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

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

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

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

INTRAVENOUS VERSUS SUBCUTANEOUS ADMINISTRATION OF TOCILIZUMAB IN AORTITIS ASSOCIATED WITH GIANT CELL ARTERITIS: MULTICENTER OPEN-LABEL STUDY OF 196 PATIENTS. (EULAR 2025) - "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, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=300 | Completed | Sponsor: Bio-Thera Solutions | Trial completion date: Apr 2025 ➔ Oct 2024 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date

Comparative effectiveness of intravenous versus subcutaneous tocilizumab for refractory uveitis: a retrospective analysis. (PubMed, Ophthalmology) - "Although interpretation of the data are limited by their retrospective nature, these data suggest that intravenous tocilizumab may result in faster resolution of uveitic macular edema than does subcutaneous tocilizumab."

HEOR • Journal • Retrospective data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P3 | "Treatment options are needed for patients with rheumatoid arthritis (RA) who experience inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). More research data in ethnically and regionally more diverse populations may be needed to further confirm the efficacy and safety of subcutaneous tocilizumab, especially as monotherapy. ClinicalTrials.gov Identifier: NCT03155347; China Center for Drug Evaluation Identifier: CTR20170141."

Clinical • Journal • Monotherapy • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Richter Announces Submission to European Medicines Agency for Biosimilar Tocilizumab in Multiple Indications (Gedeon Richter Press Release) - "Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra tocilizumab – development code: RGB-19. Tocilizumab, the first biologic to inhibit IL-6 signaling, is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, cytokine release syndrome and COVID-19."

EMA filing • Giant Cell Arteritis • Idiopathic Arthritis • Immunology • Novel Coronavirus Disease • Rheumatoid Arthritis

REPAIR: Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis (clinicaltrials.gov) - P4 | N=60 | Completed | Sponsor: Centre Hospitalier Régional d'Orléans | Recruiting ➔ Completed

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

Sarcoidosis-Associated Small Fiber Neuropathy Responsive to Tocilizumab: A Case Series (P6-8.004). (PubMed, Neurology) - "After failing methotrexate, Infliximab (anti-infliximab antibodies), and intolerance to IVIG (aseptic meningitis), he was transitioned to intravenous Tocilizumab 800 mg every 28 days...She discontinued adalimumab due to anti-adalimumab antibody development, and IVIG was stopped after superior mesenteric artery thrombosis. She was transitioned to subcutaneous Tocilizumab 162 mg every 14 days, leading to reduced numbness, improved autonomic function, and better quality of life...The institution of Dr. Barreras has received research support from American Academy of Neurology."

Journal • Cardiovascular • CNS Disorders • Hematological Disorders • Immunology • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Orthopedics • Pain • Sarcoidosis • Thrombosis

Verification of unmet medical needs in patients with juvenile idiopathic arthritis in Japan. (PubMed, Mod Rheumatol) - "The highest priority UMNs for JIA was the expansion of indications for ABT sc and especially TCZ sc. This study reveals the real-world prescribing practices of therapeutic medical treatments and test implementation for patients with JIA in Japan."

Journal • Cardiovascular • CNS Disorders • Depression • Diabetes • Hypertension • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Metabolic Disorders • Ocular Inflammation • Ophthalmology • Osteoporosis • Pediatrics • Psychiatry • Rheumatology • Uveitis

Delays in Tocilizumab Therapy for Patients With Giant Cell Arteritis in the United States. (PubMed, J Rheumatol) - "Patients with GCA experienced significant delays in starting TCZ therapy. In addition, patients on Medicare or Medicare Advantage plans had significantly higher out-of-pocket costs compared to other patients. These delays and costs are excessive for a vulnerable population with a potentially disabling disease. Further research is needed to investigate causes of delays, the high cost of medication, and effects on clinical outcomes."

Journal • Giant Cell Arteritis • Immunology

Comparative effectiveness of subcutaneous sarilumab 200 mg biweekly, subcutaneous Tocilizumab 162 mg biweekly, and intravenous Tocilizumab 8 mg/kg every 4 weeks in patients with rheumatoid arthritis: a prospective cohort study. (PubMed, Arthritis Res Ther) - "SAR-SC 200 mg biweekly initiation was associated with a statistically significantly greater decrease in disease activity than TCZ-SC 162 mg biweekly in IL-6Ri-naïve patients with RA. In contrast, no statistically significant differences were identified between TCZ-IV 8 mg/kg every 4 week and TCZ-SC 162 mg biweekly. However, the effect size of our findings should necessitate careful consideration of the cost difference between TCZ-SC 162 mg biweekly including its biosimilars and SAR-SC 200 mg biweekly."

Clinical • HEOR • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Sarcoidosis-Associated Small Fiber Neuropathy Responsive to Tocilizumab: A Case Series (AAN 2025) - "After failing methotrexate, Infliximab (anti-infliximab antibodies), and intolerance to IVIG (aseptic meningitis), he was transitioned to intravenous Tocilizumab 800 mg every 28 days...She discontinued adalimumab due to anti-adalimumab antibody development, and IVIG was stopped after superior mesenteric artery thrombosis. She was transitioned to subcutaneous Tocilizumab 162 mg every 14 days, leading to reduced numbness, improved autonomic function, and better quality of life.· Patient 3: 61 years-old female with systemic sarcoidosis involving the lungs, lymph nodes, joints, spleen, and bone, with biopsy-proven S-SFN causing neuropathic pain and dysautonomia...These three cases suggest that tocilizumab may improve S-SFN symptoms in patients refractory to other immunosuppressive therapies. These observations warrant further study of tocilizumab for otherwise refractory S-SFN."

Clinical • Cardiovascular • CNS Disorders • Hematological Disorders • Immunology • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Orthopedics • Pain • Sarcoidosis • Thrombosis

Treatment Options for NMOSD in Children: Effectiveness and Safety of Subcutaneous Tocilizumab (AAN 2025) - "Satralizumab is approved for NMOSD for ages 12 years and older. We report a pediatric case successfully treated with rituximab later transitioned to s.c. tocilizumab, which is FDA approved for juvenile arthritis age >=2...Treatment IV methylprednisolone 30mg/kg; discharged on a 3-week prednisone taper...This case highlights the effectiveness and safety of two DMTs for NMOSD in children < 12 years of age. Given the need for immunizations in children, s.c. tocilizumab may be a more suitable choice in this age group."

Clinical • CNS Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammation • Neuromyelitis Optica Spectrum Disorder • Novel Coronavirus Disease • Pediatrics • Rare Diseases • Rheumatology

A feasible treatment strategy for tapering subcutaneous tocilizumab in giant cell arteritis: a 24-month multi-center retrospective study. (PubMed, Rheumatol Int) - "Gradually extending TCZ intervals by one week each is a feasible treatment strategy for well-controlled GCA patients after achieving GC-free status. While some patients may experience relapses following the extension of TCZ intervals, these relapses might be potentially managed by adjusting only the TCZ intervals."

Journal • Retrospective data • Giant Cell Arteritis • Immunology