Delving into the Latest Updates on Ustekinumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-interleukin-12 p40 monoclonal antibody, Stellara, Sterrara

+ [13]

Target

IL-12 x IL-23

Mechanism

IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [4]

Active Indication

Colitis, UlcerativeCrohn DiseaseArthritis, Psoriatic+ [10]

Inactive Indication

DermatomyositisHidradenitis SuppurativaMultiple Sclerosis, Relapsing-Remitting+ [10]

Originator Organization

Janssen Biotech, Inc.

Active Organization

Janssen Research & Development LLCJanssen-Cilag Ltd.Janssen-Cilag Pty Ltd.

+ [9]

Inactive Organization

Centocor, Inc.

Xian-Janssen Pharmaceutical Ltd.Janssen Ortho LLC

+ [2]

Drug Highest PhaseApproved

First Approval Date

EU (15 Jan 2009),

Arthritis, PsoriaticCrohn's disease, active moderateCrohn's disease, active severe+ [3]

RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (US)

Login to view timeline

Gene Sequence

Sequence Code 143665H

Source: *****

Sequence Code 143874L

Source: *****

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Start Date01 Aug 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

[+6]

NCT06520397 / RecruitingPhase 4IIT

Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate the efficacy and safety of dual-target therapy (Ustekinumab combined with Upadacitinib) versus intensified Ustekinumab monotherapy in patients with Crohn's disease who have an inadequate response to standard doses of Ustekinumab. The main questions it aims to answer are:
Is dual-target therapy more effective than intensified Ustekinumab monotherapy in achieving endoscopic remission in Crohn's disease patients?
Is dual-target therapy as safe as intensified Ustekinumab monotherapy in terms of adverse events?
Participants will:
Receive either dual-target therapy (Ustekinumab combined with Upadacitinib) or intensified Ustekinumab monotherapy.
Attend regular clinic visits for monitoring and assessments. Complete questionnaires about their symptoms and quality of life. Undergo routine blood tests and endoscopic evaluations to assess disease activity.
Researchers will compare the dual-target therapy group to the intensified Ustekinumab monotherapy group to see if dual-target therapy is more effective in achieving endoscopic remission and is as safe in terms of adverse events.

Start Date15 Jul 2024

Sponsor / Collaborator

The Sixth Affiliated Hospital of Sun Yat-Sen University

NCT06453317 / Not yet recruitingPhase 2IIT

Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis (COMBO-UC)

The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis. It will also learn about the safety of this combination. The main questions it aims to answer are:
Does the combination therapy improve the symptoms and heal the intestine quicker and better than these drugs administered alone? Does the combination therapy improve the quality of life better than these drugs administered alone? What medical problems do participants have when taking the combination therapy?
Participants:
Patients diagnosed with UC will be qualified to biologic therapy (infliximab/ustekinumab/infliximab + ustekinumab).
Visit the clinic in stated periods for assessment and to apply medication. Take drugs based on the schedule.

Start Date01 Jul 2024

Sponsor / Collaborator

Medical University of Lodz

[+3]

100 Clinical Results associated with Ustekinumab

Login to view more data

100 Translational Medicine associated with Ustekinumab

Login to view more data

100 Patents (Medical) associated with Ustekinumab

Login to view more data

3,200

Literatures (Medical) associated with Ustekinumab

01 Jan 2025·EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY

The incidence of hepatitis B reactivation in patients receiving ustekinumab: a systematic review and proportional meta-analysis

Review

Author: Almokdad, Rasha ; Alhalabi, Marouf M.

Background::

This meta-analysis will evaluate the risk of hepatitis B reactivation in patients treated with ustekinumab for inflammatory bowel disease and psoriasis. We aim to determine the true incidence of this adverse event, reconcile discrepancies in reported reactivation rates, and elucidate the associated risk.

Methods::

We conducted a rigorous systematic review adhering to established guidelines. Major databases like MEDLINE, Google Scholar, CENTRAL, and ClinicalTrials.gov were searched. Studies involving patients with documented hepatitis B infection undergoing ustekinumab therapy were included. Patients receiving concurrent antiviral medications were excluded. To account for potential underreporting, studies without reactivation events or with sample sizes ≥3 were also considered by using generalized linear mixed models and Clopper–Pearson confidence intervals. This review was prospectively registered in PROSPERO (CRD42023418130).

Results::

We analyzed data from nine studies involving 104 hepatitis B virus (HBV)-infected patients. The pooled HBV reactivation (HBVr) incidence among hepatitis B surface antigen-positive patients was 10% [95% confidence interval (CI): 0–31%], with low heterogeneity (I2 = 7.13%, τ2 = 0.4) and a nonsignificant Q-statistic (Q = 5.38, P = 0.37). For the occult HBV-infected patients, the pooled HBVr incidence was 3% (95% CI: 0–11%), with no heterogeneity (I2 = 0%, τ2 = 0.0) and a nonsignificant Q-statistic (Q = 2.7, P = 0.61). The reactivation rates showed high consistency across studies, with no significant difference between the two groups.

Conclusions::

While our data suggest lower HBVr risk with ustekinumab, confirmation is needed due to limited sample size and retrospective design.

01 Jan 2025·Current rheumatology reviews

Rituximab Induced Flare of Psoriatic Arthritis in a Patient with Devic's Syndrome: A Case Report

Author: Arkfeld, Daniel G. ; Mortezaei, Kiana ; Gonzales, Sofia Audrey B.

Introduction/Background:::

Devic’s syndrome is a rare autoimmune disorder that occurs when the body's immune system damages and mistakenly attacks the optic nerves and spinal cord, leading to numerous neurological symptoms such as inflammation, weakness, numbness, and vision problems. Rituximab has mainly been utilized as an immunosuppressive therapy for patients with Devic’s syndrome. Although evidence has shown that rituximab is efficient and well tolerated in treating patients with Devic’s syndrome, there is the possibility of rituximab exacerbating severe psoriasis and psoriatic arthritis flare.

Case Presentation:::

In this paper, we describe a case of a 58-year-old female with Devic’s syndrome, blindness, and neurological involvement who responded exceptionally well to rituximab but developed a severe flare of psoriatic arthritis. After withdrawing from the use of rituximab, her psoriatic arthritis symptoms had resolved. However, she did have another episode of blindness, and rituximab was started once again. Although her vision improved, her psoriatic arthritis symptoms had reoccurred. The patient was switched to eculizumab and ustekinumab, which controlled both her psoriatic arthritis and Devic’s syndrome.

Conclusion:::

Very few reports have identified rituximab to induce a flare-up of psoriatic arthritis, raising uncertainty regarding its potential effects on psoriatic symptoms. The precise mechanism underlying the exacerbation of psoriatic arthritis by rituximab remains uncertain. This case report highlights that rituximab can worsen psoriasis and psoriatic arthritis, and that the complexities of Devic’s syndrome may require medication adjustments.

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

Prescribing patterns and persistence of biological therapies for psoriasis management: a retrospective cohort study from Saudi Arabia

Article

Author: Fazel, Mohammad ; Alyazidi, Wejdan ; Alkaff, Tuqa ; Almalki, Ziyad ; Alomar, Mukhtar ; Alamer, Ahmad ; Almakki, Sarah ; Mobarki, Fatimah ; Aldosari, Saad ; Alahmari, Abdullah

BACKGROUND:

Biological therapies are effective for psoriasis, but patient responses vary, often requiring therapy switching or discontinuation.

OBJECTIVES:

To identify physicians' prescribing patterns of biological therapies at a referral tertiary center in Saudi Arabia and assess the probability of biologic persistence following treatment initiation.

METHODS:

We conducted a retrospective study of biologic-naïve adult psoriasis patients who initiated therapy from October 2013 to July 2022 in Dammam. Descriptive statistics and a Kaplan-Meier analysis evaluated treatment persistence at 6, 12, 24, and 36 months.

RESULTS:

A total of 151 patients received adalimumab (n = 89), etanercept (n = 17), risankizumab (n = 30), ustekinumab (n = 14), and ixekizumab (n = 1). At 6 months, all therapies demonstrated 100% persistence. At 12 months, persistence was highest for ustekinumab (100%) and lowest for etanercept (88.2%). At 24 months, ustekinumab maintained 100% persistence, followed by risankizumab (96.6%), adalimumab (94.3%), and etanercept (76.4%). At 36 months, risankizumab had the highest persistence (96.6%), followed by adalimumab (83.1%), ustekinumab (78%), and etanercept (70.6%). The most common reasons for discontinuation were lack of effectiveness and intolerability.

CONCLUSION:

This study shows changing psoriasis treatment patterns with new therapies. Risankizumab demonstrated high long-term persistence, while etanercept and ustekinumab showed declining persistence, suggesting evolving treatment considerations.

346

News (Medical) associated with Ustekinumab

02 Dec 2024

·endpts.com

J&J looks to expand Tremfya in two pediatric indications

Johnson & Johnson has filed for two new pediatric indications as it looks to position its blockbuster immunotherapy Tremfya as a follow-on to its megablockbuster Stelara. If approved, Tremfya would become available to children 6 years and older with moderate-to-severe plaque psoriasis and children 5 years and older with active juvenile psoriatic arthritis. J&J’s immunodermatology disease area leader Liza O’Dowd said in a news release that there is a “critical gap” in the treatment of children and adolescents with those conditions, some of whom experience “debilitating symptoms.” “This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” she said. Tremfya was first approved in 2017 for adults with plaque psoriasis. It generated $3.1 billion in 2023 sales, though executives think it could eventually rival the company’s immunosuppressant Stelara, which made $10.9 billion that same year. Tremfya won approval in September to treat ulcerative colitis, expanding for the first time into inflammatory bowel disease, a key area for Stelara. Stelara is approved to treat children 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. However, biosimilars to Stelara are expected to hit the market in 2025. The latest to win approval is Biocon Biologics’ Yesintek . “When we take a look going forward and what we had seen with Stelara in terms of the strength in IBD and the potential, we think that Tremfya definitely is an asset that is of Stelara’s size or bigger and better,” J&J’s executive VP and worldwide chairman of innovative medicine Jennifer Taubert said on the company’s latest quarterly call in October, according to an AlphaSense transcript.

Drug ApprovalImmunotherapyBiosimilar

02 Dec 2024

·endpts.com

Biocon lands FDA approval for another Stelara biosimilar

Biocon Biologics scored an FDA approval for its Stelara biosimilar, marketed as Yesintek, the company announced Monday. Biocon entered into a settlement and licensing agreement with Johnson & Johnson, which owns Stelara, earlier this year, agreeing to commercialize Yesintek in the US no later than Feb. 22, 2025. A representative for the company told Endpoints News that Biocon is “unable to disclose” the price of Yesintek at this time. At least five other biosimilars to Stelara are expected to launch in the first three months of 2025. Stelara (ustekinumab) was first approved by the FDA in 2009, and will begin to see competition on Jan. 1, 2025, with the launch of Amgen’s biosimilar Wezlana. That launch and others in February from Samsung and Biocon already have implications for insurers. Optum Rx and Cigna in September each made moves to prioritize Stelara competition. Stelara pulled in $2.6 billion in the third quarter of this year for J&J, about a 6% decrease from the previous quarter. J&J’s VP of investor relations said during the third-quarter investor call that the decline was “driven by unfavorable net patient mix and share loss,” adding that biosimilar competition had already entered Europe in July and that the company expects biosimilar entry in the US next year. J&J has made at least six deals over the last two years with companies looking to launch biosimilars in 2025, including Amgen and Sandoz. Amgen will likely launch first on Jan. 1, 2025, while Samsung Bioepis , Sandoz , Fresenius Kabi (working with Formycon), and Biocon can launch their respective biosimilars in the US on Feb. 22. Teva and Alvotech in September also won FDA approval for their biosimilar, known as Selarsdi, which they expect to launch in the first quarter of 2025. In addition to the competition, Stelara was also one of the first 10 drugs selected by CMS under the Inflation Reduction Act and is subject to negotiated prices starting in 2026. While there was talk last year of potentially removing Stelara from the list due to the incoming biosimilars, Stelara so far remains subject to negotiations as J&J previously confirmed to Endpoints that it expects Wezlana to launch past the August deadline for competition.

License out/inDrug Approval

02 Dec 2024

·pipelinereview.com

U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab)

BENGALURU, Karnataka, India I December 01, 2024 I Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara® (Ustekinumab). YESINTEK™, a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. Biocon Biologics Ltd had previously notified the Stock Exchange on Feb 29, 2024, that the Company had entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialize YESINTEK™ in the United States of America no later than on February 22, 2025, upon approval from the U.S. FDA. SOURCE: Biocon Biologics

Drug ApprovalLicense out/in

100 Deals associated with Ustekinumab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D09214	Ustekinumab	L04AC05	DB05679

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	AU	Janssen-Cilag Pty Ltd.	28 Jul 2009
Crohn Disease	AU	Janssen-Cilag Pty Ltd.	28 Jul 2009
Arthritis, Psoriatic	EU	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	IS	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	LI	Janssen-Cilag International NV	15 Jan 2009
Arthritis, Psoriatic	NO	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	EU	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	IS	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	LI	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active moderate	NO	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	EU	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	IS	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	LI	Janssen-Cilag International NV	15 Jan 2009
Crohn's disease, active severe	NO	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	EU	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	IS	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	LI	Janssen-Cilag International NV	15 Jan 2009
Plaque psoriasis	NO	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	EU	Janssen-Cilag International NV	15 Jan 2009
Ulcerative colitis, active moderate	IS	Janssen-Cilag International NV	15 Jan 2009

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	US	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	AR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	DK	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	FR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	DE	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	IT	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	PL	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	ES	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	TR	Janssen Research & Development LLC	30 Aug 2022
Juvenile Idiopathic Arthritis	Phase 3	GB	Janssen Research & Development LLC	30 Aug 2022

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04882072 (CTgov)	Phase 3	Takayasu Arteritis	14	placebo+ustekinumab (Double-blind: Placebo)	esvqzbzymw(nfbhrgqlhb) = hjmutsqrqb prcvlwhqwk (eidldjkheq, hnbvqudmma - ckrlxwtufz) View more	-	02 Dec 2024
				Ustekinumab (Double-blind: Ustekinumab)	esvqzbzymw(nfbhrgqlhb) = lnjunfyfkl prcvlwhqwk (eidldjkheq, cwimkpldsj - yckotpuqti) View more
UEGW	Not Applicable	Crohn Disease	-	Ustekinumab as 1st line biologic treatment	jqeoabiaay(ytbqtonoev) = 63.9% (108/169) of patients experienced adverse events draijwzail (vgqnqsnahh ) View more	-	13 Oct 2024
				Ustekinumab as 2nd line biologic treatment
NCT03942120 (K-STAR, Pubmed \| Inflamm Bowel Dis) Manual	Not Applicable	Crohn Disease Maintenance \| Induction	464	Ustekinumab	(fxlvodnsoy) = vcxixyocnj yjiyjjctxw (rnqsoxgtqu ) View more	Positive	03 Aug 2024
				Ustekinumab (At week 52 to 66)	(fxlvodnsoy) = psqfxcrqbf yjiyjjctxw (rnqsoxgtqu ) View more
NCT04093531 (CTgov)	Phase 1	Primary Sjögren's syndrome	12	ustekinumab	jidpwltvag(sxtyssliom) = tziobzlvae xjztmfzmnz (osqsaonqov, oizxhddimo - sqspxvuiwf) View more	-	25 Jun 2024
NCT03981744 (CTgov)	Phase 3	Dermatomyositis	51	placebo+ustekinumab (Placebo)	opnzjxrsia(cnmzbyfzvj) = ynythihlbk folpfrkuxs (fzynogfvpk, eijitzfrnu - zumivhedue) View more	-	13 May 2024
				Ustekinumab (Ustekinumab)	opnzjxrsia(cnmzbyfzvj) = ngbbfknkmk folpfrkuxs (fzynogfvpk, qctinjurls - zjiitjdlxw) View more
ACR2023	Not Applicable	Arthritis, Psoriatic First line	186	UST+MTX	hchjtwxqtz(kyykckwctm) = yspahytlqm sctjhiijtr (pngdojjufw ) View more	Positive	13 Nov 2023
				UST+PBO	hchjtwxqtz(kyykckwctm) = duiqwatmnn sctjhiijtr (pngdojjufw ) View more
UEGW	Not Applicable	Crohn Disease	-	UST IV	yyqhrffqqo(fngberiayb) = jnsbbvebec kcmhfyckmo (mixcvmsjxm )	-	15 Oct 2023
				UST SC	yyqhrffqqo(fngberiayb) = dqbdolhllf kcmhfyckmo (mixcvmsjxm )
UEGW	Not Applicable	Colitis, Ulcerative	-	IV Ustekinumab	kbuezzfkyu(sdkakdhdzo) = hmvplotsqt iwtxrwysiz (cmhvnxccua )	-	15 Oct 2023
				Placebo	kbuezzfkyu(sdkakdhdzo) = qmfekqqevz iwtxrwysiz (cmhvnxccua )
EADV2023	Not Applicable	Plaque psoriasis	581	AVT04	waqmpggdxm(ukzechutdo) = nscwnwwrky ferbvtyuuz (bnyhtznhha )	Positive	11 Oct 2023
				Reference Product Ustekinumab	waqmpggdxm(ukzechutdo) = uxplharcpm ferbvtyuuz (bnyhtznhha )
NCT03782376 (POWER, CTgov)	Phase 3	Crohn Disease	215	Placebo (SC)+Ustekinumab 90 mg (SC) Group 1 (Group 1: Ustekinumab (IV Re-induction))	ddwachgbvc(kewrgrlshf) = sejvzneytt iecbybrghh (vfrkrcbfeu, rthhqnakxh - ezhicrdckc) View more	-	13 Sep 2023
				Placebo (IV)+Ustekinumab 90 mg (SC) Group 2 (Group 2: Ustekinumab (Continuous q8w SC Maintenance))	ddwachgbvc(kewrgrlshf) = lreryjqsdy iecbybrghh (vfrkrcbfeu, yugxcbfvhc - bsxcvmzhhp) View more