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

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

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Feb 2027 ➔ Jun 2029

Adverse events • Trial primary completion date • Idiopathic Arthritis • Immunology • Pediatrics • Rheumatology • CRP

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=18 | Recruiting | Sponsor: University of Southern California | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Immunomodulating • Metastases • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Breast Cancer • HER2 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

A case of polyarteritis nodosa with severe lower limb ulcer that was treated with prednisolone and tocilizumab. (PubMed, Mod Rheumatol Case Rep) - "The standard treatment for severe PAN involves combination therapy with steroids and cyclophosphamide; however, some cases prove to be challenging...Owing to steroid resistance, subcutaneous tocilizumab (162 mg/week) was initiated. Over a few months, the ulcer healed completely, and left lower limb amputation was avoided. Therefore, tocilizumab could potentially be one of the treatment options for severe cases in the future."

Journal • Vasculitis

NL-TCZ-12280: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants (clinicaltrials.gov) - P1 | N=300 | Completed | Sponsor: Biogen | Recruiting ➔ Completed

Trial completion

Impact of Mode of Drug Delivery Administration on Healthcare Costs in a Medicare Fee for Service Population (ISPOR-EU 2024) - "IV tocilizumab was examined between 2011-2013 (n= 1484, 2294, 3013); SC tocilizumab was examined between 2013-2015 (n=367, 357, 307). While inpatient costs fluctuated, outpatient costs consistently decreased and therapy costs consistently increased for belimumab and tocilizumab transitioning from IV to SC in Medicare FFS."

Clinical • HEOR • Medicare • Reimbursement • US reimbursement • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Multifaceted triggers, diagnostic and management hurdles in hemophagocytic lymphohistiocytosis in a young immunosuppressed adult with systemic juvenile idiopathic arthritis (BSR-CBC 2024) - "Introduction: We present a case of a 17 year old female with systemic JIA (generally well controlled for a long period on sc Tocilizumab), who presented unwell with fevers, sore throat and significant lymphadenopathy...ESR was <3 while CRP 123 and ferritin 32,000.• Marked tachycardia of 215bpm prior to ITU transfer - discussion regarding best place to look after HLH patients (most agree ITU is best and evidence does suggest tachycardia is precursor to cardiac arrest in these cases so important to monitor and recognise cardiac events can occur).Key learning points: • Always think of HLH in any unwell, febrile patient with low cell counts.• Involve seniors, get H score and escalate early so treatment can be started promptly.• It is not unusual to need several modalities of immunosuppression - in this case the patient had IVMP, Tocilizumab, IVIg, Rituximab and Anakinra.• EBV is a common trigger of HLH and should be considered in context of young adults presenting with..."

Clinical • Cardiovascular • Epstein-Barr Virus Infections • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Idiopathic Arthritis • Immunology • Infectious Disease • Oncology • Otorhinolaryngology • Pain • Rare Diseases • Rheumatology • Septic Shock

A complex case of psoriatic juvenile idiopathic arthritis (BSR-CBC 2024) - "She is ANA negative and RF negative.She was initially treated with intravenous methylprednisolone (IVMP), methotrexate and joint injections...September/2018S/c methotrexatePolyarthritisJanuary/2019S/c adalimumabInadequate response to MethotrexateMarch/2020S/c Methotrextae S/c adalimumabConcerns about compliance-change to IV medicationsApril/2020IV methotrexateIV infliximab 4mg/kgFebruary/2021IV infliximab increased to 6mg/kgInadequate responseMay/2021IV infliximab increased to 8mg/kgInadequate responseDecember/2021IV infliximabInadequate response to infliximab-escalateJanuary/2022IV tocilizumabDecember/2022IV methotrexateIntoleranceMarch/2023IV tocilizumabInadequate response to tocilizumab-escalateApril/2023IV abataceptJune/2023Oral methotrexateAdded as adjunct to AbataceptDecember/2023IV abatacept Oral methotrexateInadequate response to Abatacept-escalate Intolerence to methotrexateJanuary/2024Oral tofacitinibJune/2024S/c adalimumabInadequate response to tofacitinib..."

Clinical • Anesthesia • Cardiovascular • CNS Disorders • Depression • Idiopathic Arthritis • Immunology • Inflammation • Orthopedics • Psychiatry • Rheumatology • Vascular Neurology

Increased Access to Subcutaneous Relative to Intravenous Drug Regimens by Women and Minority Racial/Ethnic Patients Using Belimumab or Tocilizumab Among US Medicare Beneficiaries (ISPOR-EU 2024) - "Patients who initiated SC tocilizumab were 14% Black and 15% Hispanic relative to 5% Black and 2% Hispanic among IV tocilizumab initiators. Women and minorities more frequently access SC versus IV belimumab and tocilizumab. Patients from Pacific more frequently access SC instead of IV regimens compared to Northeast. Lower outpatient healthcare costs were associated with SC regimens."

Clinical • Medicare • Reimbursement • US reimbursement • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Blood, Sweat and Steroids (BSR-CBC 2024) - "Neutropenia resulted in stopping Tocilizumab and later Anakinra and Sarilumab...Subcutaneous Tocilizumab did cause leucopenia and he suffered from recurrent infections...Where it seems there is an inflammatory syndrome but results don't seem to add up, we should put our patients forward for testing.• At the BSR case based conference I would like to hear other cases of treating VEXAS and what difficulties and wisdom my colleagues have to share. I would also like to hear if there are other treatment strategies others are aware of."

Anemia • Cardiovascular • Coronary Artery Disease • Dermatology • Dyslipidemia • Heart Failure • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Leukopenia • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Rare Diseases • Rheumatology • Squamous Cell Carcinoma • Vasculitis

Efficacy of Subcutaneous and Intravenous Tocilizumab in Noninfectious Uveitis. (PubMed, Ophthalmology) - "This retrospective study investigates the success of subcutaneous and intravenous tocilizumab (TCZ) for the treatment of uveitis. Overall, among those with 12-month follow-up, 74.0% of patients achieved treatment success at 1 year (SQ 77.8% and IV 72.2%)."

Journal • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

Quantitative PET/CT Parameters as Prognostic Biomarkers in Giant Cell Arteritis (EANM 2024) - "Materials and GCA patients enrolled in a prospective trial and treated with three boluses of intravenous methylprednisone and weekly subcutaneous tocilizumab (TCZ) monotherapy for 52 weeks were included... Our findings suggest that, in patients with GCA, semiautomatic quantitative PET parameters, such as TIVV and TIGV, which quantify the inflammatory active volume of vessels, represent promising biomarkers and may overcome visual analysis."

Biomarker • Giant Cell Arteritis • Immunology • Inflammation

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 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Combination therapy • Metastases • 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

Association between body weight and tocilizumab effectiveness in rheumatoid arthritis: results from the BSRBR-RA. (PubMed, Rheumatology (Oxford)) - "Body weight was associated with the initial response to SC tocilizumab, although the difference in response was small, but not drug persistence. Physicians should monitor the body weight of patients and consider interventions to promote maintenance of a healthy weight."

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

A Population Pharmacokinetic Model of Tocilizumab in Kidney Transplant Patients Treated for Chronic Active Antibody-Mediated Rejection: Comparison of Plasma Exposure Between Intravenous and Subcutaneous Administration Schemes. (PubMed, BioDrugs) - "From month 3 of treatment, the subcutaneous and intravenous tocilizumab administration schemes provided average bioequivalent pharmacokinetic exposure at the population level but not at the individual level. Body weight, inflammation, ACR, and administration scheme should be considered to personalize the dose of tocilizumab for patients with CAAMR. Further studies are required to determine the target of tocilizumab exposure in kidney transplant patients with CAAMR."

Journal • PK/PD data • Antibody-mediated Rejection • Inflammation • Transplantation • CRP

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 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed

Switching from intravenous to subcutaneous tocilizumab for uveitis during the COVID-19 pandemic: A case series. (PubMed, Can J Ophthalmol) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Ocular Inflammation • Ophthalmology • Uveitis