PMID- 36327094
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230920
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 10
IP  - 1
DP  - 2023 Feb
TI  - Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis 
      Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two 
      Trials.
PG  - 161-185
LID - 10.1007/s40744-022-00503-3 [doi]
AB  - 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 naive 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.
CI  - (c) 2022. The Author(s).
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AUID- ORCID: 0000-0002-0807-7139
AD  - The First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahata-Nishi, 
      Kitakyushu, 807-8555, Japan. tanaka@med.uoeh-u.ac.jp.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, 
      Hokkaido University, Hokkaido, Japan.
FAU - Aletaha, Daniel
AU  - Aletaha D
AD  - Medical University of Vienna, Vienna, Austria.
FAU - Bartok, Beatrix
AU  - Bartok B
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Pechonkina, Alena
AU  - Pechonkina A
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Han, Ling
AU  - Han L
AD  - Gilead Sciences, Inc., Foster City, CA, USA.
FAU - Emoto, Kahaku
AU  - Emoto K
AD  - Gilead Sciences K.K., Tokyo, Japan.
FAU - Kano, Shungo
AU  - Kano S
AD  - Gilead Sciences K.K., Tokyo, Japan.
FAU - Rajendran, Vijay
AU  - Rajendran V
AD  - Galapagos NV, Mechelen, Belgium.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine, Tokyo, Japan.
AD  - Saitama Medical University, Saitama, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02886728
SI  - ClinicalTrials.gov/NCT02889796
PT  - Journal Article
DEP - 20221103
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC9931963
OTO - NOTNLM
OT  - Adalimumab
OT  - Filgotinib
OT  - Methotrexate
OT  - Rheumatoid arthritis
EDAT- 2022/11/04 06:00
MHDA- 2022/11/04 06:01
PMCR- 2022/11/03
CRDT- 2022/11/03 12:24
PHST- 2022/08/05 00:00 [received]
PHST- 2022/10/11 00:00 [accepted]
PHST- 2022/11/04 06:00 [pubmed]
PHST- 2022/11/04 06:01 [medline]
PHST- 2022/11/03 12:24 [entrez]
PHST- 2022/11/03 00:00 [pmc-release]
AID - 10.1007/s40744-022-00503-3 [pii]
AID - 503 [pii]
AID - 10.1007/s40744-022-00503-3 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 
      2022 Nov 3.