Intraarticular sprifermin (recombinant human fibroblast growth factor 18) in knee osteoarthritis: A randomized, double-blind, placebo-controlled trial

Arthritis and Rheumatology

Volumn 66, Issue 7, 2014, Pages 1820-1831

  Lohmander, L Stefan ^a,g   Hellot, Scarlett ^b,i   Dreher, Don ^c   Krantz, Eduard F W ^d   Kruger, Dawie S ^d,j   Guermazi, Ali ^e   Eckstein, Felix ^f,h  

^a LUND UNIVERSITY HOSPITAL   (Sweden)

^b MERCK SERONO S A   (Switzerland)

^c Totzke and Dreher Scientific SA   (Switzerland)

^d PAREXEL INTERNATIONAL   (United States)

^e BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f PARACELSUS MEDICAL UNIVERSITY   (Austria)

^g UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^h Chondrometrics   (Germany)

ⁱ SEA Stats Consulting   (France)

^j GVI Oncology   (South Africa)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SPRIFERMIN;

ADULT; ADVERSE OUTCOME; AGED; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; HEADACHE; HUMAN; INCIDENCE; INFECTION; INFLAMMATION; INJECTION SITE PAIN; JOINT CAVITY; JOINT SWELLING; KNEE OSTEOARTHRITIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCORING SYSTEM; SYNOVITIS; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX;

AGED; CARTILAGE, ARTICULAR; DOUBLE-BLIND METHOD; FEMALE; FIBROBLAST GROWTH FACTORS; HUMANS; INJECTIONS, INTRA-ARTICULAR; KNEE JOINT; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE; PLACEBOS; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 84903455882     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.38614     Document Type: Article

References (49)

1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2163-96.
2. Felson DT,. Developments in the clinical understanding of osteoarthritis. Arthritis Res Ther 2009; 11: 203.
3. Losina E, Weinstein AM, Reichmann WM, Burbine SA, Solomon DH, Daigle ME, et al. Lifetime risk and age at diagnosis of symptomatic knee osteoarthritis in the US. Arthritis Care Res (Hoboken) 2013; 65: 703-11.
4. Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, et al. OARSI recommendations for the management of hip and knee osteoarthritis. Part III. Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010; 18: 476-99.
5. Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken) 2012; 64: 465-74.
6. Dougados M, Nguyen M, Berdah L, Mazieres B, Vignon E, Lequesne M, for the ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Arthritis Rheum 2001; 44: 2539-47.
7. Reginster JY, Deroisy R, Rovati LC, Lee RL, Lejeune E, Bruyere O, et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomised, placebo-controlled clinical trial. Lancet 2001; 357: 251-6.
8. Pavelka K, Gatterova J, Olejarova M, Machacek S, Giacovelli G, Rovati LC,. Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3-year, randomized, placebo-controlled, double-blind study. Arch Intern Med 2002; 162: 2113-23.
9. Brandt KD, Mazzuca SA, Katz BP, Lane KA, Buckwalter KA, Yocum DE, et al. Effects of doxycycline on progression of osteoarthritis: results of a randomized, placebo-controlled, double-blind trial. Arthritis Rheum 2005; 52: 2015-25.
10. Bingham CO III, Buckland-Wright JC, Garnero P, Cohen SB, Dougados M, Adami S, et al. Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: results of the two-year multinational Knee Osteoarthritis Structural Arthritis study. Arthritis Rheum 2006; 54: 3494-507.
11. Kahan A, Uebelhart D, De Vathaire F, Delmas PD, Reginster JY,. Long-term effects of chondroitins 4 and 6 sulfate on knee osteoarthritis: the Study on Osteoarthritis Progression Prevention, a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2009; 60: 524-33.
12. Reginster JY, Badurski J, Bellamy N, Chapuriat R, Chevalier X, Christiansen C, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial. Ann Rheum Dis 2013; 72: 179-86.
13. Hellio le, Graverand MP, Clemmer RS, Redifer P, Brunell RM, Hayes CW, Brandt KD, et al. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis 2013; 72: 187-95.
14. Hunter DJ,. Pharmacologic therapy for osteoarthritis-the era of disease modification. Nat Rev Rheumatol 2011; 7: 13-22.
15. Ellsworth JL, Berry J, Bukowski T, Claus J, Feldhaus A, Holderman S, et al. Fibroblast growth factor-18 is a trophic factor for mature chondrocytes and their progenitors. Osteoarthritis Cartilage 2002; 10: 308-20.
16. Moore EE, Bendele AM, Thompson DL, Littau A, Waggie KS, Reardon B, et al. Fibroblast growth factor-18 stimulates chondrogenesis and cartilage repair in a rat model of injury-induced osteoarthritis. Osteoarthritis Cartilage 2005; 13: 623-31.
17. Gigout A, Lindemann S, Guehring H,. Intermittent but not continuous exposure to recombinant human fibroblast growth factor-18 (rhFGF18) promotes chondrocyte anabolism and phenotype in 3D culture [abstract]. Cartilage 2012; 3: 167.
18. Gigout A, Werkmann D, Lindemann S, Kleinschmidt K, Guehring H,. Recombinant human fibroblast growth factor-18 (rhFG18) promotes bovine articular chondrocyte proliferation and cartilage matrix production in vitro [abstract]. Osteoarthritis Cartilage 2012; 20 Suppl: S135.
19. Dahlberg LE, Flechsenhar K, Dreher D, Gouteux S, Jurvelin JS,. A randomized, double-blind, placebo-controlled, multicenter study of rhFGF18 administered intra-articularly using single or multiple ascending doses in patients with primary knee osteoarthritis, scheduled for total knee replacement [abstract]. Osteoarthritis Cartilage 2011; 19 Suppl: S143.
20. Eckstein F, Wirth W, Nevitt MC,. Recent advances in osteoarthritis imaging-the Osteoarthritis Initiative. Nat Rev Rheumatol 2012; 8: 622-30.
21. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986; 29: 1039-49.
22. Kellgren JH, Lawrence JS,. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957; 16: 494-502.
23. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW,. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833-40.
24. Wirth W, Hellio Le, Graverand MP, Wyman BT, Maschek S, Hudelmaier M, Hitzl W, et al. Regional analysis of femorotibial cartilage loss in a subsample from the Osteoarthritis Initiative progression subcohort. Osteoarthritis Cartilage 2009; 17: 291-7.
25. Eckstein F, Nevitt M, Gimona A, Picha K, L, ee JH, Davies RY, et al, for the Osteoarthritis Initiative Investigators Group. Rates of change and sensitivity to change in cartilage morphology in healthy knees and in knees with mild, moderate, and end-stage radiographic osteoarthritis: results from 831 participants from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken) 2011; 63: 311-9.
26. Eckstein F, Kwoh CK, Boudreau RM, Wang Z, Hannon MJ, Cotofana S, et al. Quantitative MRI measures of cartilage predict knee replacement: a case-control study from the Osteoarthritis Initiative. Ann Rheum Dis 2013; 72: 707-14.
27. Kothari M, Guermazi A, von Ingersleben G, Miaux Y, Sieffert M, Block JE, et al. Fixed-flexion radiography of the knee provides reproducible joint space width measurements in osteoarthritis. Eur Radiol 2004; 14: 1568-73.
28. Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, et al. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage 2004; 12: 177-90.
29. Roemer FW, Nevitt MC, Felson DT, Niu J, Lynch JA, Crema MD, et al. Predictive validity of within-grade scoring of longitudinal changes of MRI-based cartilage morphology and bone marrow lesion assessment in the tibio-femoral joint-the MOST study. Osteoarthritis Cartilage 2012; 20: 1391-8.
30. Burgkart R, Glaser C, Hyhlik-Durr A, Englmeier KH, Reiser M, Eckstein F,. Magnetic resonance imaging-based assessment of cartilage loss in severe osteoarthritis: accuracy, precision, and diagnostic value. Arthritis Rheum 2001; 44: 2072-7.
31. Graichen H, von Eisenhart-Rothe R, Vogl T, Englmeier KH, Eckstein F,. Quantitative assessment of cartilage status in osteoarthritis by quantitative magnetic resonance imaging: technical validation for use in analysis of cartilage volume and further morphologic parameters. Arthritis Rheum 2004; 50: 811-6.
32. Eckstein F, Buck RJ, Burstein D, Charles HC, Crim J, Hudelmaier M, et al, on behalf of the A9001140 Study Group. Precision of 3.0 Tesla quantitative magnetic resonance imaging of cartilage morphology in a multicentre clinical trial. Ann Rheum Dis 2008; 67: 1683-8.
33. Eckstein F, Ateshian G, Burgkart R, Burstein D, Cicuttini F, Dardzinski B, et al. Proposal for a nomenclature for magnetic resonance imaging based measures of articular cartilage in osteoarthritis. Osteoarthritis Cartilage 2006; 10: 974-83.
34. Wirth W, Eckstein F,. A technique for regional analysis of femorotibial cartilage thickness based on quantitative magnetic resonance imaging. IEEE Trans Med Imaging 2008; 6: 737-44.
35. Eckstein F, Charles HC, Buck RJ, Kraus VB, Remmers AE, Hudelmaier M, et al. Accuracy and precision of quantitative assessment of cartilage morphology by magnetic resonance imaging at 3.0T. Arthritis Rheum 2005; 52: 3132-6.
36. Altman RD, Gold GE,. Atlas of individual radiographic features in osteoarthritis, revised. Osteoarthritis Cartilage 2007; 15 Suppl A: A1-56.
37. Wirth W, Larroque S, Davies RY, Nevitt M, Gimona A, Baribaud F, et al, for the OA Initiative Investigators Group. Comparison of 1-year vs. 2-year change in regional cartilage thickness in osteoarthritis results from 346 participants from the Osteoarthritis Initiative. Osteoarthritis Cartilage 2011; 19: 74-83.
38. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Li L, et al. Systematic review of the concurrent and predictive validity of MRI biomarkers in OA. Osteoarthritis Cartilage 2011; 19: 557-88.
39. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Reichmann WM, et al. Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence. Osteoarthritis Cartilage 2011; 19: 589-605.
40. Raynauld JP, Martel-Pelletier J, Bias P, Laufer S, Haraoui B, Choquette D, et al, and the Canadian Licofelone Study Group. Protective effects of licofelone, a 5-lipoxygenase and cyclo-oxygenase inhibitor, versus naproxen on cartilage loss in knee osteoarthritis: a first multicentre clinical trial using quantitative MRI. Ann Rheum Dis 2009; 68: 938-47.
41. Wildi LM, Raynauld JP, Martel-Pelletier J, Beaulieu A, Bessette L, Morin F, et al. Chondroitin sulphate reduces both cartilage volume loss and bone marrow lesions in knee osteoarthritis patients starting as early as 6 months after initiation of therapy: a randomised, double-blind, placebo-controlled pilot study using MRI. Ann Rheum Dis 2011; 70: 982-9.
42. Eckstein F, Maschek S, Wirth W, Hudelmaier M, Hitzl W, Wyman B, et al. One year change of knee cartilage morphology in the first release of participants from the Osteoarthritis Initiative progression subcohort: association with sex, body mass index, symptoms and radiographic osteoarthritis status. Ann Rheum Dis 2009; 68: 674-9.
43. Felson DT,. Osteoarthritis as a disease of mechanics. Osteoarthritis Cartilage 2013; 21: 10-5.
44. Intema F, van Roermund PM, Marijnissen AC, Cotofana S, Eckstein F, Castelein RM, et al. Tissue structure modification in knee osteoarthritis by use of joint distraction: an open 1-year pilot study. Ann Rheum Dis 2011; 70: 1441-6.
45. Eckstein F, Wirth W, Hudelmaier M, Stein V, Lengfelder V, Cahue S, et al. Patterns of femorotibial cartilage loss in knees with neutral, varus, and valgus alignment. Arthritis Rheum 2008; 59: 1563-70.
46. Neogi T, Bowes MA, Niu J, De Souza KM, Vincent GR, Goggins J, et al. Magnetic resonance imaging-based three-dimensional bone shape of the knee predicts onset of knee osteoarthritis: data from the Osteoarthritis Initiative. Arthritis Rheum 2013; 65: 2048-58.
47. Angst F, Aeschlimann A, Stucki G,. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001; 45: 384-91.
48. Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I,. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage 2007; 15: 273-80.
49. Helliot Le Graverand-Gastineau MP,. OA clinical trials: current targets and trials for OA. Choosing molecular targets: what have we learned and where are we headed? Osteoarthritis Cartilage 2009; 17: 1393-401.