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Mediterr J Rheumatol 2024;35(Suppl 1):1-9
Focus on Filgotinib in Rheumatoid Arthritis: A Trial-Based Review
Authors Information

1Department of Rheumatology, 4th Department of Internal Medicine, Hippokration Hospital, Thessaloniki, Greece

2School of Healthcare Sciences, Department of Midwifery, University of Western Macedonia, Kozani, Greece

Elpida Skouvaklidou, Dimitrios Deligeorgakis, Anastasia Skalkou, Vasileios Skepastianos, Konstantinos Tsafis, Evdokia Papadimitriou, Eleni Pagkopoulou, Paraskevi Avgerou, Maria G Mytilinaiou, Maria Tzitiridou-Chatzopoulou, Nikolaos Kougkas, Christina Adamichou

References
  1. Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M, O’Shea JJ. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov 2017 Dec 6;16(12):843–62.
  2. Morris R, Kershaw NJ, Babon JJ. The molecular details of cytokine signaling via the JAK/STAT pathway. Protein Science 2018 Dec 15;27(12):1984–2009.
  3. Pandolfi F, Franza L, Carusi V, Altamura S, Andriollo G, Nucera E. Interleukin-6 in Rheumatoid Arthritis. Int J Mol Sci 2020 Jul 23;21(15):5238.
  4. Fragoulis GE, Siebert S, McInnes IB. Therapeutic Targeting of IL-17 and IL-23 Cytokines in Immune-Mediated Diseases. Annu Rev Med 2016 Jan 14;67(1):337–53.
  5. Jyseleca | European Medicines Agency [Internet]. [cited 2023 Oct 29]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca
  6. Olumiant | European Medicines Agency [Internet]. [cited 2023 Oct 29]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/olumiant
  7. Xeljanz | European Medicines Agency [Internet]. [cited 2023 Oct 29]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xeljanz
  8. Rinvoq | European Medicines Agency [Internet]. [cited 2023 Oct 29]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq
  9. Traves PG, Murray B, Campigotto F, Galien R, Meng A, Di Paolo JA. JAK selectivity and the implications for clinical inhibition of pharmacodynamic cytokine signalling by FIL, upadacitinib, tofacitinib and baricitinib. Ann Rheum Dis 2021 Jul 1;80(7):865–75.
  10. Hernández-Cruz B, Kiltz U, Avouac J, Treuer T, Haladyj E, Gerwien J, et al. Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis. Rheumatol Ther 2023 Dec;10(6):1417-1457
  11. Braun J, Kiltz U, Baraliakos X. Management of Axial Spondyloarthritis – Insights into Upadacitinib. Drug Des Devel Ther 2022 Oct;Volume 16:3609–20.
  12. Westhovens R, Taylor PC, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, et al. FIL (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis 2017 Jun 1;76(6):998–1008.
  13. Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, et al. FIL versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis 2021 Jul 1;80(7):848–58.
  14. Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, et al. Efficacy and safety of FIL 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). Mod Rheumatol 2022 Feb 28;32(2):263–72.
  15. Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, et al. Effect of FIL vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy. JAMA 2019 Jul 23;322(4):315.
  16. Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, et al. FIL 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. Ann Rheum Dis 2021 Jun 1;80(6):727–38.
  17. Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko O V, Stanislavchuk M, et al. FIL (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis 2017 Jun 1;76(6):1009–19.
  18. Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, et al. Safety and Efficacy of FIL: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol 2021 Aug 1;48(8):1230–8.
  19. Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, et al. Safety and efficacy of FIL for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results. Mod Rheumatol 2023 Jul 4;33(4):668–79.
  20. Winthrop KL, Tanaka Y, Takeuchi T, Kivitz A, Matzkies F, Genovese MC, et al. Integrated safety analysis of FIL in patients with moderately to severely active rheumatoid arthritis receiving treatment over a median of 1.6 years. Ann Rheum Dis 2022 Feb 1;81(2):184–92.
  21. van der Heijde D, Baraliakos X, Gensler LS, Maksymowych WP, Tseluyko V, Nadashkevich O, et al. Efficacy and safety of FIL, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. Lancet 2018 Dec 1;392(10162):2378–87.
  22. Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, et al. Efficacy and safety of FIL, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet 2018 Dec 1;392(10162):2367–77.
  23. Stene R. Efficacy and Safety Outcomes Up to ~4 Years of Treatment With FIL 200 mg Among Patients With Ulcerative Colitis: Results From the SELECTIONLTE Study. Gastroenterol Hepatol (N Y) 2023 Apr;19(4 Suppl 1):10–1.
  24. Schreiber S, Feagan BG, Peyrin-Biroulet L, Vermeire S, Faes M, Harris K, et al. FIL Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial. J Crohns Colitis 2023 Jun 16;17(6):863–75.
  25. D’Haens GR, Lee S, Taylor SA, Serone A, Rimola J, Colombel JF, et al. FIL for the Treatment of Small Bowel Crohn’s Disease: The DIVERGENCE 1 Trial. Gastroenterology 2023 Jul 1;165(1):289-292.e3.
  26. Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, et al. Clinical remission in patients with moderate-to-severe Crohn’s disease treated with FIL (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet 2017 Jan 21;389(10066):266–75.