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

Psychopharmacotherapy of Depression Improves Treatment Outcomes in Rheumatoid Arthritis Patients Receiving Anti-IL6 Treatment with Olokizumab and Conventional Disease-modifying Antirheumatic Drugs (ACR Convergence 2026) - No abstract available

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

Direct IL‑6 Inhibition with Olokizumab Corrects Anemia in Rheumatoid Arthritis (ACR Convergence 2026) - No abstract available

Anemia • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Direct IL-6 Inhibition with Olokizumab in Patients with Polymyalgia Rheumatica: Efficacy and Safety Results from the Phase 3 PROMISE Trial (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Polymyalgia Rheumatica • Rheumatology

Efficacy and Safety of Olokizumab in Patients With Polymyalgia Rheumatica (PROMISE) (clinicaltrials.gov) - P3 | N=125 | Active, not recruiting | Sponsor: R-Pharm International, LLC

New P3 trial • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Rheumatology • CRP

Direct interleukin-6 inhibitor olokizumab in the treatment of polymyalgia rheumatica: a case series. (PubMed, Front Med (Lausanne)) - "The disease duration of less than 36 months at the time of initiation of therapy proved to be a significant predictor of achieving low PMR activity (AUC = 0.912; p = 0.024). Olokizumab demonstrated high efficacy in reducing the activity of PMR, laboratory markers of inflammation and the dose of steroids in patients with inefficacy or intolerance to methotrexate."

Journal • Giant Cell Arteritis • Immunology • Inflammation • Musculoskeletal Pain • Pain • Rheumatology • CRP • IL6

Study of the Efficacy and Safety of Goflikicept and Olokizumab as the Second-line Therapy in Patients With Still's Disease (clinicaltrials.gov) - P3 | N=52 | Not yet recruiting | Sponsor: R-Pharm International, LLC

New P3 trial • Immunology

Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). (PubMed, Rheumatol Ther) - P3 | "Treatment with OKZ over 106 weeks resulted in sustained numerically greater and clinically meaningful improvements in PROs compared to baseline in both RA patients with MTX-IR and those with TNFi-IR. These findings support the long-term benefit of OKZ on PROs."

Clinical • Journal • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Oncology • Pain • Rheumatoid Arthritis • Rheumatology

Pharmacokinetics, Efficacy and Safety of Olokizumab In Patients With Juvenile Idiopathic Arthritis (clinicaltrials.gov) - P2 | N=71 | Recruiting | Sponsor: R-Pharm International, LLC

New P2 trial • Idiopathic Arthritis • Immunology • Pediatrics • Rheumatology • CRP

Efficacy of Olokizumab in Treating Comorbid Depression in Patients with Rheumatoid Arthritis: Results of a Single-Center Randomized Controlled Trial. (PubMed, Dokl Biochem Biophys) - "-In patients with moderate/high RA activity and comorbid depression, OKZ without PPT can lead to a decrease in the severity of depression or, less often, to a complete regression of depressive symptoms, mainly in patients 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."

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

Detection of Free and Olokizumab-Bound Interleukin-6 during Anticytokine Therapy. (PubMed, Biochemistry (Mosc)) - "Additionally, we assessed the kinetics of neutralizing anti-OKZ antibody formation in this preclinical model. The methods developed can be applied for clinical monitoring during anti-cytokine therapy and in preclinical studies using mouse models to evaluate the efficacy of such therapy in controlling IL-6-dependent inflammation in experimentally induced diseases."

Journal • Immunology • Inflammation • IL6

Open-Label Phase II Study of Olokizumab in Adolescent Patients with Polyarticular Juvenile Idiopathic Arthritis: Results of the 24-Week Treatment Period. (PubMed, Pharmaceuticals (Basel)) - "Background/Objectives: This study aimed to evaluate the pharmacokinetics (PK), effectiveness, and safety of the direct interleukin-6 (IL-6) inhibitor olokizumab (OKZ) in adolescent patients with active polyarticular juvenile idiopathic arthritis (pJIA) who had an inadequate response or intolerance to methotrexate (MTX). OKZ treatment reduced pJIA disease activity and was well tolerated. The safety profile was consistent with that of other IL-6 inhibitors, and the PK profile matched that seen in adult RA patients."

Journal • P2 data • Idiopathic Arthritis • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

The impact of comorbidities on the efficacy of IL-6 inhibitor olokizumab compared to adalimumab in a randomized controlled trial. (PubMed, Arthritis Res Ther) - "All groups had similar proportions of approximately 25% of patients with mCCI ≥ 2. There was no significant difference in efficacy between the OKZ q4w or q2w-treated NCC and CC groups at 3 and 6 months of treatment. The same was observed for the placebo group. In contrast, comorbidities reduced CDAI ≤ 10 and ACR50 outcomes upon ADA treatment at 6 months."

Journal • P3 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

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