Artlegia (olokizumab) / R-Pharm, UCB - LARVOL DELTA

OLOKIZUMAB IMPROVES PATIENT-REPORTED OUTCOMES IN MODERATE TO SEVERELY ACTIVE MTX-IR AND TNFi-IR RHEUMATOID ARTHRITIS PATIENTS UP TO 106 WEEKS (RESULTS FROM THE OPEN-LABEL EXTENSION OF PHASE III RANDOMIZED CLINICAL TRIALS) (EULAR 2025) - No abstract available

Clinical • P3 data • Patient reported outcomes • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Correction: Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. (PubMed, Ann Rheum Dis) - No abstract available

Journal

EFFICACY AND SAFETY OF OLOKIZUMAB IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS- A SYSTEMATIC REVIEW AND META-ANALYSIS. (PubMed, J Ayub Med Coll Abbottabad) - "In conclusion, Olokizumab has shown significant improvement in disease activity compared to placebo with a favourable safety profile. However, further larger and longer-term studies are required to confirm these findings."

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

Olokizumab in Real Clinical Practice: Efficacy and Safety (ACR Convergence 2024) - "In real clinical practice olokizumab significantly improves the symptoms of RA, and in some cases allows stopping steroid therapy. Olokizumab did not cause additional safety concerns."

Clinical • IL6

Olokizumab Effect on Chronic Pain in Rheumatoid Arthritis: Results of the Observational Study (ACR Convergence 2024) - "The patients reported moderate to severe pain, mean score 6.0±2.0 (numerical rating scale, NRS 0-10).All patients received olokizumab 64 mg subcutaneous injection every 4 weeks with methotrexate. Olokizumab significantly reduces RA activity and chronic pain intensity. The analgesic effect of olokizumab may be associated not only with an anti-inflammatory effect, but also with a positive effect on the nociceptive system dysfunction."

Clinical • Observational data • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Neuralgia • Pain • Peptic Ulcer • Rheumatoid Arthritis • Rheumatology • Women's Health • IL6

Olokizumab, a Monoclonal Antibody Against IL-6, in Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA): Results of 24 Weeks of the Phase 2 Open-label Clinical Trial (ACR Convergence 2024) - "The aim of this study is to assess the pharmacokinetics (PK), effectiveness and safety of OKZ in patients with pcJIA who had inadequate response to methotrexate (MTX). OKZ in patients with pcJIA was associated with improvement in disease activity and functional health status. Safety was expected for this class of agents, but it seems OKZ has advantages regarding the risk of developing neutropenia."

Clinical • P2 data • Dermatology • Hematological Disorders • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Neutropenia • Psoriasis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases (clinicaltrials.gov) - P2/3 | N=138 | Recruiting | Sponsor: R-Pharm International, LLC | Trial completion date: Dec 2026 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Olokizumab effect on chronic pain in rheumatoid arthritis: Results of the PROLOGUE observational study. (PubMed, Int J Rheum Dis) - "OKZ is effective in reducing RA activity and controlling chronic pain related to dysfunction of the nociceptive system."

Journal • Observational data • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Neuralgia • Pain • Rheumatoid Arthritis • Rheumatology

Efficacy and safety of current therapies for difficult-to-treat rheumatoid arthritis: a systematic review and network meta-analysis. (PubMed, J Transl Med) - "Tocilizumab and rituximab have better efficacy and safety in the treatment of D2T RA, and the 8 mg/4w dose of tocilizumab may be the first choice for achieving disease remission."

Clinical • Journal • Retrospective data • Review • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6

Olokizumab: its role in the treatment of rheumatoid arthritis (APLAR 2024) - "Sponsored by R-Pharm."

Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

The efficacy of olokizumab: patients' perspective (APLAR 2024) - "Sponsored by R-Pharm."

Clinical • Immunology • Rheumatoid Arthritis • Rheumatology

First olokizumab experience in APLAR region (APLAR 2024) - "Sponsored by R-Pharm."

Immunology • Rheumatoid Arthritis • Rheumatology

How to switch rheumatoid arthritis patients to olokizumab: real world dat (APLAR 2024) - "Sponsored by R-Pharm."

Clinical • Real-world • Real-world evidence • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Olokizumab, a direct IL-6 inhibitor, in polyarticular-course juvenile idiopathic arthritis (pcJIA): preliminary results of the Phase 2 open-label clinical trial (APLAR 2024) - No abstract available

Clinical • P2 data • Idiopathic Arthritis • Immunology • Rheumatoid Arthritis • Rheumatology

Clinical data from olokizumab trials (APLAR 2024) - "Sponsored by R-Pharm."

Clinical data • Immunology • Rheumatoid Arthritis • Rheumatology

Identification of critical genes and metabolic pathways in rheumatoid arthritis and osteoporosis toward drug repurposing. (PubMed, Comput Biol Med) - "The results of the present study can provide novel insights into the pathogenesis and treatment of RA and OP."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Osteoporosis • Rheumatoid Arthritis • Rheumatology • CCL2 • HIF1A • IL10 • IL1B • IL6 • MMP9 • STAT3 • TGFB1 • TP53

R-Pharm Publishes New Results on Olokizumab in European Journal (GxP News) - "P3 | N=2,106 | CREDO 4 (NCT03120949) | Sponsor: R-Pharm International, LLC | "R-Pharm has recently released the latest findings from its Phase 3 open-label study (CREDO 4) on olokizumab in the esteemed European journal Annals of the Rheumatic Diseases. The study evaluated the safety and efficacy of olokizumab, a drug developed for treating rheumatoid arthritis. Based on a study involving 2,400 patients, the results demonstrate that the drug not only achieves a clinical response, but also maintains it for a minimum of two years. The safety and tolerability of olokizumab remained stable throughout the treatment period."

P3 data • Rheumatoid Arthritis

Inflammation-mediated drug interactions of olokizumab and cytochrome P450 activities in patients with rheumatoid arthritis. (PubMed, Br J Clin Pharmacol) - "In patients with active RA, olokizumab potentially reverses the IL-6-mediated suppression of CYP3A4 and CYP2C19. According to FDA guidance, olokizumab is considered a weak inducer of CYP3A4 and CYP2C19."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CYP1A2 • CYP2C19 • CYP2C9 • CYP3A4

Results of a 12-Week Open-Label, Non-Interventional Study of the Efficacy and Safety of Olokizumab Therapy in Patients with Rheumatoid Arthritis after Switching from Anti-B-Cell Therapy during the SARS-CoV-2 Pandemic. (PubMed, Dokl Biochem Biophys) - "The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic."

Journal • Observational data • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Novel Coronavirus Disease • Pain • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology

Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment. (PubMed, Ann Rheum Dis) - "The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA."

Journal • Cardiovascular • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Neutropenia • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

EFFECT OF OLOKIZUMAB ON THE NEUTROPHIL-LYMPOCYTE RATIO IN PATIENTS WITH RHEUMATOID ARTHRITIS (EULAR 2024) - P3 | "Baseline parameters and their changes were analyzed in four groups: OKZ q2w, OKZ q4w, adalimumab group (ADA) and placebo group (PBO) all at background of MTX. Post hoc analysis of CREDO 1-3 showed an association of direct IL-6 blockade by olokizumab and NLR decrease, which was connected with the neutrophil component reduction. NLR changes correlated with changes in RA activity indices and laboratory parameters."

Clinical • Cardiovascular • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Thrombosis • HP

SWITCHING FROM IL-6R INHIBITORS TO OLOKIZUMAB, A DIRECT IL-6 INHIBITOR: EFFICACY AND SAFETY AT 1-YEAR FOLLOW-UP (EULAR 2024) - "Unlike tocilizumab or sarilumab, OKZ blocks the ligand, not the receptor. Remission was maintained in the majority of RA patients switched from an iIL6-R to OKZ for at least 12 months. Switching within the period, recommended by guidelines, prevents exacerbation of RA and maintains remission/low activity up to 1 year. There were no significant safety signals for OKZ during the 12-month treatment period."

Clinical • Immunology • Rheumatoid Arthritis • Rheumatology • IL6R

Efficacy of Olokizumab against Comorbid Depressive Disorder in Patients with Rheumatoid Arthritis: Preliminary Results of the Study. (PubMed, Dokl Biochem Biophys) - "However, a complete regression of depression symptoms when OKZ is prescribed without PPT is possible only in 25% of RA patients, mainly in the patients with mild depression. A combination of OKZ and PPT is optimal for the complete regression of depression and anxiety and a decrease in the frequency and severity of CDs."

Journal • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Immunology • Inflammatory Arthritis • Mood Disorders • Psychiatry • Rheumatoid Arthritis • Rheumatology • Sleep Disorder

Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases (clinicaltrials.gov) - P2/3 | N=116 | Recruiting | Sponsor: R-Pharm International, LLC

New P2/3 trial • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Text Mining and Drug Discovery Analysis: A Comprehensive Approach to Investigate Diabetes-Induced Osteoporosis. (PubMed, Int J Med Sci) - "After DGI analysis, we identified 7 genes targeted by 11 drugs, which represent candidates for treating DOP. This study unveils ANDECALIXIMAB, SILTUXIMAB, OLOKIZUMAB, SECUKINUMAB, and IXEKIZUMAB as promising potential drugs for DOP treatment, demonstrating the significance of utilizing text mining and pathway analysis to investigate disease mechanisms and explore existing therapeutic options."

Journal • Diabetes • Metabolic Disorders • Orthopedics • Osteoporosis • Rheumatology