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Article: Correction: Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study.

Combe, Bernard G / Tanaka, Yoshiya / Buch, Maya H / Nash, Peter / Burmester, Gerd R / Kivitz, Alan J / Bartok, Beatrix / Pechonkina, Alena / Xia, Katrina / Emoto, Kahaku / Kano, Shungo / Hendrikx, Thijs K / Landewé, Robert B M / Aletaha, Daniel

Rheumatology and therapy

2023 Volume 10, Issue 1, Page(s) 71–72

Language	English
Publishing date	2023-01-05
Publishing country	England
Document type	Published Erratum
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-022-00530-0
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials.

Tanaka, Yoshiya / Atsumi, Tatsuya / Aletaha, Daniel / Bartok, Beatrix / Pechonkina, Alena / Han, Ling / Emoto, Kahaku / Kano, Shungo / Rajendran, Vijay / Takeuchi, Tsutomu

Rheumatology and therapy

2022 Volume 10, Issue 1, Page(s) 161–185

Abstract: Introduction: We conducted a post hoc analysis of efficacy and safety of filgotinib stratified by estimated radiographic progression rate before baseline (BL) in patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate (MTX; ... ...

Abstract	Introduction: We conducted a post hoc analysis of efficacy and safety of filgotinib stratified by estimated radiographic progression rate before baseline (BL) in patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate (MTX; FINCH 1; NCT02889796) or were naïve to it (FINCH 3; NCT02886728). Methods: Radiographic progression rate was BL-Modified Total Sharp Score (mTSS) divided by RA duration (BL mTSS/year); estimated rapid radiographic progression (e-RRP) was BL change in mTSS/year ≥ 5; and estimated nonrapid radiographic progression (e-NRRP) was BL mTSS/year < 5. Efficacy and safety were compared between subgroups. All p-values are nominal. Results: In FINCH 1 and FINCH 3, 558/1755 (31.8%) and 787/1249 (63.0%) patients, respectively, had BL e-RRP. BL characteristics were generally similar between subgroups within each trial. At week (W) 24, in FINCH 1, proportions achieving a Disease Activity Score 28 for rheumatoid arthritis with C-reactive protein < 2.6 were significantly greater with filgotinib 200 (FIL200) and 100 mg (FIL100) versus placebo among e-RRP and e-NRRP subgroups. In each study, proportions of FIL-treated patients achieving Clinical Disease Activity Index ≤ 2.8 and Simple Disease Activity Index ≤ 3.3 were similar between subgroups. In FINCH 3, disease activity measures were at least numerically improved among patients receiving FIL versus MTX monotherapy. At W24, mTSS changes from BL (CFB) were greater among patients with e-RRP in FINCH 1 and FINCH 3 versus e-NRRP (0.81 versus 0.19, p = 0.001; 0.67 versus 0.25, p = 0.31, respectively). At W52, in FINCH 1, mTSS CFBs were smaller among e-RRP patients treated with FIL200 (0.40; p < 0.001) and FIL100 (0.77; p = 0.024) versus adalimumab (ADA; 1.46). In FINCH 3 at W52, mTSS CFBs were significantly smaller with FIL200 versus MTX among e-RRP patients. Rates of treatment-emergent adverse events (AEs) were comparable between subgroups and across treatment arms. Conclusions: Patients with previous e-RRP who received standard care tended to progress radiographically. FIL200 demonstrated persistent, consistent benefit for disease activity control among e-RRP and e-NRRP subgroups, and AE profiles were similar between subgroups. Although filgotinib efficacy was somewhat reduced among patients with e-RRP, filgotinib treatment slowed radiographic progression in both subgroups. Trial registration: Clinicaltrials.gov NCT02889796, NCT02886728.
Language	English
Publishing date	2022-11-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-022-00503-3
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Article: Efficacy and Safety of Filgotinib in Patients with High Risk of Poor Prognosis Who Showed Inadequate Response to MTX: A Post Hoc Analysis of the FINCH 1 Study.

Rheumatology and therapy

2022 Volume 10, Issue 1, Page(s) 53–70

Abstract: Introduction: This exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic ... ...

Abstract	Introduction: This exploratory analysis of FINCH 1 (NCT02889796) examined filgotinib (FIL) efficacy and safety in a subgroup of patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX; MTX-IR) who had four poor prognostic factors (PPFs). Methods: Patients with MTX-IR received placebo up to week (W)24 or FIL200 mg, FIL100 mg, or adalimumab up to W52; all received MTX. Efficacy and safety data were stratified by four PPFs versus fewer than four PPFs: seropositivity, high-sensitivity C-reactive protein (CRP) ≥ 6 mg/L, Disease Activity Score in 28 joints with CRP > 5.1, and erosions on X-rays. Results: At baseline, 687/1755 patients had four PPFs. At W12, whether with four PPFs or fewer than four PPFs, response rates on all American College of Rheumatology (ACR) measures were significantly greater with FIL200 and FIL100 versus placebo. At W52, FIL200 ACR20/50/70 response rates remained at least numerically higher versus adalimumab in both subgroups. At W52, FIL200 reduced modified total Sharp score (mTSS) change versus adalimumab in patients with four or fewer than four PPFs. Conclusions: In high-risk (four PPFs) patients with MTX-IR RA, FIL200 and FIL100 showed similar reductions in disease activity versus placebo at W12 as in patients with fewer than four PPFs. mTSS in patients receiving FIL200 changed little from W24 to W52, while that in patients receiving FIL100 progressed comparably to patients who received adalimumab. Tolerability was comparable across treatment arms and subgroups.
Language	English
Publishing date	2022-10-09
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-022-00498-x
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Article ; Online: Exposure-response relationships for the efficacy and safety of filgotinib and its metabolite GS-829845 in subjects with rheumatoid arthritis based on phase 2 and phase 3 studies.

Meng, Amy / Anderson, Kacey / Nelson, Cara / Ni, Liyun / Chuang, Shu-Min / Bellanti, Francesco / Chang, Peter / Comisar, Craig / Kearney, Brian P / Bartok, Beatrix / Mathias, Anita

British journal of clinical pharmacology

2022 Volume 88, Issue 7, Page(s) 3211–3221

Abstract: Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in ... ...

Abstract	Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in moderate to severe RA patients. Methods: The pharmacokinetic exposures used in ER analyses were derived from population pharmacokinetic analysis. The exposure-efficacy relationships were assessed for efficacy endpoints (ACR20/50/70 and DAS28) over effective area under curve (AUC Results: The nonlinear logistic regression showed increasing response with increasing exposure, with exposures at 200 mg dose primarily residing on the curve plateau. Also, AUC Conclusions: ER analyses confirmed that filgotinib produced more robust therapeutic effects across the exposure range observed at 200 mg once daily compared to lower doses, and collectively with the lack of exposure-safety relationship, the 200 mg once daily dose was supported for commercialization.
MeSH term(s)	Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Janus Kinase Inhibitors/adverse effects ; Pyridines/adverse effects ; Treatment Outcome ; Triazoles/adverse effects
Chemical Substances	Antirheumatic Agents ; GLPG0634 ; Janus Kinase Inhibitors ; Pyridines ; Triazoles
Language	English
Publishing date	2022-02-14
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15239
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Article ; Online: Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors

René Westhovens / Thijs Hendrikx / Beatrix Bartok / Cécile Gaujoux-Viala / Giovanni Adami / Zhaoyu Yin / Ying Guo / Osvaldo Daniel Messina / Alan Matsumoto

RMD Open, Vol 7, Iss

post hoc analysis of FINCH 3

2021 Volume 2

Abstract: Objective This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).Methods This was a ... ...

Abstract	Objective This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).Methods This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population.Results Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed.Conclusion FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2021-07-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
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Article ; Online: Development of anti-CD20 therapy for multiple sclerosis.

Bartok, Beatrix / Silverman, Gregg J

Experimental cell research

2011 Volume 317, Issue 9, Page(s) 1312–1318

Abstract: The therapeutic utility of the targeting of B lymphocytes is currently being evaluated in a range of autoimmune diseases that include multiple sclerosis (MS). For MS, even though intrathecal immunoglobulin production is a hallmark of multiple sclerosis ( ... ...

Abstract	The therapeutic utility of the targeting of B lymphocytes is currently being evaluated in a range of autoimmune diseases that include multiple sclerosis (MS). For MS, even though intrathecal immunoglobulin production is a hallmark of multiple sclerosis (MS), T cells have long been considered as the main effectors of pathogenesis. Recognition of the roles of autoreactive B cells has changed this conventional view of the disease and also provided a rationale for studies of anti-CD20 therapy in MS. Recent trials suggest that this approach may provide clinical benefits in some MS patients that equal or surpass currently approved approaches, yet not all patients may benefit. In this review we provide an overview on recent progress on these trials.
MeSH term(s)	Animals ; Antibodies/immunology ; Antibodies/therapeutic use ; Antibodies, Monoclonal, Murine-Derived/immunology ; Antibodies, Monoclonal, Murine-Derived/therapeutic use ; Antigens, CD20/immunology ; B-Lymphocytes/immunology ; Clinical Trials as Topic ; Humans ; Multiple Sclerosis/drug therapy ; Multiple Sclerosis/immunology ; Rituximab
Chemical Substances	Antibodies ; Antibodies, Monoclonal, Murine-Derived ; Antigens, CD20 ; Rituximab (4F4X42SYQ6)
Language	English
Publishing date	2011-04-12
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1493-x
ISSN	1090-2422 ; 0014-4827
ISSN (online)	1090-2422
ISSN	0014-4827
DOI	10.1016/j.yexcr.2011.04.002
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Article ; Online: Integrated Safety Analysis of Filgotinib Treatment for Rheumatoid Arthritis in Patients from Japan Over a Median of 1.5 Years.

Modern rheumatology

2022

Abstract: Objective: Characterize safety of the Janus kinase-1 preferential inhibitor filgotinib in Japanese patients with moderately to severely active rheumatoid arthritis.: Methods: Data from three Phase 3 trials (NCT02889796, NCT02873936, NCT02886728) and ... ...

Abstract	Objective: Characterize safety of the Janus kinase-1 preferential inhibitor filgotinib in Japanese patients with moderately to severely active rheumatoid arthritis. Methods: Data from three Phase 3 trials (NCT02889796, NCT02873936, NCT02886728) and a long-term extension (NCT03025308) through September 2019 were integrated; patients received ≥1 dose of filgotinib 200 (FIL200) or 100 mg (FIL100) daily, or placebo (PBO). We calculated exposure-adjusted incidence rates (EAIRs) per 100 patient-years filgotinib exposure (100PYE) for treatment-emergent adverse events (TEAEs) and adverse events of special interest. Results: Among 3691 total patients and 6080.7 PYE, 229 Japanese patients received filgotinib for 311.4 PYE (median 1.5, maximum 2.5 years). During the 12-week PBO-controlled period, serious TEAEs and TEAEs leading to study drug disruption were comparable between filgotinib and PBO. Serious infection rates were 1.9%, 0%, and 2% for FIL200, FIL100, and PBO during the PBO-controlled period; long-term FIL200 and FIL100 EAIRs were 3.8 and 2.1/100PYE. No herpes zoster or major adverse cardiovascular events (MACE) occurred during the PBO-controlled period; long-term FIL200 and FIL100 EAIRs were 3.0 and 2.1/100PYE (herpes zoster) and 0.6 and 0/100PYE (MACE). Conclusion: Long-term filgotinib treatment (median 1.5, maximum 2.5 years exposure) was well tolerated at 100- and 200-mg doses in Japanese patients with rheumatoid arthritis.
Language	English
Publishing date	2022-04-02
Publishing country	England
Document type	Journal Article
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1093/mr/roac020
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Article ; Online: Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3).

Atsumi, Tatsuya / Tanaka, Yoshiya / Matsubara, Tsukasa / Amano, Koichi / Ishiguro, Naoki / Sugiyama, Eiji / Yamaoka, Kunihiro / Westhovens, René / Ching, Daniel W T / Messina, Osvaldo Daniel / Burmester, Gerd R / Genovese, Mark / Bartok, Beatrix / Pechonkina, Alena / Kondo, Akira / Yin, Zhaoyu / Gong, Qi / Tasset, Chantal / Takeuchi, Tsutomu

Modern rheumatology

2022 Volume 33, Issue 4, Page(s) 657–667

Abstract: Objectives: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised- ... ...

Abstract	Objectives: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020. Methods: Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added. Results: Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained. Conclusions: In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events.
MeSH term(s)	Animals ; Humans ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; East Asian People ; Methotrexate/adverse effects ; Treatment Outcome
Chemical Substances	Antirheumatic Agents ; GLPG0634 ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2022-07-28
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2078157-X
ISSN	1439-7609 ; 1439-7595
ISSN (online)	1439-7609
ISSN	1439-7595
DOI	10.1093/mr/roac083
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Article ; Online: Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3.

Aletaha, Daniel / Westhovens, René / Gaujoux-Viala, Cecile / Adami, Giovanni / Matsumoto, Alan / Bird, Paul / Messina, Osvaldo Daniel / Buch, Maya H / Bartok, Beatrix / Yin, Zhaoyu / Guo, Ying / Hendrikx, Thijs / Burmester, Gerd R

RMD open

2021 Volume 7, Issue 2

Abstract: Objective: This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).: Methods: This ...

Abstract	Objective: This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs). Methods: This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population. Results: Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed. Conclusion: FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.
MeSH term(s)	Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Drug Therapy, Combination ; Humans ; Methotrexate/adverse effects ; Prognosis ; Pyridines ; Treatment Outcome ; Triazoles
Chemical Substances	Antirheumatic Agents ; GLPG0634 ; Pyridines ; Triazoles ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2021-08-12
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2812592-7
ISSN	2056-5933 ; 2056-5933
ISSN (online)	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2021-001621
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Article ; Online: Fibroblast-like synoviocytes: key effector cells in rheumatoid arthritis.

Bartok, Beatrix / Firestein, Gary S

Immunological reviews

2010 Volume 233, Issue 1, Page(s) 233–255

Abstract: Rheumatoid arthritis (RA) remains a significant unmet medical need despite significant therapeutic advances. The pathogenesis of RA is complex and includes many cell types, including T cells, B cells, and macrophages. Fibroblast-like synoviocytes (FLS) ... ...

Abstract	Rheumatoid arthritis (RA) remains a significant unmet medical need despite significant therapeutic advances. The pathogenesis of RA is complex and includes many cell types, including T cells, B cells, and macrophages. Fibroblast-like synoviocytes (FLS) in the synovial intimal lining also play a key role by producing cytokines that perpetuate inflammation and proteases that contribute to cartilage destruction. Rheumatoid FLS develop a unique aggressive phenotype that increases invasiveness into the extracellular matrix and further exacerbates joint damage. Recent advances in understanding the biology of FLS, including their regulation regulate innate immune responses and activation of intracellular signaling mechanisms that control their behavior, provide novel insights into disease mechanisms. New agents that target FLS could potentially complement the current therapies without major deleterious effect on adaptive immune responses.
MeSH term(s)	Adaptive Immunity ; Animals ; Apoptosis ; Arthritis, Rheumatoid/immunology ; Arthritis, Rheumatoid/pathology ; Arthritis, Rheumatoid/therapy ; Cartilage, Articular/immunology ; Cartilage, Articular/pathology ; Cytokines/immunology ; Fibroblasts/immunology ; Fibroblasts/pathology ; Humans ; Hyperplasia ; Immunity, Innate ; Inflammation Mediators/immunology ; Phenotype ; Signal Transduction/immunology ; Synovial Membrane/immunology ; Synovial Membrane/pathology
Chemical Substances	Cytokines ; Inflammation Mediators
Language	English
Publishing date	2010-02-25
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	391796-4
ISSN	1600-065X ; 0105-2896
ISSN (online)	1600-065X
ISSN	0105-2896
DOI	10.1111/j.0105-2896.2009.00859.x
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