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Last update 09 May 2025

Abatacept

Last update 09 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fc fusion protein

Synonyms

Abatacept (Genetical Recombination), CTLA4-Ig(Bristol-Myers Squibb), CTLA4Ig

+ [14]

Target

CD80 x CD86

Action

modulators

Mechanism

CD80 modulators(Cluster of differentiation 80 modulators), CD86 modulators(Cluster of differentiation 86 modulators)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases+ [7]

Active Indication

Acute Graft Versus Host DiseaseJuvenile Idiopathic ArthritisArthritis, Psoriatic+ [17]

Inactive Indication

airway diseaseAllergic asthmaAlopecia Areata+ [37]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.Bristol-Myers Squibb Pharma EEIG

Dr. Reddy's Laboratories Ltd.

+ [2]

Inactive Organization

Jiangsu Simcere Pharmaceutical Co., Ltd.

License Organization

Repligen Corp.

Ono Pharmaceutical Co., Ltd.

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (23 Dec 2005),

Rheumatoid Arthritis

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 19593

Source: *****

229

Clinical Trials associated with Abatacept

NCT04344873

/ Not yet recruitingEarly Phase 1IIT

Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States and other industrialized societies, and advanced age is the major risk factor for development of CVD. Advancing age appears to exert its pathological influence primarily via adverse functional and structural effects on arteries. Aging is associated with increased stiffness (reduced compliance) of large elastic arteries and impaired arterial endothelial function that is characterized by reductions in nitric oxide (NO)- mediated endothelium-dependent dilation (EDD). While several changes to arteries may contribute to age-associated increases in CVD risk; the development of endothelial dysfunction and stiffening of the large elastic arteries are among the most important contributors. Both are predictors of CV events and clinical CVD with increasing age. Although the importance of endothelial dysfunction and arterial stiffening with age are well established, the initiating events of these deleterious changes are elusive.

Start Date01 Sep 2025

Sponsor / Collaborator

University of Utah

[+1]

NCT06654882

/ Not yet recruitingPhase 3IIT

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

Start Date01 Aug 2025

Sponsor / Collaborator

Duke University

[+1]

NCT06731504

/ Not yet recruitingEarly Phase 1IIT

A Pilot Trial of Abatacept Based Graft-Versus-Host Disease Prophylaxis Following Omidubicel Hematopoietic Cell Transplantation

This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT.
Target enrollment is 10 participants. Subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. Patients will be followed for a total of 18 months and will have research blood draws and Abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study.
It is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. Accrual will be reported by race, ethnicity, gender, and age. Descriptive analyses are planned given the sample size.

Start Date01 Jul 2025

Sponsor / Collaborator

Duke University

100 Clinical Results associated with Abatacept

100 Translational Medicine associated with Abatacept

100 Patents (Medical) associated with Abatacept

3,168

Literatures (Medical) associated with Abatacept

01 Dec 2025·Current Cardiology Reports

Updates in Diagnosis and Treatment of Immune Checkpoint Inhibitor Myocarditis

Review

Author: Ostos-Mendoza, Keila C ; de Leon Derby, Regina Diaz ; Palaskas, Nicolas L ; Hachem, Anthony M ; Rodriguez, Ana Sofia Lopez ; Ebrahimi, Sara ; Desai, Aditya ; Beinart, Noah

PURPOSE OF REVIEW:

To provide an update on the literature regarding diagnosis and management of immune checkpoint inhibitor myocarditis.

RECENT FINDINGS:

The diagnosis of immune checkpoint inhibitor myocarditis has evolved to include more reliance on performing endomyocardial biopsy to clarify the diagnosis in selected cases. Additionally, there is recognition of a spectrum of disease both clinically and on endomyocardial biopsy suggesting that there is a range of severity from mild to fulminant. The treatment of immune checkpoint inhibitor myocarditis is shifting towards increased use of additional immunosuppressive medications as steroid sparing agents. There are increased studies including two randomized controlled trials evaluating abatacept in the treatment of immune checkpoint inhibitor myocarditis. This review summarizes the latest literature regarding diagnosis and management of immune checkpoint inhibitor myocarditis and provides our experience and approach to this rare but potentially fatal condition.

01 Aug 2025·SEMINARS IN ARTHRITIS AND RHEUMATISM

Non-TNFi biologic and targeted synthetic DMARDs in rheumatoid arthritis-associated interstitial lung disease: A propensity score-matched, active-comparator, new-user study

Article

Author: England, Bryant R ; Mikuls, Ted R ; Curtis, Jeffrey R ; Dong, Jianghu ; Wichman, Christopher S ; Matson, Scott M ; Yang, Yangyuna ; Roul, Punyasha ; Sauer, Brian C ; Rojas, Jorge ; Baker, Joshua F ; Johnson, Tate M ; Cannon, Grant W ; George, Michael D ; Frideres, Halie

OBJECTIVES:

This study aimed to compare treatment outcomes in rheumatoid arthritis-associated interstitial lung disease (RA-ILD) between initiators of rituximab, abatacept, tocilizumab, and tofacitinib using the Target Trial Emulation Framework.

METHODS:

We emulated three trials comparing abatacept, tocilizumab, and tofacitinib with rituximab (reference). Patients fulfilling validated RA-ILD algorithms initiating one of these non-TNFi b/tsDMARDs were propensity score (PS)-matched (1:1) using national Veterans Affairs (VA) data from 2006 to 2020. PS models included demographics, comorbidities, general health status indicators, and several RA- and ILD-related severity measures. Composite study outcomes were death and respiratory-related hospitalization, ascertained by VA data and linkages to the National Death Index and Medicare, over three-year (primary) and one-year follow-up periods (secondary). Cox regression models were used to analyze study outcomes adjusting for any unbalanced variables. Several sensitivity and subgroup analyses were performed.

RESULTS:

In the primary cohort, we 1:1 matched abatacept (n = 150), tocilizumab (n = 73), and tofacitinib (n = 94) with equal numbers of rituximab initiators (mean age 68.1-69.4 years, 88-92 % male). There were no significant differences in the primary composite outcome among any of the comparisons (abatacept aHR: 1.03 [0.72, 1.47]; tocilizumab aHR: 1.15 [0.68, 1.93]; tofacitinib aHR: 0.89 [0.54, 1.46]). Secondary, subgroup, and sensitivity analyses supported the main findings.

CONCLUSIONS:

We did not find significant differences in mortality or respiratory hospitalization between RA-ILD patients initiating different non-TNFi b/tsDMARDs, though estimates were imprecise, and residual confounding may be present. These findings emphasize the need for clinical trials of advanced immunomodulatory therapies in RA-ILD.

01 Jun 2025·ANNALES DE DERMATOLOGIE ET DE VENEREOLOGIE

Paradoxical erosive oral lichen planus possibly induced by abatacept

Letter

Author: Dezoteux, F ; Ledoult, E ; Boo, J ; Aho-Stichelbout, M ; Boileau, M ; Mille, B ; Staumont-Salle, D

News (Medical) associated with Abatacept

24 Apr 2025

·www.businesswire.com

Coya Therapeutics Announces Positive Interim Results of an Investigator-Initiated Open Label Study with Low-Dose IL-2 and CTLA4-Ig Combination Treatment in Five Patients with Mild to Moderate Frontotemporal Dementia

HOUSTON--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function announced positive interim results of an investigator-initiated proof of concept open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with Frontotemporal Dementia (FTD). The study is led by Dr. Alireza Faridar and Dr. Stanley Appel at the Houston Methodist Neurological Institute (Houston, TX) with funding from The Peggy and Gary Edwards Endowment Fund. Study patients received subcutaneously administered CTLA4-Ig, followed by a 5-day course of low-dose IL-2 every four weeks, for a total of 22 weeks of dosing and follow-up. The study aims to enroll up to 10 patients, and these interim results include data from the first 5 patients with mild to moderate FTD who have completed the full course of treatment. Dr. Arun Swaminathan, Coya’s Chief Executive Officer followed: “The results thus far are consistent with previously published encouraging data from an open-label investigator-initiated study of patients with ALS treated with low-dose IL-2/CTLA4-Ig. This interim data in FTD provides us further confidence of our approach to target and enhance Treg biology to address devastating neurodegenerative diseases including ALS and FTD.” Previous biomarker data presented by the Company demonstrated that FTD patients exhibit a compromised immunosuppressive function of regulatory T cells (Tregs), along with increased peripheral levels of inflammatory cytokines and chemokines, dysregulation of monocytes, and systemic activation of the inflammatory cascade, supporting the critical role of the immune system in the pathophysiology of FTD. One previous study showed that a cohort of 68 patients with FTD worsened by an average of 3.57 points over a 12-month period per the Clinical Dementia Rating - Frontotemporal Lobar Degeneration (CDR‐FTLD) scale (Knopman et al. Brain 2008; 131(11): 2957-2968). In addition, patients with FTD typically have shorter survival times and more rapid rates of cognitive and functional decline compared to patients with Alzheimer’s disease (Rascovsky et al. Neurology 2005; 65(3): 397-403). Dr. Fred Grossman, Coya’s Chief Medical Officer stated: “We are excited with the results observed in this initial group of patients with this proof-of-concept study. We believe that the increase in Treg numbers and suppressive function, with subsequent anti-inflammatory biological activity still to be evaluated, underscores the potential for this low-dose IL-2/CTLA4-Ig combination to be further studied as a therapy for FTD, for which there are no currently approved treatments.” Summary of Interim Study Results Overall, treatment with low-dose IL-2 and CTLA4-Ig was well tolerated. All 5 patients enrolled in the first cohort completed the study and received the investigational treatment as planned. The most common adverse events were mild injection site reactions. No serious adverse events were reported. Treg numbers and suppressive function increased after the first treatment cycle (p < 0.01 and p < 0.05, respectively), and remained at higher significant levels throughout the treatment period. Clinical functional assessments were performed in all patients at pre-specified timepoints over the course of the study using validated tools, including the Clinical Dementia Rating - Frontotemporal Lobar Degeneration (CDR‐FTLD) scale, the Montreal Cognitive Assessment (MoCA) scale, and the Progressive Aphasia Severity Scale (PASS). Results of the functional tests show that, on average, these five FTD patients treated with low-dose IL-2 and CTLA4-Ig combination exhibited minimal to no cognitive decline over the course of the study, compared to pre-treatment values. The Company intends to publish and/or present more comprehensive data in a future peer-reviewed meeting and/or publication. About Frontotemporal Dementia Frontotemporal dementia (FTD) refers to a group of neurodegenerative disorders characterized by altered behavior and language, with a progressive decline in executive function.1 FTD affects an estimated 30,000 Americans.2 FTD is categorized clinically into various subtypes; the main three include behavioral-variant frontotemporal dementia and two language variants, semantic dementia (also known as semantic variant primary progressive aphasia) and progressive non-fluent aphasia (also known as non-fluent variant primary progressive aphasia). It's a presenile dementia, meaning it can occur in younger individuals, often between the ages of 45 and 64. The average age of onset is 58, with an average survival time of 7.5 years.1,2 References Knopman et al. Development of methodology for conducting clinical trials in frontotemporal lobar degeneration. Brain 2008; 131(11): 2957-2968 Rascovsky et al. Rate of progression differs in frontotemporal dementia and Alzheimer disease. Neurology 2005; 65(3): 397-403 About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. COYA 302 is a combination treatment comprised of low-dose IL-2 and CTLA4-Ig is an investigational therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of Tregs and suppress the inflammation produced by activated monocytes and macrophages. Coya is developing COYA 302 for the treatment of fatal neurogenerative diseases characterized by chronic inflammation and Treg dysfunction. For more information about Coya, please visit www.coyatherapeutics.com Forward-Looking Statements This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Clinical ResultCell Therapy

15 Apr 2025

·www.prnewswire.com

U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab)

YUFLYMA ® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira ® (adalimumab) biosimilar, that is now interchangeable [1] Interchangeable designation of YUFLYMA ® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis INCHEON, South Korea, April 14, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA ® (adalimumab-aaty), as an interchangeable biosimilar to Humira ® (adalimumab). YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.[1] "With this new designation, YUFLYMA is further positioned to help more patients gain access to and afford the therapy they need," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "YUFLYMA has the same dosage form, route of administration, and dosing regimen as the reference product. The pharmacist's ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab." The interchangeable designation was supported by data from the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Week 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV) 2024.[2] FDA-approved interchangeable biosimilars may be substituted for the reference product at the pharmacy without the intervention of the prescribing health care provider, subject to state laws.[3] The high-concentration form of YUFLYMA was FDA-approved in May 2023 and is currently available as 20mg, 40 mg and 80mg solution for injection in a prefilled syringe and in an autoinjector pen. YUFLYMA was introduced into the US commercial market on July 2, 2023. YUFLYMA is available in two pricing options to help provide more affordable options for patients. Adalimumab-aaty, the unbranded version, is priced at an 85% discount to the current wholesale acquisition cost (WAC) list price of Humira (adalimumab), providing economic benefits for patients and overall healthcare system. The branded version is priced at a 5% discount to the current WAC of Humira (adalimumab). Notes to Editors: About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)[1] YUFLYMA is the world's first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL. IMPORTANT SAFETY INFORMATION[1] This important safety information also applies to YUFLYMA® (adalimumab-aaty) SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion , Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks Humira is a registered trademark of AbbVie. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References [1] YUFLYMA US prescribing information (2023) [2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at: [3] 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Available at : For further information please contact:  Andria Arena [email protected] +1 516-578-0057 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical ResultPhase 3

28 Jan 2025

·pipelinereview.com

Kashiv Biosciences Announces Successful Phase 1 Results for Abatacept Biosimilar Candidate, KSHB002

PISCATAWAY, NJ, USA I January 28, 2025 I Kashiv Biosciences, LLC, a global leader in biopharmaceutical innovation, today announced that their abatacept biosimilar candidate, KSHB002, has successfully met the primary endpoints in its Phase 1 clinical trial. The trial demonstrated pharmacokinetic equivalence to the US-licensed and EU-authorized reference product, ORENCIA®. KSHB002, a 125 mg/mL pre-filled syringe injection, was evaluated in a randomized, open-label study involving 300 healthy male and female adults. The study was designed with three parallel arms and assessed the pharmacokinetics, safety, and immunogenicity of KSHB002 compared to the reference product. All participants received a single subcutaneous dose. The results demonstrated that both primary endpoints, maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC₀–∞), were within the 80-125% bioequivalence range, confirming pharmacokinetic equivalence. Furthermore, the safety and immunogenicity profiles of KSHB002 were comparable to those of ORENCIA®. Kashiv Biosciences is developing the proposed abatacept biosimilar as both subcutaneous and intravenous formulations. “We are thrilled with the results of our Phase 1 study and are excited to move forward with our global Phase 3 efficacy and safety trial. This represents a pivotal step in advancing the evaluation of KSHB002 for patients with rheumatoid arthritis,” stated Dr. Sandeep Athalye, CEO of Kashiv Biosciences. About Kashiv Biosciences: Kashiv Biosciences, LLC is a vertically integrated biopharmaceutical company with a diverse portfolio of commercial and advanced clinical-stage assets. Operating in the United States and India, Kashiv Biosciences leverages robust infrastructure and highly skilled teams to deliver global R&D, clinical, manufacturing, regulatory, and IP capabilities. Our mission is to advance patient care and improve access to affordable essential medicines. SOURCE: Kashiv Biosciences

Phase 1Clinical Result

100 Deals associated with Abatacept

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KEGG	Wiki	ATC	Drug Bank
D03203	Abatacept	L04AA24	DB01281

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Graft Versus Host Disease	United States	Bristol Myers Squibb Co.	15 Dec 2021
Juvenile Idiopathic Arthritis	United States	Bristol Myers Squibb Co.	25 Aug 2009
Arthritis, Psoriatic	European Union	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Iceland	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Arthritis, Psoriatic	Norway	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	European Union	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Iceland	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Polyarticular Juvenile Idiopathic Arthritis	Norway	Bristol-Myers Squibb Pharma EEIG	21 May 2007
Rheumatoid Arthritis	United States	Bristol Myers Squibb Co.	23 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocarditis	Phase 3	United States	Bristol Myers Squibb Co.	22 Jun 2022
Myocarditis	Phase 3	Canada	Bristol Myers Squibb Co.	22 Jun 2022
Polymyalgia Rheumatica	Phase 3	France	Bristol Myers Squibb Co.	13 Dec 2018
Giant Cell Arteritis	Phase 3	United States	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Australia	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Austria	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Belgium	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Bulgaria	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Canada	Bristol Myers Squibb Co.	15 Jul 2017
Giant Cell Arteritis	Phase 3	Denmark	Bristol Myers Squibb Co.	15 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03215927 (ATtackMy-ILD, CTgov)	Phase 2	Antisynthetase Syndrome \| Interstitial lung disease due to systemic disease	20	Placebo (Placebo)	zifupautov(bvwjxhxnfs) = qwotkobckm wvrpuvpszm (rhartkldzv, mmjukitmei - qnydeoqsgw) View more	-	07 Jan 2025
				Abatacept (Abatacept)	zifupautov(bvwjxhxnfs) = oepjtwcjql wvrpuvpszm (rhartkldzv, nuiwyzyqmg - ukqsnutewf) View more
NCT04909801 (AMPLIFIED, CTgov)	Phase 3	Rheumatoid Arthritis	338	Abatacept (Abatacept)	fitlydfjmm = ewyvcnqkbg pogcpqjkgh (sxqtcrxfqz, wsmjapkgaf - grmrmllori) View more	-	15 Oct 2024
				Abatacept+Adalimumab (Adalimumab, Then Abatacept (OLE Period))	fitlydfjmm = qoleioqdqz pogcpqjkgh (sxqtcrxfqz, gnzwqrlttt - jpyjmitsor) View more
NCT03680092 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Lymphoblastic Leukemia \| Hematologic Neoplasms ... View more	43	Abatacept+cyclophosphamide (Cyclophosphamide and Abatacept)	kdpldfewhd = kjfymofhci fzxhknvzrd (ffhbtxqgkk, wpqdmlhgcs - weycivrsca) View more	-	02 Oct 2024
				Tacrolimus+Methotrexate (Methotrexate and Tacrolimus)	kdpldfewhd = rttqdkdlzn fzxhknvzrd (ffhbtxqgkk, vaweficzfe - lmcgdmahec) View more
NCT03882008 (CTgov)	Phase 4	Rheumatoid Arthritis	25	Abatacept	wwkirqyexy = amglvnlngm qtyzjsvzfy (pwckjccohi, mfmviaatwn - gagmkjbjze) View more	-	30 Jul 2024
NCT04120831 \| EUCTR2018-003877-91-DE (TOLERA, EULAR 12024 \| EULAR 22024) Manual	Phase 2	Rheumatoid Arthritis ACPA-positive	20	Rituximab+Abatacept+Methotrexate	chcvghaprb(kypdczfhpo) = tiaftsqtzo amswsurluz (lquuslyury, 441.64) View more	Negative	12 Jun 2024
				Rituximab+Methotrexate	chcvghaprb(kypdczfhpo) = iuhbehdyzg amswsurluz (lquuslyury, 51.98) View more
NCT04909801 (AMPLIFIED, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Rheumatoid Arthritis	338	Abatacept+Methotrexate	bxmalfggqf(rvoxrnpmzk) = rqgzegxfuc kffiucaerx (lpnnhxlgzk ) Not Met View more	Non-superior	12 Jun 2024
				Adalimumab+Methotrexate	bxmalfggqf(rvoxrnpmzk) = mfqoysytgb kffiucaerx (lpnnhxlgzk ) Not Met View more
EULAR2024	Not Applicable	Idiopathic Inflammatory Myopathies	-	Abatacept 125mg weekly subcutaneous	gyaukauqxy(lhcbnfugsu) = wmulfealyd tvbhshovwe (cggeccaosl )	-	05 Jun 2024
				Placebo+SOC	gyaukauqxy(lhcbnfugsu) = aqmpbqxpql tvbhshovwe (cggeccaosl )
EULAR2024	Not Applicable	Progressive fibrotic interstitial lung disease	526	Abatacept	aqvefvunkc(tcjcoigxmu) = ooqaswphhg qqtyyrftge (wsbcfgtoth )	Positive	05 Jun 2024
EULAR2024	Not Applicable	ACPA-positive	92	ABT	qmrbytrkte(txqziawvqx) = usqivdxqui hqlnghezud (yjrtwoixyf ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Neoplasms	-	Abatacept	oeanejwrnq(efjhlatwoo) = highlighted an increased risk of non-melanoma skin cancer (NMSC) with abatacept, compared with conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) mlhqeyahfg (rqupzzhgnw )	Negative	05 Jun 2024
				Placebo

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