INNORYOS® – Publication Summary
Efficacy of intra-articular hyaluronic acid injections with INNORYOS® 2.2% in patients with knee osteoarthritis
Publication Summary
INNORYOS® 2.2% in patients with knee osteoarthritis
Efficacy of intra-articular hyaluronic acid injections with INNORYOS® 2.2% in patients with knee osteoarthritis1,2
The first visco-booster study
Lola Hofweber1, Wolfgang Kemmler1, Jörg Nürnberger2 and Simon von Stengel1
1Institute of Radiology, University Hospital Erlangen, Erlangen, Germany.
2Practice of Orthopedics and Trauma Surgery, Öttingen, Germany.
Overview
Purpose:
To evaluate the efficacy and safety of intra-articular hyaluronic acid (HA) injections with INNORYOS® 2.2% compared to Synvisc 0.8% in patients with knee osteoarthritis (OA).
Study design and methods:
A 26-week prospective non-interventional open clinical trial testing the non-inferiority of INNORYOS® 2.2% (ALBOMED GmbH) compared to the avian-derived HA product Synvisc (0.8%, 2.0 ml).
• Patients with knee OA (Kellgren-Lawrence grade I to III), aged 40-85 years, were randomly allocated to 2 groups
• Three HA injections were administered at baseline and after 1 and 2 weeks
• Additional visits for data collection were made after 14 and 26 weeks
Case number:
90 participants (90 knees, 45 in each group)
Study endpoints & examinations:
Changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, changes in WOMAC subscales (pain, stiffness, function), pain visual analogue scale (VAS), side effects, and confounders.
Results
WOMAC total score (change from baseline):
INNORYOS® showed greater improvement (37.1%) than Synvisc (29.2%) at 26 weeks, a trend already evident at 2 weeks.
WOMAC subscores (change from baseline):
At 26 weeks, INNORYOS® consistently outperformed the control group across all WOMAC subcategories (see table below).
|
WOMAC subcategory
|
INNORYOS® 2.2%
|
Control group
|
p value
|
|---|---|---|---|
|
Pain reduction
|
43.6%
|
29.1%
|
0.260
|
|
Stiffness reduction
|
25.9%
|
0.0%
|
0.009
|
|
Function improvement
|
37.0%
|
27.6%
|
0.490
|
- Statistically significant difference between both groups for the “stiffness“ category, where the INNORYOS® group showed a 25.9% improvement while the control group showed none.
- Both groups showed the highest improvement in the “pain“ category.
- The “function“ category saw similar improvements in both groups, with the INNORYOS® group slightly outperforming the control group.
Already 2 weeks post-injection, a positive treatment effect on the WOMAC “pain” subscale was observed in 77.8% of INNORYOS® patients.
INNORYOS® showed a slightly better VAS pain reduction (-35.2%) than Synvisc (-31.0%) at 26 weeks.
High tolerability and safety: No adverse effects were reported in both groups.
No changes in co-medication impacting study outcomes were observed.
key massages
INNORYOS® 2.2% showed non-inferiority to Synvisc, a well-established hyaluronic acid for knee osteoarthritis, with superior stiffness reduction and overall improvement, suggesting a more effective treatment option:
✓ Superior stiffness reduction: INNORYOS® 2.2% showed significantly better results in reducing joint stiffness compared to the control group, which can be a key point for patients seeking improved mobility.
✓ Comprehensive symptom relief: The study shows that INNORYOS® 2.2% effectively reduces pain, improves function, and decreases stiffness in patients with knee OA.
✓ Excellent safety profile: No adverse effects were reported during the study, highlighting the safety of INNORYOS® 2.2% for patients.
✓ All patients completed the study: The rapid onset of a positive effect after the first injection motivated all participants to finish the treatment.
✓ Potential for enhanced efficacy: INNORYOS® 2.2% contains niacinamide, which has anti-inflammatory properties and may increase efficacy compared to standard HA treatments.[1-3]
References:
[1] Gobbi A, Herman K, Bizzoco L, Avio G. Evaluation of Safety And Performance of Hyaluronic Acid Combined with Niacinamide Versus Standard Infiltrative Therapy in the Treatment of Joint Degenerative and Post-Traumatic Diseases. J Orthop Muscular Syst. 2023; 6(2): 1024.
[2] Hadjab F. Scientific abstract AB0046 Resistance to oxidative degradation of a formulation combining hyaluronic acid and niacinamide. Annals of the Rheumatic Diseases 2022;81:1158.
[3] Jonas WB, Rapoza CP, Blair WF. The effect of niacinamide on osteoarthritis: a pilot study. Inflamm Res. 1996 Jul;45(7):330-4.
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