Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial

Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations >8 μg/mL was not inferior to standard.

Start Date01 Jan 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

NCT02586831 / WithdrawnPhase 1/2IIT

A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT06016517 / Not yet recruitingNot ApplicableIIT

Application of the N-of-1 Trial Design in Rheumatoid Arthritis

The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
What are the effects of different treatments on RA symptoms and condition for each individual patient
What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. adalimumab, 2. sarilumab, and 3. upadacitinib. Participants will be asked to complete questionnaires about their condition and quality of life weekly (either in clinic or remotely) and report their level of pain daily (remotely).

Start Date01 Jul 2024

Sponsor / Collaborator

Tufts Medical Center, Inc.

100 Clinical Results associated with Adalimumab

100 Translational Medicine associated with Adalimumab

100 Patents (Medical) associated with Adalimumab

8,971

Literatures (Medical) associated with Adalimumab

31 Dec 2024·Journal of medical economics

Cost-effectiveness analysis of upadacitinib as a treatment option for patients with rheumatoid arthritis in the Kingdom of Saudi Arabia

Article

Author: Al-Homood, Ibrahim ; Alsaqa'aby, Mai ; Sharma, Yuvraj ; Anwar, Ali ; Alzahrani, Zeyad ; Hamad, Tharwat M ; Mohamed, Omneya ; Husain, Waleed ; Al-Abdulkarim, Hana ; Al Omari, Bedor ; Attar, Suzan M ; Jaheen, Ahmed M

AIM:

To evaluate cost-effectiveness of upadacitinib (targeted synthetic-disease modifying anti-rheumatic drug [ts-DMARD]) as first-line (1 L) treatment versus current treatment among patients with rheumatoid arthritis (RA) in the Kingdom of Saudi Arabia (KSA), who had an inadequate response to prior conventional-synthetic (csDMARDs) and/or biologic-DMARDs (bDMARDs).

METHODS:

This Excel-based model included patients with moderate (Disease Activity Score [DAS28]: >3.2 to ≤5.1) or severe RA (DAS28 > 5.1). Cost-effectiveness of current treatment (1 L: adalimumab-originator/biosimilar; second-line (2 L): other bDMARDs/tofacitinib) was compared against a new treatment involving two scenarios (1 L: upadacitinib, 2 L: adalimumab-biosimilar [scenario-1]/adalimumab-originator [scenario-2]) for a 10-year time-horizon from societal perspective. Model outcomes included direct and indirect costs, quality-adjusted life-years (QALYs), hospitalization days, number of orthopedic surgeries, and incremental cost-utility ratio (ICUR) per QALY.

RESULTS:

With the current pathway, estimated total societal costs for 100 RA patients over 10-year period were Saudi Riyal (SAR) 50,450,354 (United States dollars [USD] 13,453,428) (moderate RA) and SAR50,013,945 (USD13,337,052) (severe RA). New pathway (scenario-1) showed that in patients with moderate-to-severe RA, upadacitinib led to higher QALY gain (+8.99 and +15.63) at lower societal cost (cost difference: -SAR2,023,522 [-USD539,606] and -SAR3,373,029 [-USD899,474], respectively). Thus, as 1 L, upadacitinib projects "dominant" ICUR per QALY over current pathway. Moreover, in alternate pathway (scenario-2), upadacitinib also projects "dominant" ICUR per QALY for patient with severe RA (QALY gain: +15.63; cost difference: -SAR 164,536 [-USD43,876]). However, moderate RA was associated with additional cost of SAR1,255,696 (USD334,852) for improved QALY (+8.99) over current pathway (ICUR per QALY: SAR139,742 [USD37,264]). Both scenarios resulted in reduced hospitalization days (scenario-1: -14.83 days; scenario-2: -11.41 days) and number of orthopedic surgeries (scenario-1: -8.36; scenario-2: -6.54) for moderate-to-severe RA over the current treatment pathway.

CONCLUSION:

Upadacitinib as 1 L treatment in moderate-to-severe RA can considerably reduce healthcare resource burden in KSA, majorly due to reduced drug administration/monitoring/hospitalization/surgical and indirect costs.

01 Jun 2024·International journal of pharmaceutics: X

Effect of treatment with original or biosimilar adalimumab on SARS-CoV2 vaccination antibody titers

Article

Author: Pavloková, Sylvie ; Vetchý, David ; Dokoupilová, Eva ; Hanuštiaková, Markéta

The technological process of production of biosimilars determines the degree of biosimilarity to the original biological drug. In particular, the focus is on the similarity of immunogenic responses. The primary endpoint of our retrospective study was to find the differences in SARS-CoV-2 antibody amount between patients treated with original adalimumab and biosimilar adalimumab MSB11022 (Idacio) and the differences in the SARS-CoV-2 antibody amount between patients treated with and without biological treatment. We collected the gender, autoimmune disease type, age, and treatment data of the patients in the outpatient clinic MEDICAL PLUS, s.r.o., Uherske Hradiste. These patients suffer from autoimmune rheumatic diseases. All patients received the mRNA vaccine (Pfizer/BioNTech - BNT162b2), with a 21-day (interquartile range, 21-24) gap between the two vaccinations. Patients receiving adalimumab were able to develop cellular immune responses after the second vaccination dose, as well as the individuals without adalimumab. In the period of 6-23 weeks after the second vaccination dose (D63 - D182), the SARS-CoV-2 antibody levels did not change significantly in the patients receiving the original adalimumab, while in the patients receiving biosimilar adalimumab a significant decrease was revealed. A statistically significant difference in the SARS-CoV-2 antibody amount between the patients without biological treatment (median: 504.3 U/mL) and with biological treatment (Original and Biosimilar - median: 47.2 and 28.2 U/mL, respectively) was confirmed on day 182. According to our observation, the effect of the treatment type on the increase/decrease of antibodies over time is dominant, while the impact of other variables (gender, methotrexate treatment, autoimmune disease type, and age) was confirmed as insignificant or minor.

01 Mar 2024·European journal of ophthalmology

Ocular toxoplasmosis following anti-tumour necrosis factor-α therapy combined with oral methotrexate therapy: A case report and review of literature

Review

Author: Patnaik, Gazal ; Dutta Majumder, Parthopratim ; Kaushik, V V ; Pyare, Richa

Purpose: To report a case of ocular toxoplasmosis following long-term treatment with adalimumab and review the literature on ocular toxoplasmosis following anti-Tumour necrosis factor-α therapy. Method: A retrospective chart review of A 21-year-old male who developed retinochoroiditis in his left eye following adalimumab therapy combined with oral methotrexate. Result: A known patient of juvenile idiopathic arthritis (JIA) on adalimumab and oral methotrexate for the last four years presented to us with a blurring of vision for the last 15 days. Fundus examination of the left eye revealed severe vitritis and two patches of retinochoroiditis in the inferior part of the fundus. Subsequent investigations confirmed it to be a case of toxoplasma retinochoroiditis, and he responded to anti-toxoplasma treatment. A review of literature on a similar topic revealed five such cases, and the index case was the first such report in patients with JIA. Conclusion: The index case highlights the importance of early recognition and management of opportunistic infections in patients receiving biologicals.

905

News (Medical) associated with Adalimumab

28 Jun 2024

·www.prnewswire.com

Innovent Provides Interpretation and Updates on Clinical Data from Mazdutide GLORY-1 Study and General Biomedicine Pipeline

SAN FRANCISCO and SUZHOU, China, June 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, provided interpretation and updates on clinical data from Mazdutide's GLORY-1 study and its general biomedicine pipeline at an investor conference call on June 25. Continue Reading At the 2024 American Diabetes Association (ADA) Scientific Meeting, the company reported the results of its first Phase 3 clinical study (GLORY-1) on the GLP-1R/GCGR dual agonist mazdutide (Innovent R&D code: IBI362) in overweight or obese adults in China, along with the exploratory analysis results on liver fat content. During the June 25 conference call, leadership offered an in-depth interpretation of the clinical data. Innovent's Chief Financial Officer Rachel You and General Biomedicine Vice President of Clinical Development Lei Qian attended the meeting and made reports. Professor Linong Ji, MD, the principal investigator of the GLORY-1 study and Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People's Hospital, also provided commentary. GLORY-1 is the first Phase 3 clinical study worldwide evaluating a GLP-1R/GCGR dual agonist for weight loss. The findings demonstrate significant weight reduction, robust safety, unique liver fat reduction and comprehensive improvement in metabolic indicators, confirming the distinctive advantages of mazdutide as a dual agonist targeting GLP-1R and GCGR. At the same time, Innovent is actively pursuing new development pathways, including innovative molecules that extend beyond T2D and weight management, with the aim to deliver transformative treatments in metabolic health. Mazdutide is an analogue of oxyntomodulin (OXM), a natural peptide hormone existing in humans that activates both glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), to scientifically and effectively reduce weight, increase energy expenditure, burn fat and improve liver fat metabolism. It can also achieve comprehensive metabolic benefits and improve physical health. The findings from GLORY-1 underscore mazdutide's impressive weight loss effects, safety and tolerability, and further highlight its ability to significantly reduce liver fat content and improve multiple cardiovascular metabolic risk factors. These results reaffirm the distinct advantages of new-generation of GLP-1R/GCGR dual agonists. Excellent weight loss efficacy The GLORY-1 study demonstrated mazdutide's remarkable weight loss efficacy. After 48 weeks of treatment, the mazdutide 6mg group experienced an average weight reduction of 14.3% compared to baseline. Additionally, mazdutide showed significant reductions in waist circumference, hip circumference, and neck circumference, indicating its potential in reducing body fat. Unprecedented liver benefits In addition to its exceptional weight management capabilities, mazdutide also demonstrated an 80.2% reduction in liver fat content in the GLORY-1 study, indicating improvements to liver health. Acting directly on the liver as a GLP-1R/GCGR dual agonist, mazdutide shows promise in treating metabolic-associated fatty liver disease (MAFLD) and metabolic-associated steatohepatitis (MASH), enhancing liver metabolic function and mitigating factors contributing to liver metabolic dysfunction. Significant reduction in multiple cardiovascular metabolic risk indicators The data at week 48 showed that mazdutide outperformed placebo in reducing waist circumference, systolic blood pressure, triglycerides, total cholesterol, LDL-C, blood uric acid, and ALT levels compared to baseline. Furthermore, mazdutide significantly normalized blood sugar level for participants with HbA1C≥5.7%. These findings highlight mazdutide's potential to mitigate cardiovascular metabolic risk factors and improve blood sugar management. Well tolerated and favorable safety profile Mazdutide showed excellent safety and tolerability in the GLORY-1 study, establishing itself as a safe treatment choice. Most gastrointestinal symptoms observed in the treatment group, such as nausea, vomiting, and diarrhea, were mild or moderate, with no signals indicating increased cardiovascular risk. These findings underscore mazdutide's effectiveness in weight loss and improving metabolic conditions, while also highlighting its promising safety profile, positioning it as a potential best-in-class treatment option. The marketing application for mazdutide's first weight loss indication is currently under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). If approved, mazdutide is positioned to be a safe, effective, and comprehensive solution for chronic weight management among obese and overweight individuals in China, and could aid them to improve liver fat metabolism and address obesity-related comorbidities. Moving forward, Innovent plans to explore additional indications for mazdutide, advance the research and development of next-generation GLP-1 products, and contribute to improving the quality of life for patients with chronic diseases. Additionally, Innovent discussed its products in the cardiovascular and metabolic (CVM) field targeting various clinical needs currently in development. SINTBILO® (PCSK9) is the first and only Chinese-developed PCSK9 monoclonal antibody approved for treating hyperlipidemia. IBI128 (a new xanthine oxidase inhibitor) represents a next-generation candidate for managing gout and hyperuricemia, with ongoing Phase 3 clinical trials overseas and planned Phase 1/2 studies in China starting in 2024. IBI3016 (AGT siRNA) is an innovative siRNA therapy for hypertension, with a Phase 1 clinical trial scheduled to commence in 2024. Furthermore, several early-stage projects are poised to enter the IND stage, bolstering Innovent's strategic positioning and competitive edge in CVM. Metabolic diseases significantly affect quality of life and overall well-being. Innovent is accelerating innovation in this crucial area, dedicated to addressing unmet clinical needs and delivering safer, more effective treatments to patients. Over the next five years, Innovent plans to introduce 5-6 new metabolic products targeting diabetes, weight loss, cardiovascular conditions and other indications, aiming to establish itself as a leading research and development company in the field of cardiovascular metabolic diseases in China. Autoimmune: addressing global unmet clinical needs In the field of autoimmune, Innovent has successfully launched SULINNO® (adalimumab injection), which is approved for eight indications including rheumatoid arthritis and psoriasis and is covered under the National Reimbursement Drug List. Picankibart (R&D code: IBI112), a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, successfully met primary and key secondary endpoints in its Phase 3 clinical study (CLEAR-1) for moderate to severe plaque psoriasis in China. CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients, and Innovent is preparing for a NDA submission to the CDE of NMPA. Innovent continues to explore unmet clinical needs in autoimmune diseases globally with advancements like IBI355 (CD40L), IBI356 (OX40L), IBI3002 (IL-4Rα/TSLP) and other innovative First-in-class/Best-in-class molecules targeting indications including primary Sjögren's syndrome, systemic lupus erythematosus, atopic dermatitis, asthma, and other diseases. Ophthalmology: advancing treatment standards In the field of ophthalmology, Innovent's new drug application for IBI311 Injection (recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, R&D) has been accepted for the treatment of thyroid eye disease (TED). This biologic with an innovative mechanism of action is poised to address a 60-year gap in domestic TED treatment, meeting significant clinical needs and offering effective, safe, and accessible treatment options for Chinese TED patients. In addition, Phase 3 clinical trials for IBI302 (VEGF/C) have commenced to address neovascular age-related maculopathy, with long-interval administration expected to achieve significant efficacy and potentially enhance management of geographic atrophy. Furthermore, IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are currently in Phase 1 clinical trials to explore their differentiated clinical value. About Innovent Biologics: Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics

Clinical ResultPhase 3Phase 1Drug ApprovalPhase 2

28 Jun 2024

·www.biopharmadive.com

PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

Today, a brief rundown of news from PTC Therapeutics, Esperion Therapeutics and Coherus Biosciences, as well as updates from Sanofi, Lantheus Holdings and Forbion that you may have missed.Drug regulators in Europe have, for a third time, recommended against renewing the approval of PTC TherapeuticsDuchenne muscular dystrophy medicine Translarna. The European Medicines Agency panel had been asked to re-evaluate PTCs application after the European Commission, in an unusual step, rejected its recommendation and suggested it consider data from patient registries and real-world use. That evidence still doesnt prove Translarna is effective, the panel said Friday. PTC will again seek another opinion, during which time Translarna will remain on the market in Europe. Ben FidlerEsperion Therapeutics said Friday it has sold rights to sales royalties in Europe for its cholesterol-lowering pill bempedoic acid to Omers Life Sciences for $305 million.Omers will own those royalties until its received 1.7-times its initial investment, after which Esperion will reclaim rights. Esperion will use some of the proceeds to pay off a loan from Oberland Capital, and is still eligible to receive up to $300 million in sales-based milestone payments under a licensing deal with Daiichi Sankyo. Jonathan GardnerCoherus BioSciences is selling rights to Yusimry, a biosimilar version of Humira, to Hong Kong King-Friend Industrial for $40 million in cash. The biosimilaris the second Coherus has divested this year as part of a plan to focus its business on branded cancer drugs. It won U.S. approval for its first, a cancer immunotherapy called Loqtorzi, in 2023. Jonathan GardnerSanofi is investing $40 million in Vigil Neuroscience, a biotech developing drugs for neurodegenerative diseases. The deal gives Sanofi an exclusive right of first negotiation to license from Vigil an experimental antibody aimed at the protein TREM2. Vigil has one such medicine in early-stage testing for Alzheimers disease treatment. The biotech, which went public in 2022but has lost much of its value since, said the deal will extend its cash runway into 2026. Gwendolyn WuLantheus Holdings, a developer of radiopharmaceutical drugs and diagnostics, paid $35 million to acquire rights to what it calls a radiotheranostic pair from Life Molecular Imaging. The pair consists of a lutetium-based treatment and a gallium-based diagnostic for prostate cancer, both aimed at the gastrin-releasing peptide receptor. Discovered at the Universities Bern and Basel, the pair was initially developed by Bayer and then licensed to Life Molecular. Lantheus plans to start a Phase 1/2a study of the radiopharmaceutical next year, with the gallium-based agent used as a companion diagnostic. Ned PagliaruloEuropean venture capital firm Forbion has hired former Dyne Therapeutics CEO Josh Brumm to help expand its presence in the U.S. Brumm will serve as a general partner and support Forbions current portfolio companies as well as source new opportunities in the U.S. and Europe, the firm said Thursday. Though Forbion is based in the Netherlands, about 30% of its investments are in the U.S. and Canada. Gwendolyn Wu '

License out/inDrug Approval

28 Jun 2024

·www.biospace.com

AbbVie Expands Immuno Portfolio With $250M Celsius Buy as Humira Hits Patent Cliff

Pictured: AbbVie's headquarters in California/iStock, Michael Vi AbbVie on Thursday announced that it has bought Cambridge, Massachusetts-based startup Celsius Therapeutics and its lead inflammatory bowel disease antibody CEL383. Details of the acquisition agreement were sparse, with the companies only revealing that AbbVie will snap up all of Celsius’ remaining equity for $250 million in cash, subject to certain adjustments. The companies have not yet announced when they plan to close the transaction. “We are eager the advance the development of CEL383 with a goal of helping more patients with [inflammatory bowel disease (IBD)] achieve remission,” Kori Wallace, global head of immunology clinical development at AbbVie, said in a statement. Developed using Celsius’ proprietary SCOPE platform, which allows the startup to “understand the cells that drive disease progression,” CEL383 is a potentially first-in-class monoclonal antibody that works by targeting the TREM1 protein. TREM1 mediates the interaction between the microbiome and the immune system while amplifying mucosal inflammation, according to the biotech’s website. Preclinical studies have validated this mechanism of action, showing that CEL383 could disrupt TREM1 signaling and lowering the concentration of several inflammatory mediators. CEL383 has recently completed a first-in-human, placebo-controlled, single-ascending-dose Phase I trial in healthy volunteers, designed to evaluate its safety, tolerability and pharmacokinetic profile. Thursday’s acquisition of Celsius is part of AbbVie’s strategy to deepen its portfolio as it weathers a particularly steep patent cliff for its blockbuster immuno therapy Humira (adalimumab). Since losing its most important patent protections, Humira has mostly retained market dominance despite the flurry of biosimilars that flooded the U.S. market. However, in April 2024, fueled by CVS Caremark delisting Humira from its major national commercial formularies, copycats have enjoyed a surge in demand and sales. To shore up its revenues and target future growth, AbbVie has been striking a series of deals giving it access to promising assets and technologies. In February 2024, the pharma put $713 million on the line for an exclusive right to develop, manufacture and commercialize OSE Immunotherapeutics’ investigational antibody OSE-230, being assessed for chronic and severe inflammation. Soon after, AbbVie dropped $212 million to acquire Landos Biopharma gaining access to the oral NLRX1 agonist NX-13, which is being studied as a treatment for ulcerative colitis and Crohn’s disease. AbbVie has joined a recent biopharma spending spree in the projected $257 billion immunology market. Outside the immuno space, AbbVie has also invested heavily in the mental health market entering a potential $2 billion deal with Gilgamesh Pharmaceuticals in May 2024 to develop neuroplastogens for psychiatric disorders. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 1ImmunotherapyAcquisitionBiosimilar

100 Deals associated with Adalimumab

External Link

KEGG	Wiki	ATC	Drug Bank
D02597	Adalimumab	L04AB04	DB00051

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pyoderma Gangrenosum	JP	AbbVie GK	27 Nov 2020
Pustular psoriasis	JP	AbbVie GK	23 Mar 2018
Behcet Syndrome	JP	AbbVie GK	17 Jun 2016
Psoriasis vulgaris	JP	AbbVie GK	17 Jun 2016
Colitis, Ulcerative	AU	AbbVie (Pty) Ltd. (South Africa)	10 Dec 2003
Enthesitis-Related Arthritis	AU	AbbVie (Pty) Ltd. (South Africa)	10 Dec 2003
Hidradenitis Suppurativa	AU	AbbVie (Pty) Ltd. (South Africa)	10 Dec 2003
Polyarticular Juvenile Idiopathic Arthritis	AU	AbbVie (Pty) Ltd. (South Africa)	10 Dec 2003
Psoriasis	AU	AbbVie (Pty) Ltd. (South Africa)	10 Dec 2003
Juvenile Arthritis	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Arthritis	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Arthritis	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Juvenile Arthritis	NO	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Pediatric Crohn's Disease	NO	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Plaque psoriasis	EU	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Plaque psoriasis	IS	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003
Plaque psoriasis	LI	AbbVie Deutschland GmbH & Co. KG	08 Sep 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	Phase 3	-	AbbVie, Inc.	28 Sep 2015
Oral Ulcer	Phase 3	US	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	AT	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	BE	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	CA	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	CZ	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	DK	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	FR	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	DE	AbbVie, Inc.	01 May 2014
Oral Ulcer	Phase 3	HU	AbbVie, Inc.	01 May 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2023	Not Applicable	Rheumatoid Arthritis	-	Tapering ADL first	djeezmemat(ucnwegdrnn) = ewxfhcdaac chfljbzbsb (emxzmxuuay )	-	13 Nov 2023
EADV2023	Not Applicable	Spherocytosis, Type 1	51	Adalimumab	lehkgdncuc(ejltwwgoqq) = ijgqoqzbpx zmxeryeerx (naxazzogko ) View more	-	11 Oct 2023
EADV2023	Not Applicable	Spherocytosis, Type 1	51	Secukinumab	lehkgdncuc(ejltwwgoqq) = llpemreuit zmxeryeerx (naxazzogko ) View more	-	11 Oct 2023
EADV2023	Not Applicable	Pemphigus	-	Adalimumab	yyssbsozhc(stnzyldkdt) = A near-complete response was achieved without adverse events (AEs) for the last 6 months ebwrfpbdwt (rmbojzamdu )	-	11 Oct 2023
EADV2023	Not Applicable	Hidradenitis Suppurativa TNF-alpha inhibitor Adalimumab	56	Adalimumab 40mg weekly	yypykrbygr(bvusjhmkzh) = scovvgfbkv vcnlyhrabq (aaenblrwhm )	Negative	11 Oct 2023
WCD2023	Not Applicable	Hidradenitis Suppurativa	37	Adalimumab biosimilar	zbbjysvlcn(moenbopexd) = 5 patients discontinued treatment due to severe injection site pain nanapzybur (mdfkpuwzdz ) View more	-	03 Jul 2023
ARVO2023	Not Applicable	Scleritis	15	Adalimumab	ajrevabrmc(zbwkulrzec) = futnfrsekf abmhjbcffa (yetvgnstbs ) View more	Positive	01 Jun 2023
NOR-DMARD study (EULAR2023)	Not Applicable	Arthritis	378	Originator Adalimumab (Humira)	nfwandavav(jemjwwlbtg) = zrjaogvvuo yywxmwynie (gkvkjkpeej ) View more	-	31 May 2023
NOR-DMARD study (EULAR2023)	Not Applicable	Arthritis	378	Biosimilar Adalimumab (Hyrimoz)	nfwandavav(jemjwwlbtg) = jmbesyrgas yywxmwynie (gkvkjkpeej ) View more	-	31 May 2023
EULAR2023	Not Applicable	Arthritis	343	Adalimumab	crvbevfwxg(rpeemzxybs) = ibdcfmjepg razvvxltmt (jtzpwsrspd ) View more	Positive	31 May 2023
EULAR2023	Not Applicable	Takayasu Arteritis	-	Adalimumab (ADA)	mzvlicxdzb(xdriwdztuo) = Adverse event incidence was comparable between the two groups (ADA vs. TCZ: 38.10% vs. 47.37%) baotxheqwn (zxkwzlxnwj )	Positive	31 May 2023
EULAR2023	Not Applicable	Takayasu Arteritis	-	Tocilizumab (TCZ)		Positive	31 May 2023
NCT02760407 (CREDO-2, EULAR2023)	Phase 3	Charlson Comorbidity Index	1,402	Olokizumab	nsyzbvognz(gqyqwlhcvz) = ryovrmtgsz tvgtbbefeo (wkaivywsud ) View more	-	31 May 2023
NCT02760407 (CREDO-2, EULAR2023)	Phase 3	Charlson Comorbidity Index	1,402	Adalimumab	nsyzbvognz(gqyqwlhcvz) = sblyelfvyd tvgtbbefeo (wkaivywsud ) View more	-	31 May 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis