Mark C. Genovese
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View article: Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study
Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study Open
Objectives DARWIN 3 (ClinicalTrials.gov: NCT02065700 ) assessed the safety and efficacy of filgotinib in a long-term extension (LTE) of two phase II randomised controlled rheumatoid arthritis (RA) trials. Methods Eligible patients completi…
View article: Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial
Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial Open
Galapagos.
View article: Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4
Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4 Open
Objectives The aim of this article is to describe the safety and efficacy of filgotinib 200 mg (FIL200) or FIL 100 mg (FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (NCT03025308). Methods Patients who comp…
View article: Filgotinib in Active Noninfectious Uveitis
Filgotinib in Active Noninfectious Uveitis Open
Importance Noninfectious uveitis is a leading cause of visual impairment with an unmet need for additional treatment options. Objective To assess the efficacy and safety of filgotinib, a Janus kinase 1 (JAK1) preferential inhibitor, for th…
View article: Long-Term Safety, Efficacy, and Patient-Centered Outcomes of Filgotinib in the Treatment of Rheumatoid Arthritis: Current Perspectives
Long-Term Safety, Efficacy, and Patient-Centered Outcomes of Filgotinib in the Treatment of Rheumatoid Arthritis: Current Perspectives Open
Filgotinib is an orally administered, preferential Janus kinase (JAK) inhibitor indicated for the treatment of moderate-to-severe rheumatoid arthritis (RA). The short-term safety, efficacy, and patient-reported outcomes (PROs) with filgoti…
View article: A Plain Language Summary of What Clinical Studies Can Tell Us About the Safety of Evobrutinib – a Potential Treatment for Multiple Sclerosis
A Plain Language Summary of What Clinical Studies Can Tell Us About the Safety of Evobrutinib – a Potential Treatment for Multiple Sclerosis Open
The safety data from all three clinical studies are encouraging and can be used to inform further research into using evobrutinib in MS. Clinical Trial Registration: NCT02975349 (multiple sclerosis), NCT03233230 (rheumatoid arthriti…
View article: POS0834 LONG-TERM EXTENSION STUDY OF THE SAFETY AND EFFICACY OF NEUROIMMUNE MODULATION USING A VAGUS NERVE STIMULATION DEVICE IN PATIENTS WITH RHEUMATOID ARTHRITIS
POS0834 LONG-TERM EXTENSION STUDY OF THE SAFETY AND EFFICACY OF NEUROIMMUNE MODULATION USING A VAGUS NERVE STIMULATION DEVICE IN PATIENTS WITH RHEUMATOID ARTHRITIS Open
View article: POS0829 SAFETY AND EFFICACY OF FILGOTINIB: AN UPDATE FROM THE DARWIN 3 PHASE 2 LONG-TERM EXTENSION WITH A MAXIMUM OF 8.2 YEARS OF EXPOSURE
POS0829 SAFETY AND EFFICACY OF FILGOTINIB: AN UPDATE FROM THE DARWIN 3 PHASE 2 LONG-TERM EXTENSION WITH A MAXIMUM OF 8.2 YEARS OF EXPOSURE Open
View article: Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis
Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis Open
Objective Analyse the integrated safety profile of evobrutinib, a Bruton’s tyrosine kinase inhibitor (BTKi), using pooled data from multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) trials. Methods P…
View article: AB0398 AURICULAR TRANSCUTANEOUS HI-FREQUENCY E-MMUNOTHERAPY SEQUENCES (ATHENS) FOR THE TREATMENT OF RHEUMATOID ARTHRITIS: 1-YEAR CHANGES IN SYNOVITIS, OSTEITIS, AND BONE EROSION
AB0398 AURICULAR TRANSCUTANEOUS HI-FREQUENCY E-MMUNOTHERAPY SEQUENCES (ATHENS) FOR THE TREATMENT OF RHEUMATOID ARTHRITIS: 1-YEAR CHANGES IN SYNOVITIS, OSTEITIS, AND BONE EROSION Open
View article: Integrated safety analysis of filgotinib treatment for rheumatoid arthritis in patients from Japan over a median of 1.5 years
Integrated safety analysis of filgotinib treatment for rheumatoid arthritis in patients from Japan over a median of 1.5 years Open
Objective Characterize safety of the Janus kinase-1 preferential inhibitor filgotinib (FIL) in Japanese patients with moderately to severely active rheumatoid arthritis (RA). Methods Data from three Phase 3 trials (NCT02889796, NCT02873936…
View article: The Incidence, Prevalence, and Associated Costs of Anemia, Malignancy, Venous Thromboembolism, Major Adverse Cardiovascular Events, and Infections in Rheumatoid Arthritis Patients by Treatment History in the United States
The Incidence, Prevalence, and Associated Costs of Anemia, Malignancy, Venous Thromboembolism, Major Adverse Cardiovascular Events, and Infections in Rheumatoid Arthritis Patients by Treatment History in the United States Open
Objective Comorbidities in rheumatoid arthritis (RA) can influence treatment selection, impact treatment persistency, and increase health care costs. This study assessed the magnitude of comorbidity burden via epidemiology (incidence and p…
View article: Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years
Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years Open
Over a median of 1.6 and maximum of 5.6 years of exposure, safety/tolerability of FIL200 and FIL100 were similar, with a lower incidence of infections with FIL200 among the long-term, as-treated dataset.
View article: Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study
Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study Open
Treatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low …
View article: 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis
2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis Open
Objective To develop updated guidelines for the pharmacologic management of rheumatoid arthritis. Methods We developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic l…
View article: Long-term safety and efficacy of olokizumab in patients with rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitor therapy in phase II studies
Long-term safety and efficacy of olokizumab in patients with rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitor therapy in phase II studies Open
Objective: This study aimed to evaluate the long-term safety and efficacy of olokizumab (OKZ), an anti-interleukin (IL)-6 monoclonal antibody, in patients with rheumatoid arthritis (RA) and inadequate response to tumor necrosis factor-alph…
View article: Corrigendum to: Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials
Corrigendum to: Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials Open
In the originally published version of this manuscript, there were errors in the rate of latent TB reported for IXE PsA population. These errors have been corrected online. Specifically, the following changes have been made: The definition…
View article: Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs
Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs Open
Objective The long-term safety and efficacy of filgotinib (from phase II studies), with or without methotrexate (MTX), for the treatment of patients with rheumatoid arthritis was assessed in DARWIN 3, a long-term, open-label extension stud…
View article: Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial
Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial Open
View article: Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity
Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity Open
Rheumatoid arthritis (RA) is a systemic and incurable autoimmune disease characterized by chronic inflammation in synovial lining of joints. To identify the signaling pathways involved in RA, its disease activity, and treatment response, w…
View article: Phase II, randomised, double-blind, multicentre study evaluating the safety and efficacy of filgotinib and lanraplenib in patients with lupus membranous nephropathy
Phase II, randomised, double-blind, multicentre study evaluating the safety and efficacy of filgotinib and lanraplenib in patients with lupus membranous nephropathy Open
Objectives Patients with lupus membranous nephropathy (LMN) are at risk for prolonged proteinuria and progressive chronic kidney disease. There are no proven effective treatments for LMN, and controlled trials are lacking. This trial asses…
View article: Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods
Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods Open
Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in safety pro…
View article: Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials
Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials Open
View article: Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis
Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis Open
Aim This study, FKB327‐003, is a phase 3, open‐label extension (OLE) study comparing the long‐term immunogenicity of an adalimumab biosimilar, FKB327 (F), with the reference product (RP). Methods In the OLE, patients completing 24 weeks of…
View article: Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis
Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis Open
View article: Infections in baricitinib clinical trials for patients with active rheumatoid arthritis
Infections in baricitinib clinical trials for patients with active rheumatoid arthritis Open
Increased rates of treatment-emergent infections including HZ were observed in patients with RA treated with baricitinib, consistent with baricitinib's immunomodulatory mode of action.
View article: Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies
Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies Open
View article: THU0204 A SUBGROUP ANALYSIS OF LOW DISEASE ACTIVITY AND REMISSION FROM PHASE 3 STUDY OF FILGOTINIB IN PATIENTS WITH INADEQUATE RESPONSE TO BIOLOGIC DMARDS
THU0204 A SUBGROUP ANALYSIS OF LOW DISEASE ACTIVITY AND REMISSION FROM PHASE 3 STUDY OF FILGOTINIB IN PATIENTS WITH INADEQUATE RESPONSE TO BIOLOGIC DMARDS Open
View article: AB0802 SAFETY PROFILES OF IXEKIZUMAB VERSUS ADALIMUMAB: 52-WEEK RESULTS FROM A HEAD-TO-HEAD COMPARISON IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
AB0802 SAFETY PROFILES OF IXEKIZUMAB VERSUS ADALIMUMAB: 52-WEEK RESULTS FROM A HEAD-TO-HEAD COMPARISON IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS Open
View article: THU0167 ASSOCIATIONS BETWEEN RHEUMATOID ARTHRITIS DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN SARILUMAB CLINICAL TRIALS
THU0167 ASSOCIATIONS BETWEEN RHEUMATOID ARTHRITIS DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN SARILUMAB CLINICAL TRIALS Open