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

Serum pharmacodynamic biomarkers of IPI/NIVO/RELA plus sarilumab in Stage III-IV melanoma: Stage 1 results of a Simon Phase II trial (NCT05428007) (AACR 2026) - P2 | "Here, we focus on longitudinal serum cytokine profiling using Luminex assays to explore pharmacodynamic biomarkers for response in a phase II trial combining nivolumab (3 mg/kg), ipilimumab (1 mg/kg), the IL-6 receptor inhibitor sarilumab (150 mg), and the LAG-3 antibody relatlimab (160 mg) (INR + S) in patients with unresectable or advanced melanoma. We analyzed serum cytokines from 33 melanoma patients treated with INR + S using samples from baseline, week 4, week 6, week 12, week 18, and week 28 (final timepoint after discontinuation of sarilumab), and categorized patients according to response and toxicity. Longitudinal analyses in the present study revealed increased IL-6 and decreased IL-6R levels. These dynamics likely reflect a more active mode of IL-6R blockade and may have contributed to improved clinical outcomes. The next phase of the trial is a randomized comparison of INR +/- S, and biospecimens from this randomized comparison will be analyzed to..."

Biomarker • IO biomarker • P2 data • PK/PD data • Melanoma • Oncology • Solid Tumor • CSF1 • CXCL10 • CXCL8 • IL10 • IL4 • IL6R • LAG3 • RELA

A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC16

Biosimilars in Adult and Pediatric Noninfectious Uveitis. (PubMed, Clin Ophthalmol) - "Golimumab, certolizumab pegol, tocilizumab, sarilumab, and rituximab reference biologic studies offer promising results for treatment of NIU, but clinical trials evaluating biosimilar biologics lack in the literature. Current evidence suggests that adalimumab and infliximab biosimilars are effective and safe in comparison to reference biologics for treatment of NIU in the adult and pediatric populations. Expanded investigation in pediatric cohorts, including prospective clinical trials and inclusion of other biosimilar biologic agents are needed to address current gaps in evidence and to inform clinical decision-making."

Journal • Review • Ocular Inflammation • Oncology • Ophthalmology • Pediatrics • Uveitis

Effect of Interleukin-6 Inhibitors on Rheumatoid Arthritis Pain: Overview of Evidence and Mechanistic Pathways. (PubMed, Pharmacol Res Perspect) - "This review synthesizes current mechanistic and clinical evidence on IL-6 inhibitors, particularly sarilumab and tocilizumab, concerning their effect on pain in RA. Differences in their pharmacokinetics, receptor binding, and suppression of CRP may translate into differences in their analgesic profiles. However, it is analyzed that a subset of patients with persistently painful rheumatoid arthritis despite IL-6 inhibition demonstrates the existence of non-inflammatory drivers like nociplastic pain and the inadequacy of conventional indices of disease activity to capture the burden of pain."

Journal • Review • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Pain • Oncology • Pain • Rheumatoid Arthritis • Rheumatology • CRP • IL6

EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS PRESENTING AS CRESCENTIC GLOMERULONEPHRITIS IN A RHEUMATOID ARYHRITIS PATIENT TREATED WITH SARILUMAB (ISN-WCN 2026) - "Treatment included methylprednisolone pulse therapy, oral prednisolone (30 mg/day), and rituximab (375 mg/m2 weekly for 4 weeks)...Maintenance therapy with prednisolone and mepolizumab sustained disease control.Download: Download high-res image (475KB)Download: Download full-size imageDownload: Download high-res image (485KB)Download: Download full-size imageResults RA rarely coexists with EGPA...assessed serum IL-6 levels pre- and post-EGPA development in a patient treated with tocilizumab for microscopic polyangiitis (MPA) and secondary amyloidosis...In our patient, reduction of sarilumab dose may have been associated with overproduction of IL-6, contributing to EGPA development.Conclusion We report a case of EGPA characterized by crescentic glomerulonephritis that developed during interval prolongation of anti-IL-6 receptor antibody administration. Enhanced IL-6 signaling resulting from the prolonged dosing interval of sarilumab is suggested to have contributed to the..."

Clinical • Amyloidosis • Asthma • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Langerhans Cell Histiocytosis • Lupus Nephritis • Nephrology • Otorhinolaryngology • Rare Diseases • Respiratory Diseases • Rheumatoid Arthritis • Sinusitis • Vasculitis • MPO

Modeling, Simulation, and Extrapolation to Optimize Pediatric Development Plan: Sarilumab Polyarticular-Course juvenile arthritis Application. (PubMed, J Pharmacokinet Pharmacodyn) - No abstract available

Journal • Idiopathic Arthritis • Immunology • Pediatrics • Rheumatology

Infected Coronary Artery Aneurysm Within Chronically Occluded Stents. (PubMed, JACC Case Rep) - "In immunocompromised patients, infective endocarditis can cause ICAA involving even chronically occluded stents, which serve as an isolated site for infection. Implanted devices can become a nidus for fatal complications caused by low-virulence pathogens."

Journal • Cardiovascular • Coronary Artery Disease • Infectious Disease • Septic Shock

IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Stanford University

New P1 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Coverage generosity of novel anti-rheumatic drugs in Medicare Advantage and stand-alone Part D plans. (PubMed, Arthritis Rheumatol) - "The growing exclusions of self-administered DMARDs across several mechanisms of action and heterogeneity in coverage by plan type suggest potential barriers to accessing optimal RA treatments. Further monitoring of formulary adequacy and research into the clinical impacts of formulary exclusions are warranted."

Journal • Medicare • Reimbursement • US reimbursement • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Real-World Radiographic Outcomes of Sarilumab in Rheumatoid Arthritis: A Multicenter Study of Structural Remission and Progression (EULAR 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Early Use of Sarilumab in Patients with Glucocorticoid-Resistant PMR Improves Outcomes ─ Insights from Randomized Controlled Trial and Real-World Data (EULAR 2026) - No abstract available

Clinical • Real-world • Real-world evidence

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biologic disease-modifying antirheumatic drugs: 2025 update. (PubMed, Ann Rheum Dis) - "These updated EULAR recommendations provide consensus on RA management based on currently available evidence regarding efficacy, safety, and cost."

Journal • Cardiovascular • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

From Methotrexate Resistance to Biologic and Targeted Pharmacotherapy: A Decade of Phase 4 Clinical Trials Evidence in Rheumatoid Arthritis. (PubMed, Drug Des Devel Ther) - "Phase 4 evidence highlights the continued role of TNF inhibitors alongside newer biologic and targeted synthetic therapies in MTX-resistant RA. Trial heterogeneity reflects real world clinical complexity, underscoring the importance of treatment optimization, safety monitoring, and emerging precision strategies in contemporary RA management."

Journal • P4 data • Review • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Effectiveness and Safety of Sarilumab in Polymyalgia Rheumatica: a retrospective study of the FIRST Registry. (PubMed, Mod Rheumatol) - "These findings suggest that sarilumab may have the potential to improve disease activity in polymyalgia rheumatica compared to conventional therapy."

Journal • Retrospective data • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatoid Arthritis • Rheumatology

Demyelination Reported with Biologic Therapies for Rheumatologic and Inflammatory Bowel Diseases: Insights from FAERS (AAN 2026) - "Mechanistic classes included: anti–tumor necrosis factor (TNF)-α agents, anti-integrin antibodies (excluding natalizumab), anti-interleukin agents (including IL-12/23, IL-23, IL-17, IL-6, and IL-1 inhibitors), B-cell targeted therapies (excluding rituximab), and T-cell co-stimulation modulators... Safety signals for demyelination were identified with TNF-α inhibitors (infliximab, adalimumab, certolizumab pegol, golimumab, and etanercept) with a PRR of 7.34 (95% CI: 6.75–7.98), and abatacept, a selective T-cell co-stimulation modulator (PRR: 2.12; 95% CI: 1.41–3.20). No safety signals were observed for IL-12/23 inhibitors (ustekinumab), IL-17 inhibitors (secukinumab, ixekizumab, bimekizumab), IL-23 inhibitors (mirikizumab, guselkumab, tildrakizumab, risankizumab), and anti-α4β7 integrin (vedolizumab). Reporting counts were insufficient for IL-6 inhibitors (tocilizumab and sarilumab), IL-1 inhibitors (anakinra, canakinumab, and rilonacept), and B-lymphocyte stimulator..."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL17A • IL23A

IL-6 Receptor Antagonists and Severe Post-COVID-19 Outcomes: An Emulated Target Trial. (PubMed, medRxiv) - "We conducted an emulated target trial in a retrospective cohort of patients with moderate-to-severe rheumatoid arthritis who were prescribed IL-6 receptor antagonists (sarilumab or tocilizumab, pooled treatment) or other biologic agents (anakinra or baricitinib, pooled comparator) in 2022. IL-6 receptor antagonists may prevent the incidence of severe post-COVID-19 outcomes, such as Long COVID or mortality. This supports the hypothesis that IL-6 may be a mechanistic biomarker of COVID-19 sequelae and that acute COVID-19 severity may mediate this relationship."

Journal • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Rheumatoid Arthritis • Rheumatology • IL6

BIO3: Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients with Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide (clinicaltrials.gov) - P4 | N=286 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Mar 2022 ➔ Mar 2025 | Trial primary completion date: Mar 2022 ➔ Mar 2025

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

BIO3: Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients with Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide (clinicaltrials.gov) - P4 | N=286 | Recruiting | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Mar 2025 ➔ Mar 2029 | Trial primary completion date: Mar 2025 ➔ Mar 2029

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

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: UMC Utrecht | Phase classification: P4 ➔ P3 | N=7100 ➔ 10000 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=6800 | Recruiting | Sponsor: MJM Bonten | N=4000 ➔ 6800 | Trial completion date: Feb 2019 ➔ Jun 2022 | Trial primary completion date: Feb 2019 ➔ Dec 2021 | Initiation date: Dec 2015 ➔ Apr 2016

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=7100 | Recruiting | Sponsor: MJM Bonten | Trial completion date: Jun 2022 ➔ Dec 2023

Trial completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P4 | N=4000 | Recruiting | Sponsor: UMC Utrecht

New P4 trial • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=10000 | Recruiting | Sponsor: UMC Utrecht | Trial completion date: Dec 2025 ➔ Feb 2028 | Trial primary completion date: Dec 2023 ➔ Feb 2026

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (clinicaltrials.gov) - P3 | N=20000 | Recruiting | Sponsor: UMC Utrecht | N=10000 ➔ 20000

Enrollment change • Infectious Disease • Influenza • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

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: Sep 2027 ➔ May 2027

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