Sprifermin: a recombinant human fibroblast growth factor 18 for the treatment of knee osteoarthritis

References

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019;393(10182):1745–1759.
   PubMed Web of Science ®Google Scholar
• Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021;384:51–59.
   PubMed Web of Science ®Google Scholar
• Li J, Zhu Z, Li Y, et al. Qualitative and quantitative measures of prefemoral and quadriceps fat pads are associated with incident radiographic osteoarthritis: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2020;28(4):453–461.
   PubMed Web of Science ®Google Scholar
• Zhu Z, Li J, Ruan G, et al. Investigational drugs for the treatment of osteoarthritis, an update on recent developments. Expert Opin Investig Drugs. 2018;27(11):881–900.
   PubMed Web of Science ®Google Scholar
• Hermann W, Lambova S, Muller-Ladner U, et al. Current Treatment Options for Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):108–116.
   PubMed Web of Science ®Google Scholar
• Armiento AR, Stoddart MJ, Alini M, et al. Biomaterials for articular cartilage tissue engineering: learning from biology. Acta Biomater. 2018;65:1–20.
   PubMed Web of Science ®Google Scholar
• Correa D, Lietman SA. Articular cartilage repair: current needs, methods and research directions. Semin Cell Dev Biol. 2017;62:67–77.
   PubMed Web of Science ®Google Scholar
• Sprifermin - Merck. Adis Insight. Switzerland AG: Springer Nature.
   Google Scholar
• Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27:1578–1589.
   PubMed Web of Science ®Google Scholar
• Kolasinski SL, Neogi T, Hochberg MC, et al. American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2019;2020(72):149–162.
   Google Scholar
• Bruyère O, Altman RD, Reginster JY, et al. Efficacy and safety of glucosamine sulfate in the management of osteoarthritis: evidence from real-life setting trials and surveys. Semin Arthritis Rheum. 2016;45:S12–17.
   PubMed Web of Science ®Google Scholar
• Cai X, Yuan S, Zeng Y, et al. New Trends in Pharmacological Treatments for Osteoarthritis. Front Pharmacol. 2021;12:645842.
   PubMed Web of Science ®Google Scholar
• Latourte A, Kloppenburg M, Richette P, et al. Emerging pharmaceutical therapies for osteoarthritis. Nat Rev Rheumatol. 2020;16:673–688.
   PubMed Web of Science ®Google Scholar
• Ohbayashi N, Hoshikawa M, Kimura S, et al. Structure and expression of the mRNA encoding a novel fibroblast growth factor, FGF-18. J Biol Chem. 1998;273(29): 18161–18164.
   PubMed Web of Science ®Google Scholar
• Whitmore TE, Maurer MF, Sexson S, et al. Assignment of fibroblast growth factor 18 (FGF18) to human chromosome 5q34 by use of radiation hybrid mapping and fluorescence in situ hybridization. Cytogenet Cell Genet. 2000;90:231–233.
   PubMedGoogle Scholar
• Ornitz DM, Itoh N. Fibroblast growth factors. Genome Biol. 2001;2(3):3005. Reviews.
   Web of Science ®Google Scholar
• Katoh M, Katoh M. Comparative genomics on FGF8, FGF17, and FGF18 orthologs. Int J Mol Med. 2005;16:493–496.
   PubMed Web of Science ®Google Scholar
• Greco V, Chen T, Rendl M, et al. A two-step mechanism for stem cell activation during hair regeneration. Cell Stem Cell. 2009;4(2):155–169.
   PubMed Web of Science ®Google Scholar
• Hasegawa H, Ashigaki S, Takamatsu M, et al. Laminar patterning in the developing neocortex by temporally coordinated fibroblast growth factor signaling. J Neurosci. 2004;24:8711–8719.
   PubMed Web of Science ®Google Scholar
• Ishibe T, Nakayama T, Okamoto T, et al. Disruption of fibroblast growth factor signal pathway inhibits the growth of synovial sarcomas: potential application of signal inhibitors to molecular target therapy. Clin Cancer Res. 2005;11(7):2702–2712.
   PubMed Web of Science ®Google Scholar
• Long F, Ornitz DM. Development of the endochondral skeleton. Cold Spring Harb Perspect Biol. 2013;5(1):a008334.
   PubMed Web of Science ®Google Scholar
• Song L, Huang Z, Chen Y, et al. High-efficiency production of bioactive recombinant human fibroblast growth factor 18 in Escherichia coli and its effects on hair follicle growth. Appl Microbiol Biotechnol. 2014;98(2):695–704.
   PubMed Web of Science ®Google Scholar
• Dong X, Tang B, Li J, et al. Expression and purification of intact and functional soybean (Glycine max) seed ferritin complex in Escherichia coli. J Microbiol Biotechnol. 2008;18:299–307.
   PubMed Web of Science ®Google Scholar
• Park SY, Binkley RM, Kim WJ, et al. Metabolic engineering of Escherichia coli for high-level astaxanthin production with high productivity. Metab Eng. 2018;49:105–115.
   PubMed Web of Science ®Google Scholar
• Gigout A, Guehring H, Froemel D, et al. Sprifermin (rhFGF18) enables proliferation of chondrocytes producing a hyaline cartilage matrix. Osteoarthritis Cartilage. 2017;25(11):1858–1867.
   PubMed Web of Science ®Google Scholar
• Mori Y, Saito T, Chang SH, et al. Identification of fibroblast growth factor-18 as a molecule to protect adult articular cartilage by gene expression profiling. J Biol Chem. 2014;289(14):10192–10200.
   PubMed Web of Science ®Google Scholar
• Xie Y, Zinkle A, Chen L, et al. Fibroblast growth factor signalling in osteoarthritis and cartilage repair. Nat Rev Rheumatol. 2020;16(10):547–564.
   PubMed Web of Science ®Google Scholar
• Ellman MB, Yan D, Ahmadinia K, et al. Fibroblast growth factor control of cartilage homeostasis. J Cell Biochem. 2013;114(4):735–742.
   PubMed Web of Science ®Google Scholar
• Yan D, Chen D, Cool SM, et al. Fibroblast growth factor receptor 1 is principally responsible for fibroblast growth factor 2-induced catabolic activities in human articular chondrocytes. Arthritis Res Ther. 2011;13(4):R130.
   PubMed Web of Science ®Google Scholar
• Wang XB, Zhao FC, Yi LH, et al. MicroRNA-21-5p as a novel therapeutic target for osteoarthritis. Rheumatology (Oxford). 2019. DOI:https://doi.org/10.1093/rheumatology/kez102.
   Google Scholar
• Makower AM, Wroblewski J, Pawlowski A, et al. Effects of IGF-I, rGH, FGF, EGF and NCS on DNA-synthesis, cell proliferation and morphology of chondrocytes isolated from rat rib growth cartilage. Cell Biol Int Rep. 1989;13(3):259–270.
   PubMedGoogle Scholar
• Sieber S, Gigout A. Sprifermin (recombinant human FGF18) is internalized through clathrin- and dynamin-independent pathways and degraded in primary chondrocytes. Exp Cell Res. 2020;395(2):112236.
   PubMed Web of Science ®Google Scholar
• Behr B, Sorkin M, Manu A, et al. Fgf-18 Is Required for Osteogenesis But Not Angiogenesis During Long Bone Repair. Tissue Eng Part A. 2011;17(15–16):2061–2069.
   PubMed Web of Science ®Google Scholar
• Ellsworth JL, Berry J, Bukowski T, et al. Fibroblast growth factor-18 is a trophic factor for mature chondrocytes and their progenitors. Osteoarthritis Cartilage. 2002;10(4):308–320.
   PubMed Web of Science ®Google Scholar
• Moore EE, Bendele AM, Thompson DL, et al. Fibroblast growth factor-18 stimulates chondrogenesis and cartilage repair in a rat model of injury-induced osteoarthritis. Osteoarthritis Cartilage. 2005;13(7): 623–631.
   PubMed Web of Science ®Google Scholar
• Reker D, Kjelgaard-Petersen CF, Siebuhr AS, et al. Sprifermin (rhFGF18) modulates extracellular matrix turnover in cartilage explants ex vivo. J Transl Med. 2017;15(1):250.
   PubMedGoogle Scholar
• Meloni GR, Farran A, Mohanraj B, et al. Recombinant human FGF18 preserves depth-dependent mechanical inhomogeneity in articular cartilage. Eur Cell Mater. 2019;38:23–34.
   PubMed Web of Science ®Google Scholar
• Sennett ML, Meloni GR, Farran AJE, et al. Sprifermin treatment enhances cartilage integration in an in vitro repair model. J Orthop Res. 2018;36:2648–2656.
   PubMed Web of Science ®Google Scholar
• Hendesi H, Stewart S, Gibison ML, et al. Recombinant fibroblast growth factor-18 (sprifermin) enhances microfracture-induced cartilage healing. J Orthop Res. 2021. DOI:https://doi.org/10.1002/jor.25063.
   Google Scholar
• Dahlberg LE, Aydemir A, Muurahainen N, et al. A first-in-human, double-blind, randomised, placebo-controlled, dose ascending study of intra-articular rhFGF18 (sprifermin) in patients with advanced knee osteoarthritis. Clin Exp Rheumatol. 2016;34:445–450.
   PubMed Web of Science ®Google Scholar
• Lohmander LS, Hellot S, Dreher D, et al. Intraarticular sprifermin (recombinant human fibroblast growth factor 18) in knee osteoarthritis: a randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2014;66:1820–1831.
   PubMed Web of Science ®Google Scholar
• Eckstein F, Wirth W, Guermazi A, et al. Brief report: intraarticular sprifermin not only increases cartilage thickness, but also reduces cartilage loss: location-independent post hoc analysis using magnetic resonance imaging. Arthritis Rheumatol. 2015;67(11):2916–2922.
   PubMed Web of Science ®Google Scholar
• Brett A, Bowes MA, Conaghan PG, et al. Automated MRI assessment confirms cartilage thickness modification in patients with knee osteoarthritis: post-hoc analysis from a phase II sprifermin study. Osteoarthritis Cartilage. 2020;28(11):1432–1436.
   PubMed Web of Science ®Google Scholar
• Hochberg MC, Guermazi A, Guehring H, et al. Effect of Intra-Articular Sprifermin vs Placebo on Femorotibial Joint Cartilage Thickness in Patients With Osteoarthritis: the FORWARD Randomized Clinical Trial. Jama. 2019;322(14): 1360–1370.
   PubMed Web of Science ®Google Scholar
• Eckstein F, Kraines JL, Aydemir A, et al. Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial. Ann Rheum Dis. 2020;79(4):525–528.
   PubMed Web of Science ®Google Scholar
• Roemer FW, Kraines J, Aydemir A, et al. Evaluating the structural effects of intra-articular sprifermin on cartilage and non-cartilaginous tissue alterations, based on sqMRI assessment over 2 years. Osteoarthritis Cartilage. 2020;28(9):1229–1234.
   PubMed Web of Science ®Google Scholar
• Guehring H, Kraines J, Moreau F, et al. Cartilage Thickness Modification with Sprifermin in Knee Osteoarthritis Patients Translates into Symptomatic Improvement over Placebo in Patients at Risk of Further Structural and Symptomatic Progression: post-Hoc Analysis of a Phase II Trial [abstract]. Arthritis Rheumatol. 2019;71 (suppl 10).
   Web of Science ®Google Scholar
• Eckstein F, Hochberg MC, Guehring H, et al. Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study. Ann Rheum Dis. 2021. DOI:https://doi.org/10.1136/annrheumdis-2020-219181.
   Google Scholar
• Zeng N, Chen XY, Yan ZP, et al. Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis. Arthritis Res Ther. 2021;23:107.
   PubMed Web of Science ®Google Scholar
• Eckstein F, Hochberg M, Kraines J, et al. Long-term efficacy and safety of intra-articular sprifermin in patients with knee osteoarthritis: results from the 5-year forward study. Osteoarthritis Cartilage. 2020;28:S77–S78.
   Web of Science ®Google Scholar
• Van Spil WE, Kubassova O, Boesen M, et al. Osteoarthritis phenotypes and novel therapeutic targets. Biochem Pharmacol. 2019;165:41–48.
   PubMed Web of Science ®Google Scholar
• McAlindon TE, LaValley MP, Harvey WF, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: a Randomized Clinical Trial. Jama. 2017;317(19):1967–1975.
   PubMed Web of Science ®Google Scholar
• Bacon K, LaValley MP, Jafarzadeh SR, et al. Does cartilage loss cause pain in osteoarthritis and if so, how much? Ann Rheum Dis. 2020;79(8):1105–1110.
   PubMed Web of Science ®Google Scholar