Delving into the Latest Updates on Abrocitinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ABRO

+ [5]

Target

JAK1

Mechanism

JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [3]

Active Indication

Dermatitis, AtopicModerate Atopic DermatitisSevere Atopic Dermatitis+ [2]

Inactive Indication

EczemaLiver InjuryPlaque psoriasis+ [3]

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.

Huizhi Pharmaceutical (Dalian) Co., Ltd.Pfizer Europe MA EEIG

+ [3]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

GB (08 Sep 2021),

Dermatitis, Atopic

RegulationPromising Innovative Medicine (GB), Breakthrough Therapy (US), Priority Review (CN)

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Structure

Molecular FormulaC14H21N5O2S

InChIKeyIUEWXNHSKRWHDY-PHIMTYICSA-N

CAS Registry1622902-68-4

The primary purpose of this phase 2a study is to compare the efficacy of abrocitinib to placebo in improving severe fatigue in non-hospitalized adults with symptomatic Post-COVID Condition (PCC) (also called Long COVID). We are also interested in learning if abrocitinib is effective in improving overall health status in people suffering from severe fatigue from PCC. Eligible participants with a confirmed history of COVID19 infection who also have PCC according to the World Health Organization definition, will be randomized to receive abrocitinib at a dose of 50 mg, 100 mg, or placebo by mouth daily for 12 weeks (84 days).

Start Date27 Dec 2024

Sponsor / Collaborator

Beth Israel Deaconess Medical Center, Inc.

[+1]

CTIS2023-504539-42-00 / Recruiting

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 - INNO-6052

Start Date20 Oct 2024

Sponsor / Collaborator

Innovaderm Research, Inc.

NCT06573593 / RecruitingNot ApplicableIIT

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

Start Date29 Jul 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

100 Clinical Results associated with Abrocitinib

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100 Translational Medicine associated with Abrocitinib

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100 Patents (Medical) associated with Abrocitinib

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278

Literatures (Medical) associated with Abrocitinib

31 Dec 2024·Journal of Medical Economics

Short- and long-term cost-effectiveness of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis in China

Article

Author: Shi, Yin ; Liu, Shao ; Li, Shuishi ; Zhou, Yanwu ; Guan, Haijing

BACKGROUNDSBiologics and JAK inhibitors were the most effective innovative systemic treatments for moderate-to-severe atopic dermatitis (AD). However, their cost-effectiveness in China remains unclear. This study aims to compare both the short- and long-term cost-effectiveness of abrocitinib and dupilumab in adults with moderate-to-severe AD from the perspective of the Chinese healthcare system.METHODSA hybrid decision tree and Markov model were developed to simulate the costs and health outcomes of interventions on both short-term and long-term horizons. Short- and long-term horizons were employed to reflect the 26-week induction treatment and model the extended 10-year maintenance treatment period, respectively. The cost-effectiveness of strategies was measured by incremental cost-effectiveness ratios (ICERs), which were then compared with the willingness-to-pay threshold (WTP) that was equivalent to the gross domestic product (GDP) per capita of China in 2023 ($12,681 [€11679.26]). One-way and probabilistic sensitivity analyses were conducted to validate the robustness of the model.RESULTSOver the short-term horizon, the QALYs (quality-adjusted life years) gained were 0.43 for the abrocitinib group and 0.42 for the dupilumab group, with the costs being $2,716.01 (€2501.46) and $3,940.33 (€3629.06), respectively. Over the long-time horizon, abrocitinib therapy yields higher QALYs (6.60 versus 6.53) and incurs a lower cost ($22,765.15 [€20966.81] versus $30,683.38 [€28259.54]) compared to dupilumab. The probability of abrocitinib being cost-effective was nearly 100% under the current WTP. Both short- and long-term results showed that abrocitinib was more effective and less costly than dupilumab, making abrocitinib the dominant option.CONCLUSIONSAbrocitinib was dominant compared to dupilumab both over the short- and long-term horizon for moderate-to-severe AD in China. Future research incorporating real-world evidence and long-term efficacy outcomes could further refine these economic evaluations.

31 Dec 2024·Journal of Dermatological Treatment

Oral abrocitinib in the treatment of granuloma annulare: a case report

Article

Author: Liang, Jingyao ; Chen, Weifeng ; Zhang, Xibao ; Yu, Yihui ; Liu, Wenyan ; Zhu, Junhui ; Tian, Xin

Aim: To evaluate the therapeutic efficacy and safety of JAK inhibitor abrocitinib in patients with localized granuloma annulare (GA) and to review the available cases documented in English.Methods: We presented a patient who had a persistent, localized granuloma anulare (GA) for one year and did not respond to traditional therapies. This patient was treated with oral abrocitinib at a dosage of 150 mg daily.Results: After 6 weeks of treatment with abrocitinib, the patient exhibited notable symptom improvement with no new lesions. No adverse events or recurrences were reported during the 5-month follow-up period.Conclusions: Abrocitinib may be a promising and safe treatment option for patients with localized GA who do not respond to traditional therapies.

31 Dec 2024·Journal of Dermatological Treatment

Short-term effectiveness and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis: results from a 16-week real-world multicenter retrospective study – il AD (Italian landscape atopic dermatitis)

Article

Author: Napolitano, Maddalena ; Calzavara-Pinton, Piergiacomo ; Gola, Massimo ; Vaccino, Marco ; Maurelli, Martina ; Caccavale, Stefano ; Patruno, Cataldo ; Alfano, Angela ; Tirone, Benedetta ; Narcisi, Alessandra ; Pezzolo, Elena ; Morrone, Pietro ; Balato, Anna ; Ortoncelli, Michela ; Rossi, Mariateresa ; Veronese, Federica ; Fargnoli, Maria C. ; Barei, Francesca ; Amoruso, Fabrizio ; Guanti, Mario B. ; Esposito, Maria ; Savoia, Paola ; Costanzo, Antonio ; Malagoli, Piergiorgio ; Ribero, Simone ; Musumeci, Maria L. ; Ibba, Luciano ; Gargiulo, Luigi ; Ferrucci, Silvia M. ; Sciarrone, Claudio ; Girolomoni, Giampiero ; Burroni, Anna G. ; Gurioli, Carlotta ; Magliulo, Manfredi ; Foti, Caterina ; Piraccini, Bianca M.

Aim: Abrocitinib is a JAK-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD). We conducted a 16-week multicenter retrospective study to assess the short-term effectiveness and safety of abrocitinib in patients with moderate-to-severe AD.Our retrospective study included 85 adult patients from 14 Italian Dermatology Units affected by moderate-to-severe AD treated with abrocitinib 100/200 mg.Methods: Effectiveness of abrocitinib at weeks 4 and 16 was assessed by using the Eczema Area and Severity Index (EASI), the Investigator Global Assessment (IGA), the peak pruritus and sleep- Numerical Rating Scale (PP-NRS and S-NRS, respectively).Results: At week 16, improvement of at least 90% in EASI (EASI90) and IGA 0/1 was observed in 49.4% and 61.2% of patients, respectively. A reduction of at least 4 points in PP-NRS and S-NRS compared with baseline was achieved by 70.6% of patients for both endpoints. No significant safety reports were observed during the study period. Naïve patients had better rates of EASI 90 compared to patients who previously failed dupilumab.Conclusion: Our data confirm the effectiveness of abrocitinib in a real-world setting with better clinical responses at weeks 4 and 16, compared with Phase-III clinical trials. Longer analyses are required to further establish the safety profile of abrocitinib.

35

News (Medical) associated with Abrocitinib

09 Sep 2024

·www.biospace.com

The Highly Anticipated FDA Approvals of Galderma’s Nemolizumab and Eli Lilly’s Lebrikizumab are Expected to Shift Dermatologists’ Perceptions of the Atopic Dermatitis Market

While reported use of Sanofi/Regeneron’s Dupixent has declined with the adoption of LEO’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq, the overall population receiving advanced treatments is on the rise, according to Spherix Global Insights. EXTON, PA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Since its 2017 debut as the first advanced systemic treatment for atopic dermatitis (AD), Sanofi/Regeneron’s Dupixent has dominated the US market. However, the introduction of LEO Pharma’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq has started to disrupt the treatment landscape. While Dupixent still holds the highest market share by a significant margin, its dominance is gradually diminishing with the rising adoption of these newer treatments and is expected to continue declining as additional therapies emerge. Spherix Global Insights has been closely monitoring the AD market since before Dupixent’s launch, providing quarterly updates through the RealTime Dynamix™ service. The latest quarterly results indicate that despite a mixed initial reception, Adbry has significantly grown and now competes closely with Rinvoq, whose usage has plateaued since 2022. Despite the evolution of the treatment landscape, results from the study also reveal dermatologist (n=105) estimates of the adult population receiving advanced systemic treatments have grown over the past two years, now capturing two-fifths of adult atopic dermatitis patients. This growth highlights the increasing demand for effective AD treatments and underscores the need for new options in the market. With a growing pipeline and increased competition, manufacturers will need to differentiate their assets. According to Spherix’s latest quarterly report, specific efficacy attributes including itch reduction as well as mechanism of action are considered key differentiators, both of which Galderma’s nemolizumab brings to the market. Further, physicians report the highest unmet needs for patients on a second-line advanced systemic and those with severe itch, two patient types manufacturers are keen to capture. The potential approvals of Galderma’s nemolizumab and Eli Lilly’s lebrikizumab are poised to further shift physician perceptions. Preference for the IL-13 mechanism has been steadily declining over the past few years in favor of the IL-31 mechanism, now on par with JAK inhibitors. As such, the percentage of dermatologists that prefer nemolizumab to gain FDA approval is more than double that of lebrikizumab, however, dermatologists are anticipating adopting both therapies at the expense of Dupixent. Of note, the potential adoption of nemolizumab is further supported by the anticipated prescriber experience from nemolizumab’s recent approval for prurigo nodularis , a skin condition characterized by chronic itch. Spherix Global Insights remains dedicated to tracking these developments, offering critical insights into the evolving atopic dermatitis market and guiding stakeholders through the shifting treatment landscape. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit  spherixglobalinsights.com  or connect through  LinkedIn .  For more details on Spherix’s primary market research reports and interactive dashboard offerings, visit or register here:  NOTICE : All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement. CONTACT: Gianna Melendez, Dermatology Franchise Head Spherix Global Insights 4848794284 gianna.melendez@spherixglobalinsights.com

Drug Approval

28 Aug 2024

·firstwordpharma.com

Pfizer launches virtual platform to help patients navigate the US healthcare system

Pfizer announced on Tuesday the launch of PfizerForAll, a virtual health platform designed to streamline health services and resources for Americans, including filling prescriptions and receiving help with co-pays to save money on Pfizer medicines.PfizerForAll offers vaccination appointment scheduling, access to same-day in-person and telehealth appointments, home delivery of prescriptions and diagnostic tests, migraine managements, and patient support services nationwide. Patients will be able to access services from UpScriptHealth, Alto Pharmacy and Instacart in addition to existing insurance and pharmacy programs.The list of medications Pfizer provides for savings assistance includes Cibinqo (abrocitinib), Genotropin (somatropin) and Ibrance (palbociclib). The latter is a breast cancer medication whose price rose nearly 7% in 2022, and analysts have pegged it as a likely target for future rounds of Medicare price negotiations. The company’s prostate cancer drug Xtandi was the subject of criticism several years ago for its high cost to patients, though it was not included as an option under PfizerForAll cost savings assistance. This launch aims to help people navigate the complexities and “roadblocks” in the US healthcare system. The company’s Executive Vice President and Chief US Commercial Officer Aamir Malik described the US healthcare system’s current gaps as “time-consuming” and overwhelming for patients, leading to indecision and therefore “poor health outcomes.”Malik remarked, “We are pleased to offer PfizerForAll to help relieve this burden on people, especially as we enter the fall season in the US, and streamline the path for those seeking better health.”

10 Jul 2024

·www.pharmaceutical-technology.com

NICE recommends Ebglyss for atopic dermatitis patients

Around 5.2 million adults in the UK have moderate to severe atopic dermatitis. Image credit: Shutterstock / Kmpzzz. England’s National Institute for Health and Care Excellence ( Nice ) has recommended Almirall ’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma ’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer , Eli Lilly, and AbbVie , respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of up to 4.4% among adults in the EU. In the UK alone, around 5.2 million adults have moderate to severe atopic dermatitis. See Also: Dupixent “addresses current gap” in COPD biologics landscape Peltopepimut-s by ISA Pharmaceuticals for Cervical Cancer: Likelihood of Approval Ebglyss, which was approved in Europe in October 2023, and then two months later in the UK, works by inhibiting interleukin-13 (IL-13) signalling. IL-13 pathways play an important role in inflammation, driving the type-2 inflammatory loop in the skin. Adbry similarly targets IL-13 while Dupixent inhibits IL-13 and IL-4. The National Eczema Society’s chief executive Andrew Proctor said: “It’s important we have a range of treatment options, so patients have the chance to access a treatment that works well for them.” Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. By 2030, the drug is predicted to generate nearly $3.4bn in global sales. GlobalData is the parent company of Pharmaceutical Technology. Amid Sanofi and Regeneron’s Dupixent dominance , Johnson & Johnson (J&J) made a play for the atopic dermatitis space earlier this year when it spent $1.25bn to acquire Numab Therapeutics’ antibody NM26 in May.

Drug ApprovalAcquisition

100 Deals associated with Abrocitinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D11400	Abrocitinib	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
Moderate Atopic Dermatitis	Phase 3	AU	Pfizer Inc.	07 Dec 2017
Moderate Atopic Dermatitis	Phase 3	CZ	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	PL	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	DE	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	CA	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	CZ	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	AU	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	HU	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	GB	Pfizer Inc.	07 Dec 2017
Severe Atopic Dermatitis	Phase 3	US	Pfizer Inc.	07 Dec 2017

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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)	tvxzlnmyty(eputwanlrf) = tbgabigwfe rxqwmkmcbz (ncihkklmuu, eueakodeck - gbpafqhagm) View more	-	31 May 2024
				Omeprazole+Efavirenz+Abrocitinib+Caffeine (Abrocitinib 200 mg QD + Caffeine 100 mg + Efavirenz 50 mg + Omeprazole 10 mg)	tvxzlnmyty(eputwanlrf) = taxkyjrocp rxqwmkmcbz (ncihkklmuu, gszxbcbhea - tydzuybhha) View more
NCT03575871 \| NCT03422822 \| NCT03349060 \| NCT02780167 \| NCT03720470 (Pubmed \| Skin Health Dis) Manual	Phase 2/3	Dermatitis, Atopic	-	Abrocitinib 100 mg	(xokktacoxk) = jyaorvzcwa xzeqznmnjx (xumiloshhq ) View more	Positive	05 May 2024
				Abrocitinib 200 mg	(xokktacoxk) = tygcrqgvqi xzeqznmnjx (xumiloshhq ) View more
EADV2023	Not Applicable	Dermatitis, Atopic	90	Abrocitinib	eggnycacuh(mnevobvnah) = 23 ( 0.85/patient year ( PY )) czghpbffem (ojstolivmf ) View more	-	11 Oct 2023
NCT04345367 (JADE DARE, EADV2023)	Phase 3	Dermatitis, Atopic	727	Abrocitinib 200 mg QD	yrvmjavkfy(nxygubjgjs) = zuykloqhkx xncmnhugsp (vlcarevbhf )	Positive	11 Oct 2023
				Dupilumab 300 mg Q2W	yrvmjavkfy(nxygubjgjs) = zrlfgcnxvw xncmnhugsp (vlcarevbhf )
JADE COMPARE and JADE DARE (WCD2023)	Not Applicable	Dermatitis, Atopic	-	Abrocitinib 200 mg QD	(hxdpetqfei) = kmieajttdi ijfeygcfch (joatofqjks ) View more	-	05 Jul 2023
				Dupilumab 300 mg every 2 weeks	(hxdpetqfei) = yobgyfnxwh ijfeygcfch (joatofqjks ) View more
NCT03422822 (JADE EXTEND, WCD2023)	Phase 3	Dermatitis, Atopic	3,155	Abrocitinib 200 mg	(rtrhlidwgd) = yjbtuqyxbb sjmxhluvwh (fimakpechm ) View more	-	05 Jul 2023
				Abrocitinib 100 mg	(rtrhlidwgd) = nmqbfbkdsm sjmxhluvwh (fimakpechm ) View more
JADE COMPARE and JADE DARE (WCD2023)	Not Applicable	Asthma \| Rhinitis, Allergic \| Dermatitis, Atopic	1,195	Abrocitinib 200 mg QD	pascrdytpa(vrrexjunye) = dlsnrlmfey nnxxtodahy (ntimkyevpc ) View more	-	03 Jul 2023
				Dupilumab 300 mg Q2W	pascrdytpa(vrrexjunye) = jaxknnhnrn nnxxtodahy (ntimkyevpc ) View more
NCT05038982 (CTgov)	Phase 2	prurigo nodularis \| Pruritus	20	Abrocitinib (Prurigo Nodularis)	lxvqdsmnes(miguiusmxb) = iamidlcbwn imnuaddqnw (tazmfbdoaz, zqtcofuedv - gbkddmlwav) View more	-	03 Jul 2023
				Abrocitinib (Chronic Pruritus of Unknown Origin)	lxvqdsmnes(miguiusmxb) = kwdoabittg imnuaddqnw (tazmfbdoaz, ecxueekgbm - qwuaopafin) View more
NCT03627767 (JADE REGIMEN, Pubmed)	Phase 3	Dermatitis, Atopic	1,235	Abrocitinib 200mg	khthkwzynl(xqjgsdixyz) = incidence was higher in adolescents kcrztzgflo (ijtskzxxqk )	Positive	10 Apr 2023
				Abrocitinib 100mg
NCT03915496 (JADE MOA \| JADE-MOA, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	46	Placebo	ddgugnxxch(kdurnrbsvi) = zfqcfoibla tymytgxxhx (yegifygcwe, swzoygdgul - ajhvsyicwj) View more	-	08 Feb 2023