Performance
That Delivers
Take OA knee pain relief to another level
Performance
Pain Reduction
Powerful OA knee
pain reductions
In a 12-week pivotal trial, maximum
pain relief was achieved with
EUFLEXXA
10 weeks after the 3rd injection2,3*
Pain reduction began as early as 1-week
post-injection and improved with each
injection:
19% after injection 1 (n=160), 37% after injection
2 (n=159), and 48% after
injection 3 (n=159).2*
The most commonly reported adverse events in
this trial were arthralgia (14/160),
back pain
(8/160), and joint effusion (1/160).2
*Based on % reduction in WOMAC pain score from baseline in a
pivotal, 12-week trial of EUFLEXXA (n=157) vs Synvisc (n=158).
Pain-free defined as symptom-free for the 5 WOMAC pain
questions (with average visual analog scale [VAS] scores of <20 mm).2
†Primary endpoint: Mean change from baseline in 5 WOMAC pain
scores (noninferiority vs Synvisc). Synvisc
reduced OA knee pain by 55% (P<0.0001).2
‡Change from baseline in VAS (100-mm scale) for the average of 5
WOMAC scores.2
OA=osteoarthritis; VAS=visual analog scale; WOMAC=Western
Ontario and McMaster Universities Osteoarthritis Index.
Rescue Medication
In a 12-week pivotal trial,
fewer
patients needed
rescue medication2,3
-
Among patients with unilateral OA knee pain who avoided pain medication, 51% had received EUFLEXXA (n=34/67) vs 18% who had received Synvisc (n=13/72); P=0.0012*
-
In the overall population (unilateral and bilateral OA of the knee), ~44% more EUFLEXXA patients (62/159) avoided pain medication vs Synvisc patients (43/161); P=0.0132
*In a pivotal trial vs Synvisc; acetaminophen was the only rescue medication provided.2
OA=osteoarthritis.
†Unilateral means OA knee pain in one knee
Repeat Treatment
Treatment that performs and
can be repeated3-5
In the FLEXX trial, the most common treatment
related adverse events were
arthralgia (27/293),
back pain (12/293), and musculoskeletal pain
(6/293).3
In the FLEXX extension, the most common
treatment related adverse events
were arthralgia
(19/219), joint swelling (6/219), and back pain
(6/219).3
*Primary efficacy outcome of the FLEXX trial based on the 50-foot
walk test.4
†Open-label extension study of the FLEXX trial (n=219) was not
designed to establish long-term efficacy of
a repeat injection series
of EUFLEXXA.5
OA=osteoarthritis.
Early Treatment
Treat early and repeat for better results6
*KL=Kellgren-Lawrence grading scale based on radiographical classification of knee osteoarthritis. KL-2
(n=235), KL-3 (n=353).
†In a post-hoc analysis of the FLEXX and FLEXX extension trials.
‡All numbers rounded to the nearest whole number.
OA=osteoarthritis.
Joint Effusions
Low incidence of joint effusions
In a pivotal trial, 1 effusion with EUFLEXXA (n=1, 0.6%) vs 15 effusions with Synvisc (n=13, 8.1%); P=0.0015.2
-
EUFLEXXA is not synthesized from avian protein
and has not been shown to cause pseudoseptic
reactions in clinical trials3 -
The most common adverse events were
arthralgia (11/160), back pain (1/160),
blood
pressure increase (3/160), joint effusion
(1/160), joint swelling (3/160),
nausea (1/160),
paresthesia (2/160), feeling of sickness of
injection (3/160),
skin irritation (1/160), and
tenderness in study knee (1/160)3
OA=osteoarthritis.
References
-
1. Rolling 12 month average of IQVIA claims data based on unique patients (November 2021). 2. Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006;14(2):154-162. 3. EUFLEXXA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 4. Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX Trial). Semin Arthritis Rheum. 2009;39(1):1-9. 5. Altman RD, Rosen JE, Bloch DA, et al. Safety and efficacy of retreatment with a bioengineered hyaluronate for painful osteoarthritis of the knee: results of the open-label Extension Study of the FLEXX Trial. Osteoarthritis Cartilage. 2011;19(10):1169-1175. 6. Altman RD, Farrokhyar F, Fierlinger A, et al. Analysis for prognostic factors from a database for the intra-articular hyaluronic acid (Euflexxa) treatment for osteoarthritis of the knee. Cartilage. 2016;7(3):229-237.
