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

Efficacy of Olokizumab in Treating Comorbid Depression in Patients with Rheumatoid Arthritis: Results of a Single-Center Randomized Controlled Trial (ACR Convergence 2025) - "In patients with moderate/high RA activity and comorbid depression, OKZ without PPT can lead to a decrease in severity of depression in 51% of patients with RA, with complete regression of depressive symptoms observed in 16.3% of patients, mainly those with minor depression. OKZ therapy without PPT also reduces the severity of anxiety, but does not eliminate it completely. The combination of OKZ and PPT is optimal for achieving complete regression of depression and anxiety in this category of RA patients."

Clinical • CNS Disorders • Depression • Immunology • Inflammatory Arthritis • Mood Disorders • Psychiatry • Rheumatoid Arthritis • Rheumatology • SMAD2

IL-6 as a Predictor of Response to Olokizumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Results of the Phase 2 Clinical Trial (ACR Convergence 2025) - "The aim of the study was to identify the subpopulation of patients with polyarticular-course juvenile idiopathic arthritis (pJIA) who can be expected to have a better treatment response compared to the whole pJIA population. Adolescent patients with active pJIA who had failed methotrexate were included in the Phase 2 open-label multicenter study in Russia and received OKZ in a dose of 64 mg every 4 weeks (q4w) subcutaneously (SC) during the main 24-week part of the study. OKZ is a good therapeutic option for the pcJIA that leads to improvement in disease activity and has acceptable safety. It seems that OKZ response may be more successful in patients with higher baseline IL-6 levels."

Clinical • P2 data • Dermatology • Idiopathic Arthritis • Immunology • Infectious Disease • Psoriasis • Rheumatology • CRP • IL6

Olokizumab Improves Patient-Reported Outcomes in Rheumatoid Arthritis MTX-IR and TNF-IR Patients up to 106 Weeks (Results from Clinical Phase III Program) (ACR Convergence 2025) - P3 | "Overall 1982 patients were included. MTX-IR and TNFi-IR populations were comparable at baseline with a mean age of 53 years, mostly women (77-90%), 56-61% using glocucorticoids, and DAS28-CRP approximately 5.87-5.99 (RA duration, CDAI, intolerance to ≥15 mg/week MTX dose and HAQ-DI were numerically higher in TNFi-IR patients). At week 12, OKZ biweekly (q2w), and every four weeks (q4w), compared with placebo showed significantly greater LSM improvements in all PROs for MTX-IR patients (Table 1)."

Clinical • P3 data • Patient reported outcomes • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL6

Impact of Olokizumab on Pain in Rheumatoid Arthritis: a Meta-analysis (ACR Convergence 2025) - "OKZ significantly reduces patient-reported pain in RA, with greater improvements than placebo observed in clinical trials and similarly robust pain relief reported in real-world studies. These meta-analytic findings underscore the value of OKZ as an effective therapy for managing pain in RA."

Retrospective data • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatoid Arthritis • Rheumatology • IL6

Impact of Comorbidity Burden on the Efficacy of, a Direct Interleukin 6 Inhibitor, Olokizumab: Real World Evidence (ACR Convergence 2025) - "The study purpose was to determine the impact of comorbidity burden on the OKZ efficacy in RA patients in the real-world data (RWD) study. Biologic DMARDs (bDMARD)-naive patients with RA on methotrexate ± glucocorticoids (GC) inefficacy who received OKZ for at least 24 weeks were included in our retrospective RWD study. There were no significant differences in effectiveness outcomes in OKZ-treated RA patients with high and low comorbidity burden over 24 observation weeks in the RWD study. Further research may clarify the impact of comorbidities on OKZ outcomes."

Clinical • HEOR • Real-world • Real-world evidence • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Metabolic Disorders • Osteoarthritis • Osteoporosis • Rheumatoid Arthritis • Rheumatology • IL6

Repurposing Antidiabetic Drugs for Gangrene: A Mendelian Randomization and Text Mining Study. (PubMed, Int J Med Sci) - "Subsequent DGI analysis revealed six genes targeted by 12 drugs (DGI score > 5), presenting them as candidates for treating DG. In conclusion, this study not only validates the causal effect of diabetes on gangrene risk but also identifies several potential therapeutic agents (CILAZAPRIL, RESATORVID, SILTUXIMAB, and OLOKIZUMAB) by integrating bioinformatics analysis, providing new directions for future clinical interventions."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

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