No Conclusive Evidence that Histologically Found Granulomas and Acute Local Reactions Following Hylan G-F 20 Injections Are Related or Have Clinical Significance

David D. Waddell; Alan Beyer; Terry L. Thompson; Jennifer Morawiak; Clare Elkins; Andrew Rosenberg; Andrew Spitzer

doi:10.1055/s-0033-1348407

The Journal of Knee Surgery, Inhaltsverzeichnis

J Knee Surg 2014; 27(02): 099-104
DOI: 10.1055/s-0033-1348407

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

No Conclusive Evidence that Histologically Found Granulomas and Acute Local Reactions Following Hylan G-F 20 Injections Are Related or Have Clinical Significance

David D. Waddell

¹Department of Orthopedics, Orthopedic Specialists of Louisiana, Shreveport, Louisiana

,

Alan Beyer

²Department of Orthopedics, Newport Orthopedic Institute, Newport Beach, California

,

Terry L. Thompson

³Department of Orthopedics, Howard University Hospital, Washington, District of Columbia

,

Jennifer Morawiak

⁴Department of Clinical Research, Genzyme Biosurgery, Cambridge, Massachusetts

^*Current affiliation for Jennifer Morawiak is Aveo Pharmaceuticals, Cambridge, Massachusetts; current affiliation for Claire Elkins is Alexion Pharmaceuticals, Cambridge, Massachusetts

,

Clare Elkins

⁵Department of Biostatistics, Genzyme Biosurgery, Cambridge, Massachusetts

^*Current affiliation for Jennifer Morawiak is Aveo Pharmaceuticals, Cambridge, Massachusetts; current affiliation for Claire Elkins is Alexion Pharmaceuticals, Cambridge, Massachusetts

,

Andrew Rosenberg

⁶Department of Anatomic Pathology, University of Miami Hospital, Miami, Florida

,

Andrew Spitzer

⁷Department of Orthopedics, Cedars-Sinai Orthopedics, San Francisco, California

› Institutsangaben

Abstract

Osteoarthritic (OA) knee pain can be successfully treated with hylan G-F 20 (Synvisc, Sanofi Biosurgery, Cambridge, MA) with few local adverse events. However, a few studies have identified hyaluronate positive (HA+) granulomas in the synovial tissue of patients treated with hylan G-F 20 raising the question of their relationship and clinical significance. To understand the potential relationship of HA+ granulomas with the occurrence of acute local reactions (ALRs), we evaluated the synovial tissue of OA patients undergoing total knee replacement that had previously been treated with hylan G-F 20 (n = 101) or had not been treated (n = 20). Granulomas were observed in nine patients, of which eight were in the hylan G-F 20 group (7.9%); HA+ granulomas were identified in six of these eight patients (5.9%). Three of the six patients with HA+ granulomas experienced an ALR within 30 days of administering an injection. Overall, we found no consistent relationship between histologically found HA+ granulomas and the occurrence of an ALR following hylan G-F 20 treatment. These microscopic granulomas were not associated with any symptoms and likely have little clinical significance. The low occurrence of granulomas and/or ALRs should not preclude use of hylan G-F 20 for the treatment of knee pain associated with OA.

Keywords

acute local reaction - granuloma - hylan G-F 20 - viscosupplementation

Volltext

Referenzen

References
1 Wobig M, Dickhut A, Maier R, Vetter G. Viscosupplementation with hylan G-F 20: a 26-week controlled trial of efficacy and safety in the osteoarthritic knee. Clin Ther 1998; 20 (3) 410-423
2 Scale D, Wobig M, Wolpert W. Viscosupplementation of osteoarthritic knees with hylan: a treatment schedule study. Curr Ther Res 1994; 55: 220-232
3 Synvisc® (hylan G-F 20) Prescribing Information. Ridgefield, NJ: Genzyme Biosurgery; 2006
4 Waddell DD. The tolerability of viscosupplementation: low incidence and clinical management of local adverse events. Curr Med Res Opin 2003; 19 (7) 575-580
5 Waddell DD, Bricker DC. Clinical experience with the effectiveness and tolerability of hylan G-F 20 in 1047 patients with osteoarthritis of the knee. J Knee Surg 2006; 19 (1) 19-27
6 Chen AL, Desai P, Adler EM, Di Cesare PE. Granulomatous inflammation after Hylan G-F 20 viscosupplementation of the knee : a report of six cases. J Bone Joint Surg Am 2002; 84-A (7) 1142-1147
7 Michou L, Job-Deslandre C, de Pinieux G, Kahan A. Granulomatous synovitis after intraarticular Hylan GF-20. A report of two cases. Joint Bone Spine 2004; 71 (5) 438-440
8 Zardawi IM, Chan I. Synvisc perisynovitis. Pathology 2001; 33 (4) 519-520
9 Marino AA, Dunn S, Waddell DD. Granulomatous inflammation after Hylan G-F 20 viscosupplementation of the knee. J Bone Joint Surg Am 2003; 85-A (10) 2051-2052 , author reply 2052–2053
10 Marino AA, Waddell DD, Kolomytkin OV, Pruett S, Sadasivan KK, Albright JA. Assessment of immunologic mechanisms for flare reactions to Synvisc. Clin Orthop Relat Res 2006; 442: 187-194
11 Jones A, Regan M, Ledingham J, Pattrick M, Manhire A, Doherty M. Importance of placement of intra-articular steroid injections. BMJ 1993; 307 (6915) 1329-1330