Altebrel (etanercept biosimilar) / AryoGen Pharmed - LARVOL DELTA

Drug- and Vaccine-Induced Cutaneous T-Cell Lymphoma: A Systematic Review of the Literature. (PubMed, J Skin Cancer) - "Infliximab (n = 6) and etanercept (n = 5) were the most commonly reported biologics...Six patients passed away after being diagnosed with CTCL: two because of CTCL recurrence and four because of other complications. It is important recognizing CTCL as a possible, although rare, adverse effect of certain drugs and vaccines, and taking a history of vaccinations, especially COVID-19 vaccines, and immunosuppressive drugs such as fingolimod, TNF-a inhibitors, and methotrexate."

Journal • Review • CNS Disorders • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lymphoma • Multiple Sclerosis • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Rheumatoid Arthritis • Rheumatology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Golimumab and certolizumab pegol for the treatment of hidradenitis suppurativa: a literature review and future perspective. (PubMed, Ther Adv Chronic Dis) - "The safety and efficacy of tumor necrosis factor-α (TNF-α) inhibitors, adalimumab, infliximab, and etanercept, are well studied in this patient population, and in some cases, HS was unresponsive to them...Also, golimumab showed promise in treating recalcitrant HS after the failure of other treatments, such as adalimumab and anti-interleukin-1. CPZ and golimumab can be efficacious treatment options for moderate-to-severe HS, especially in patients who are unresponsive to other TNF inhibitors, such as adalimumab."

Journal • Review • Acne Vulgaris • Dermatology • Hidradenitis Suppurativa • Immunology • Oncology

Prevalence and complication of COVID-19 in patients with ankylosing spondylitis (AS) and its relationship with TNF-a inhibitors. (PubMed, Immun Inflamm Dis) - "The use of the TNF-α inhibitors in patients with AS, may be associated with reduced hospitalization and death rate in COVID-19 cases."

Journal • Ankylosing Spondylitis • Diabetes • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Type 1 Diabetes Mellitus

Serious Infection Risk in Pediatric Psoriasis with Ustekinumab, Etanercept, or Methotrexate (RheumNow) - "Etanercept was FDA approved for use in pediatric psoriasis (PsO) in 2016 and ustekinumab was similarly approved in 2020. This comparative analysis looks at the risk of serious infections (SIE) requiring hospitalization in pediatric PSO patients treated with ustekinumab, etanercept, or methotrexate prior to 2016....Pediatric psoriasis treated with immunomodulating agents infrequently causes serious infections, with little difference between etanercept, ustekinumab or MTX."

Online posting

Effects of Biologic Therapies on the Chance of COVID-19 Infection Among Rheumatoid Arthritis and Lupus Patients During the First Wave of the Pandemic. (PubMed, Arch Bone Jt Surg) - "Identical results were observed among RA patients (P-value<0.001), however, all 5 (3%) lupus cases treated with Rituximab infected with covid 19...Patients treated with conventional and biological medicine had a higher disease risk than those taking exclusively conventional drugs. However, more studies are required to deliberate the relation of the reviewed factors with the severity of COVID-19."

Journal • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Novel Coronavirus Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • CRP

TNFAIP3 mutation causing haploinsufficiency of A20 with a hemophagocytic lymphohistiocytosis phenotype: a report of two cases. (PubMed, Pediatr Rheumatol Online J) - "This report is a hypothesis for developing of the HLH phenotype in the presence of TNFAIP3 mutation. Our results provide a new perspective on the role of TNFAIP3 mutation in HLH phenotypes, but more extensive studies are required to confirm these preliminary results."

Journal • Cerebral Hemorrhage • Dyslipidemia • Gastrointestinal Disorder • Hematological Disorders • Hypertriglyceridemia • Immunology • Infectious Disease • Inflammation • Musculoskeletal Diseases • Rare Diseases • TNFAIP3

The role of TNF-α and anti-TNF-α agents in the immunopathogenesis and management of immune dysregulation in primary immunodeficiency diseases. (PubMed, Immunopharmacol Immunotoxicol) - "In the current review, we aimed to highlight the characteristics of TNF-α and its important role in the pathogenesis of related complication in PID diseases. Critical evaluation of the mAbs targeting TNF-α (e.g. infliximab, etanercept, and adalimumab) in various immune-mediated complications in PID diseases will be provided, and finally, their clinical efficacy and safety will be reported."

Journal • Immunology • Infectious Disease • Inflammation • Oncology • Primary Immunodeficiency • TNFA

Live Varicella Zoster Vaccine Safe, Effective with TNF Inhibitors (The Rheumatologist) - "'The prohibition against live virus vaccines in patients receiving TNFi biologics may not be as inviolable as might have been thought,' says lead study author Jeffrey Curtis...but for people on cytokine inhibitors, this live virus vaccine would seem to be ok,' Dr. Curtis said by email."

Media quote

Disease modifying drugs in idiopathic sclerosing orbital inflammatory syndrome. (PubMed, Orbit) - "Mean follow up was 32.80 (SD = 30.80, range: 12-86) months. Biologic DMD (b-DMD) including anti-TNF alpha, corticosteroid and azathioprine were effective in decreasing disease activity and could change course of the disease. This study supports the concept of using b-DMD regimen in treatment of ISOIS."

Journal • Inflammation • Ocular Inflammation • Ophthalmology

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study. (PubMed, Adv Ther) - P=N/A | "The results demonstrated the real-world safety and effectiveness of biosimilar etanercept in patients with RA, PsA, and AS."

Clinical • HEOR • Journal • P4 data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Optimization of culture conditions for high-level expression of soluble and active tumor necrosis factor-α in E. coli. (PubMed, Protein Expr Purif) - "Also, the affinity of an anti-TNF-α agent, Altebrel, was investigated against the expressed protein through ELISA. Binding kinetics were also studied using Cimzia as an anti-TNF-α molecule and 7.2 EM was calculated as the equilibrium dissociation constant value (K). The significant expression level of the recombinant protein in the soluble form, its high purity, and assessment of its biological activity showed that the expressed protein could be used in tests of ELISA and MTT to assess the activity of anti-TNF-α agents."

Journal • TNFA

ASQA: Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (clinicaltrials.gov) - P; N=583; Completed; Sponsor: AryoGen Pharmed Co.

Clinical • HEOR • New trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Physicochemical Characterization of Altebrel™, a Proposed Etanercept Biosimilar. (PubMed, Iran J Biotechnol) - "Moreover, amino acid analysis indicated similar primary structure and circular dichroism study implied a similar secondary structure for Altebrel™ and Enbrel. Overall, our data provide analytical evidence for structural and in vitro functional similarity between Altebrel™ and Enbrel."

Journal • TNFA

The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar (Curr Med Res Opin) - "The totality of the evidence from all analyses and performed trials provides a robust scientific bridge between the biosimilar and clinical experience with the reference medicine, and is used to justify the use of the biosimilar in all indications for which the reference medicine is approved."

Review

Structural and In Vitro Functional Comparability Analysis of Altebrel™, a Proposed Etanercept Biosimilar: Focus on Primary Sequence and Glycosylation. (PubMed, Pharmaceuticals (Basel)) - "Finally, investigation of the functional properties of N-deglycosylated and non-modified etanercept samples using surface plasmon resonance analysis and in-vitro bioassay showed that N-glycosylation has no significant effect on its in-vitro functionality. Analysis of etanercept and its biosimilar, revealed a high similarity in terms of glycosylation, primary structure and in-vitro functionality."

Journal • Preclinical