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

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

CORIMUNO-SARI: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI (clinicaltrials.gov) - P2/3 | N=239 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Unknown status ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

New treatments for systemic mastocytosis in 2025. (PubMed, Curr Opin Allergy Clin Immunol) - "Despite the considerable therapeutic progress in recent years, systemic mastocytosis is an incurable disease. In the last 20 years, the management of systemic mastocytosis has transformed from a one-size-fits-all approach, characterized by nonspecific cytoreductive drugs, to a tailored strategy focused on increasingly precise molecular targets, with the most notable example being the KIT inhibitors. Recently, the FDA and EMA have approved two drugs for treating systemic mastocytosis: avapritinib and midostaurin. Moreover, numerous trials are currently assessing the efficacy of new molecules: most are testing new-generation KIT inhibitors (ripretinib, bezuclastinib, elenestinib, masitinib, nintedanib), others focusing on Bruton's kinase (TL-895), interleukin-6 (sarilumab), sialic acid-binding immunoglobulin-like lectin-8 (lirentelimab), mTOR and CD33, among others. Real-life data are needed to confirm preliminary preclinical results."

Journal • Aggressive Systemic Mastocytosis • CD33 • IL6

Lurbinectedin with immunotherapy in extensive-stage small cell lung cancer: Current insights and future prospects—A systematic review. (ASCO 2025) - P1/2, P2 | " A total of 54 patients from two studies investigating the role of LUR in combination with pembrolizumab and atezolizumab (ATZ) were included in this systematic review...Three ongoing trials (NCT04607954, NCT04253145, NCT06497530), including 230 recruiting patients and 30 not yet recruiting patients, are going to explore LUR combination with durvalumab, ATZ, and sarilumab, respectively. LUR-IO shows promising efficacy and manageable safety profiles in extensive-stage small-cell lung cancer. However, further results from ongoing trials are essential to understand its long-term potential and broader applicability better."

Review • Anemia • Febrile Neutropenia • Lung Cancer • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor

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 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 (EULAR 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 systematic review 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. High quality adequately sized RCTs in TAK are still..."

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

THE EFFECTS OF GLUCOCORTICOID ON TREATMENT COURSE IN PATIENTS WITH DIFFICULT TO TREAT RHEUMATOID ARTHRITIS (EULAR 2025) - "Inability to taper glucocorticoids (below 7.5 mg/day prednisone or equivalent) was included in the EULAR definition of D2TRA...In these 673 patients, 137 patients met D2TRA criteria (tocilizumab: n=21, sarilumab: n=10, abatacept: n=31, tofacitinib: n=30, baricitinib: n=30, Upadacitinib: n=10, peficitinib: n=4, filgotinib: n=1)...In the logistic regres-sion analysis, ORs were adjusted for age, sex, body mass index, disease durations, titer of rheumatoid factor, titer of antibodies against cyclic citrullinated peptide, DAS-ESR, HAQ, methotrexate dose, glucocorticoid dose, type of bDMARDs/JAKi, number of past bDMARDs/JAKi, history of lymphoproliferative disorders, history of pancytopenia and history of interstitial pneumonia based on the results of the univariate analysis and general risk factors of inability to taper glucocorticoid... Drug retention rate and clinical efficacy of D2TRA patients were not different between glucocorticoid use group and glucocorticoid non-use..."

Clinical • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

CRP AS A PREDICTOR AND CORRELATE OF IMPROVEMENT IN SEXUAL FUNCTION DURING INITIAL BIOLOGIC THERAPY IN WOMEN WITH RHEUMATOID ARTHRITIS (EULAR 2025) - " A total of 36 women completed the questionnaires at both time intervals (mean ± SD at M0: age 45.3 ± 9.9 years; DAS28-ESR 5.43 ± 1.04; DAS28-CRP 5.31 ± 1.07; 74.3% were RF positive, and 76.5% were anti-CCP positive), and were treated with b/tsDMARD therapy: 94.4% with anti-TNF agents (adalimumab: 52.8%, certolizumab: 13.9%, etanercept: 25.0%, golimumab: 2.8%) and 5.6% with JAK inhibitors (baricitinib). At 6 months, 5/36 (13.9%) had switched therapies, with transitions to IL-6 inhibitors (tocilizumab, sarilumab), JAK inhibitors (baricitinib, tofacitinib), and alternative anti-TNF agents (golimumab)... This study highlights the potential role of CRP as both a predictor and correlate of improvement in sexual function during initial b/tsDMARD therapy in women with RA. While overall group-level changes in FSFI scores were not statistically significant, individual-level improvements were observed in over half of participants, with reductions in CRP..."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

TREATMENT PATTERNS AND DETERMINANTS OF DMARD SWITCHING IN EUROPEAN RHEUMATOID ARTHRITIS COHORTS: A MULTI-NATIONAL ANALYSIS (EULAR 2025) - "The type of DMARD initiated was categorised as MTX, other conventional synthetic DMARD (csDMARD: hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine), tumor necrosis factor inhibitors (TNFi: adalimumab, infliximab, etanercept, certolizumab pegol, golimumab), non-TNFi (abatacept, anakinra, rituximab, tocilizumab, sarilumab), and Janus Kinase inhibitors (JAKi: tofacitinib, baricitinib, upadacitib, filgotinib). Despite similar treatment guidelines within the Europe countries, there are clear differences in the use and sequencing of DMARDs in newly diagnosed RA, particularly for second-line DMARDs. Further analyses are needed to understand how these differences affect remission rates and other treatment outcomes in RA."

Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Factors for early introduction of bDMARDs in patients with RIC and cancer in remission for less than 5 years. (EULAR 2025) - "Before cancer diagnosis, patients had received TNFi in 69% of cases (etanercept (n= 51), adalimumab (n= 48), infliximab (n= 17), golimumab (n= 10), certolizumab (n= 7)), IL6 in 11,4% of cases (tocilizumab (n= 21), sarilumab (n= 1)), abatacept in 8.3% of cases (n=16), JAKi in 4,7% of cases (n tofacitinib (n= 5), baricitinib (n= 4)), IL17 in 3.6% of cases (secukinumab (n= 5), ixekizumab (n = 2)), rituximab in 2.6% of cases (n=5), and ustekimumab in 0.4% of cases (n=1). After a cancer diagnosis, rituximab and TNFi are the preferred bDMARDs for inflammatory rheumatism (RA, SA, or PsA). The retreatment is more frequent in RA and SA than in PsA and in patients who had less bDMARDs before the cancer. Most patients change therapeutic classes after a cancer diagnosis."

Clinical • Ankylosing Spondylitis • Basal Cell Carcinoma • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Gynecologic Cancers • Immunology • Inflammatory Arthritis • Lung Cancer • Non-melanoma Skin Cancer • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Skin Cancer • Solid Tumor • Spondylarthritis • Urethral Cancer • IL17A • IL6

Choice and Effectiveness of Second DMARDs After MTX: Comparing Biological, Targeted, and Conventional Options in European RA Cohorts (EULAR 2025) - "Background: Current guidelines recommend treatment escalation to a biological (b) disease-modifying anti-rheumatic drug (DMARD) in patients with active rheumatoid arthritis (RA) failing methotrexate (MTX), at least among patients with poor prognostic factors such as anti-CCP positivity...The second DMARDs were categorised as other conventional synthetic DMARD (csDMARD: hydroxychloroquine, sulfasalazine, leflunomide, cyclosporine, azathioprine), tumor necrosis factor inhibitors (TNFi: adalimumab, infliximab, etanercept, certolizumab pegol, golimumab), non-TNFi (abatacept, anakinra, rituximab, tocilizumab, sarilumab), and Janus Kinase inhibitors (JAKi: tofacitinib, baricitinib, upadacitib, filgotinib)... Patients starting a TNFi as second DMARD after failing MTX had better retention but similar percentage of remission as compared to other DMARD regimens used as second DMARDs. Further analyses are needed to understand how these differences are affected by confounding by..."

Oncology • Rheumatoid Arthritis

Predicting infection risk in rheumatoid arthritis patients treated with biologic and targeted synthetic DMARDs: A machine learning approach (EULAR 2025) - "Among the b/ts DMARDs, rituximab was associated with the highest risk of infection, whereas tofacitinib, upadacitinib, and sarilumab were linked to the lowest risk. This study presents an effective ML-based tool for serious infection risk prediction among RA patients receiving b/ts DMARDs. The model presented good predictive capacity and external validity, offering the opportunity for personalized b/ts DMARD therapy and improved patient outcomes. Biomarker thresholds identified could refine infection risk stratification and guide early interventions for high-risk patients receiving b/tsDMARDs."

Clinical • Machine learning • Diabetes • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Rheumatoid Arthritis • Rheumatology

Which biomarker to predict response to a targeted therapy or to monitor disease activity in polymyalgia rheumatica (EULAR 2025) - "However, interleukin-6 receptor (IL-6R) inhibitor sarilumab is approved in the USA and some recommendations call for the use of either tocilizumab or sarilumab... We conducted an ancillary study involving five clinical trials (four randomized, placebo-controlled trials and one open-label study) from two different countries, evaluating the efficacy of four different targeted therapies (tocilizumab in two studies, abatacept, baricitinib, and rituximab) in PMR... In this study, we identified a biomarker (sCD25) that may assist in selecting a targeted therapy and some candidates in monitoring disease activity. These findings will need to be confirmed in a validation cohort."

Biomarker • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology • ANGPT1 • CCL2 • CHI3L1 • CRP • CXCL10 • IL1R1 • LGALS3 • MMP1 • MMP3 • PTX3 • SPP1 • TIMP1

The MAGIC of VEXAS : A case of overlap between Bechet's disease and VEXAS syndrome. (EULAR 2025) - "He responded well to prednisone and methotrexate (MTX)...MTX was discontinued, colchicine and azathioprine were initiated achieving remission. In 2019, he was diagnosed with pulmonary embolism, treated with high-dose corticosteroids and cyclophosphamide, followed by a maintenance therapy with infliximab and azathioprine, achieving remission...Treatment included corticosteroids and Azacitidine reducing transfusion dependency...Tocilizumab was attempted but discontinued due to an anaphylaxis-like reaction. Sarilumab was initiated after ruxolitinib was denied by health care provider...Ongoing management focuses on systemic disease control and addressing hematologic complications. Learning points for clinical practice: Key lesson from this case was the decision to further explore VEXAS in an already diagnosed Bechet’s patient, as well as treatment consequences of this diagnosis."

Clinical • Anemia • Cardiovascular • Dermatitis • Dermatology • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Musculoskeletal Diseases • Myelodysplastic Syndrome • Ocular Inflammation • Oncology • Ophthalmology • Pulmonary Embolism • Rare Diseases • Respiratory Diseases • Rheumatology • Uveitis • Vasculitis

Rheumatoid arthritis, non-TNFi bDMARDs and JAKi - risks of keratinocyte cancer (EULAR 2025) - "The treatment groups under study were; i) JAKi (baricitinib, filgotinib, tofacitinib, upadacitinib), ii) non-TNFi bDMARD (abatacept, rituximab, sarilumab, tocilizumab), and iii) TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab). This study suggests that patients with RA treated with JAKi have a higher incidence of a first ever KC, primarily driven by the BCC subtype. Additionally, although based on a limited number of events, we observed a higher incidence of a second KC in patients treated with JAKi compared to those treated with TNFi. Our findings support the notion that skin examination may benefit this population, and that skin cancer risks with JAKi treatment should be further monitored."

Basal Cell Carcinoma • Congestive Heart Failure • Coronary Artery Disease • Dermatology • Diabetes • Genetic Disorders • Heart Failure • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Non-melanoma Skin Cancer • Oncology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Skin Cancer • Solid Organ Transplantation • Squamous Cell Carcinoma

The risk of cancer recurrence with bDMARD treatment in patients with rheumatoid arthritis and a history of cancer: a nationwide Danish register-based cohort study (EULAR 2025) - "We defined three bDMARD exposure groups and one csDMARD comparator group according to the type(s) of DMARD initiated after algorithm-defined cancer remission: 1) any bDMARD, i.e., TNFi, rituximab, tocilizumab/sarilumab, or abatacept, 2) TNFi, 3) rituximab, and 4) csDMARD. Treatment with bDMARDs as used in Danish clinical practice in patients with RA and a solid cancer in remission was not associated with increased risks of cancer recurrence compared with csDMARD treatment. This study corroborates the findings made by the EULAR task force regarding bDMARD treatment in patients with a history of cancer, and—in line with the EULAR task force’s call for improved reporting within this research area in respect of differentiating cancer recurrence from new primary cancers—constitutes one of the first studies with an explicit definition of cancer recurrence risk. However, in view of the limited study power we cannot rule out a clinically important excess risk of cancer..."

Clinical • Bladder Cancer • Breast Cancer • Endometrial Cancer • Immunology • Inflammatory Arthritis • Lung Cancer • Melanoma • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor

A New Combination Therapy for Advanced Melanoma Shows Promise (NYU Langone Health) - P2 | N=69 | NCT05428007 | "After nearly 10 months of follow-up, the combination showed promising results. The tumor response rate at 24 weeks was 63.6 percent, and only 12.1 percent of patients experienced serious immune-related side effects—significantly lower than what is typically seen with similar treatment combinations. Additionally, fewer patients discontinued treatment due to toxicity....The study concludes that adding sarilumab may offer a safer, effective approach to treating advanced melanoma and supports ongoing research to confirm these findings in larger, randomized trials."

P2 data • Melanoma

Systematic review and meta-analysis of the efficacy of biologic and targeted synthetic therapies in sarcoidosis. (PubMed, Thorax) - "Meta-analysis supports infliximab use in pulmonary sarcoidosis, although improvements in lung function are modest. There is limited but promising evidence for the use of adalimumab and tofacitinib in cutaneous disease and efzofitimob in pulmonary disease. Study interpretation is limited by small sample sizes and heterogeneity in study design and population.PROSPERO registration numberCRD42024599560."

Journal • Retrospective data • Immunology • Pulmonary Disease • Respiratory Diseases • Sarcoidosis

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Apr 2028 ➔ Dec 2028 | Trial primary completion date: Apr 2028 ➔ Dec 2028

Platinum resistant • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Tocilizumab, sarilumab and anakinra in critically ill patients with COVID-19: a randomised, controlled, open-label, adaptive platform trial. (PubMed, Thorax) - P3 | "In critically ill patients with COVID-19, tocilizumab and sarilumab have equivalent effectiveness at reducing duration of organ support and death. Anakinra is not effective in this population."

Journal • Critical care • Infectious Disease • Novel Coronavirus Disease • Pneumonia

sarilumab (Kevzara) is not recommended for use within NHSScotland (Scottish Medicines Consortium) - "Indication under review: treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result, we cannot recommend its use within NHSScotland."

Reimbursement • Inflammation

A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11

A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: University of Southern California | Trial completion date: Nov 2026 ➔ Sep 2027 | Trial primary completion date: Nov 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Abatacept, Golimumab, and Sarilumab as Selected Bio-Originator Disease-Modifying Antirheumatic Drugs with Diverse Mechanisms of Action in Their Current Use in Treatment. (PubMed, J Clin Med) - " Treating arthritis continues to be challenging due to its numerous underlying causes and the varied ways in which patients respond to treatment. Although biologics and targeted therapies have brought progress, additional research is needed to identify new treatment targets and enhance patient results."

Journal • Review • Gout • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Osteoarthritis • Pain • Rheumatoid Arthritis • Rheumatology

Anti-Rheumatic potential of biological DMARDS and protagonistic role of bio-markers in early detection and management of rheumatoid arthritis. (PubMed, Innate Immun) - "Non-tumor necrosis factor inhibitors (Non-TNFi) such as abatacept, rituximab, tocilizumab, and sarilumab are examples, as are anti-tumor necrosis factor (TNF) medications such as infliximab, adalimumab, etanercept, golimumab, and certolizumab pegol. The assessment of RA treatment response typically combines patient-reported outcomes, physical evaluations, and laboratory findings, as there isn't a single biomarker that has proven sufficient for measuring disease activity. This review explores the usage of biologic DMARDs as a therapeutic approach for RA, as well as the biomarkers typically used for RA early diagnosis, prognosis prediction, and disease activity evaluation."

Biomarker • Journal • Review • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology