BIONICIIE

LOCALTREATMENT
OF RH)ZARTHRO
RANDC
A PROSPECTIVE
RicardoGabezas
Gelaber
1 InternalMedicineDe ftment,Hos ital r
ABSTRACT
Background. Rhizarthrosisis a very frequentdiseaseaffectingabout 29.5%of the generalpopulation(25-74yeas old) and even more in specialgroups of population.
Rhizarthrosiscausespain.functionaland estheticchangesresponsibleof an importanteconomicand socialcost.
Objective. The goal of this studywas to evaluatethe dficacy and the safetyof repeatedintra-articular
infiltrationof the trapezcmetacarpaljoint with hyaluronicacid (HA.
versusdexamethasonein patientssufferingfrom rhizarthrosis.
Suplasyn@)
Methods. Patientssatisfyingthe criteriaof rhizarthrosisin any hand were randomizedto Suplasyn@or dexamethasonein an open, prospeçtive.comparativestudy. A
minimum pain score of 50 measured on a visual analogic scale (VAS from 0 to,|00) was required.The two groups received the same standard of care, the
each). Evaluationwas
dexamethasonegroup receivedone infiltrationof dexamethasone(4mg/1ml)and the Suplasynegroup received4 weekly infiltrations(5mg/0.5m1
done in both groups at baseline,one month and 6 months.The primaryendpointwas the efficacyon the pain level as measuredby the VAS score, the secondary
endpointswere the treatmenttoleranceand the overalltreatmentefiicacyevaluationby the patientand the physician
Results. Both groups had comparableVAS at baseline(59 6 in the groupSuplasyn@versus 59.0 in the dexamethasonegroup), A significantimprcr/ementof the VAS
score (p<0 0001) was observed at the month one evaluation compared to baselanebut there was no statisticallysignificant difference between the two groups at this
point. The final evaluationat 6 monthsshowed that the improvementobservedin the group Suplasyn@was sustained.(i.e.VASscore of 30.6 at month 1 and 30.7 at
month 6): in the dexamethasonegroup, the positiveeffect was fading away, with a VAS score of 48.6 at month six comparedto 36.7 at month one. The difference
between the two groups was statistically significant (p=0.0001). Secondaryendpoints efficacy results showed no statisticallydifferent observations between physician
and patient in both groups. Secondary endpoints tolerance results showed no severe adverse events in both groups. there were just 3 minor local reactions (1 in the HA
groupwho leftthe study/2 in the dexametasonegroup)
Conclusion. In conclusionthis study showed a safe and comparableefficacyof hyaluronicacid and dexamethasoneinfiltrationin the treatmentof rhizarthrosisin the
shorttime but a superiorand sustainedefficacyof hyaluronicacid at 6 months.
STUDYDESIGN
INTRODUCTION
Osteoarthritis(OA) of the trapeziometacarpaljoint at the base of the thumb causes
pain and disabilityin a large section of the adult population,particularlywomen.
However, the severity of clinical symptoms does not always correspond to the
radiographicstage of the disease. so decisions about treatmentare commonly
based on the extent to which the pain and functional limitationscaused by the
disease interfere with the patient's normal daily activities rather than on the
appearanceof the joint on X-ray.
The results of a study by Petrella et al (2002)1 suggest that hyaluronicacid is as
effectiveas nonsteroidalanti-inflammatory
drugs (NSAlDs)for restingpain reliefin
patientswith OA of the knee and may even be superiorto placebo alone or to
NSAIDSalone in relievingOA pain associatedwith physicalactiviÇ or functional
performance. Finally, Petrella also demostrated the efficacy of intrarticular
injections by hyaluronic acid in the treatment of OA of the first
joint or Golfer'sToe2.
Metatarsalphalangeal
The present study appears to be the first of its kind in that it explores
viscosupplementation
as a treatmentfor OA in the hand.
OBJECTIVES
The objectiveof this studywas to comparethe efficacyand safetyof
intra-articular
injectionsof Suplasyn@
and dexamethasone
for the
joint at the base of the
treatmentof OA of the trapeziometacarpal
th u mb .
Refêr6nc6s
(1) Petrella R.J.. Di Silvestro. M.D.. Hildebrand C. Sodium Hyaluronate effects on pain and physicê{ frnc{iming
h
osteoarthritis of the knee: A randomized. ddble$lind. placebæontrolled cliriæl trial Arch. Intem. Med. i20O2r. 162: N2298.
(2) Petrella R,J.. Di Silvestro, M.D., Hildebrand C. Intrarticular Hyalurmic Acid lmprows
22-25 Septernber. 2002.
Symptms
ir cofd
Reprintswere providedthroughan unrestrictededucationalgrantfrom:
BIONICIIE
LIFE
SCIENCES
JNC
Cc
s Tæ. OARSI.
.
of hand
Patients
witha clinicaldiagnosis
andX-rayevidence
osteoarthritis
Randomization
{1:1}
.
60 hands (51 patients)in 2 cohorts:
30 hands receiveddexamethasone(D): 1 injection
30 hands receivedSuplasynr'(S): weekly injections
Treatment
.
(20 mgl2 ml).Administration
Suplasyn@**
of 5 mg in 0.5 ml
sal i nesol uti on.
.
(4 mg/1ml )
D examethasone
EVALUATION
Eff icacv
Primary end point: Pain
Parameter:0-10 VAS
Secondary end point: Change in Patient Global Condition
Parameter.GlobalAssessment
(patient's& physician'so b s e r v a t i o n s )
SafeW
End points: Adeverse and Serious Adverse Events
Parameter.Cases reported(number.reason.time)
I: SUPLASYN@
VERSUSDEXAMETHASONE
IIZEDCONTROLLED
STUDY
ArturoRodriguezde la Serna1
Sant Pau i de la SantaGreu,Barcelona,Spain
RESULTS
parisonof painintensityscoredusinga visualanalogscale(VAS)at differenttime pointsin
patientstreatedwith Suplasyn@
or dexamethasone
e
tl Suptasyn@lDexamethason
80
Suplasyn*
n=24
Dexamethason p value
e n=27
t1l
Mean+ SD VAS Mean+ SD VAS
60
59.6+ 9.4
30.7+ 12.9
59.0+ 9. 9
36.7+ 20.4
6 months
p val ue[1]
3 0 . 6+ 1 3 . 1
4 8 . 6+ 1 9 . 1
1 monthvs
baseline
<0.0001
<0.0001
0.9111
< 0.0001
Baseline
1 month
40
2A
6 monthsvs 1
month
0
4.7271
0.4029
<0. 0001
[1] p-valueobtainedby Wlcoxon Rank Sum Test
Baseline
1 month
6 months
Time of eva luation
Muchbetter
Better
No change
Worse
Muchbetter
Better
No change
Worse
Patienfs Observations
Physician's Observation s
(number of patienb)
(number of patients)
Supfasynoln=241
3
15
I
3
Dexamethasonen=271
2
I
11
I
CONCLUSIONS
4
14
10
2
. Suplasyn@shows comparable efficacy to
dexamethasone after 1 month treatment;
however,the efficacyis mantainedfor at least 6
months as opposed to that observed for
dexamethasone,
2
12
7
I
. Suplasyn@
is safe for the treatmentof symptoms
of osteoarthritis.
Participatinq investioators:
RicardoCabezas Gelabert [1]
Arturo Rodriguezde la Serna [1]
tl: Hospital Sant Pau i de la Santa Creu
Barcelona, Spain
Presentedat the Annual European Congress of Rheumatology "EULAR 2003"
Lisbon. Portugal.June 20, 2003
Topic 16: Osteoarthritis- Clinicalaspects and treatment
Abstract FRIO237 Poster P237