Actemra SC (tocilizumab SC) / Roche, Halozyme - LARVOL DELTA

A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA) (clinicaltrials.gov) - P3 | N=58 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: May 2026 ➔ Sep 2026 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Idiopathic Arthritis • Immunology • Rheumatology

Overseas sales (Chugai Press Release) - "Overseas sales amounted to ¥605.4 billion (an increase of 12.8% year on year). In terms of exports to Roche, sales of Hemlibra and Actemra (a humanized anti-human IL-6 receptor monoclonal antibody) grew from the same period of the previous fiscal year. Meanwhile, compared to the full year forecast announced on January 30, 2025, overseas sales increased by 9.0% to ¥605.4 billion, due to the increase in exports of Actemra and Hemlibra to Roche and other factors."

Commercial • Giant Cell Arteritis • Hemophilia A • Idiopathic Arthritis • Rheumatoid Arthritis • Systemic Sclerosis

Forecast assumptions for the next fiscal year (FY2026) (Chugai Press Release) - "Revenue is expected to increase to ¥1,345.0 billion (an increase of 6.9% year on year). Overseas sales are expected to be at levels similar to the same period of the previous fiscal year at ¥602.0 billion (a decrease of 0.6% year on year), due to factors such as a decrease in Actemra despite the growth in sales of NEMLUVIO and Hemlibra."

Sales projection • Atopic Dermatitis • Giant Cell Arteritis • Hemophilia A • Prurigo Nodularis • Rheumatoid Arthritis • Systemic Sclerosis

Pulmonary artery aneurysm as a rare manifestation of giant cell arteritis. (PubMed, BMJ Case Rep) - "Histopathological examination revealed granulomatous arteritis with multinucleated giant cells and disruption of the elastic lamina, consistent with large-vessel giant cell arteritis (GCA). The patient was treated with corticosteroids and subsequently transitioned to subcutaneous tocilizumab, achieving postoperative stability on imaging and normalisation of inflammatory markers.This case highlights an unusual presentation of GCA with isolated pulmonary artery involvement, underscoring the diagnostic value of surgical tissue biopsy and the importance of considering vasculitis in aneurysmal disease, even in the absence of systemic manifestations."

Journal • Cardiovascular • Giant Cell Arteritis • Immunology • Vasculitis

SUBCUTANEOUS VERSUS INTRAVENOUS TOCILIZUMAB IN AORTITIS ASSOCIATED WITH GIANT CELL ARTERITIS: MULTICENTER STUDY OF 196 PATIENTS. (PubMed, Arthritis Care Res (Hoboken)) - "In this real-world cohort of GCA-associated aortitis, SC TCZ showed slightly greater effectiveness than IV TCZ in achieving EULAR-defined remission while no significant differences were observed between both routes regarding imaging remission."

Clinical • Journal • Cardiovascular • Giant Cell Arteritis • Immunology • Inflammation

1B-22-2: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: University of Southern California | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Enrollment closed • IO biomarker • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Melanoma • Merkel Cell Carcinoma • Oncology • Osteosarcoma • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • HER-2 • PD-L1

NCI-2021-04325: Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Bladder Cancer • Cutaneous Melanoma • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer • BRAF

A Challenging Case of MOG-Associated Optic Neuritis: The Role of IL-6 Inhibition in Refractory Disease. (PubMed, Int Med Case Rep J) - "Despite multiple immunosuppressive therapies-including corticosteroids, intravenous immunoglobulin (IVIG), azathioprine, mycophenolate mofetil, and rituximab-the patient continued to experience disabling relapses, particularly during steroid tapering. There are sparse reports about the use of subcutaneous tocilizumab (TCZ) in MOGAD, and this case contributes to the growing body of real-world evidence supporting its use. As no standardized treatment protocol currently exists, reporting such cases is vital for advancing future therapeutic strategies and guidelines."

Journal • CNS Disorders • Ocular Inflammation • Ophthalmology • Optic Neuritis • Solid Tumor

Switch from Intravenous to Subcutaneous Formulation of Tocilizumab in Rheumatoid Arthritis: Retrospective Cohort Analysis and Systematic Literature Review. (PubMed, Biologics) - "By the end of follow-up, SC-TCZ maintenance in our cohort was lower than in other experiences (25.9% versus 78.7%), but with a longer follow-up (up to 4.5 years). Intravenous to subcutaneous tocilizumab switch is an effective and safe option in rheumatoid arthritis management, especially in the case of a shared decision."

Journal • Retrospective data • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Comparison of clinical practices during the transitional and young adult phases between patients with oligoarticular/polyarticular juvenile idiopathic arthritis and those with rheumatoid arthritis in Japan. (PubMed, Pediatr Rheumatol Online J) - "Despite an overlap in age, patients with JIA and RA exhibit distinct disease characteristics and therapeutic patterns. These differences underscore the need to expand approved treatment options for JIA, promote equitable access to biologics, and strengthen transitional care frameworks. Further research is warranted to explore long-term outcomes, reproductive health considerations, and socioeconomic barriers that influence treatment continuity in young adults with childhood-onset arthritis."

Clinical • Journal • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Pediatrics • Rheumatoid Arthritis • Rheumatology

Tocilizumab vs prednisone in established rheumatoid arthritis patients (TOPIRA): an investigator-initiated randomised clinical trial. (PubMed, Rheumatology (Oxford)) - P4 | "TCZ led to greater improvement in disease activity than prednisone. There was no significant difference in joint damage progression over 12 months and there were no major differences in adverse events."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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

Giant Cell Arteritis Manifesting as Area Postrema Syndrome: A Case Report. (PubMed, Cureus) - "Treatment with corticosteroids was initiated, followed by the introduction of weekly subcutaneous tocilizumab, an IL-6 inhibitor, ultimately resolving both his APS and its underlying cause, giant cell arteritis. To our limited knowledge, this is only the second case of area postrema syndrome caused by GCA in the literature."

Journal • Cardiovascular • Giant Cell Arteritis • Immunology • Ischemic stroke

A Case of Steroid-Dependent Immune Checkpoint Inhibitor Pneumonitis Treated With Subcutaneous Tocilizumab. (PubMed, Respirol Case Rep) - "A 57-year-old male with a history of urothelial cancer status post neoadjuvant cisplatin and gemcitabine, cystoprostatectomy and adjuvant nivolumab developed immune checkpoint inhibitor pneumonitis (ICI-p) following nivolumab treatment. Ultimately, he received intravenous followed by subcutaneous tocilizumab, and after a few months of treatment, he was weaned off steroids with sustained resolution of ICI-p, had improvement in steroid-related side effects, and had no progression or recurrence of his underlying bladder cancer. To our knowledge, this is the first case of subcutaneous tocilizumab being utilised for steroid-dependent ICI-p."

Checkpoint inhibition • Journal • Bladder Cancer • Genito-urinary Cancer • Inflammation • Oncology • Pneumonia • Solid Tumor • Urothelial Cancer

While biosimilar competition is here to stay for a number of Roche's medicines, including an increased impact on Actemra in the fourth quarter, the drugmaker indicated that the overall hit this year is expected to be CHF 800 million, down from an earlier forecast of CHF 1 billion. (Firstwordpharma Press Release)

Sales • Giant Cell Arteritis • Idiopathic Arthritis • Rheumatoid Arthritis • Systemic Sclerosis

Intravenous versus subcutaneous administration of Tocilizumab in aortitis associated with giant cell arteritis: multicenter open-label study of 196 patients (ACR Convergence 2025) - "Tocilizumab (TCZ) has demonstrated efficacy in large-vessel vasculitis (LVV) including GCA, previous pharmacokinetic studies, have shown more stable and sustained levels of tocilizumab with the subcutaneous form compared to the intravenous form... In GCA-aortitis, SC TCZ might be more effective than IV in achieving the EULAR remission target in clinical practice conditions after 24-month follow-up."

Clinical • Giant Cell Arteritis • Immunology • Vasculitis

A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety and immunogenicity of BAT1806 SC with Tocilizumab in healthy Chinese male subjects. (PubMed, Expert Opin Biol Ther) - P1 | "This study compared the pharmacokinetics (PK), safety, and immunogenicity of the tocilizumab biosimilar, BAT1806 SC (Tocilizumab biosimilar, Subcutaneous Injection), with Tocilizumab (RoActemra®) in healthy Chinese male subjects. This study demonstrated bioequivalent PK, comparable safety and immunogenicity profiles of BAT1806 SC and Tocilizumab in healthy subjects. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05968508)."

Clinical • Journal • PK/PD data

Transcatheter Aortic Valve Implantation for Severe Bicuspid Aortic Stenosis With Concomitant Giant Cell Arteritis Aortitis. (PubMed, JACC Case Rep) - "This case demonstrates the feasibility of TAVI in severe bicuspid AS in patients with aortitis and emphasizes the need for careful patient selection."

Journal • Cardiovascular • Congestive Heart Failure • Giant Cell Arteritis • Heart Failure • Immunology

Long-term treatment with Interleukin-6 Receptor Inhibitor Tocilizumab in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (ECTRIMS 2025) - "Long-term tocilizumab treatment appears effective in patients with MOGAD and severe complications are rare. Subcutaneous tocilizumab administration may improve therapy adherence."

CNS Disorders • Dyslipidemia • Infectious Disease • Metabolic Disorders • Solid Tumor

Real-world use of biologics for systemic juvenile idiopathic arthritis: information from a Japanese hospital claims database. (PubMed, Mod Rheumatol) - "Our study described the real-world usage of biologics for sJIA in Japan."

Journal • Real-world evidence • Idiopathic Arthritis • Immunology • Oncology • Rheumatology

Diagnostics, Efficacy, and Safety of Immunomodulatory and Anti-Fibrotic Treatment for Interstitial Lung Disease Associated with Systemic Scleroderma (SSc-ILD). (PubMed, Diagnostics (Basel)) - "Clinical studies have demonstrated moderate to good efficacy of immunosuppressants such as cyclophosphamide (CYC) and mycophenolate mofetil (MMF), showing improvements in lung function parameters, such as forced vital capacity (FVC), and slowing disease progression...However, despite these therapeutic advances, many studies had small sample sizes, heterogeneous patient populations, and varying inclusion criteria. Given the challenges in diagnostics and the critical need to evaluate the efficacy alongside the safety of immunomodulatory and anti-fibrotic therapies in systemic sclerosis-associated interstitial lung disease (SSc-ILD), there remains a strong demand for large, well-designed, multicenter trials with clearly defined patient cohorts to reliably assess the long-term outcomes of agents such as tocilizumab and nintedanib."

Journal • Review • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=256 | Active, not recruiting | Sponsor: AO GENERIUM | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Apr 2025

Enrollment closed • Trial completion date • Trial primary completion date

TOGIAC: Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (clinicaltrials.gov) - P3 | N=66 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Active, not recruiting

Enrollment closed • Giant Cell Arteritis • Immunology

Relationships of serum levels of tocilizumab to interleukin-6 and endogenous markers of CYP3A activity in patients with rheumatoid arthritis. (PubMed, Ann Clin Biochem) - "Methods RA patients (n = 35) with controllable disease activity using intravenous or subcutaneous tocilizumab were enrolled...Conclusions Tocilizumab treatment raised the serum IL-6 level in a concentration-dependent manner. In the RA patients with functional CYP3A5 protein, the serum tocilizumab level partially explained the interindividual variation in CYP3A activity."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CYP3A5 • IL6

Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial. (PubMed, BMJ Open) - P4 | "Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials...The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio...The results will inform future recommendations on the management of RA. NCT03227419 and EudraCT2017-000947-41."

Clinical • Clinical protocol • Head-to-Head • Journal • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • TNFA