Delving into the Latest Updates on Abatacept with Synapse

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+ [4]

Active Indication

Acute Graft Versus Host DiseaseJuvenile Idiopathic ArthritisArthritis, Psoriatic+ [8]

Inactive Indication

acute leukemiaAcute Lymphoblastic LeukemiaAcute Myeloid Leukemia+ [51]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

Baker Heart & Diabetes InstituteBristol-Myers Squibb Pharma EEIG

+ [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)

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Structure/Sequence

Sequence Code 19593

Source: *****

Background:
T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma.
Objective:
To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma.
Eligibility:
People aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.
Azacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm.
Participants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours.
Imaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....

Start Date09 Feb 2026

Sponsor / Collaborator

National Cancer Institute

NCT06731504

/ 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 Date12 Nov 2025

Sponsor / Collaborator

Duke University

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 Nov 2025

Sponsor / Collaborator

Duke University

[+1]

100 Clinical Results associated with Abatacept

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100 Translational Medicine associated with Abatacept

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100 Patents (Medical) associated with Abatacept

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2,754

Literatures (Medical) associated with Abatacept

01 Apr 2026·SEMINARS IN ARTHRITIS AND RHEUMATISM

Predictors of achieving clinical remission in ACPA-positive RA-patients treated with abatacept and methotrexate and methotrexate monotherapy: a post-hoc analysis of the AVERT and AVERT-II trials

Article

Author: Huizinga, T W J ; Niemantsverdriet, E ; Verstappen, M ; van der Helm-van Mil, A H M ; Bergstra, S A

OBJECTIVE:

To predict which early RA-patients achieve clinical remission on initial treatment with methotrexate monotherapy or with abatacept+methotrexate.

METHODS:

This study is a subanalysis of the AVERT and AVERT-2 randomized controlled trials, which were performed in ACPA-positive early RA-patients who received methotrexate monotherapy or abatacept + methotrexate. External model validation of patients on methotrexate monotherapy was performed in the observational Leiden Early Arthritis Clinic (EAC) cohort. Primary outcome was DAS28-CRP remission at 6 and 12 months follow-up. Prediction models were developed using logistic regression analysis. First, a model including clinical baseline variables only was estimated. Subsequently, it was assessed whether adding serological or imaging data, shared epitope or early DAS28 response improved model performance.

RESULTS:

In the methotrexate-monotherapy group (n=388), 27% and 39% of patients achieved DAS28-remission after 6 and 12-months. In the abatacept + methotrexate group (n=743) this was 43% and 53%. Baseline DAS28-CRP was predictive for clinical remission in all models. Optimism-adjusted model performance (AUROC) for DAS28-remission at 6 and 12-months was 0.66/0.65 in the methotrexate-group and 0.68/0.59 in the abatacept + methotrexate group. Adding baseline MRI-detected joint-inflammation, baseline serology or HLA-shared epitope alleles did not significantly improve model performance. Early DAS28-response did improve model performance. In the external validation cohort model performance was very similar.

CONCLUSION:

Determining which patients achieve clinical remission upon methotrexate or abatacept+methotrexate treatment remains challenging. Disease activity at disease presentation and early DAS response were the only consistent predictors for achieving clinical remission. Genetic, imaging and serology parameters did not improve model performance.

01 Apr 2026·SEMINARS IN ARTHRITIS AND RHEUMATISM

Risk of ILD and safety outcomes across DMARD classes in rheumatoid arthritis and RA-ILD

Article

Author: Lee, Bora ; Kim, Hyun-Sook ; Lee, Kyung-Ann

OBJECTIVES:

To evaluate the risk of interstitial lung disease (ILD) and safety outcomes of disease-modifying antirheumatic drug (DMARD) classes in rheumatoid arthritis (RA), focusing on patients with RA-associated ILD (RA-ILD).

METHODS:

We conducted a nationwide cohort study using Korean National Health Insurance Service data (2011-2020). Adults with newly diagnosed RA prescribed at least one csDMARD were included and followed until 2022. Four treatment groups were evaluated: TNFi, non-TNFi biologics (abatacept, rituximab, tocilizumab), JAKi, and csDMARDs. RA-ILD was defined as ≥2 ILD claims plus chest computed tomography confirmation. Outcomes included ILD incidence, hospitalisation, infection, MACE, and all-cause mortality. Time-varying Cox models with inverse probability of treatment weighting were applied for first-event analyses.

RESULTS:

We analysed 26,120 patients with RA (209,852 treatment episodes), including 641 RA-ILD patients (1688 episodes). Adjusted ILD incidence was similar across DMARD classes. In RA and RA-ILD, non-TNFi biologics were associated with higher risks of hospitalisation (RA aHR 1.30, 95% CI 1.21-1.40; RA-ILD 1.35, 1.02-1.80), infection (RA 1.16, 1.05-1.28; RA-ILD 1.51, 1.06-2.15), and mortality (RA 4.09, 3.04-5.50; RA-ILD 4.31, 2.21-8.41) compared with csDMARDs. ILD-related admissions were similar, but pneumonia-related hospitalisations and recurrences were higher with non-TNFi biologics. TNFi and JAKi showed no significant associations with hospitalisation or infection. MACE risk did not differ across groups.

CONCLUSIONS:

DMARD class was not associated with ILD incidence or ILD-related hospitalisation. Non-TNFi biologics were consistently linked to increased pneumonia-related hospitalisation, recurrence, and mortality, highlighting the need for close infection monitoring in patients receiving these agents.

02 Mar 2026·JOURNAL OF EXPERIMENTAL MEDICINE

Oral antigen exposure under costimulation blockade induces Treg cells to establish immune tolerance

Article

Author: Kawakami, Ryoji ; Arai, Masaya ; Kimoto, Tomiko ; Nakamura, Yamami ; Naito, Yoko ; Sakaguchi, Shimon ; Mikami, Norihisa ; Sugimoto, Atsushi ; Ohkura, Naganari ; Motooka, Daisuke

Antigen-specific oral tolerance prevents harmful immune responses in naïve animals but is difficult to induce in antigen-primed hosts. Here, we showed that feeding of antigen-containing diet generated peripherally derived regulatory T (pTreg) cells with tissue-adapted effector properties. They acquired Treg-specific epigenomic changes at Treg signature genes, including Foxp3, exhibiting stable suppressive function. Cessation of antigen feeding diminished pTreg cells, hampering tolerance induction. Notably, pTreg cells induced by antigen feeding predominantly expressed CD101. CD101+ Treg cells with similar phenotypic and epigenetic features could also be generated in vitro from antigen-primed naïve CD4+ T cells by blocking CD28-mediated costimulation during TGF-β–dependent Treg induction. Furthermore, in mice already antigen-sensitized by nonoral routes, in vivo blockade of CD28 signaling with CTLA4-Ig prior to antigen feeding promoted differentiation of antigen-specific T cells into CD101+ pTreg cells, facilitating oral tolerance. Thus, continuous oral antigen exposure combined with CD28 blockade generates functionally stable CD101+ pTreg cells, thereby establishing systemic antigen-specific tolerance even in antigen-presensitized hosts.

82

News (Medical) associated with Abatacept

28 Jan 2026

·www.biopharmadive.com

Drugs for cancer, arthritis and HIV on Medicare’s list for 2028 price cuts

The federal government announced the next 15 medicines for which it will seek price reductions with the help of Medicares new negotiating power, including the breast cancer drugs Kisqali and Verzenio and the HIV treatment Biktarvy. Those cuts, which are allowed through the Inflation Reduction Act, will go into effect in 2028.Also included in the third annual round of price negotiations were the rheumatoid arthritis medicines Orencia, Cimzia and Xeljanz, as well as Botox when its used for therapeutic purposes like migraines. The Centers for Medicare and Medicaid Services designated these drugs for price negotiations under IRA provisions meant to limit expenditures on the drugs associated with the programs highest costs.Combined, the 15 drugs account for $27 billion in Medicare spending and are used by some 1.8 million enrollees. Eli Lillys weekly GLP-1 shot for diabetes, Trulicity, is associated with $4.9 billion in annual costs, the highest of any medication on the list.CMS is taking strong action to target the most expensive drugs in Medicare, negotiate fair prices, and make sure the system works for patients not special interests, said CMS Administrator Mehmet Oz, in a statement. This approach delivers real savings while strengthening accountability across the program.For the first time, these negotiations will include medicines covered by its Part B program that involves drugs administered in a physicians office or other healthcare facility. Orencia, Cimzia and Botox are three examples.However, two key drugs that had been previously been expected to make this years list the widely used cancer immunotherapies Keytruda and Opdivo were left off. The inclusion of both was delayed by at least a year through provisions of the One Big Beautiful Bill Act, which changed the way the IRA program is applied to certain drugs.The price cuts will, as a result, be immaterial for most of the companies whose drugs are on the list, according to Leerink Partners analyst David Risinger. The one exception is Biktarvy, which has Medicare revenue that could represent 8% of Gilead Sciences 2027 sales, Risinger wrote in a note to clients.The exposure for all of the other companies involved comes to 3% or less of overall revenue, Risinger wrote.Nonetheless, the industry group Pharmaceutical Research and Manufacturers of America railed against the announcement. The group argued that the IRA is undermining future medical progress by discouraging investment in new drugs, particularly the chemical, or small molecule, drugs that are subject to IRA price negotiations sooner than biologic medications.CMS is now planning to set prices for additional small molecule cancer treatments that would otherwise be spared without this penalty driving even more investment away from these critical treatment options, said Elizabeth Carpenter, the groups executive vice president of policy and research, in a statement.The first round of price negotiations, conducted in 2024,took effect this year. '

Immunotherapy

23 Jan 2026

·www.drugs.com

One Year of Abatacept Delays Progression to RA for Up to Four Years in At-Risk Population

FRIDAY, Jan. 23, 2026 -- One-year treatment with abatacept delays progression to rheumatoid arthritis for up to four years among at-risk patients, according to a study published online Jan. 20 in The Lancet Rheumatology . Andrew P. Cope, M.D., from King's College London, and colleagues recruited 213 anticitrullinated protein antibody-positive individuals with arthralgia to a phase 2b randomized controlled trial (the Arthritis Prevention In the Preclinical Phase of Rheumatoid arthritis with Abatacept [APIPPRA]). Participants were randomly assigned to receive 52 weekly subcutaneous injections of 125 mg abatacept or placebo (110 and 103 patients, respectively), with 52 weeks of follow-up. Follow-up was extended to between four and eight years in the APIPPRA Long-Term Outcome (ALTO) study; 143 APIPPRA participants were enrolled in ALTO: 71 and 72 in the abatacept and placebo groups, respectively. The researchers observed an increase of 54 primary events to 119. The initial between-group difference in restricted mean arthritis-free survival time, which was observed at two years, persisted at four years (4.9 months); over time, the magnitude of the difference diminished. No significant between-group differences were seen in assessments of disease activity and patient-reported outcomes beyond the treatment period. Participants with a broad autoantibody profile at baseline had the highest risk for progressing, but they had better response to abatacept. "We have shown that this approach is safe and can prevent disease while patients are on treatment as well as substantially relieve symptoms," Cope said in a statement. "Importantly, it can also delay the onset of RA for several years, even after treatment has stopped." Several authors disclosed ties to biopharmaceutical companies, including Bristol Myers Squibb, which manufactures abatacept and funded the study. Abstract/Full Text Editorial (subscription or payment may be required)

Phase 2Clinical Result

22 Jan 2026

·www.drugs.com

Advance Treatment with Orencia Can Delay Onset Of Rheumatoid Arthritis By Years, Trial Data Show

THURSDAY, Jan. 22, 2026 — People can delay rheumatoid arthritis (RA) for several years by receiving treatment in advance using a long-standing biologic drug, a clinical trial found. People receiving a year of abatacept ( Orencia ) injections had onset of rheumatoid arthritis postponed by up to four years, researchers reported Jan. 20 in The Lancet Rheumatology . Currently, no licensed therapy can prevent rheumatoid arthritis, researchers noted. But these results indicate treating high-risk patients with abatacept could potentially reduce the number of years they must live with the disease, researchers said. “Intervening early in people at high risk of RA can have lasting benefits,” said lead researcher Andrew Cope , head of the King’s College London Center for Rheumatic Diseases. “We have shown that this approach is safe and can prevent disease while patients are on treatment as well as substantially relieve symptoms,” Cope said in a news release. “Importantly, it can also delay the onset of RA for several years, even after treatment has stopped. This could reduce how long people live with symptoms and complications, drastically improving their quality of life.” The U.S. Food and Drug Administration (FDA) approved abatacept for treatment of rheumatoid arthritis in late 2005, according to Drugs.com . Abatacept works by reducing activation of the immune cells that cause the disorder. For the new study, researchers analyzed data based on the original clinical trial for abatacept, which involved 213 people in the U.K. and the Netherlands. The original trial followed participants for two years, but the new study reports outcomes from an extended follow-up between four and eight years, researchers said. Results showed that a year of once-a-week abatacept injections provided benefits that persisted well beyond the treatment period. Even at the end of six years of follow-up, only 29% of all at-risk patients had not progressed to RA, the study found. The drug was most effective in people at highest risk of developing RA, based on results from a blood test looking at specific autoantibodies associated with the disease. While they were at higher risk of arthritis, these people also were much more likely to benefit from early treatment. Symptoms like joint pain and fatigue also eased while people were taking abatacept, but returned to usual levels after the one-year treatment period, the study said. “The data show that, after stopping treatment, abatacept delays but does not prevent rheumatoid arthritis,” researchers concluded. “Indeed, the benefit of study drug on patient-reported outcomes was short-lived and confined to the treatment period, indicating that continuous treatment is required to suppress symptoms such as fatigue, pain and impaired physical and mental well-being.” The study received funding from Bristol Myers Squibb, maker of abatacept. Sources King’s College London, news release, Jan. 20, 2026 The Lancet Rheumatology, Jan. 20, 2026

Clinical ResultDrug Approval

100 Deals associated with Abatacept

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External Link

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.	02 Jul 2022
Myocarditis	Phase 3	Canada	Bristol Myers Squibb Co.	02 Jul 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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Hematologic Neoplasms	99	Abatacept + Post-transplant Cyclophosphamide + Tacrolimus	hhvitlulfd(yuyzskjqqd) = odpgbmgeoo mkrijqeaxc (tzsjcqujae ) View more	Positive	06 Dec 2025
				Mycophenolate + Post-transplant Cyclophosphamide + Tacrolimus	hhvitlulfd(yuyzskjqqd) = frgdnylqjm mkrijqeaxc (tzsjcqujae ) View more
ASH2025	Not Applicable	Hematologic Neoplasms	2,683	conventional GVHD prophylaxis + immunosuppressive agent	qhpwbfluou(evunzrbeec) = kpiegpveij mmqteuhyhm (wafaxeeumm, 0.95 - 1.31) View more	Positive	06 Dec 2025
				conventional GVHD prophylaxis	-
EUCTR2014-000555-93-CZ (ARIAA, ACR2025)	Phase 3	ACPA-positive	98	Abatacept 125 mg sc weekly	hpmapzekuu(dfmyfeiddn) = yyreuuatod jtdhxbdiyw (neewpozomy ) View more	Positive	24 Oct 2025
				Placebo	hpmapzekuu(dfmyfeiddn) = eamvlgfeil jtdhxbdiyw (neewpozomy ) View more
NCT04120831 (ALTO, ACR2025)	Phase 3	Arthralgia	143	Abatacept	ipdjdhgfvd(yegmsuyspk) = noswbsgtgf yepvqmhuel (bzbwbcffgc ) View more	Positive	24 Oct 2025
				Placebo	ipdjdhgfvd(yegmsuyspk) = kmrgjjjldj yepvqmhuel (bzbwbcffgc ) View more
NORD-STAR (ACR2025)	Not Applicable	-	624	Methotrexate combined with other csDMARDs/corticosteroids or steroids alone	qbiykvmubz(zaoxorbblb) = zfewablzgn ygyvmprnue (cwdvwovynm ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Rheumatoid arthritis with rheumatoid lung disease	526	Abatacept (Progressive ILD)	ovdavdsarg(waltvmkumc) = ttdzgpomoo mfialsypuy (zfvrhonbzu ) View more	Positive	24 Oct 2025
ARIAA (EULAR2025)	Phase 3	ACPA-positive	98	Abatacept 125 mg sc weekly	uhnivlydaj(nmlmqkvnkm) = nhemrlxwir vmrspioyzg (hplrumloeq )	Positive	11 Jun 2025
				Placebo	-
PALABA (EULAR2025)	Not Applicable	Palindromic Rheumatism rheumatoid factor (RF) \| anti-citrullinated protein antibodies (ACPA)	70	Abatacept	rbgttcduup(cajksqnugo) = vzdcafvxjm rmjywpgqzi (zhxzdzxrgi ) View more	Positive	11 Jun 2025
				Hydroxychloroquine	rbgttcduup(cajksqnugo) = ciaylbmdbh rmjywpgqzi (zhxzdzxrgi ) View more
NCT03215927 (ATtackMy-ILD, Pubmed \| Rheumatology (Oxford))	Phase 2	Interstitial lung disease due to systemic disease	-	Abatacept	pjqhnylybx(qyyhykphos) = jvxulclbrw aazmovvvgw (umrgdqgrir, -6.91 to 6.21)	Negative	24 Apr 2025
NCT03215927 (ATtackMy-ILD, CTgov)	Phase 2	Antisynthetase Syndrome \| Interstitial lung disease due to systemic disease	20	Placebo (Placebo)	pdhjkcbxwj(qeqvfgtzbo) = zeaddtrikh qjwoyewxuz (mtvdawzglt, mpkmagxgfs - mmqzlfhutm) View more	-	07 Jan 2025
				Abatacept (Abatacept)	pdhjkcbxwj(qeqvfgtzbo) = jkphuqdqpa qjwoyewxuz (mtvdawzglt, bzfxbvrnhc - vbbrcwaids) View more

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Abatacept

Overview

Basic Info

Structure/Sequence

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External Link

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Clinical Result

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Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation