For Patients with Osteoarthritis Knee PainGo with a
Hyaluronic Acid
Designed for
Performance^2,3*

Pivotal trial design:
EUFLEXXA vs Synvisc¹

• Only acetaminophen (up to 4 g daily)
  was permitted for rescue analgesia;
  use was quantified through
  pill counts
• Patients were evaluated at screening;
  at baseline (prior to the first injection);
  and at Weeks 1, 2, 3, 6,
  and 12 following the initial injection. Patients
  were asked to assess levels of pain,
  stiffness, and
  physical function

Pivotal trial adverse
events: EUFLEXXA vs
Synvisc¹

No reported adverse events of pseudosepsis in this trial.

A total of 160 patients received 478
injections of EUFLEXXA. There were 27
reported AEs considered
to be related to
EUFLEXXA injections: arthralgia, 11
(6.9%); back pain, 1 (0.63%); blood
pressure increase,
3 (1.88%); joint
effusion, 1 (0.63%); joint swelling, 3
(1.88%); nausea, 1 (0.63%); paresthesia, 2
(1.25%)
feeling of sickness from injection,
3 (1.88%); skin irritation, 1 (0.63%); and
tenderness in study knee,
1 (0.63%). Four
AEs were reported in the EUFLEXXA
group for which the relationship to
treatment was
considered to be
unknown: fatigue, 3 (1.88%) and nausea,
1 (0.63%).¹

Trial design: FLEXX and
FLEXX Extension

In the FLEXX trial, only acetaminophen
(up to 4 g daily) was permitted for rescue
analgesia; use was
quantified through pill
counts in both FLEXX and FLEXX
extension^1,2

Adverse events: FLEXX
and FLEXX Extension

No cases of pseudosepsis were reported
in the trial and extension.

Post-Hoc Analysis¹

The effect of baseline KL grade was
one of the variables evaluated in
this post-hoc
analysis

Objective:

To identify potential predictors of
response to IA-HA and help clinicians
determine the most appropriate
patients
for IA-HA therapy for OA knee pain.

Method:

Data from patients receiving
intra-articular HA in the FLEXX and
FLEXX extension trials were evaluated
to
identify factors that may predict either
successful or less successful outcomes
with respect to the
outcome measures
used in the trials.

VARIABLES EVALUATED (baseline values):

• Treatment received
• Age
• Body mass index
• Sex
• Alcohol use
• Smoking status
• KL grading scale (radiographically determined OA severity)
• OA in contralateral knee
• History of physical therapy, steroid injection, other injection, arthrocentesis, NSAID treatment
• VAS pain
• WOMAC pain, stiffness, and disability scores