Explanipedia

Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjögren’s syndrome: a randomized, phase 2, double-blind, placebo-controlled study Open

Elizabeth Price, Stefano Bombardieri, Alan Kivitz, F. Matzkies, Oksana Gurtovaya , et al. · 2022

Objective The aim of this study was to characterize the safety and efficacy of filgotinib, lanraplenib and tirabrutinib in patients with active SS. Methods This multicentre, double-blind study randomized patients with active primary or sec…

Integrated safety analysis of filgotinib treatment for rheumatoid arthritis in patients from Japan over a median of 1.5 years Open

Naoki Ishiguro, Yoshiya Tanaka, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano , et al. · 2022

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…

Integrated safety analysis of filgotinib in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years Open

Kevin Winthrop, Yoshiya Tanaka, Tsutomu Takeuchi, Alan Kivitz, F. Matzkies , et al. · 2021

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.

Semi‐Mechanistic PK/PD Modeling and Simulation of Irreversible BTK Inhibition to Support Dose Selection of Tirabrutinib in Subjects with RA Open

Amy Meng, Rita Humeniuk, Juliane M. Jürgensmeier, Chia‐Hsiang Hsueh, F. Matzkies , et al. · 2021

Tirabrutinib is an irreversible, small‐molecule Bruton’s tyrosine kinase (BTK) inhibitor, which was approved in Japan (VELEXBRU) to treat B‐cell malignancies and is in clinical development for inflammatory diseases. As an application of mo…

Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study Open

Victoria P. Werth, Roy Fleischmann, Michael Robern, Zahi Touma, I. Tiamiyu , et al. · 2021

Objectives To explore the safety and efficacy of filgotinib (FIL), a Janus kinase 1 inhibitor, and lanraplenib (LANRA), a spleen kinase inhibitor, in cutaneous lupus erythematosus (CLE). Methods This was a phase 2, randomized, double-blind…

Efficacy and safety of filgotinib in combination with methotrexate in Japanese patients with active rheumatoid arthritis who have an inadequate response to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 1) Open

Yoshiya Tanaka, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano, Naoki Ishiguro , et al. · 2021

Objectives Evaluate the efficacy and safety of the Janus kinase-1 inhibitor filgotinib in Japanese patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX). Methods Data from 147 Japanese patients in FINCH 1, a…

P133 Filgotinib in patients with RA with inadequate response to methotrexate: FINCH 1 52-week efficacy and patient reported outcomes data Open

David Walker, Alan Kivitz, Yoshiya Tanaka, Susan Lee, Lei Ye , et al. · 2021

Background/Aims Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy, safety and patient reported outcome (PRO) data in patients (pts) with rheumatoid arthritis (RA) wi…

Characterization of the mechanism of action of lanraplenib, a novel spleen tyrosine kinase inhibitor, in models of lupus nephritis Open

Christopher W. Pohlmeyer, Ching Shang, Pei Han, Zhi-Hua Cui, Randall M. Jones , et al. · 2021

Background B cells are critical mediators of systemic lupus erythematosus (SLE) and lupus nephritis (LN), and antinuclear antibodies can be found in the serum of approximately 98% of patients with SLE. Spleen tyrosine kinase (SYK) is a non…

Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial Open

Bernard Combe, Alan Kivitz, Yoshiya Tanaka, Désirée van der Heijde, J. Simón , et al. · 2021

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial Open

René Westhovens, William F. C. Rigby, Désirée van der Heijde, D. W. T. CHING, William Stohl , et al. · 2021

Characterization of the Mechanism of Action of Lanraplenib, a Novel Spleen Tyrosine Kinase Inhibitor, in Models of Lupus Nephritis Open

Christopher W. Pohlmeyer, Ching Shang, Pei Han, Zhihua Cui, Randall M. Jones , et al. · 2021

Background B cells are critical mediators of systemic lupus erythematosus (SLE) and lupus nephritis (LN), and antinuclear antibodies can be found in the serum of approximately 98% of patients with SLE. Spleen tyrosine kinase (SYK) is a non…

Characterization of the Mechanism of Action of Lanraplenib, a Novel Spleen Tyrosine Kinase Inhibitor, in Models of Lupus Nephritis Open

Christopher W. Pohlmeyer, Ching Shang, Pei Han, Zhihua Cui, Randall M. Jones , et al. · 2020

Background B cells are critical mediators of systemic lupus erythematosus (SLE) and lupus nephritis (LN), and antinuclear antibodies can be found in the serum of approximately 98% of patients with SLE. Spleen tyrosine kinase (SYK) is a non…

SAT0158 EFFICACY AND SAFETY OF FILGOTINIB IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS: FINCH 3 52-WEEK RESULTS Open

René Westhovens, WFC Rigby, D. van der Heijde, Daniel Ching, William Stohl , et al. · 2020

THU0198 EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS WITH INADEQUATE RESPONSE TO METHOTREXATE: FINCH 1 52-WEEK RESULTS Open

Bernard Combe, A. Kivitz, Yoshiya Tanaka, D. van der Heijde, Jesus Abraham Simón Campos , et al. · 2020

THU0202 INTEGRATED SAFETY ANALYSIS OF FILGOTINIB TREATMENT FOR RHEUMATOID ARTHRITIS FROM 7 CLINICAL TRIALS Open

Mark C. Genovese, Kevin Winthrop, Yoshiya Tanaka, Tsutomu Takeuchi, Alan Kivitz , et al. · 2020

O09 Pooled safety analyses from Phase 3 studies of filgotinib in patients with RA Open

David Walker, Kevin Winthrop, Mark C. Genovese, Bernard Combe, Yoshiya Tanaka , et al. · 2020

Background Filgotinib (FIL) is an oral, selective janus kinase 1 inhibitor under development for the treatment of rheumatoid arthritis (RA) and other inflammatory diseases. Safety and efficacy of FIL was investigated in the FINCH clinical …

P210 Efficacy and safety of filgotinib for patients with RA with inadequate response to methotrexate: FINCH1 primary outcome results Open

David Walker, Bernard Combe, Alan J. Kivitiz, Yoshiya Tanaka, Désirée van der Heijde , et al. · 2020

Background Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 inhibitor that has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objective of this study was to evaluate efficacy and saf…

P217 Efficacy and safety of filgotinib for patients with RA naïve to MTX therapy: FINCH3 primary outcome results Open

Neil D McKay, Désirée van der Heijde, René Westhovens, William F. C. Rigby, D. W. T. CHING , et al. · 2020

Background Filgotinib (FIL), an orally administered, potent, selective inhibitor of janus kinase 1 (JAK1), has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objectives of this study were to comp…

Characterization of the Mechanism of Action of Lanraplenib, a Novel Spleen Tyrosine Kinase Inhibitor, in Models of Lupus Nephritis Open

Christopher W. Pohlmeyer, Ching Shang, Pei Han, Zhihua Cui, Randall M. Jones , et al. · 2020

Background B cells are critical mediators of systemic lupus erythematosus (SLE) and lupus nephritis (LN), and antinuclear antibodies can be found in the serum of approximately 98% of patients with SLE. Spleen tyrosine kinase (SYK) is a non…

Integrated safety analysis of filgotinib treatment for rheumatoid arthritis from seven clinical trials Open

Peter Nash, Edward V. Loftus, Mark C. Genovese, Kevin Winthrop, Yasushi Tanaka , et al. · 2020

Background and Aim: Filgotinib (FIL), an oral, potent, selective JAK‐1 inhibitor, provided statistically significant and clinically meaningful improvement in rheumatoid arthritis (RA) signs and symptoms, physical function, radiographic pro…

Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy Open

Mark C. Genovese, Kenneth Kalunian, Jacques‐Eric Gottenberg, Neelufar Mozaffarian, Beatrix Bartók , et al. · 2019

ClinicalTrials.gov Identifier: NCT02873936.

LB0003 EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS NAïVE TO METHOTREXATE THERAPY: FINCH3 PRIMARY OUTCOME RESULTS Open

René Westhovens, William F. C. Rigby, Désirée van der Heijde, Daniel Ching, Beatrix Bartók , et al. · 2019

FRI0154 SAFETY AND EFFICACY OF FILGOTINIB IN PATIENTS AGED 65 YEARS AND OLDER: RESULTS FROM A PHASE 3 STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGICAL DMARDS (BDMARD-IR) Open

Kenneth Kalunian, Jacques-Éric Gottenberg, Mark C. Genovese, Neelufar Mozaffarian, Beatrix Bartók , et al. · 2019

FRI0150 GS-9876, A NOVEL, HIGHLY SELECTIVE, SYK INHIBITOR IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: SAFETY, TOLERABILITY AND EFFICACY RESULTS OF A PHASE 2 STUDY Open

Alan Kivitz, Daksha Mehta, F. Matzkies, Afsaneh Mozaffarian, Rebecca Kunder , et al. · 2019

LB0001 EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS WITH INADEQUATE RESPONSE TO METHOTREXATE: FINCH1 PRIMARY OUTCOME RESULTS Open

Bernard Combe, Alan Kivitz, Yoshiya Tanaka, Désirée van der Heijde, F. Matzkies , et al. · 2019

FRI0092 SAFETY AND EFFICACY OF FILGOTINIB IN ACTIVE RHEUMATOID ARTHRITIS BY PRIOR BIOLOGICAL DMARD EXPOSURE IN PATIENTS WITH PRIOR INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGICAL DMARDS (BDMARD-IR) Open

Mark C. Genovese, Kenneth Kalunian, Jacques-Éric Gottenberg, Neelufar Mozaffarian, Beatrix Bartók , et al. · 2019

THU0173 FILGOTINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGICAL DMARDS (BDMARD-IR) BY RACE & GEOGRAPHIC REGION Open

Jacques-Éric Gottenberg, Mark C. Genovese, Kenneth Kalunian, Neelufar Mozaffarian, Beatrix Bartók , et al. · 2019

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