Nanozora (ozoralizumab) / Sanofi, Taisho, Edding Genor Group - LARVOL DELTA

Efficacy and Safety of Ozoralizumab Plus Methotrexate in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (ACR Convergence 2026) - No abstract available

Retrospective data • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Albumin-Binding Domains in Therapeutic Protein Engineering: A Structural and Computational Perspective on Rational Design. (PubMed, SynBio) - "Clinical validation through approved therapeutics like ozoralizumab demonstrates the success of this approach, with preclinical studies showing fusion to an ABD extended half-life to 18 days...We establish practical guidelines for integrating computational screening with experimental validation. This review provides protein engineers and synthetic biologists with a comprehensive framework for rational design of albumin-binding therapeutics, emphasizing the synergistic integration of structural insight, computational prediction, and systematic experimental validation to accelerate development of next-generation long-acting biotherapeutics."

Journal

Assessment of drug levels as a biomarker in rheumatoid arthritis. (PubMed, EULAR Rheumatol Open) - "One example is the levels of methotrexate (MTX)-polyglutamates (PGs), and the second one is that of biological disease-modifying antirheumatic drugs (DMARDs) in patients with RA. In addition, we also experienced the measurements of drug levels of a unique bDMARD, ozoralizumab, a bispecific Variable domain of Heavy chain of Heavy chain antibody (VHH) molecule, which is directed against TNFα and albumin in clinical trials. We introduced our experiences and explored the viewpoint of the measurements of drug levels as a biomarker in RA."

Biomarker • Journal • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TNFA

Relevant factors for successful spacing of a TNF blocker or methotrexate dose reduction in patients with rheumatoid arthritis in remission or low disease activity with ozoralizumab and methotrexate: subanalyses of a randomised, controlled, SORAIRO trial (EULAR 2026) - "CDAI and serum albumin levels were relevant for successful spacing of ozoralizumab and CDAI for methotrexate dose reduction, suggesting better CDAI leads to the successful treatment reduction. The high dose methotrexate use with a TNF inhibitor to achieve treatment target may indicate the difficulty in methotrexate-free status."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritis. (PubMed, Ann Rheum Dis) - "This SLR, together with the safety review, informed the 2025 update of the EULAR RA management recommendations. Although few phase 3 trials on novel agents were available, strategic and head-to-head studies provided important insights that enabled further refinement of the established treatment algorithm."

Journal • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Cryo-EM elucidates the interaction mechanism of ozoralizumab, a humanized anti-TNFα NANOBODY® compound. (PubMed, Biochem Biophys Res Commun) - "Furthermore, surface plasmon resonance (SPR) analysis demonstrated that the 1:1-bivalent binding mode confers an exceptionally slow dissociation rate, thereby contributing to the potent TNFα-neutralizing activity of OZR. These findings not only lend support to the favorable clinical efficacy of OZR from a structural standpoint but also lay the foundation for the rational design and development of next-generation TNFα inhibitors with enhanced and sustained efficacy."

Journal

Spacing of a TNF inhibitor or dose reduction of methotrexate vs continued treatment in patients with rheumatoid arthritis in remission or low disease activity: a randomised, controlled trial (SORAIRO trial). (PubMed, Ann Rheum Dis) - "Treatment tapering may not be feasible in patients with low disease activity, whereas both extending the TNF inhibitor interval and reducing the methotrexate dose may be reasonable options for patients in remission."

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

Perioperative Ozoralizumab Management for Patients with Rheumatoid Arthritis Who Underwent Orthopaedic Surgery: A Retrospective Case Series. (PubMed, J Clin Med) - " Preoperative OZR discontinuation for up to four weeks appeared to be safe in this cohort. These findings may assist orthopaedic surgeons in determining an appropriate perioperative discontinuation strategy for OZR that minimises SSI and DWH risk while reducing the likelihood of RA flare."

Journal • Retrospective data • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Orthopedics • Rheumatoid Arthritis • Rheumatology

Impact of Anti-Drug Antibodies and Neutralising Antibodies on Safety and Efficacy of Ozoralizumab in Rheumatoid Arthritis. (PubMed, Mod Rheumatol) - "ADA induction had no apparent impact on safety. The effect of NAb expression on efficacy was limited particularly in OHZORA, suggesting that methotrexate co-administration may reduce NAb development and contribute to the optimal preservation of efficacy and safety in clinical practice."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ozoralizumab-Induced Multifocal Demyelinating Neuropathy in a Patient With Rheumatoid Arthritis. (PubMed, Cureus) - "Symptoms persisted after discontinuation of ozoralizumab but resolved after two courses of intravenous immunoglobulin therapy, with complete clinical and electrophysiological recovery. This case suggests that ozoralizumab may trigger multifocal demyelinating neuropathy."

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

Efficacy of ozoralizumab in rheumatoid arthritis patients with large joint involvement: a post hoc analysis of OHZORA and NATSUZORA trials. (PubMed, RMD Open) - "Ozoralizumab has the potential to improve disease activity and physical dysfunction and prevent joint destruction in patients, regardless of the presence of LJI, and is a reasonable treatment option, even for patients with LJI."

Biomarker • Clinical • Journal • Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • IL6

Ozoralizumab in rheumatoid arthritis: a novel Fc-free anti-TNF agent with serology-independent efficacy. (PubMed, Rheumatology (Oxford)) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Early effects of ozoralizumab 30 mg in patients with rheumatoid arthritis and inadequate response to methotrexate: a post hoc trajectory analysis of the phase II/III OHZORA trial. (PubMed, RMD Open) - "OZR 30 mg demonstrated both immediate and sustained efficacy in MTX-IR patients with RA. Multivariate analysis suggested that both baseline inflammation and disease activity-represented by CRP and CDAI-may independently influence treatment response. However, residual confounding due to baseline disease activity cannot be completely excluded, and this remains a limitation of the present study."

Journal • P2/3 data • Retrospective data • Immunology • Inflammation • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

EFFECTIVENESS OF CYTOTOXIC T-LYMPHOCYTE ANTIGEN-4-Ig AND JANUS KINASE INHIBITOR IN RHEUMATOID ARTHRITIS PATIENTS WITH HIGH RHEUMATOID FACTOR LEVELS: A RETROSPECTIVE COMPARATIVE STUDY IN SINGLE CENTER (EULAR 2025) - "Among the TNFi group, 31 TCs involved Fc-free agents (certolizumab pegol and Ozoralizumab). In high RF levels group, CTL-4-Ig was highest retention rate, while TNFi and aIL-6R showed lower retention rates. JAKi retention was comparable to CTLA-4-Ig and was less influenced by RF levels, supporting its use as a second-line option for high RF patients. Based on our results of the survival analysis, it will be necessary to consider comparing disease activity to further investigate the effectiveness of treatments based on RF levels."

Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CTLA4 • IL6R

Spacing of a TNF blocker and dose reduction of methotrexate in patients with rheumatoid arthritis in remission or low disease activity with ozoralizumab and methotrexate: a randomised, controlled trial (SORAIRO trial) (EULAR 2025) - "In patients who have achieved remission with a combination of TNF inhibitor and MTX therapy, extending OZR interval or reducing MTX dose can be feasible and favorable under careful clinical monitoring. This study also re-emphasises the importance of achieving remission for the subsequent successful treatment reduction."

Clinical • Late-breaking abstract • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Efficacy of ozoralizumab based on baseline RF titres in patients with RA: A post hoc analysis of the OHZORA trial (EULAR 2025) - "The Phase II/III OHZORA trial evaluated the efficacy and safety of OZR at 30 or 80 mg for 52 weeks in patients with active rheumatoid arthritis (RA) despite methotrexate therapy [2, 3]. Generally, the efficacy of anti-TNF antibodies containing the fragment crystallizable (Fc) portion is reduced in patients with high titres of rheumatoid factor (RF) [4, 5]; on the other hand, certolizumab pegol (CZP) that lacks the Fc portion is effective regardless of RF titres [6, 7]... OZR is an effective anti-TNF treatment for RA, regardless of RF and ACPA titres, and exhibits promise as a novel therapeutic option."

Clinical • Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Effects of immunotherapy on isolated optic neuritis associated with ozoralizumab, a novel anti-tumor necrosis factor α NANOBODY® compound: A case report. (PubMed, eNeurologicalSci) - "She was diagnosed with ozoralizumab-associated isolated optic neuritis and cured with two courses of high-dose intravenous methylprednisolone, followed by oral prednisolone. Ozoralizumab may be associated with optic neuritis although early diagnosis and immunotherapy possibly achieve a good outcome."

Journal • Immunology • Inflammatory Arthritis • Ocular Inflammation • Oncology • Ophthalmology • Optic Neuritis • Rheumatoid Arthritis • Rheumatology • TNFA

New anti-TNF biologics in RA: What is new and what is old? (PubMed, Semin Arthritis Rheum) - "This review summarizes the recent advancement of fragmented immunoglobulin molecules targeting on Tumot Necrosis Factor (TNF) alpha and highlighted the nanobody, which is the first approved product for the patients with rheumatoid arthritis (RA), ozoralizumab (OZR)...It has been approved in Japan in 2022 and marked as the fixth products of TNF inhibitors for RA in Japan. The similarities and differences among these products are discussed in this review."

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ozoralizumab shows effectiveness regardless of baseline RF and ACPA titres in patients with RA: A post hoc analysis of the OHZORA trial. (PubMed, Rheumatology (Oxford)) - "OZR is an effective anti-TNF treatment for RA, regardless of RF and ACPA titres, and exhibits promise as a novel therapeutic option."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Rapid improvement of rheumatoid arthritis symptoms with ozoralizumab: a case of progress monitored by musculoskeletal ultrasonography. (PubMed, Scand J Rheumatol) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Rheumatoid Arthritis • Rheumatology

Research trends in the use of nanobodies for cancer therapy. (PubMed, J Control Release) - "In recent years, several nanobody-based drugs, including Caplacizumab, KN-035, and Ozoralizumab, have been approved for clinical use. Future trends were also predicted. This study provides a unique, comprehensive, and objective perspective on the use of nanobodies in tumor research, laying a foundation for future research directions and offering valuable insights for researchers in the field."

Journal • Review • Infectious Disease • Oncology • Solid Tumor • Targeted Protein Degradation

Effect of Ozoralizumab Administration with or without Methotrexate in Patients with Rheumatoid Arthritis: A Post-Hoc Analysis. (PubMed, Rheumatol Ther) - "OZR administration without MTX was associated with an improvement in the signs and symptoms of RA compared to placebo administration (continuation of MTX monotherapy). OZR and MTX administration showed better efficacy than OZR administration alone."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Correction: Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. (PubMed, RMD Open) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Acute Heart Failure with Reduced Ejection Fraction Following Ozoralizumab in A Patient with Rheumatoid Arthritis: A Case Report. (PubMed, Mod Rheumatol Case Rep) - "Her condition improved after OZR discontinuation, suggesting that OZR may have precipitated the HFrEF despite tolerance with previous TNF inhibitors. Further studies are warranted to elucidate the mechanism and incidence of OZR-associated HF."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. (PubMed, RMD Open) - P3 | "This integrated analysis revealed no new safety concerns, and the efficacy was maintained in patients with RA under long-term ozoralizumab administration."

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