Managing Arthritis Flare-Ups

Report
Managing Arthritis Flare-Ups
Prof.Hisham Hamoud
Prevalence of Osteoarthritis
 Arthritis is considered the most common joint disorders in the
world.
 Osteoarthritis is by far the most common form of arthritis
occurring in practice and is a leading cause for chronic disability
in elderly patients
 The annual prevalence of knee pain associated with OA is 46% in
those over age 50.
 In those with knee pain, around 1 in 5 patients indicate problems
at work.
Arthritis Foundation. The facts about arthritis. Available at: www.arthritis.org/resources/gettingstarted/default.asp. Accessed September 8, 2006
Lawrence, et al. 1998; Woolf, et al. 2003
Deborah Symmons, Colin Mathers, Bruce Pfleger. Global burden of osteoarthritis in the year 2000.
ww.who.int/entity/healthinfo/statistics/bod_osteoarthritis.pdf
Adapted from Jinks C, Jordan K, Ong BN, Croft P. A brief screening tool for knee pain in primary care (KNEST).
Wilkie R, Jordan K, Blagojevic, M, Croft P. What will happen if state pension age rises for people with joint pain? Impact
Pathophysiology
50 folds more PGE2 in osteoarthritis patients’ chondrocytes
 PGE2 has important pro-inflammatory properties
and contributes to vasodilation and pain
in patients with OA 2
 Chondrocytes isolated from patients with OA produce 50-fold
more PGE2 than chondrocytes from patients without OA
CLEVELAND CLINIC JOURNAL OF MEDICINE, VOLUME 69 , SUPPLEMENT, SI-6
Arthritis Flare-Ups
Definition of Arthritis Flare Ups
 Some forms of arthritis go through cycles of getting better and
worse
1
 A flare-up means the disease is more active1
• Increased morning stiffness1
• More pain and swelling in the joints,1 (the pain becomes more
severe and responds less to rest, tending to become continuous)2
• Involvement of other joint1
• Increased tiredness and fatigue1
1. M. Marty et al. / Joint Bone Spine 76 (2009) 268e272
2. Spector T, Hart DJ, Nandra D, et al. Arthritis Rheum 1997;40:723e7
Impact of Arthritis flare-ups & considerations
Disability & sleep disorders are key symptoms associated with flare ups,
proper management of flare-ups are crucial to avoid further damage
 In patients with symptoms of OA flare-ups the following conditions
are reported
 Significant work disability
 Reduced ability to deal with household duties
 Sleep disorders
 It's important to address arthritic flare-ups as soon as possible,
because of the damage ,the increased inflammation can do to
already compromised joints
http://www.ehow.com/about_4759080_arthritis-flare-up-symptoms.html
Subjective impact of osteoarthritis flare-ups on patients' quality of life, Giuseppina Majani
Health and Quality of Life Outcomes 2005, 3:14
Diagnostic score for knee OA:
KOFUS ( Knee Osteoarthritis Flare-Ups Score)
Diagnostic score for knee OA
KOFUS ( Knee Osteoarthritis Flare-Ups Score)
Objectives

Is to identify & validate a criteria for defining knee osteoarthritis flare-up, based on
data from two large cross-sectional studies based on clinical features ,NO blood tests
or joint fluid studies were performed
Clinical features associated with a flare-up were






Morning stiffness for longer than 20 min
Nocturnal awakenings due to knee pain
Limping
Swelling
Warmth
Joint effusion
M. Marty et al. / Joint Bone Spine 76 (2009) 268e272
Diagnostic score for knee OA:
KOFUS ( Knee Osteoarthritis Flare-Ups Score)
Patients with a score of 7 & above are diagnosed as flare-ups patients
A score equal to or greater than 7 points
indicates diagnosis of flare-up
M. Marty et al. / Joint Bone Spine 76 (2009) 268e272
Osteoarthritis Management
NSAIDs in Guidelines
To fully treat inflammation, a higher dose of NSAIDs
must be taken on a regular basis for 2-4 weeks
http://www.uptodate.com
Diclofenac in Arthritis Flare-Ups
• The recommended dose for arthritis
flare-ups is, the full dose of Diclofenac
which is 150 mg / day for 2 weeks.
Voltaren Basic Prescribing Information
http://www.merck.com/mmpe/lexicomp/diclofenac.html
http://www.rxlist.com/voltaren-drug.htm
Fast Acting Oral NSAIDs at Maximum Doses are the
Drugs of Choice in Patients with Arthritis for 1-2 Weeks
Nazli Conway et al,Diagnosis&Management of acute gout, Medicine&Health, vol.92, no 11, novemb. 2009
Full Dose of Diclofenac is Recommended for
Management of Inflammation of Arthritis
Nazli Conway et al ,Diagnosis&Management of acute gout, Medicine&Health, vol.92, no 11, novemb. 2009
Arthrofast
What is Arthrofast
• Arthrofast is 150mg Diclofenac sodium in a modified
release formulation.1
• Arthrofast is a once daily modified release 2NSAID that
provides fast & lasting 3pain relief for patients suffering
from flare-ups of both arthritis & spondylosis2 through
it’s bilayer technology. 1&4
1. Clinical Overview Diclofenac Modified Release Bi-Layer Tablets 75 and 150 mg Prepared by: Dr. Wilhelm Ackermann, September 2004, Hamburg.
2. Arthrofast basic prescribing information.
3. Adapted from Pharmacokinetic pilot study of a new diclofenac slow release formulation after single oral administration in six healthy male volunteers. Cephac
Institute, Paris, 1994
4. Effective treatment of osteoarthritis with a 150 mg prolonged-release of diclofenac sodium , P. ARCANGELI, European Review for Medical and Plhannacological
Sciences 1996; 18: 217-223
Arthrofast unique technology provide
Immediate release within 15 minutes sustained effective concentration
for 24 hours
Mean + s.d. diclofenac plasma concentrations measured after single oral
administration of 150 mg diclofenac as one slow-release tablet.2
1. Clinical Overview Diclofenac Modified Release Bi-Layer Tablets 75 and 150 mg Prepared by: Dr. Wilhelm Ackermann, September 2004, Hamburg.
2. Pharmacokinetic pilot study of a new diclofenac slow release formulation after single oral administration in six healthy male volunteers. Cephac Institute, Paris, 1994
* Effective treatment of osteoarthritis with a 150 mg prolonged-release of diclofenac sodium , P. ARCANGELI, European Review for Medical and Plhannacological Sciences 1996; 18: 217-223
Arthrofast® Efficacy & Safety in acute Painful
Attacks of Chronic rhEumatic disorders
Arthrofast® Efficacy & Safety in Acute Painful
attacks associated with chronic rheumatic disorders
(AEROSPACE)
A 2 week treatment period, local, multicenter, open
label, non-controlled, observational, non-interventional
study to assess efficacy & safety of Arthrofast 150mg
MR administered orally once daily for acute painful
attacks in chronic Rheumatic Disorders like OA, back
pain and gouty arthritis
Novartis data on file
21
Arthrofast provides 65 % reduction of pain
after 2 weeks
Patient's pain intensity dropped from 7.24 in visit 1 to 2.55 in visit 2, where 0cm is
very good and 10cm is very poor, with % change of -65% and Results are very
highly statistically significant (p-value = 0.0000 <0.001 – T-test)
Novartis data on file
Arthrofast provides 66% reduction in limitation
of daily activity
Patient's Limitation of daily activity
Patient's limitation of daily activity dropped from 6.42 in visit 1 to 2.16 in visit
2, where 0 is very good and 10 is very poor, with % change of -66% and
Results are very highly statistically significant (p-value = 0.0000 <0.001 – Ttest).
Novartis data on file
23
Arthrofast provides 76 % improvement in joint
tenderness
Tenderness of joints score dropped from 1.94 in visit 1 to 0.46 in visit 2, where 0 = No, 1 = Mild, 2
= Moderate and 3 = Sever, with % change of -317% and Results are very highly statistically
significant (p-value = 0.0000 <0.001 – T-test, Chi-Square)
Novartis data on file
24
8 out of 10 patients treated with Arthrofast are
relieved from swelling after 2 weeks
Swelling of joints dropped from 54.4% of patients in V1 to 11.4% of
patients at V2
60
Swelling
54.4
50
40
30
Swelling
20
11.4
10
0
Visit 1
Novartis data on file
25
Visit 2
Almost 9 out of 10 patients are satisfied &
extremely satisfied * with Arthrofast after 2 weeks
89.6 % of Patients are Satisfied and Extremely Satisfied
Novartis data on file
26
93.8 % of Investigators are Satisfied and
Extremely Satisfied
Novartis data on file
27
Safety Results
87% of Patients Have no Adverse Event
Patients and Investigators Satisfaction
87% of Patients Have no Adverse Event
The safety information collected included adverse events (AE) and serious adverse events
(SAE) reported
Novartis data on file
28
Arthrofast Modified Release Formulation
Provides
 Immediate release starting in 15 minutes with sustained
effective concentration lasting for 24 hours
 65 % reduction of pain after 2 weeks
 66% reduction in limitation of daily activity
 76 % improvement in joint tenderness
 8 out of 10 patients treated with Arthrofast are relieved
from joint swelling after 2 weeks
 Recommended dose for arthritis flare-ups

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