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

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

Comparative Effects of IL-6 inhibition, Methotrexate, and Glucocorticoid Monotherapy on Bone Mineral Density, 3D-DXA femoral structure and Bone Turnover Markers in GCA and PMR (ACR Convergence 2025) - "At baseline visit for osteoporosis check-up 22 received IL-6 inhibitors (21 tocilizumab, 1 Sarilumab), 36 MTX, and 131 GC monotherapy; 14 received no immunosuppressive treatment. In patients with GCA and PMR, sex and BMI were key predictors of BMD and femoral bone structure. Treatment with IL-6 inhibitors was associated with more favorable cortical and trabecular bone parameters than GC monotherapy. This suggests that GC-sparing IL-6 blockade may help preserve bone microarchitecture in patients with inflammatory vasculitis."

Monotherapy • Giant Cell Arteritis • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoporosis • Rheumatoid Arthritis • Rheumatology • Vasculitis

A PHASE 1/2 STUDY OF UBAMATAMAB (REGN4018) IN LOW-GRADE SEROUS OVARIAN CANCER COHORT (IGCS 2025) - P1/2 | "Prior to Q3W dosing of ubamatamab, patients will receive once-weekly step-up dosing to mitigate the risk of cytokine release syndrome, as well as sarilumab 350 mg IV prophylaxis on Day 1. Initial data analysis of the LGSOC-specific cohort is expected by March 2027. Insights gained from the efficacy and safety of ubamatamab in patients with LGSOC from this cohort may further validate MUC16 as a novel therapeutic target for LGSOC."

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

Safety of sarilumab in more than 1000 patients with rheumatoid arthritis in Japan by age group: a post-marketing surveillance study (ACR Convergence 2025) - "These results show that SAR treatment was well tolerated by pts in Japan with RA regardless of age, and no new safety concerns were identified. Additionally, no link was established between occurrence of neutropenia during SAR treatment and the development of serious infections."

Clinical • P4 data • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Neutropenia • Rheumatoid Arthritis • Rheumatology • CRP

Efficacy of sarilumab in patients with rheumatoid arthritis of different disease activity at treatment initiation: a post-hoc analysis of a Phase 3 trial of sarilumab in Japan (ACR Convergence 2025) - P3 | "Background/Purpose: The efficacy and safety of sarilumab (SAR) and methotrexate (MTX) in patients (pts) in Japan with moderate-to-severely active rheumatoid arthritis (RA) and inadequate response to MTX have been demonstrated in the phase 3 KAKEHASI trial (NCT02293902). These results indicate that the efficacy of SAR is generally similar across pts with RA of different disease activity."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Modern Management of Isolated Polymyalgia Rheumatica. (PubMed, Rheumatol Ther) - "The urgent need for effective GC-sparing agents has resulted in pivotal developments over the past decade, notably the SAPHYR trial, which supported the US Food and Drug Administration (FDA) approval of sarilumab as the first biologic therapy for refractory PMR...This review explores current diagnostic and treatment strategies for isolated PMR. We also highlight unmet needs in PMR management, and discuss future directions aimed at improving outcomes and redefining the care pathway for PMR."

Journal • Review • Giant Cell Arteritis • Immunology • Inflammation • Musculoskeletal Pain • Pain • Rheumatology

Cytokine Blockade Attenuates Inflammation and Improves Depressive Psychopathology After COVID-19: A Naturalistic Observational Study. (PubMed, J Neuroimmune Pharmacol) - "In the present naturalistic observational study we evaluated the possible effect of the cytokine-blocking agents in preventing the development of post-COVID depression in a large sample of survivors also exploring the relationship between post-COVID depressive risk, treatment with cytokine-blocking agents, and innate immune response markers. 588 COVID-19 survivors were included, of them 374 received the best available treatment at the time and 131 received standard treatment combined with cytokine-blocking agents (anakinra, tocilizumab, sarilumab, reparixin and mavrilimumab). Finally, we observed that cytokine-blocking agents' impact on depression was mediated by lowering of systemic inflammation. Our findings indicate potential efficacy of cytokine-blocking agent treatment during the early stages of COVID-19, mitigating post-COVID depressive symptoms by attenuating systemic inflammation. Further investigation through preclinical and clinical studies is..."

Journal • Observational data • CNS Disorders • Depression • Infectious Disease • Inflammation • Novel Coronavirus Disease • Psychiatry

Changes in use and utilisation patterns of drugs with reported shortages between 2010 and 2024 in Europe and North America: a network cohort study. (PubMed, Lancet Public Health) - "This study highlighted changes in incidence and prevalence of use of medicines after shortage announcements, and changes observed in patient care in terms of the indication, duration, or prescribed dose of medicines. Our findings showed that some reductions in use were observed across Europe and the USA, and others differed across countries. More research is needed to reduce the effects of drug shortages globally."

Journal • Cardiovascular • Immunology • Inflammatory Arthritis • Pulmonary Embolism • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Safety of Sarilumab in the treatment of rheumatoid arthritis: a real-world study based on the FAERS database. (PubMed, Front Med (Lausanne)) - "This real-world analysis highlights Sarilumab's safety profile, emphasizing the need for close patient monitoring, particularly during the early initiation phase and throughout long-term treatment. The findings provide valuable insights for clinicians in pre-medication assessment, during-treatment monitoring, and adverse reaction management, while underscoring the need for further research into the mechanisms and risk factors of these adverse events."

Journal • Real-world evidence • Alopecia • CNS Disorders • Depression • Fatigue • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Psychiatry • Rheumatoid Arthritis • Rheumatology • IL6

Single-Center Cross-Sectional Analysis of Patients with RA, SpA, and PsA: Data from the Prescription Database. (PubMed, J Pers Med) - "For RA, 34.2% of patients were difficult to treat (D2T) (98 pt), 54.8% (157 pt) were in monotherapy (tocilizumab-sarilumab-upadacitinib-filgotinib). Abatacept was the most prescribed treatment in RF and ACPA-positive patients and in those with ILD. The anti-IL-17A secukinumab was prescribed in 12% of SpA, of which 71% had enthesitis and dactylitis (14 pt). Ixekizumab was prescribed in 10.4% of PsA patients over 65 years with previous CV events, enthesitis, and dactylitis (21 pt). Apremilast was present in 71% of PsA with previous cancer...The cross-sectional analysis of prescriptions in patients with RA, SpA, and PsA demonstrates how the ITABIO recommendations can guide towards the correct appropriateness of prescription. RA and especially D2T-RA remains the disease with the greatest therapeutic failures, with the highest percentage of monotherapy (anti-IL-6 and Jak-i) and of discontinuation of MTX."

Journal • Ankylosing Spondylitis • Cardiovascular • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Interstitial Lung Disease • Metabolic Disorders • Ocular Inflammation • Oncology • Ophthalmology • Psoriatic Arthritis • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • Uveitis • IL17A

Management of Rheumatoid Arthritis in a Patient with Aplastic Anemia and Ulcerative Colitis: A Case Report. (PubMed, Am J Case Rep) - "Hydroxychloroquine was initially selected over methotrexate due to its relatively lower risk of bone marrow suppression, an important consideration in patients with underlying aplastic anemia...Sarilumab was introduced but led to recurrent anemia and thrombocytopenia...Tocilizumab proved to be an effective and well-tolerated treatment option, demonstrating the importance of individualized therapy and close hematologic monitoring. Further research is needed to optimize treatment strategies for RA in patients with concurrent aplastic anemia."

Journal • Anemia • Aplastic Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Rheumatoid Arthritis • Rheumatology • Thrombocytopenia • Ulcerative Colitis

Targeting IL-6 Signaling: Safety and Effectiveness in Older Patients with Rheumatoid Arthritis. (PubMed, Drugs Aging) - "Recent postmarketing surveillance (PMS) data on the safety and effectiveness of sarilumab (SAR) in Japanese patients with RA, along with PMS data from Japan and registry data from France and Germany of tocilizumab (TCZ), provide valuable insights for both current and future management of RA. While the effectiveness of TCZ was somewhat lower in older patients compared with younger ones, the effectiveness of SAR was similar across age groups. Consequently, the use of anti-IL-6R antibodies is anticipated to expand to other IMIDs beyond RA, particularly in increasingly superaged societies worldwide."

Journal • Review • Cardiovascular • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • IL6

Treatment and prognostic factors in polymyalgia rheumatica: a systematic literature review informing German, Austrian and Swiss guidelines. (PubMed, Rheumatology (Oxford)) - "IL6-R inhibitors are effective GC sparing agents in PMR; rituximab and tofacitinib are also promising. High-quality trials are needed to refine treatment strategies and establish reliable prognostic markers for clinical decision-making."

Biomarker • Journal • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology