Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi - LARVOL DELTA

A phase II study of the interleukin-6 (IL-6) receptor blocking antibody sarilumab (Sari) in combination with ipilimumab (Ipi), nivolumab (Nivo) and relatlimab (Rela) in patients with unresectable stage III or stage IV melanoma. (ASCO 2025) - P2 | "Nivo, Rela, Ipi, + Sari demonstrated encouraging efficacy and tolerability. At 24 weeks, 63.6% BORR and 12.1% gr 3/4 irAE rate were observed. 2 patients had gr 4 toxicity; no gr 5 events were reported."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Immunology • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF • IL4 • IL6

A phase 1/2 trial investigating REGN5668, a MUC16×CD28 costimulatory bispecific antibody, in combination with other targeted therapies in patients with recurrent ovarian or endometrial cancer: trial in progress update (ESGO 2026) - P1/2 | "Module 2 dose-escalation will evaluate REGN5668 + ubamatamab (± sarilumab [anti–interleukin-6 receptor α-subunit monoclonal antibody]) in an OC cohort using a Bayesian optimal interval design. Key secondary endpoints: ORR (Module 2 dose-escalation), safety and pharmacokinetics (Module 1 dose-expansion), further efficacy outcomes, immunogenicity.Results Module 1 dose-expansion has enrolled the first patient. Module 2 dose-escalation has progressed through multiple dose levels (enrolment ongoing).Conclusion This trial will evaluate REGN5668 + cemiplimab ± fianlimab or + ubamatamab in patients with OC/EC."

Clinical • Combination therapy • First-in-human • P1/2 data • Carcinosarcoma • Endometrial Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • IL6R • MUC16

Stand UP to Rheumatoid Arthritis (SUPRA) (clinicaltrials.gov) - P=N/A | N=75 | Recruiting | Sponsor: Marie Hudson, MD | Trial completion date: Dec 2026 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ Dec 2028

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A phase 1/2 study of ubamatamab (REGN4018): low-grade serous ovarian cancer expansion cohort (ESGO 2026) - P1/2 | "Sarilumab, an anti–interleukin-6 receptor α-subunit monoclonal antibody, is being evaluated for mitigation of ubamatamab-associated cytokine release syndrome (CRS). Results As of April 2025, 19 patients with LGSOC have been treated; initial data analysis is expected by March 2027. Conclusion Insights into the efficacy and safety of ubamatamab in patients with LGSOC may further validate MUC16 as a novel therapeutic target for LGSOC."

P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • IL6R • MUC16

Benefit and risk associated with interleukin-6 receptor inhibitor administration during severe COVID-19: a retrospective multicentric study. (PubMed, Sci Rep) - P=N/A | "224 received at least one dose of tocilizumab or sarilumab. Mortality of patients admitted in ward was higher in the IL-6Ri group (18.7% vs 10.5%, p = 0.0155). No difference in 28 days, ICU, hospital of 90 days mortality was noticed among ICU patients.Clinical trial registration: This study was registred on ClinicalTrial.gov: NCT05017441."

Journal • Retrospective data • Hematological Disorders • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Pneumonia

Structural remission rate and factors associated with radiographic progression in patients with rheumatoid arthritis treated with sarilumab in clinical practice. (PubMed, Clin Rheumatol) - "Sarilumab was associated with limited radiographic progression in patients with RA in clinical practice. Associations with MTX use and baseline GC exposure should be interpreted cautiously given the observational design. Key Points • This study reports the structural remission rate and factors associated with radiographic progression in patients with rheumatoid arthritis treated with sarilumab in clinical practice. • The structural remission rate for sarilumab was 78.0%. The change in the joint space narrowing score was significantly higher in the MTX- group (0.42 ± 1.34) compared with the MTX + group (- 0.20 ± 1.22). • Glucocorticoid use was associated with radiographic progression at 52 weeks (odds ratio, 13.1)."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Sarilumab in the management of Graves orbitopathy with low clinical activity scores. (PubMed, Sci Rep) - "No major adverse events were registered. Our findings suggest that Sarilumab is an effective and safe option for the treatment of low CAS GO."

Journal • Ophthalmology • Thyroid Eye Disease

Diverse Vascular Manifestations of Takayasu Arteritis: Coronary Artery Stenosis and Aneurysmal Dilation in pediatric patients. (PubMed, Clin Med Insights Arthritis Musculoskelet Disord) - "She was diagnosed with c-TA based on the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and responded favorably to high-dose corticosteroids, infliximab, methotrexate, and antiplatelet therapy...Despite treatment with sarilumab, corticosteroids, methotrexate, and antiplatelet therapy, she continued to experience symptoms and required further intervention. These cases underscore the need to consider TA in pediatric patients with hypertension, absent or diminished pulses, blood pressure discrepancies, limb claudication, chest pain, or unexplained systemic inflammatory symptoms. Early recognition and aggressive immunosuppressive therapy are essential to prevent irreversible vascular damage and improve long-term outcomes."

Journal • Cardiovascular • CNS Disorders • Hematological Disorders • Hypertension • Inflammation • Pain • Pediatrics • Pulmonary Disease • Rheumatology • Vasculitis • CRP

Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma (clinicaltrials.gov) - P2 | N=105 | Recruiting | Sponsor: NYU Langone Health | N=69 ➔ 105 | Trial completion date: Dec 2025 ➔ Feb 2028 | Trial primary completion date: Jun 2025 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date • Mucosal Melanoma • Oncology • Solid Tumor

Real-world comparative effectiveness of sarilumab versus Janus kinase inhibitors as monotherapy in rheumatoid arthritis. (PubMed, Arthritis Res Ther) - "SAR and JAKi showed no statistically significant differences in 12-month retention or disease control in MTX-free monotherapy settings. Higher CRP and Plt with lower Hb, particularly in younger patients, identified better response to SAR and support biomarker guided selection between IL-6Ri and JAKi. In Phase 2, GC discontinuation with SAR suggests a practical strategy to reduce AEs while maintaining efficacy. Prospective studies should validate these findings and define actionable thresholds."

HEOR • Journal • Monotherapy • Real-world evidence • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Varicella Zoster • CRP

Immunogenicity assay supporting clinical development of RGB-19, a proposed biosimilar to RoActemra®. (PubMed, Bioanalysis) - "To mitigate target interference, sarilumab - a high-affinity anti-sIL-6R antibody - was incorporated into the sample preparation. By ensuring accurate ADA detection under clinically relevant conditions, it supports biosimilarity demonstration and streamlines regulatory review, ultimately facilitating timely access to cost-effective biologic therapies. https://jrct.mhlw.go.jp.Identifiers are: jRCT2031230029 and jRCT2031220512."

Journal • IL6

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica (clinicaltrials.gov) - P4 | N=300 | Not yet recruiting | Sponsor: Sanofi

New P4 trial • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology

TAFRO Syndrome in Disguise: A Case of Idiopathic Multicentric Castleman Disease-Like Syndrome with Renal Thrombotic Microangiopathy and Autoimmune Overlap (KIDNEY WEEK 2025) - "Post-discharge, regimen was changed to anti-IL6 therapy, sarilumab. Treatment options are glucocorticoids, IL-6 inhibitors (tocilizumab/siltuximab), anti-IL-1 drugs (anakinra/ canakinumab), along with supportive care. BM biopsy with reticulin fibrosis"

Clinical • Fibrosis • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Nephrology • Rare Diseases • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Thrombocytopenia

Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and One-Year Analysis of a Phase 2b, Open-Label, Multicenter Study. (PubMed, Arthritis Care Res (Hoboken)) - P2 | "In pcJIA patients receiving the selected dose from baseline, pharmacokinetic exposure was comparable to a dose of 200mg q2w for adults with rheumatoid arthritis. Clinically relevant improvements were observed in disease activity, with safety being consistent with the known profile of sarilumab."

Clinical • Journal • P2b data • Hematological Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Neutropenia • Rheumatoid Arthritis • Rheumatology

Tocilizumab vs. Sarilumab Among Adults Hospitalized Due to COVID-19: A Federated Comparative Effectiveness Study Across England and Scotland Under the Target Trial Emulation Framework (ISPOR-EU 2025) - "In this large-scale comparative effectiveness study during the delta/omicron period across two UK nations, we found no significant difference in effectiveness between tocilizumab and sarilumab in terms of mortality and time to hospital discharge among adults hospitalised due to COVID-19."

Clinical • HEOR • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Sarilumab as a potential mitigator of ubamatamab (MUC16×CD3)-induced cytokine release syndrome (CRS) in patients with advanced ovarian cancer (OC) or endometrial cancer (EC) (SITC 2025) - P1/2 | "The research protocol was approved by the relevant institutional review boards or ethics committees at each site. All patients provided written informed consent.Abstract 546 Figure 1Request permissionsSunburst plot of the incidence of CRS by grade over the first 4 weeks of ubamatamab administration in patients treated A) with sarilumab prophylaxis and B) without sarilumab prophylaxisAbstract 546 Figure 2Request permissionsMedian IL-6 (A) and CRP (B) levels in patients treated with and without sarilumab prophylaxis"

Clinical • Cytokine release syndrome • Metastases • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • CCL11 • CRP • CXCL8 • IFNG • IL6 • MUC16 • TNFA

The Efficacy Of Targeted Therapies In Giant Cell Arteritis: A Systematic Review and Meta-Analysis (ACR Convergence 2025) - "SR rates were significantly higher compared to placebo in the patients who received tocilizumab (tocilizumab IV RR(CI 1.90 (1.01-3.56), tocilizumab SC 1.45 (1-06-1.99)), mavrilumab (RR (CI) 1.67(1.12-2.47)), secukinumab (RR(CI): 7.41 (1.89-29.02)) and upadacitinib 15 mg (RR (CI) 1.58 (1.14-2.17). Tocilizumab, mavrilumab, secukinumab and upadacitinib appear to increase the rate of 52-week sustained remission rate. Sarilumab and sirukumab has not shown significant efficacy."

Retrospective data • Review • Giant Cell Arteritis • Immunology

A Systematic Literature Review to Inform the 2025 EULAR Recommendations for Management of Polymyalgia Rheumatica and Large Vessel Vasculitis: Management of Disease Including Relapse and Complications (ACR Convergence 2025) - "RCTs of GCA (low RoB) reported superiority of secukinumab (Phase-2, n=1), mavrilimumab (Phase-2, n=1) and upadacitinib (Phase-3, n=1) vs placebo; Phase-2 trials of sarilumab (n=1) and sirukumab (n=1) were prematurely terminated (high RoB)...RCTs of TAK reported similar effectiveness of methotrexate or mycophenolate (unclear RoB), and superiority of adalimumab vs tocilizumab (high RoB). Phase-3 RCTs in PMR revealed superiority of tocilizumab and sarilumab (low RoB) vs. placebo while smaller phase-2 studies provided initial evidence for efficacy of rituximab (low RoB) and abatacept (unclear RoB) vs placebo (Table 1). A RCT showed similar efficacy of tofacitinib or glucocorticoids in PMR although this study was at high risk of bias. The SLR identified several new Phase-2 and Phase-3 RCTs about the efficacy and safety of IL-6i, IL-17i, Janus kinase inhibitors and B-cell depletion therapies in GCA and PMR. The SLR identified several new Phase-2 and Phase-3 RCTs about the..."

Review • Fatigue • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology • Vasculitis

Trends in Cost and Utilization of Biologic Medications for Rheumatologic Conditions: A Medicare Claims Study (2013–2022) (ACR Convergence 2025) - "This study leverages national Medicare Part D data from 2013 to 2022 to evaluate the cost of biologics prescribed for rheumatologic conditions with focus on the influence of market competition. This is a retrospective analysis of publicly available Medicare Part D Prescription Drug Event Data from 2013 to 2022 for Xeljanz, Olumiant, Rinvoq, Actemra, Kevzara, and Orencia. This analysis demonstrates that the cost of biologics continues to increase, surpassing inflation. While the rate of increase is declining, these results suggest that market competition alone may not be a sufficient mechanism for controlling drug prices. Notably, the rate of decline in annual cost increases was similar across Xeljanz, Actemra, and Orencia—despite Orencia lacking a direct market competitor during the study period."

Medicare • Reimbursement • US reimbursement • Hematological Disorders • Rheumatology

Drug Survival and Discontinuation Reasons of Eight Biological Disease-Modifying Antirheumatic Drugs in 1,182 Patients with Rheumatoid Arthritis: A Retrospective Study Using the Niigata Orthopedic Rheumatoid Arthritis Database (NOSRAD) (ACR Convergence 2025) - "Background/Purpose: To retrospectively evaluate drug survival and reasons for discontinuation of eight biological disease-modifying antirheumatic drugs (bDMARDs) in rheumatoid arthritis (RA) patients using the Niigata Orthopedic Rheumatoid Arthritis Database (NOSRAD). Of 1,517 RA patients registered in NOSRAD from May 2001 to August 2022, 1,182 who received at least one of the following bDMARDs were included: abatacept (ABT), adalimumab (ADA), certolizumab pegol (CZP), etanercept (ETN), golimumab (GLM), infliximab (IFX), sarilumab (SAR), and tocilizumab (TCZ)...All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan). In the naïve group (n = 784), significant inter-drug differences were observed in sex, age, disease duration, the 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR), concomitant methotrexate (MTX) use, concomitant prednisolone (PSL) use, and PSL dose... In the..."

Retrospective data • Immunology • Inflammatory Arthritis • Orthopedics • Rheumatoid Arthritis • Rheumatology

Cardiovascular Outcomes in Diabetic Rheumatoid Arthritis Patients: TNF-α Inhibitors versus IL-6 Inhibitors (ACR Convergence 2025) - "Patients were divided into two cohorts: those receiving IL-6i (sarilumab or tocilizumab) without TNFi (n=1,579) and those receiving TNFi without IL-6i (n=1,579), matched using propensity score on 20+ potential confounders. In this propensity-matched analysis of RA patients with T2DM, treatment with IL-6i was associated with significantly higher risk of mortality and multiple cardiovascular adverse events compared to TNFi treatment. While both drug classes effectively manage RA symptoms, our findings suggest TNFi may be preferable for this specific patient population from a cardiovascular safety perspective. These results highlight the importance of considering cardiovascular risk profiles when selecting biologic therapy for RA patients with comorbid T2DM."

Clinical • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Type 2 Diabetes Mellitus

Real-World Comparative Safety of Tocilizumab and Sarilumab in Rheumatoid Arthritis: A Multi-Center Observational Study (ACR Convergence 2025) - "In this large real-world RA cohort, sarilumab was associated with lower all-cause mortality than tocilizumab, particularly among male patients. Cardiovascular outcomes were similar across treatments. These findings support the need for individualized IL-6 inhibitor selection, with consideration of treatment duration and patient sex."

Clinical • Observational data • Real-world • Real-world evidence • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Inflammatory Arthritis • Myocardial Infarction • Rheumatoid Arthritis • Rheumatology • Venous Thromboembolism

Arrhythmia Risk in Diabetic Rheumatoid Arthritis Patients: Comparative Analysis of IL-6 Inhibitors versus TNF-α Inhibitors (ACR Convergence 2025) - "Adult patients with RA and T2DM receiving either IL-6i (sarilumab/tocilizumab) without TNFi or TNFi without IL-6i were identified. In RA patients with comorbid T2DM, treatment with IL-6i was associated with higher risk of cardiac arrhythmias, particularly ventricular tachycardia, compared to TNFi therapy. These findings suggest that TNFi may offer a more favorable cardiac safety profile in this high-risk population. Clinicians should consider arrhythmia risk when selecting biologic therapy for patients with both RA and T2DM, and closer cardiac monitoring may be warranted for those receiving IL-6i."

Clinical • Atrial Fibrillation • Cardiovascular • Diabetes • Immunology • Inflammatory Arthritis • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology • Type 2 Diabetes Mellitus • Ventricular Tachycardia

Infection Risk Associated with Steroid-Sparing Therapies in GCA, PMR, and ANCA-Associated Vasculitis: A Systematic Review (ACR Convergence 2025) - "This systematic review aimed to evaluate the infection risk associated with these therapies along with concomitant GC treatment, as compared to GC treatment alone, in vasculitis clinical trials. A comprehensive search of PubMed, Embase, and Cochrane, supplemented by ClinicalTrials.gov was conducted using terms related to GCA, PMR, AAV, biologic therapies (tocilizumab, sarilumab), small molecule therapies (upadacitinib, avacopan), glucocorticoids, and infections. Although biologics and small molecules had lower overall cumulative GC exposure, they did not consistently lead to a lower infection risk. When GC exposure was notably higher in the comparator group, infection risk was lower in the intervention group suggesting a possible protective effect of reducing GC. However, when GC doses were more comparable between groups, infection risk was higher in the active intervention arm, likely due to the immunosuppressive effects of combining biologic and small molecules with GC."

Review • ANCA Vasculitis • Giant Cell Arteritis • Immunology • Infectious Disease • Musculoskeletal Pain • Rheumatology • Vasculitis

Risk of Arrhythmias Following IL-6 Inhibitor Use; A Pharmacosurvellience Study of FDA Adverse Event Reporting System (FAERS) (ACR Convergence 2025) - "Background/Purpose: Interleukin-6 (IL-6) inhibitors, including tocilizumab and sarilumab, are immunomodulatory agents commonly used in the treatment of rheumatoid arthritis and COVID-19. IL-6 inhibitors, particularly tocilizumab and siltuximab, are associated with increased reporting of specific arrhythmias. These findings highlight the need for arrhythmia monitoring in susceptible patients receiving IL-6 inhibitors. Further studies are needed to clarify causality and the mechanisms underlying these associations."

Adverse events • Atrial Fibrillation • Cardiovascular • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology • Ventricular Tachycardia • ROR1