PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date01 Apr 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT03787290

/ SuspendedPhase 2IIT

Examining Immune-Based Mechanisms of Action for Mild-Intensity Whole Body Hyperthermia (WBH) in the Treatment of Major Depressive Disorder

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

Start Date01 Dec 2025

Sponsor / Collaborator

The General Hospital Corp.

[+1]

NCT06016517

/ Not yet recruitingNot ApplicableIIT

Application of the Personalized N-of-1 Trial Design in Patients With 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. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life fortnightly, monthly and/or quarterly (either in clinic or remotely) and report their level of pain on alternate days (remotely).

Start Date15 Nov 2025

Sponsor / Collaborator

Tufts Medical Center, Inc.

100 Clinical Results associated with Tocilizumab

100 Translational Medicine associated with Tocilizumab

100 Patents (Medical) associated with Tocilizumab

6,909

Literatures (Medical) associated with Tocilizumab

01 Jan 2026·INTERNATIONAL JOURNAL OF FOOD MICROBIOLOGY

Physicochemical properties, microbial diversity, metabolites and their potential relationships of traditional Chinese Zhacai fermented for different periods

Article

Author: Wang, Xinhui ; Ren, Ting ; Wang, Xinyi ; Gu, Yuanqing ; Nie, Xin ; Liu, Dayu ; Zhao, Zhiping ; Luo, Yuanli ; Zhao, Nan ; Liu, Yuling

In this study, we investigated the physicochemical properties, dominant microorganisms, non-volatile metabolites and their relationships of traditional Chinese Zhacai (TCZ) at the "second-time pickling and pressing" stage fermentation. pH and amino acid nitrogen contents exhibited an increasing and then decreasing trend. Metagenomics analysis revealed the dominant bacterial species Lactiplantibacillus (Lpb.) plantarum and Latilactobacillus (Lat.) sakei, and fungal species Debaryomyces (D.) hansenii. LEfSe analysis identified a total of 47 differentially abundant bacteria, including Lpb. plantarum and Lat. Sakei. Metabolomics analysis indicated organic acids and their derivatives, organic heterocyclic compounds, lipids and lipid-like molecules as the major differential metabolites. Spearman's correlation results showed significant correlations among differential bacteria, non-volatile metabolites and physicochemical properties. Unexpectedly, differential fungi were not observed in TCZ at this fermentation period. Pathway enrichment identified phenylpropanoid biosynthesis and tryptophan metabolism as dominant metabolic pathways, both influencing the TCZ flavor development. This study contributes to further understanding of quality formation of TCZ, providing a foundational resource for future optimization and industrial application.

01 Dec 2025·Journal of Translational Autoimmunity

Acylcarnitine enrichment as a characteristic of rheumatoid arthritis fibroblast-like synoviocyte metabolic fingerprint

Article

Author: Hørslev-Petersen, Kim ; Østergaard, Mikkel ; van Vollenhoven, Ronald ; Sureshkumar, Reshmi ; Guma, Monica ; Nurmohamed, Michael ; Hultgård Ekwall, Anna-Karin ; Gröndal, Gerdur ; Nordström, Dan ; Vasileiadis, Georgios K ; Fatima, Tahzeeb ; Zhang, Yuan ; Haavardsholm, Espen A ; Lend, Kristina ; Rudin, Anna ; Maglio, Cristina ; Gudbjornsson, Bjorn ; Borén, Jan ; Lampa, Jon ; Uhlig, Till ; Hetland, Merete L ; Sokka-Isler, Tuulikki ; Laudette, Marion

Objective:

In rheumatoid arthritis (RA), fibroblast-like synoviocytes (FLS) alter their metabolism to support their activation. We aimed to analyse the full spectrum of metabolic alterations associated with RA by performing untargeted metabolomics in RA FLS vs. non-inflamed (NI) FLS.

Methods:

Untargeted annotated metabolomics was performed using mass spectrometry on ten primary RA and seven NI FLS culture extracts and 220 serum samples from participants with early RA from the randomised controlled NORD-STAR trial. Carnitine-related proteins were measured with Western blot. FLS bioenergetic profile was assessed with a Seahorse flux analyser.

Results:

Metabolomics analysis based on 138 annotated metabolites revealed a distinct metabolic fingerprint between RA and NI FLS. Of the 12 metabolites enriched in RA FLS, 11 were acylcarnitines. Pro-inflammatory stimulation of NI FLS also led to acylcarnitine accumulation. RA FLS exhibited lower levels of CD36, a fatty acid transporter, but similar levels of L-carnitine transporter, and carnitine palmitoyltransferase 1 A and 2 compared to NI FLS. Seahorse analyses showed no difference in fatty acid oxidation between RA and NI FLS; however, RA FLS displayed mitochondrial dysfunction and energetic impairment. Serum acylcarnitine content decreased after 24 weeks of treatment with methotrexate combined with abatacept or tocilizumab in patients with early RA achieving remission.

Conclusion:

Acylcarnitine accumulation is a characteristic of RA FLS metabolic fingerprint and could be linked to mitochondrial dysfunction. In patients with early RA, acylcarnitine content in serum decreases after successful anti-rheumatic treatment. These results indicate a dysregulation in acylcarnitine metabolism in RA at the joint level and systemically.

01 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Comparison of utilization and total medicare fee-for-service expenditures for subcutaneous versus intravenous versions of a select group of therapies.

Article

Author: Sarocco, Phillip ; Kardel, Peter ; Maynard, Jason ; Sheetz, Caitlin

INTRODUCTION:

Comparisons of subcutaneous (SC) and intravenous (IV) delivery of biotherapeutics in Europe have revealed differences in cost, convenience, and preference. In the US, claims-based studies comparing SC and IV delivery have been limited. This study compared resource utilization and expenditures between cohorts of patients receiving the same drug by the SC or IV route of administration (ROA) across several indications.

METHODS:

Medicare Fee-For-Service claims were compared between cohorts of patients who received SC- or IV-delivered abatacept, belimumab, daratumumab, infliximab, tocilizumab, trastuzumab/pertuzumab, or vedolizumab. For each drug, utilization rates and healthcare expenditures per service site were compared between ROAs. Observed differences in baseline characteristics were accounted for using Inverse Probability Treatment Weighting models that balanced pre-index differences between ROAs per drug. Each ROA comparison per drug and service site was weighted and conducted independently.

RESULTS:

Across seven drugs, a total sample size of 158,632 (72,820 IV; 85,812 SC) was analyzed. For most comparisons, high-spend sites were utilized at a higher rate for IV administration. In particular, all comparisons revealed more frequent hospital outpatient department utilization for the IV ROA. For five of the seven drugs, SC treatment was associated with lower mean total Medicare expenditures, with savings of up to $56,000 per patient annually. Although three SC treatments had higher medication index spend, the total spend for these drugs across sites was significantly lower for SC delivery.

LIMITATIONS:

Limitations of this study include differences in billing between the SC and IV ROAs, potential treatment selection bias, and the assumption of equivalent efficacy.

CONCLUSIONS:

To our knowledge, this study was the first and largest US Medicare claims analysis, comparing patients receiving SC or IV versions of the same therapeutic across multiple drugs and indications. Findings demonstrated that SC delivery may facilitate reduced resource utilization and expenditures across drugs and disease indications.

265

News (Medical) associated with Tocilizumab

06 Nov 2025

·pharma.economictimes.indiatimes.com

Aurobindo negotiating deals in Europe for biosimilars portfolio expansion, says Company CEO

Mumbai: With an eye on the growing biosimilars opportunity for blockbuster brands, Hyderabad-based Aurobindo Pharma is in advanced stages of discussions for multiple “deals in Europe ” aimed at expanding the company’s product portfolio and enhancing supply potential. Speaking at the company’s Q2 FY26 earnings call, Dr Satakarni Makkapati, CEO, Biologics , Vaccines and Peptides businesses, Aurobindo Pharma , said, “we are in the process of negotiating a couple of strategic deals in the European market.” “The deals will broaden our portfolio, maximize our supply potential, and we expect to share more clarity on these developments in the next quarter,” he added. Alongside this, the company management in India also shared plans to add additional filing capacity at its Hyderabad-based biosimilars manufacturing plant. “Meanwhile, we are focusing on streamlining operations with CRMO partners to ensure timely distribution and are also aligning our manufacturing and supply capacities to ensure continuous supply to our European partners,” the CEO said. In 2022, Aurobindo’s biosimilars arm, CuraTeQ Biologics , had inked a biosimilar distribution agreement with Orion Corporation, under which Orion has secured select market rights of CuraTeQ biosimilars that are still in development or regulatory phases between 2023 and 2026. Sharing an update on Aurobindo’s biosimilar pipeline, Dr. Makkapati noted that the company has completed the PK/PD study for its Tocilizumab--an immunology therapy---biosimilar, Iztalvys, and secured a Phase 3 clinical study waiver from the European Medicines Agency (EMA). The company will also seek a similar waiver from the FDA to fast-track the therapy’s market approval. For Denosumab —an orthopaedic biologic sold under the brand names Prolia (for osteoporosis) and Xgeva (for cancer-related bone conditions)—the company’s biosimilars, Fugevy and Filvizy, have completed the Phase 3 study and are planned for regulatory submissions in April 2026 in Europe and in Q3 CY26 in the US. FDA Biosimilars Push Commenting on the new FDA draft guidance on biosimilars, Dr. Makkapati said that the document emphasizes reducing reliance on comparative efficacy studies, though it does not eliminate them at this stage but moving forward similar to EMA and MHRA, the FDA may eventually move to a point where regulators may move away from the requirement of interchangeability studies. However, while reducing development hurdles and costs may attract new players, it is still not easy, considering that biosimilar development—though excluding original discovery—requires strong analytical and comparative data expertise, which remains a significant barrier for most companies, he stated. Financials & Future plans In the second quarter of fiscal year 2025-26, Aurobindo Pharma's revenue from operations increased by 6.3 per cent on Year-on-Year (YoY) basis to Rs 8,286 crore, and its net profit increased by 3.8 per cent to Rs 848 crore. EBITDA stood at ₹2,064 crore, and on margins, the drugmaker maintained its overall guidance for the current fiscal at 20–25 per cent. The company's total formulation business increased by 10.3 per cent to Rs 7,325 crore, while API revenues plummeted 16.1 per cent to Rs 961 crore. For its Semaglutide formulation, the company shared plans to launch its brand in the second wave from its Vizag plant. During the July–September quarter, Aurobindo submitted a representation to the Department of Pharmaceuticals seeking minimum import duty for its Kakinada-based penicillin manufacturing facility. Currently, the plant is operating at a capacity of 6,000 units per month and is progressing toward achieving break-even EBITDA. Commenting on the company’s brownfield expansion plans, Santhanam Subramanian, CFO, Aurobindo Pharma, said that the company is open to considering opportunities and technologies that unlock new markets and will evaluate them on a case-by-case basis. On the company’s India business, Subramanian shared that it does not plan any “aggressive push currently, but may consider small acquisitions over time.” By Abhijeet Singh ,

Phase 3BiosimilarFinancial Statement

03 Nov 2025

·www.prnewswire.com

Recordati Rare Diseases to Share New Data at the American Society of Hematology (ASH) Meeting

Poster presentations at ASH highlight advances in the understanding and research of Castleman disease, cold agglutinin disease, B-cell lymphoma, and other hematologic conditions BRIDGEWATER, N.J., Nov. 3, 2025 /PRNewswire/ -- Recordati Rare Diseases Inc. today announced the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67th American Society of Hematology (ASH) Annual Meeting, which takes place December 6-9, 2025, in Orlando, Fla. In a series of nine poster presentations, Recordati researchers and independent investigators will present research detailing advances in Castleman disease (CD), cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS), and immune-related complications of CAR T-cell therapy. Highlights include a report on the development of an artificial intelligence (AI) model that evaluates CD tissue samples; an analysis of the morbidity burden and healthcare costs among patients with idiopathic multicentric Castleman disease (iMCD); the first real-world evaluation of sutimlimab in the treatment of patients with CAD or CAS; and a prospective evaluation of siltuximab in the prevention or treatment of cytokine release syndrome (CRS) after CAR T-cell therapy. "We are particularly excited about the long-term safety data for sutimlimab in cold agglutinin disease and the growing body of research investigating the use of siltuximab in Castleman disease," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "Also notable is the poster describing an innovative, AI-based approach to lymph node analysis, which could represent a meaningful step toward earlier and more consistent diagnosis of Castleman disease, one of the most difficult hematologic conditions to diagnose accurately. Altogether, the datasets presented at ASH 2025 reflect Recordati's ongoing commitment to advancing care for people living with rare hematologic disorders." "The ASH Annual Meeting is an important opportunity to showcase research advances in hematologic diseases, and we are pleased that the meeting organizers have accepted nine abstracts related to our therapies," said Mohamed Ladha, President and General Manager at Recordati Rare Diseases North America. "Together with our independent research partners, Recordati is at the forefront of advancing potential therapeutic solutions for people living with devastating conditions such as Castleman disease. We look forward to these data sparking further dialogue and collaboration as we continue in our efforts to improve patients' lives." The ASH 2025 Annual Meeting will feature the following poster presentations: Castleman Disease Poster number: 2606 Title: Retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls (BURDEN-iMCD) Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic Poster number: 3001 Title: Comprehensive analysis of subtype-specific outcomes and management in Castleman disease: a 20-year cohort study Presenting author: Yoshito Nishimura, MD, PhD, MPH, Mayo Clinic Poster number: 3002 Title: Automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model Presenting author: Muir Morrison, PhD, University of Utah Poster number: 3009 Title: Pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab Presenting author: Bridget Austin, MS, Perelman School of Medicine, University of Pennsylvania, Center for Cytokine Storm Treatment & Laboratory Poster number: 3006 Title: Epidemiology and clinical characteristics of idiopathic multicentric Castleman disease in Spain (ARCANA study): Prevalence cohort Presenting author: José-Tomás Navarro, MD, PhD, Catalan Institute of Oncology, Josep Carreras Leukaemia Research Institute Poster number: 4788 Title: Siltuximab-mediated suppression of CRP is associated with clinical response in idiopathic multicentric Castleman disease Presenting author: Jean-Francois Rossi, MD, PhD, Université de Montpellier Cold Agglutinin Disease (CAD) Poster number: 6242 Title: Real-world safety of sutimlimab in patients with CAD/CAS: a multinational, multicenter, observational, prospective cohort study Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen CAR T-Cell Therapy Toxicity (including in B-Cell Lymphoma)* Poster number: 2385 Title: Safety and immunomodulatory effects of siltuximab prophylaxis prior to standard of care CD19 directed chimeric antigen receptor T-cell (CD19.CART) therapy for B-cell lymphomas: final Phase I trial results Presenting author: Nathan Denlinger, DO, MS, The Ohio State University Wexner Medical Center, James Comprehensive Cancer Center Poster number: 5919 Title: Siltuximab versus tocilizumab for the management of CAR T-cell associated cytokine release syndrome Presenting author: Mayur Narkhede, MD, University of Alabama at Birmingham *These studies were conducted as investigator-sponsored studies without research involvement by Recordati. About Idiopathic Multicentric Castleman Disease (iMCD) Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a central pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats. About Cold Agglutinin Disease (CAD) Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients' quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30. About Recordati Rare Diseases Recordati Rare Diseases is Recordati's dedicated business unit focused on Rare Diseases. Recordati is an international pharmaceutical Group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas, and APAC, with over 4,500 employees. Recordati Rare Diseases' mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis, and expand availability of treatments for people with rare diseases. Recordati Rare Diseases Inc. is the company's U.S. corporate headquarters located in Bridgewater, NJ, with the global headquarter offices located in Milan, Italy. For full prescribing information, including approved indications and important safety information about marketed products, please visit: . SOURCE Recordati 21% more press release views with Request a Demo

Phase 1ASHCell TherapyClinical Result

03 Nov 2025

·www.gilead.com

Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025

– Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally – – New Findings Reinforce Yescarta’s® Curative Potential as Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma – – Next-Generation CAR T-cell Therapies Suggest High Response Rates and Encouraging Durability in B-Cell Malignancies – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 21 abstracts, including 5 oral presentations, during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition (December 6-9). These data showcase Kite’s continued progress in transforming blood cancer care and expanding the reach and impact of CAR T-cell therapy. “Kite is dedicated to advancing cell therapy as a path to cures, and our data at ASH will reflect meaningful progress toward this goal,” said Cindy Perettie, Executive Vice President of Kite. “Together with our partner Arcellx, we’ll unveil the updated results from the pivotal Phase 2 iMMagine-1 study. These findings will lay the foundation for our aspiration with anito-cel to deliver a differentiated treatment for relapsed/refractory multiple myeloma with strong potential for community oncology access and reduced burden on patients and caregivers.” Anito-cel Data Updates Key presentations for anitocabtagene autoleucel (anito-cel) include updated results from the fully enrolled, ongoing iMMagine-1 Phase 2 pivotal study. No delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune-mediated enterocolitis, have been observed to date. Data on Next-Generation Pipeline Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753. These therapies are designed to target two antigens (CD19 and CD20) found on cancer cells and use two co-stimulatory domains (CD28 and 4-1 BB) to help the immune system fight cancer more effectively. This dual-targeting approach may lower the chance of the cancer escaping treatment and could also improve safety, making it possible to treat patients outside of a hospital setting. Survival Outcomes with Yescarta® Based on ASCT Eligibility A key presentation for Yescarta® (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible. Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment. Dates and times are listed in ET for the following accepted abstracts and presentations: Oral Presentations Abstract Details Titles Axicabtagene Ciloleucel Clinical Data Abstract #671 Sunday, December 7, 2025 5:30 PM – 5:45 PM OCCC – Tangerine Ballroom F3-4 Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) for Second-Line High-Risk Large B-Cell Lymphoma (LBCL): Interim Results from a Phase 1b Study Brexucabtagene Autoleucel Clinical Data Abstract #569 Sunday, December 7, 2025 1:00 PM – 1:15 PM OCCC – Tangerine Ballroom F3-4 ZUMA-25 Preliminary Analysis: A Phase 2 Study of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Burkitt Lymphoma (BL), Substudy C Anitocabtagene Autoleucel Clinical Data Abstract #256 Saturday, December 6, 2025 2:45 PM – 3:00 PM OCCC – West Halls D1 Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Updated Results from iMMagine-1 Kite Next Generation CAR T Clinical Data Abstract #265 Saturday, December 6, 2025 2:00 PM – 2:15 PM OCCC – West Halls D2 A Phase 1 Study of KITE-753 or KITE-363 in Patients with Relapsed/Refractory B-Cell Lymphoma: Initial Safety and Preliminary Efficacy of KITE-753 and Updated Results of KITE-363 Translational Medicine Abstract #805 Monday, December 8, 2025 10:30 AM – 10:45 AM OCCC – W331 Blood and CSF Metabolomics Identifies Tryptophan Catabolism and Polyamine Synthesis as Drivers of CAR T-Cell-Associated Neurotoxicity Poster Presentations Axicabtagene Ciloleucel Abstract #1799 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4 Patient Journey with Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma in Canada: Manufacturing experience and Impact of Patient Location to Treatment Centre Abstract #3714 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Axi-Cel Delivers Similar Outcomes Regardless of ASCT-Eligibility in Second Line R/R LBCL: Combined Data from ZUMA-7 and ALYCANTE Abstract #1894 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4 Diffuse Large B Cell Lymphoma in Brazil: Understanding the Patient Journey to Improve Healthcare Assistance Abstract #4510 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Estimating the Survival Impact of Not Receiving CAR T-cell (CAR T) Therapy When Eligible in Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the United States (US) Abstract #6194 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 US Cost Consequence and Time Toxicity Model for Advanced Therapies in the Treatment for Relapsed/Refractory Third-line or Later Diffuse Large B-cell Lymphoma: A Comparison of Axicabtagene Ciloleucel with Bispecific Antibodies Abstract #5356 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Real-World Effectiveness and Safety Outcomes by Age, Comorbidity, Frailty, and Treatments Prior to Infusion in Relapsed or Refractory (R/R) Follicular Lymphoma Patients Treated with Axicabtagene Ciloleucel Abstract #3717 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Surrogate Endpoints as Prognostic Factors for Long-Term Outcomes Among Patients Receiving Axicabtagene Ciloleucel in Frontline High-risk Large B Cell Lymphoma Abstract #4503 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Real-World Treatment Patterns and Survival Outcomes in Second and Third Line Settings in Large B-cell Lymphoma (LBCL) Brexucabtagene Autoleucel Abstract #1588 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4 Endogenous Regulation of Inflammatory Response as a Determinant of Durable Remission Without Stem Cell Transplant Following Brexucabtagene Autoleucel (Brexu-Cel) Therapy in ALL Abstract #1799 Saturday, December 6, 2025 5:30 PM – 7:30 PM OCCC – West Halls B3-B4 Two-year Update of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Had Not Received Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy Abstract #3606 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Real-world Effectiveness and Safety Outcomes by Age, Comorbidities, and Frailty Among Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients Treated with Brexucabtagene Autoleucel (Brexu-Cel) Above Brand Abstract #5882 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Pre-Treatment CD19 Antigen Density and Multi-Antigen Profiling by Calibrated Quantitative Flow Cytometry Correlates with CAR T Efficacy in LBCL Multiple Myeloma Unmet Clinical Need Abstract #6344 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Visualizing Geographic Variation and Systemic Inequities of Disease Burden and CAR T-Cell Therapy Access in Multiple Myeloma in the US Abstract #6284 Monday, December 8, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Outcomes of Inpatient and Outpatient Chimeric Antigen Receptor T-cell Therapy (CAR T) in Newly Authorized Treatment Centers (ATCs) in the United States (US) Abstract #4411 Sunday, December 7, 2025 6:00 PM – 8:00 PM OCCC – West Halls B3-B4 Real-world Healthcare Resource Utilization (HCRU) Following CAR T-Cell Therapy in US Patients Treated in Newly Authorized Treatment Centers Publication Only: Anitocabtagene Autoleucel Pre-Clinical Data Abstract #7644 The Fast Off-Rate of Anito-cel’s D-Domain Binder Contributes to Its Distinctive Pharmacology Profile in Preclinical Models of Multiple Myeloma Investigator-Sponsored / Collaboration: Anitocabtagene Autoleucel Pre-Clinical Data* Oral Abstract #203 Sunday, December 7, 2025 10:30 AM – 10:45 AM OCCC – Sunburst Room (W340) Single-cell Transcriptomics Reveal Mechanisms of Efficacy and Toxicity in Anti-BCMA CAR-T Cell Therapies for Multiple Myeloma For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2025/webprogram/start.html *Presentations independently led and sponsored feature Kite CAR T-cell therapies but are not included in total number of Kite accepted abstracts. About Yescarta INDICATIONS YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. HYPERSENSITIVITY REACTIONS Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur in patients receiving YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. ADVERSE REACTIONS The most common adverse reactions (incidence ≥ 20%) in: patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. Please see full Prescribing Information, including BOXED WARNING and Medication Guide. About Gilead and Kite Oncology Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. About Arcellx and Kite Collaboration Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States. About Anitocabtagene autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signalling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta, anito-cel, KITE-363 and KITE-753; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Yescarta, including BOXED WARNING, is available at www.kitepharma.com. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X/Twitter (@KitePharma) and LinkedIn (Kite-Pharma). Ashleigh Koss, Gilead Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

Clinical ResultImmunotherapyCell TherapyPhase 2ASH

100 Deals associated with Tocilizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D02596	Tocilizumab	L04AC07	DB06273

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Interstitial lung disease due to systemic disease	United States	Genentech, Inc.	04 Mar 2021
Still's Disease, Adult-Onset	Japan	Chugai Pharmaceutical Co., Ltd.	22 May 2019
Takayasu Arteritis	Japan	Chugai Pharmaceutical Co., Ltd.	25 Aug 2017
COVID-19	European Union	Roche Registration GmbH	16 Jan 2009
COVID-19	Iceland	Roche Registration GmbH	16 Jan 2009
COVID-19	Liechtenstein	Roche Registration GmbH	16 Jan 2009
COVID-19	Norway	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	European Union	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Iceland	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Norway	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	European Union	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Iceland	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Norway	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	European Union	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Iceland	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Norway	Roche Registration GmbH	16 Jan 2009
Oligoarticular Arthritis	European Union	Roche Registration GmbH	16 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypoxic respiratory failure	Phase 3	United States	Genentech, Inc.	20 Apr 2020
Osteoarthritis	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Pain	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Inflammation	Phase 3	Denmark	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Finland	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Norway	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Sweden	Hoffmann-La Roche, Inc.	28 May 2014
Scleroderma, Systemic	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Mar 2012
Scleroderma, Systemic	Phase 3	Canada	Hoffmann-La Roche, Inc.	01 Mar 2012
Scleroderma, Systemic	Phase 3	France	Hoffmann-La Roche, Inc.	01 Mar 2012

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACR2025	Not Applicable	Giant Cell Arteritis	30	TCZ and short prednisone taper	icibgifzpj(tooncaonhu) = prgpwukeyv kkbuqknild (pkdeisxvjf, 8.6 - NE) View more	Negative	24 Oct 2025
ACR2025	Not Applicable	Giant Cell Arteritis	38	Tocilizumab-biosimilarMethotrexatebiosimilar + Tocilizumab-biosimilarMethotrexate	pczgasszkh(igwnutyjtq) = One patient developed herpes zoster one month after switching fromTCZ-reference product to TCZ-biosimilar ypdqhimjbn (ssnheaznko ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Juvenile Idiopathic Arthritis	929	Tocilizumab	wjhunqitxl(uxxpdwaqnm) = kvdlyftobf wnkedflfvp (rlbynnebxo ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Lung Diseases, Interstitial	45	Tocilizumab	uqixlgfauh(otasniwbgk) = xxezzzzajl csgzsiqjoq (ijqiezxsac ) View more	Positive	24 Oct 2025
				Corticosteroids with or without conventional immunosuppressants	uqixlgfauh(otasniwbgk) = lbfqvhtkdy csgzsiqjoq (ijqiezxsac ) View more
METOGiA (ACR2025)	Not Applicable	Giant Cell Arteritis	218	Tocilizumab	jqobsbtrmg(zedqbueoxg) = pxvyyycgel szcgmtsbsi (hkurxvdwhs )	Negative	24 Oct 2025
				Methotrexate	nfkkmmelta(lvqmffvvjs) = ebjmubyrlj qgwpftgvvm (sprhghpbds ) View more
ACR2025	Not Applicable	Giant Cell Arteritis	471	Tocilizumab	douzsfgfxy(xobvoxjadm) = jrvlteqdgr ircugdjejg (xhplgmzhtw ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Aortitis \| Giant Cell Arteritis	196	Tocilizumab mono	beattcvuba(xpyihxrdtu) = omdjwfjomu vdffkgtvhk (tfrgdgmmai ) View more	Positive	24 Oct 2025
				Tocilizumab combined with conventional synthetic disease modifying anti-rheumatic drugs	beattcvuba(xpyihxrdtu) = dwrpisgrwz vdffkgtvhk (tfrgdgmmai ) View more
ACR2025	Not Applicable	COVID-19 \| Rheumatoid Arthritis	107,540	Tocilizumab	lrmhcrpyri(nenetrfvkx) = uvsncikdms nlxoucnnta (bcpgpklutv ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Cardiovascular Diseases	206	Anakinra	qfnqctjder(wesfifvniu) = yfrzdsstew llcapnapld (uinhgdwlyr ) View more	Positive	24 Oct 2025
				Tocilizumab	ycxaeguxsx(pcqwegoxwq) = bauhcrufqd yainecszfn (ntzjmamzjs )
ACR2025	Not Applicable	Juvenile-Onset Scleroderma	7	Tocilizumab	ejkbdayqny(wtowsjyqor) = mzwdvpdmeo gtrvysijqw (kaxhzmxaue ) View more	Positive	24 Oct 2025
				Tofacitinib	ejkbdayqny(wtowsjyqor) = pvvjkhfuhc gtrvysijqw (kaxhzmxaue ) View more

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