesi Indication: Non-central nervous system manifestations of alpha-mannosidosis Sounds like: A vegan meal Pluvicto vs. Lunsumio Pluvicto Maker: Novartis Indication: Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies Sounds like: A new planet Lunsumio Maker: Roche Indication: Relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma Sounds like: A Japanese wrestler Briumvi vs. Camzyos Briumvi Maker: TG Therapeutics Indication: Relapsing forms of multiple sclerosis Sounds like: A sixth-generation cheese Camzyos Maker: Bristol Myers Squibb Indication: Obstructive hypertrophic cardiomyopathy Sounds like: A Spanish holiday resort Voquezna vs. Mounjaro Voquezna Maker: Phathom Pharmaceuticals Indication: Helicobacter pylori infection Sounds like: A sports drink with a kick Mounjaro Maker: Eli Lilly Indication: Lowering blood sugar levels in Type 2 diabetes Sounds like: A legendary medieval sword fighter Vtama vs. Amvuttra Vtama Maker: Dermavant Indication: Plaque psoriasis Sounds like: A mouthful Amvuttra Maker: Alnylam Indication: Polyneuropathy of hereditary transthyretin-mediated amyloidosis Sounds like: A pope’s gift Xenpozyme vs. Daxxify Xenpozyme Maker: Sanofi Indication: Acid sphingomyelinase deficiency Sounds like: An alien protein Daxxify Maker: Revance Indication: The treatment of cervical dystonia and for the temporary improvement of frown lines Sounds like: A ray gun to make you sassy Fruzaqla vs. Sotyktu Fruzaqla Maker: Takeda Pharmaceuticals Indication: Refractory, metastatic colorectal cancer Sounds like: A European swear word Sotyktu Maker: Bristol Myers Squibb Indication: Moderate to severe plaque psoriasis Sounds like: Gesundheit! Terlivaz vs. Imjudo Terlivaz Maker: Mallinckrodt Pharmaceuticals Indication: Improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function Sounds like: A Hungarian dance Imjudo Maker: AstraZeneca Indication: Unresectable hepatocellular carcinoma Sounds like: A self-confident martial artist Elahere vs. Vabysmo Elahere Maker: ImmunoGen Indication: Recurrent ovarian cancer that is resistant to platinum therapy Sounds like: An inebriated attempt at Hawaiian Vabysmo Maker: Roche Indication: Neovascular (wet) aged-related macular degeneration and diabetic macular edema Sounds like: A new way of saying fantastic Pyrukynd vs. Rystiggo Pyrukynd Maker: Agios Indication: Hemolytic anemia in pyruvate kinase deficiency Sounds like: A drunk Scrabble game Rystiggo Maker: UCB Indication: Generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive Sounds like: An Italian village Beyfortus vs. Xdemvy Beyfortus Maker: AstraZeneca Indication: To prevent respiratory syncytial virus lower respiratory tract disease Sounds like: A medieval stronghold Xdemvy Maker: Tarsus Pharmaceuticals Indication: Demodex blepharitis Sounds like: Elon Musk’s drunk attempt at renaming his business Tzield vs. Rezlidhia Tzield Maker: Provention Bio Indication: Delay the onset of stage 3 Type 1 diabetes Sounds like: An electronic barrier Rezlidhia Maker: Rigel Pharmaceuticals Indication: Relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation Sounds like: A new Disney princess Krazati vs. Leqembi Krazati Maker: Mirati Therapeutics Indication: KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy Sounds like: A crazy party Leqembi Maker: Eisai Indication: Alzheimer’s disease Sounds like: An inspirational French aphorism Cibinqo vs. Brenzavvy Cibinqo Maker: Pfizer Indication: Refractory, moderate to severe atopic dermatitis Sounds like: A game of cheeky bingo Brenzavvy Maker: TheracosBio Indication: Glycemic control in adults with Type 2 diabetes mellitus as an adjunct to diet and exercise Sounds like: Heard in a copy of "Pirates of the Caribbean" Jaypirca vs. Skyclarys Jaypirca Maker: Eli Lilly Indication: Relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor Sounds like: A strong coffee Skyclarys Maker: Biogen Indication: Friedreich’s ataxia Sounds like: A high-rise building Zavzpret vs. Paxlovid Zavzpret Maker: Pfizer Indication: Migraine treatment Sounds like: A Turkish fast-food restaurant Paxlovid Maker: Pfizer Indication: Mild to moderate COVID-19 in adults at high risk for progression to severe COVID-19 Sounds like: A bizarre Pac-Man sequel Inpefa vs. Columvi Inpefa Maker: Lexicon Pharmaceuticals Indication: Heart failure Sounds like: An anti-fascist offshoot group Columvi Maker: Roche Indication: Diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy Sounds like: An ancient Roman detective Daybue vs. Zynyz Daybue Maker: Acadia Indication: Rett syndrome Sounds like: How my five-year-old insists debut is spelled Zynyz Maker: Incyte Indication: Metastatic or recurrent locally advanced Merkel cell carcinoma Sounds like: Drug naming companies may be running out of ideas Rezzayo vs. Qalsody Rezzayo Maker: Melinta Therapeutics Indication: Candidemia and invasive candidiasis Sounds like: A phrase used when you’ve had a great nap in the day Qalsody Maker: Biogen Indication: Amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation Sounds like: From the makers of “Better Call Saul” comes “better Qalsody” Elfabrio vs. Veozah Elfabrio Maker: Chiesi Indication: Fabry disease Sounds like: The lost Spanish Mario brother Veozah Maker: Astellas Indication: Moderate to severe hot flashes caused by menopause Sounds like: A Broadway play Epkinly vs. Zurzuvae Epkinly Makers: AbbVie/Genmab Indication: Relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy Sounds like: Someone who watches too many streaming episodes Zurzuvae Makers: Sage/Biogen Indication: Postpartum depression Sounds like: A mouthful Izervay vs. Talvey Izervay Maker: Iveric Bio Indication: Geographic atrophy secondary to age-related macular degeneration Sounds like: A new app for scanning the land Talvey Maker: Johnson & Johnson Indication: Relapsed or refractory multiple myeloma who have received at least four prior therapies Sounds like: A little too close to talc… Elrexfio vs. Veopoz Elrexfio Maker: Pfizer Indication: Relapsed or refractory multiple myeloma who have received at least four prior lines of therapy Sounds like: A new dinosaur found in Mexico Veopoz Maker: Regeneron Pharmaceuticals Indication: Patients 1 year old and older with CD55-deficient protein-losing enteropathy Sounds like: Double-plus good! Zilbrysq vs. Ojjaara Zilbrysq Maker: UCB Indication: Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive Sounds like: Absolute zero Ojjaara Maker: GSK Indication: Intermediate or high-risk myelofibrosis in adults with anemia Sounds like: “What’s my name?” Exxua vs. Pombiliti Exxua Maker: Fabre-Kramer Pharmaceuticals Indication: Major depressive disorder Sounds like: Someone who’s always leaving Pombiliti Maker: Amicus Indication: Late-onset Pompe disease Sounds like: The ability to treat Pompe disease (this feels a little on the nose) Rivfloza vs. Velsipity Rivfloza Maker: Novo Nordisk Indication: Urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function Sounds like: An exuberant DJ Velsipity Maker: Pfizer Indication: Moderately to severely active ulcerative colitis in adults Sounds like: A deodorant brand you wouldn’t want to buy Bimzelx vs. Omvoh Bimzelx Maker: UCB Indication: Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Sounds like: Throwing away unwanted antacids Omvoh Maker: Eli Lilly Indication: Ulcerative colitis Sounds like: A new age prayer Loqtorzi vs. Defencath Loqtorzi Maker: Coherus Biosciences Indication: Recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies Sounds like: How you close the door in a magical kingdom Defencath Maker: CorMedix Indication: Reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis Sounds like: A Dungeons and Dragons character Augtyro vs. Ryzneuta Augtyro Maker: Bristol Myers Squibb Indication: ROS1-positive non-small cell lung cancer Sounds like: A virtual reality game where you’re the bad guy Ryzneuta Maker: Acrotech Biopharma Indication: Neutropenia Sounds like: Getting rid of someone’s charisma Truqap vs. Ogsiveo Truqap Maker: AstraZeneca Indication: Breast cancer that meets certain disease criteria Sounds like: A limit on truth Ogsiveo Maker: SpringWorks Indication: Progressing desmoid tumors who require systemic treatment Sounds like: Oh, give us a go! Quviviq vs. Ztalmy Quviviq Maker: Idorsia Indication: Insomnia Sounds like: A producer asking a biotech founder turned politician to get ready for his TV appearance Ztalmy Maker: Marinus Indication: Seizures in cyclin-dependent kinase-like 5 deficiency disorder Sounds like: A nefarious Yevgeny Zamyatin character Opdualag vs. Wainua Opdualag Maker: Bristol Myers Squibb Indication: Unresectable or metastatic melanoma Sounds like: A Russian prison Wainua Maker: AstraZeneca Indication: Polyneuropathy of hereditary transthyretin-mediated amyloidosis Sounds like: A Premier League footballer

15 Dec 2023

·www.prnewswire.com

Pusan National University Researchers Dive Deep Into the Safety of JAK Inhibitors for Atopic Dermatitis

BUSAN, South Korea, Dec. 15, 2023 /PRNewswire/ -- Atopic dermatitis (or AD) is a heterogenous, inflammatory condition of the skin and is usually accompanied by itch, redness, and swelling. AD can have a significant impact on the patient's quality of life. While several biologic treatment approaches have been proposed in the recent years for the treatment of AD, they often fall short of providing the required care in relieving symptoms of moderate-to-severe AD. Continue Reading The comprehensive safety analysis establishes evidence regarding the safety of systematic Janus kinase inhibitors in patients with atopic dermatitis. In this context, Janus kinase (or JAK) inhibitors are small molecules that have emerged as a promising treatment option for managing AD. They act by blocking the JAK family kinases and inhibiting the inflammatory pathways involved in AD and other inflammatory diseases. Recently, ten JAK inhibitors have been approved by the US Food and Drug Administration (FDA) to treat diseases like rheumatoid arthritis, ankylosing spondylarthritis, COVID-19, and AD, among others. However, the FDA has also issued a boxed warning for JAK inhibitors to include the risk of major adverse events. Since then, many meta-analyses focusing on the safety of JAK inhibitors have been published, but these analyses are fraught with several limitations. Further research is therefore needed to understand the safety profile of JAK inhibitors. This can help in tailoring the therapeutic strategies of AD as per patient's needs, while also minimizing adverse effects and enhancing the effectiveness of JAK inhibitors. To this end, a group of researchers from Pusan National University led by Associate Professor Yun Hak Kim, affiliated with the university's Department of Anatomy and Department of Biomedical Informatics, conducted an extensive analysis of randomized controlled trials (RCTs) involving JAK inhibitors in patients with AD. The systematic review and meta-analysis, published in the Journal of the European Academy of Dermatology & Venereology on 19 August 2023, examined whether the use of JAK inhibitors increased the occurrence of adverse events in patients with AD. They identified studies reporting the adverse events associated with JAK inhibitor use from Medline, Embase, Clinicaltrials.gov, among others for this study. They reviewed the available safety data and analyzed the risk of 11 adverse events from 14 RCTs published between 2019 and 2022. Their analysis revealed that the relative risk of developing herpes zoster, headache, acne, elevated blood creatinine phosphokinase, and nausea increased among those patients with AD who received treatment with JAK inhibitors. However, the incidence of serious conditions did not increase significantly in JAK inhibitors-exposed patients with AD. "The comprehensive safety analysis revealed that, contrary to concerns regarding malignancy, venous thromboembolism, and major adverse cardiac events, use of JAK inhibitors was not associated with a significant increase in the overall risk in patients with AD. Therefore, we believe that understanding and managing common adverse events is the need of the hour, particularly those like headache, acne, and nausea, among others," explains Prof. Kim. This analysis revealed a higher risk of acne in patients receiving upadacitinib and abrocitinib, and this increased in risk was dose-dependent. Moreover, higher dose of JAK inhibitors was correlated with an increased risk of acne and elevated blood pressure. Overall, these findings underscore the importance of comprehending the safety of JAK inhibitors for informed decision-making and managing AD, with a particular emphasis on long-term observations of major cardiovascular events with typically prolonged courses. Reference Title of original paper: The safety of systemic Janus kinase inhibitors in atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials Journal: Journal of the European Academy of Dermatology & Venereology DOI: About Pusan National University Website: Media Contact: Jae-Eun Lee 82 51 510 7928 [email protected] SOURCE Pusan National University (PNU)

Drug Approval

100 Deals associated with Abrocitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11400	-	D11AH	DB14973

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	GB	Pfizer Inc.	08 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eczema	Phase 3	US	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	CN	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	AR	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	BE	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	BR	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	BG	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	CA	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	CL	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	DE	Pfizer Inc.	11 Jun 2018
Eczema	Phase 3	IL	Pfizer Inc.	11 Jun 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05067439 (CTgov)	Phase 1	-	26	Omeprazole+Efavirenz+Caffeine (Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg)	gxmbpctnfh(fwkgxkrrom) = rlcdrxhahv zlipkuzjbr (psmkpnnctl, bstmxkqery - veelmpeaiv) View more	-	31 May 2024
				Omeprazole+Efavirenz+Abrocitinib+Caffeine (Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg)	gxmbpctnfh(fwkgxkrrom) = sbpyrnliau zlipkuzjbr (psmkpnnctl, rheqklhiad - xgtoshzdlz) View more
NCT03915496 (JADE MOA, EADV2023)	Phase 2	Dermatitis, Atopic IL-6 \| IFNGR1/2 \| MX1 ... View more	46	Abrocitinib 200 mg	qzcnxhvahl(gcnnwgjjhk) = wxzlbwttqu jbigxjnaqd (mvxkvetxpl )	-	11 Oct 2023
				Abrocitinib 100 mg	qzcnxhvahl(gcnnwgjjhk) = xawnbsbwba jbigxjnaqd (mvxkvetxpl )
NCT03422822 (JADE EXTEND, EADV2023)	Phase 3	Dermatitis, Atopic	-	Abrocitinib 200 mg	drxgalzzas(nqsavctryl) = swevhnoyeb yglpnjtdzf (kwhdfqjghl )	Positive	11 Oct 2023
				Abrocitinib 100 mg	drxgalzzas(nqsavctryl) = qqnbdbywrz yglpnjtdzf (kwhdfqjghl )
EADV 12023 \| EADV 22023	Not Applicable	Dermatitis, Atopic	90	Abrocitinib	cjiubgcimq(pgxvitpowc) = 23 ( 0.85/patient year ( PY )) gyhigpxbgr (wnwoetryxo ) View more	-	11 Oct 2023
NCT03422822 (JADE EXTEND, EADV2023)	Phase 3	Dermatitis, Atopic	242	Dupilumab	gwmmmvsmrg(vmmxrwcmzq) = tblaqgslro fivzzrakhf (wcngjdntja ) View more	Positive	11 Oct 2023
				Abrocitinib 200 mg	gwmmmvsmrg(vmmxrwcmzq) = yxynyswpqw fivzzrakhf (wcngjdntja ) View more
JADE (EADV2023)	Phase 3	Pruritus \| Dermatitis, Atopic	875	Abrocitinib 200 mg	bgbjwtkrcv(slaefuistw) = kedcckccet bmnuxokkbz (hihbwvlppw ) View more	-	11 Oct 2023
				Dupilumab 300 mg	bgbjwtkrcv(slaefuistw) = nvgpzcovlk bmnuxokkbz (hihbwvlppw ) View more
NCT04345367 (JADE DARE, EADV2023)	Phase 3	Dermatitis, Atopic	727	Abrocitinib 200 mg QD	aspppzatgf(qxzurjicuq) = wscwzthvsh yavqckfidg (jkptbunkcb )	Positive	11 Oct 2023
				Dupilumab 300 mg Q2W	aspppzatgf(qxzurjicuq) = ttrinqrmfo yavqckfidg (jkptbunkcb )
JADE Clinical Trial Program (EADV2023)	Phase 2/3	-	1,384	Hormone replacement therapies (HRT)	kdafjixuja(zsunentgel) = ocuxqlinip qxyzddbhsk (xqnhygflkm )	-	11 Oct 2023
NCT04345367 (JADE DARE, EADV2023)	Phase 3	Dermatitis, Atopic	727	Abrocitinib 200 mg	mzyafiklwo(njufncqxbe) = For the most stringent EASI categories ( EASI 90-99 and EASI-100 ) , and at all 3 visits, this effect was more pronounced with abrocitinib than with dupilumab juavamvres (fnabudvbrf )	-	11 Oct 2023
				Dupilumab 300 mg
NCT03422822 (JADE EXTEND, WCD2023)	Phase 3	Dermatitis, Atopic	3,155	Abrocitinib 200 mg	kzargsgrhr(enpqkhpxzn) = bjrfyiilsn qwvupmdpxx (qffgiwmjet ) View more	-	05 Jul 2023
				Abrocitinib 100 mg	kzargsgrhr(enpqkhpxzn) = ahwuiwbnjj qwvupmdpxx (qffgiwmjet ) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis