Actemra IV (tocilizumab) / Roche, JW Pharma - LARVOL DELTA

Effect of Tocilizumab on Outpatient Versus Inpatient Dose Ramp up of Bispecific Antibody Agents Associated Cytokine Release Syndrome (CRS), Neurotoxicity, and Hospital Admission Rates (ASHP 2025) - No abstract available

Clinical • Cytokine release syndrome • Inflammation

Evaluating the effects on disease activity when switching rheumatology patients from reference self-administered tocilizumab to biosimilar (ASHP 2025) - No abstract available

Clinical • Rheumatology

Evaluating The Risk of Cytokine Release Syndrome/Immune Effector Cell-Associated Neurotoxicity Syndrome with Expedited Bispecific-Antibody Administration and Impact of Tocilizumab Prophylaxis on Inpatient Length of Stay (ASHP 2025) - No abstract available

Clinical • Cytokine release syndrome • Inflammation

Evaluating Concomitant Use of Baricitinib Plus Tocilizumab for Hospitalized COVID-19 Patients (ASHP 2025) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=792 | Recruiting | Sponsor: Hoffmann-La Roche | N=580 ➔ 792 | Trial completion date: May 2028 ➔ Sep 2030 | Trial primary completion date: May 2028 ➔ Sep 2030

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PIK3CA

Predictive values of baseline 18F-FDG PET/CT for toxicities and outcomes in patients with relapsed or refractory multiple myeloma following BCMA CAR T-cell therapy. (PubMed, Bone Marrow Transplant) - "Moreover, the administration of tocilizumab for the treatment of CRS was associated with high MTV (P = 0.005) or high TLG (P = 0.010). Notably, our multivariate Cox models that incorporated either MTV (P = 0.029) or TLG (P = 0.009) along with plasmacytoma types, high-risk cytogenetics, and high bone marrow plasma cell frequencies demonstrated strong predictive capabilities for the 5.3-year long-term OS. Therefore, baseline high MTV or TLG measured by PET/CT are recognized as adverse prognostic indicators for the incidence of severe CRS and poor outcomes in patients with R/R MM undergoing BCMA CAR T-cell therapy."

IO biomarker • Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma

Consensus recommendations for the diagnosis and management of neuromyelitis optica spectrum disorder: A Saudi expert panel review. (PubMed, Mult Scler Relat Disord) - "This expert consensus provides evidence-based guidance for the diagnosis and management of NMOSD in Saudi Arabia, striking a balance between clinical evidence and expert opinion where data gaps exist. It emphasises individualised care, antibody testing, and long-term immunosuppressive strategies while highlighting the need for further research on treatment duration and failure criteria."

Journal • Review • CNS Disorders • Immunology • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

High Rate of Cytokine Release Syndrome-Related Coagulopathy with Low Incidence of Bleeding and Thrombosis in Patients Treated with B-Cell Maturation Antigen (BCMA)-Targeted Chimeric Antigen Receptor T-Cells (CAR-T). (PubMed, Cancers (Basel)) - P1 | " We conducted a prospective analysis of 108 adult patients with multiple myeloma or light chain amyloidosis treated with the academic anti-BCMA CAR-T HBI0101 in a single-center trial (NCT04720313)...Laboratory markers, tocilizumab and blood product use, and thrombotic and bleeding complications were recorded. Patients received a short (3-day) or extended course of enoxaparin thromboprophylaxis as well as fresh frozen plasma in cases of severe coagulopathy... CRS-related coagulopathy is common following BCMA-targeted CAR-T treatment and correlates closely with CRS severity. Despite the high rate of laboratory coagulopathy, thrombosis and bleeding events were infrequent, suggesting the benefit of the prophylactic strategies used."

IO biomarker • Journal • Cardiovascular • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Thrombosis

Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov) - P1/2 | N=314 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety profile of inaticabtagene autoleucel in Chinese patients with Philadelphia chromosome-positive b-ALL: Insights from real-world data (ASH 2025) - P | "Prior therapies included hematopoietic stem cell transplantation (HSCT) (24.1%), inotuzumab ozogamicin (14.8%), and blinatumomab (24.1%)...The median infusion dose was 0.60 (range: 0.44–1.00) × 10 8 viable CAR-T cells, with 88.9% of patients receiving bridge therapy...All patients recovered without sequelae: 9 received corticosteroids, and 11 received tocilizumab. Conclusion Real-world data demonstrate that Inati-cel exhibits excellent efficacy in patients with Ph+ B-ALL, yielding low toxicity, short treatment cycles, high complete molecular response rates, and favorable long-term survival. Extended follow-up could illuminate the long-term outcomes of Inati-cel use."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Hematological Malignancies • Leukemia • ABL1 • IKZF1

Efficacy and safety profile of inaticabtagene autoleucel in Chinese patients with B-cell acute lymphoblastic leukemia: Insights from real-world data (ASH 2025) - P | "Prior immunotherapies included: HSCT(21.4%), inotuzumab ozogamicin (18.6%), and blinatumomab (28.3%)...All patients recovered without sequelae, with 38 treatedwith corticosteroids, and 33 with tocilizumab or siltuximab.Real-world data on Inati-cel corroborates its robust response rate, favorable toxicity profile, and survivalbenefits. Real-world data on Inati-cel corroborates its robust response rate, favorable toxicity profile, and survivalbenefits. Inati-cel demonstrates efficacy in patients with active extramedullary diseases, particularlythose with CNSL. In vivo expansion was observed across different disease states."

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • CD4 • CD8 • IKZF1 • KMT2A • PAX5 • TP53

Deeper remission achievement and longer leukemia-free survival with inati-cel as consolidation therapy in allogeneic transplant-ineligible adolescent and adult patients with B-ALL (ASH 2025) - P1/2 | "All patients receivedlymphodepletion with fludarabine (30 mg/m2/d ×3 days) and cyclophosphamide (500 mg/m2/d×2 days) followed by Ina-cel infusion (0.6×108 live CAR-T cells)...Specially, only one patient had grade 3 CRS and grade 3 ICANS, characterized by high fever andhypotension, and was managed with tocilizumab in combination with dexamethasone (80 mg).Additionally, 7 patients (63.6%) suffered from cytopenia... Our preliminary results of the intervention study demonstrate inati-cel, a CD19 CAR-T celltherapy leads to high MRD-negativity conversion and survival rates with manageable toxicity intransplant-ineligible B-ALL patients. More patients are being enrolled and followed up. Long-termsurvival data are likely to support CD19 CAR-T cell therapy as a new paradigm for consolidation therapyfor B-ALL patients."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Transplantation

Real-world step-up dosing of patients receiving elranatamab for multiple myeloma in Japan (ASH 2025) - "Almost all patients received dexamethasone during the SUD period (Group A: 192 [99.5%], Group A+B: 217 [99.5%]) and acetaminophen (Group A: 191 [99.0%], Group A+B: 216 [99.1%]). Other supportive medications received include diphenhydramine (Group A: 109 [56.5%], Group A+B: 124 [56.9%]) and tocilizumab (Group A: 101 [52.3%], Group A+B: 120 [55.0%])...Both the frequency and timing of CRS and ICANS were generally consistent with past findings from elranatamab clinical trials. Despite the occurrence of CRS and ICANS events, many patients continued to receive complete and timely SUD."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Inflammation • Multiple Myeloma

Feasibility and safety of bispecific antibodies outpatient model in triple-refractory multiple myeloma patients in two Italian centers (ASH 2025) - "All patients underwent premedication with acetaminophen, chlorphenamine and dexamethasone during SUD and first full dose whereas three patients received post-medication with dexamethasone 16 mg the day after SUD1, SUD2 and first full dose...Seven patients were treated with teclistamab and one with talquetamab, approved after teclistamab in Italy...For both these two patients, tocilizumab was administered with rapid resolution of CRS and no need of hospitilization...A solid collaboration with emergency room doctors and nurses, the education of the patient and the outline of a path to rapidly and safely manage complications has been documented to be crucial. These encourage the feasibility of managing BSAbs therapy for MM patients in an outpatient setting in hub centres where multidisciplinary collaboration can be easily achieved."

Clinical • CNS Disorders • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma

Real-world outcomes of autologous CD19-directed CAR T-cell therapy in relapsed/refractory large B-cell lymphoma: A single-center experience (ASH 2025) - "Twenty-two patients (73.3%) received R-CHOP as first-line chemoimmunotherapy...Two patients (6.7%) had prior anti-CD19 therapy, five (16.7%) had bendamustine exposure, and all patients received prior anti-CD20 monoclonal antibody...The most commonly used CART product was axicabtagene ciloleucel (N=28, 93%)...Tocilizumab was administered in 19 patients (63.3%), with 13 (68.4%) requiring only one dose...All ICANS patients received steroids, and four (33.3%) received anakinra...These findings affirm the safety and efficacy of autologous CD19-directed CAR T-cell therapy in routine clinical practice at a medium-sized academic institution. Continued research with larger sample sizes and extended follow-up periods is warranted to validate these results further."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Evaluation of payment reimbursement models for teclistamab administration and monitoring in the community hospital setting (ASH 2025) - "Five doses of tocilizumab were given in model 1 and 0 doses were given in model 2 (p=0.26). Eight doses of supplemental dexamethasone were given in model 1 and 7 doses were given in model 2 (p=0.88)...Conclusion Outpatient model 1 had significantly higher payment reimbursement and net profit margins compared to inpatient model 2. Our study showed that site of care is an important consideration with BsAbs to optimize revenue and minimize costs, in addition to enhancing access among community-based practices."

Clinical • Reimbursement • US reimbursement • Hematological Malignancies • Multiple Myeloma

Inpatient vs outpatient treatment management with teclistamab in relapsed and refractory multiple myeloma: A cost and healthcare resource utilization analysis (ASH 2025) - "Like in the inpatient setting, patients developing CRS in the outpatient setting would be treated with 8mg/kg tocilizumab, steroids, or supportive care. While teclistamab SUD is currently predominantly administered in the inpatient setting in the Netherlands, there is consensus among clinical experts strongly indicating that teclistamab SUD can be administered feasibly, safely and conveniently in the outpatient setting. In addition, it leads to more efficient healthcare resource use and cost savings. While there is heterogeneity in prophylactic medication used to mitigate CRS, potential costs associated with this are largely offset by the hospitalisation costs and potential re-admission costs saved."

Clinical • HEOR • Hematological Malignancies • Multiple Myeloma

A rubric‑based comparison of code red and specialists in managing CAR‑T–Related cytokine release syndrome and icans (ASH 2025) - "Its margin was driven by a consistently protocol-level presentation—explicit monitoring schedules, predefined intervention thresholds (e.g., tocilizumab at 24 h of persistent fever), steroid regimens, ICU escalation criteria, and tertiary options (anakinra/siltuximab)—delivered in concise, highly actionable language. Conclusions A lean, expert-guided RAG system (Code Red) can outperform individual CAR-T specialists on simulated toxicity management scenarios while delivering rapid guidance. Ongoing improvement will rely on continuous user feedback and automated literature surveillance to preserve patient safety and guideline fidelity."

Cytokine release syndrome • Inflammation

Impact of antibiotic use in early fever after haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide (ASH 2025) - "All patients received PTCY 50 mg/kg on days +3 and +4, followed by tacrolimus and mycophenolate mofetil as graft-versus-host disease (GVHD) prophylaxis...Eleven patients received tocilizumab for CRS grade ≥2. Levofloxacin prophylaxis was used in 72.8% of cases. Most (85/103, 82.5%) received empirical BSA, mainly piperacillin/tazobactam (67%)... The median patient age was 53 years, and 60.3% were male. The most frequent diagnosis was AML (38.8%). Most patients had intermediate disease risk (65.3%) and a high age-adjusted HCT-CI (76%)."

Post-transplantation • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Infectious Disease • Inflammation • Pneumonia • Transplantation • CRP

Aberrant lymphocytes are associated with increased inflammatory complications following CAR-T infusion (ASH 2025) - "CAR-T products included axi-cel (Yescarta) (n=10), brexu-cel (Tecartus) (n=2), liso-cel (Breyanzi) (n=1), tisa-cel (Kymriah) (n=1), or CD19-Car_Lenti (produced by the Officina Farmaceutica of Bambino Gesù Children's Hospital) (n=2)...Associations were not found between number of aberrant lymphocytes and development of neurotoxicity (eg, ICANS) nor with doses of Tocilizumab, Dexamethasone, or Anakinra or with WBC. While the number of patients is small, presence of increased aberrant lymphocytes, as pre-classified by the Scopio full-field digital morphology platform, appears to be associated with increased inflammatory complications following CAR-T infusion, including CRS of grade ≥2 and prolonged neutropenia requiring G-CSF support. Digital morphology combined with artificial intelligence may represent a novel platform for predicting clinical outcomes in CAR-T therapy."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Rheumatology

CAR t-cell therapy-related cytokine release syndrome and neurotoxicity: Real-world outcomes from a comprehensive cancer center (ASH 2025) - "Treatment options included ciltacabtagene autoleucel, brexucabtagene autoleucel, and axicabtagene ciloleucel...Secondary outcomes included use of tocilizumab, corticosteroids, vasopressors, anakinra, intrathecal chemotherapy, dasatinib, and thiamine; length of stay; survival at 100 days and 1 year... 53 patients were included in the study. Most patients receiving axi-cel experienced grade 1 or 2 CRS, with only three patients experiencing grade ≥3 CRS. The incidence of CRS was lower here compared to ZUMA-1 and ZUMA-5."

CAR T-Cell Therapy • Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Tocilizumab prophylaxis in patients receiving CAR-T cell immunotherapy for hematological malignancies: A systematic review and meta-analysis (ASH 2025) - "Four studies examining 91 patients with hematological malignancies (B-cell non-Hodgkin lymphomas: 76, ALL: 6, in 9 not specified) receiving tocilizumab prophylaxis (1 dose, 8 mg/kg) before CAR-T therapy (Axicabtagene ciloleucel: 38, Tisagenlecleucel: 2, other CD19-CAR-T cell products: 43, in 8 not specified) were included in the qualitative analysis. Based on these data, tocilizumab prophylaxis prior to infusion in patients who receive CAR-T cell immunotherapy can significantly decrease the risk of both any grade and grade >2 CRS. ICANS incidence was similar to ongoing published data and more than half of patients receiving tocilizumab prophylaxis achieved PFS. The need for larger, randomized controlled trials to confirm the observed effects and determine the impact of prophylactic tocilizumab on OS, TRM, adverse events, and infectious complications is warranted."

CAR T-Cell Therapy • Retrospective data • Review • Acute Lymphocytic Leukemia • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • IL6

A randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of CTO1681 (GP1681) in healthy adult participants (ASH 2025) - P1 | "The current standard-of-care treatment for CRS is tocilizumab and/or corticosteroids. Latent viruses (EBV, HSV, VZV, and CMV) were not detected in any participant, and there were no reports of skin lesions that might be indicative of viral reactivation. The PK, PD, and safety data presented in this clinical study report supports further clinical development of CTO1681."

Clinical • PK/PD data • Hypotension • Immunology • Infectious Disease • Influenza • Respiratory Diseases • Systemic Inflammatory Response Syndrome

Which inflammation matters? distinct risk signatures before CAR-T cell therapy and the role of inflamix (ASH 2025) - "Next, we evaluated potential differences in the use of tocilizumab, steroid therapy, and intensive care unit (ICU) hospitalization between the two groups...Overall, 65 patients (71%) received axicabtagene ciloleucel (axicel), and 27 patients (29%) received tisagenlecleucel (tisacel)...Its divergence from mEASIX and CAR-HEMATOTOX suggests that it reflects a distinct inflammatory profile. This underscores the importance of incorporating multiple biomarkers to enhance risk stratification."

CAR T-Cell Therapy • IO biomarker • Hematological Disorders • Hematological Malignancies • Inflammation • Lymphoma • Neutropenia

Real-world outcomes of teclistamab in triple-exposed relapsed/refractory multiple myeloma: Brazilian single-center experience (ASH 2025) - "Cytokine release syndrome (CRS) occurred in 62% (39% grade 2–4; 23% grade 3–4), with 93% receiving tocilizumab. We included 19 patients with a median follow-up of 16 months. The mean age was 70.4 years (SD=11.7) and 43% had high-risk cytogenetics (62% Double/Triple-hit) by mSMART criteria. The median number of prior therapy lines was 4 (47% had 2–3 lines; 32%, 4–5; 21%, ≥6)."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Multiple Myeloma • Rare Diseases