Post on 18-Apr-2015
transcript
JOAcid injection for Osteoarthritis
VISKOSUPLEMEN INTRAARTIKULER PADA OSTEOARTRITIS
OSTEOARTHRITIS
• Most common joint disease in human
• Suffering of pain
• Causing disability in 2% of population in the world
Grading of knee OAKellgren-Lawrence
• Grade I
• Grade II
• Grade III
• Grade IV
Treatment of OA Non Pharmacological
- Patient education & empowerment
- Physiotherapy , occupational therapy & joint protection
Pharmacological
- Painkillers : Paracetamol, opioid, NSAIDs
- Intra-articular injection : corticosteroid, Hyaluronic acid (viscosupplementation)
Surgery
- Arthroscopy, osteotomy, Arthrodesis, joint replacement
ViscosupplementationEuropean League Against Rheumatism (EULAR)
• Recommends viscosupplementation for pain reduction and function improvement in the management of OA1
American College of Rheumatology (ACR)
• Recommends viscosupplementation for patients who have not responded to nonpharmacologic therapy or simple analgesics2
1. Jordan KM, Arden NK, Doherty M, et al. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003;62:1145-1155. 2. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendation for the medical management of osteoarthritis of the hip and knee. Arthritis Rheum. 2000;43:1905-1915.
Viscosupplementations
1. Rooster combs hyaluronic acid (Hyalgan®)
2. Synthetic cross-linked hyaluronic acid
(Synvisc®)
3. Bacterial fermentation (Nuflexa®)
4. NASHATM / Non Animal Stabilized
Hyaluronic Acid (Durolane®)
Hyaluronic Acid Glycosaminoglycan
Poly d-glucuronic acid-n-acetyl-d-glucosamine
Hyaluronate
Synthesis of Hyaluronic Acid
Enzyme : Hyaluronic Acid Synthase
Mechanism of action of Viscosupplementation
1. Restoration of the elastoviscous properties
of synovial fluid
2. Anti-inflamatory & antinociceptive
properties
Greatest advantages with
HA
* Datamonitor 2002 (interviews)
• Ability to delay surgery
• Treatment given as an out-patient setting
• No drug medication (no regime of medicine)
• It works among majority of patients
• HA reduces NSAID´s consumptions
Greatest disadvantages
with HA
* Datamonitor 2002 (interviews)
• Number of injections
• Risk involved with several injections
NASHA Technology
• Combination of modern biotechnological techniques &
carefully controlled stabilisation process
NASHA Technology
• Non-Animal
−Produced by bacterial fermentation.
−Elimination of:
• animal-related allergic reaction.
• risk of transfer of diseases from animals.
• Stabilized:
−Long duration → single injection treatment.
−Minimal tissue disturbance.
• Patent protection until 2015.
NASHA Technology High purity
Mildest form of stabilisation : binds to receptors as effectively as
unmodified HA
Low degree of molecular cross-linking (<0.5% -1%) ensures
biocompatibility is retained (assured safety profile)
Highest molecular weight (1013)
Prolonged half life (4 weeks) (Note : t½ Hyalgan = 13.2 hours, t½
Synvisc = 1.5-8.8 days)
Permits very high density of HA (high dose)
Superior viscoelasticity (superior cushioning of joint) compared to all
comparators
NASHA Technology
Mildest form of stabilisation
NASHA Technology – 3-dimension
NASHA product consist of three-dimensional network of hyaluronic acid
NASHA Synthetic HANatural HA
The Durolane® differences
The elastic modulus and viscous modulus as functions of frequency on log scales for Durolane®, Synvisc®, and Artzal®, in comparison with endogenous HA from a young healthy subject, an old healthy subject, and a patient with osteoarthritis.14
14. Ågerup B, Berg P, Åkermark C. Non-animal stabilised hyaluronic acid: a new formulation for the treatment of osteoarthritis. BioDrugs. In press.
Bohlin VOR Rheometer System
Content
• 3 ml prefilled glass syringe
• Each ml contains
- Stabilized hyaluronic acid 20 mg
- Phys. NaCl solution, pH 7 qs.
Indications
Symptomatic treatment of mild to moderate knee or hip osteoarthritis
Contraindications
None known
Dosage & Administration
Single dose 3 ml (one syringe) per knee or hip joints Recommended needle size : 18 – 22 G
The single-injection advantage
Overall intra-articular exposure to HA following i²€tion of different HA preparations. Synvisc is a registered trademark of Genzyme Corporation. Artzal is a registered trademark of Seikagaku Corporation.
Elimination comparison of Durolane®, Synvisc®, and Artzal®4-7
4. Synvisc® (Hylan GF 20) Prescribing Information, Genzyme Corp., Cambridge, MA. Available at: www.synvisc.com. Accessed February 15, 2005. 5. Brown TJ, Laurent UN, Frazer JR. Turnover of hyaluronan in synovial joints: elimination of labeled hyaluronan from the knee joint of the rabbit. Exp Physiol. 1991;76:125-134. 6. Lindenhayn K, Heilmann HH, Niederhausen T, et al. Elimination of tritium-labelled hyaluronic acid from normal and osteoarthritic rabbit knee joints. Eur J Clin Chem Clin Biochem. 1997;35:355-363. 7. Lindqvist U, Tolmachev V, Kairemo K, Åström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41:603-613.
Warnings
Durolane should not be injected :If the joints is infected or severely inflammed
If there is an active skin disease or infection
present at or near the injection site
Intravascularly or extra-articularly or in the
synovial tissues or capsule
Adverse events
Transient pain
Swelling
Stiffness
In OA of the knee:restoring flexibility
Åkermark C, Adalberth T, Ericsäter J, Isacsson J. Patient-perceived efficacy of non-animal stabilized hyaluronic acid in the treatment of osteoarthritis of the knee. Poster presented at OARSI 2004.
In OA of the knee:an advantage for patientsPatients responding after a
single injection of Durolane®13Patient response after a
single injection of Durolane®15
13. Åkermark C, Berg P, Björkman A, Malm P. Non-animal stabilized hyaluronic acid in the treatment of osteoarthritis of the knee—a tolerability study. Clin Drug Invest. 2002;22:157-166. 15. Altman RD, Moskowitz RW, Group atHS. Intra-articular hyaluronate (Hyalgan) in the treatment of patients with osteoarthritis of the knee: a randomized clinical trial. J Rheumatol. 1998;25:2203-2212.
In OA of the knee:
NASHA
Placebo
** P < 0.05
Percent response rate (WOMAC pain score)
Altman RD, Akermark C, Beaulieu,etal. Effficacy and safety of a single intraarticular injection of non-animal stabilized hyaluronic acid (NASHA) in patientsWith osteoarthritis of the knee. Osteoarthritis Cartilage 2004; 12:624-9
WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index
In OA of the hip:the new flexible advantage
Improvement in WOMAC scores8
Patient assessment of global status8
8. Berg P, Olsson U. Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: a pilot study. Clin Exp Rheumatol. 2004;22:300-306.
One flexible advantage Restores mobility and flexibility to the knee and hip
with the convenience of a single injection Cushions the blow of OA with proven pain relief and patient
satisfaction Superior physiochemical properties compared to
other HA preparations Well tolerated and safe
− Longer half life : one injection / 6 months− Non animal origin (↓ allergic reaction, ↓ risk of transfer of diseases from
Animal )
NASHATM
-based products have benefited patients throughout the world in numerous indications
Durolane is a registered trademark and NASHA is a trademark owned by Q-Med AB.
All content © 2005, Q-Med AB.