References
1. Bonnevie ED, Galesso D, Secchieri C, Bonassar LJ. Frictional characterization of injectable hyaluronic acids is more predictive of clinical outcomes than traditional rheological or viscoelastic characterization. PLOS One. 2019 May 10;14(5):e0216702. 2. Finelli I, Chiessi E, Galesso D, Renier D, Paradossi G. A new viscosupplement based on partially hydrophobic hyaluronic acid: a comparative study. Biorheology. 2011;48(5):263-75. 3. Data on file, Fidia Farmaceutici S.P.A., Italy. 4. HYMOVIS® [package insert]. Fidia Farmaceutici S.P.A. Abano Terme, Italy 2017. 5. Bisicchia S, Bernardi G, Tudisco C. HYMOVIS® (HYADD® 4) versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with a 1-year follow-up. Clin Exp Rheumatol. 2016;34(5):857-863. 6. Priano F. Early Efficacy of Intra-Articular HYADD® 4 (HYMOVIS®) Injections for Symptomatic Knee Osteoarthritis. Joints. 2017 Jul 28;5(2):79-84. 7. Benazzo F, Perticarini L, Padolino A, et al. A multi-centre, open-label, long-term follow-up study to evaluate the benefits of a new viscoelastic hydrogel (HYMOVIS®) in the treatment of knee osteoarthritis. Eur Rev Med Pharmacol Sci. 2016;20:959-968.
STUDY SUMMARY: BISICCHIA S, 2016
HYMOVIS® (HYADD® 4) Versus Methylprednisolone Acetate in Symptomatic Knee Osteoarthritis: A Single-centre Single Blind Prospective Randomised Controlled Clinical Study With a 1-year Follow-up5
Study design
Single-center, single blind prospective, randomized controlled clinical study
Objective
To compare clinical results. quality of life, and safety achieved by intra-articular (IA) injections of HYMOVIS® versus an IA corticosteroid (methylprednisolone acetate) in the treatment of symptomatic knee OA
Study population
Ambulatory male and female patients (N=150, > 45 years of age) with unilateral symptomatic primary knee OA
Intervention
- Patients were randomized to receive 2 intra-articular (IA) injections of either HYMOVIS® (n=75) or corticosteroid (n=75) in the affected knee, 7 days apart
- All patients were followed up for 52 weeks
Primary endpoint
WOMAC total scores at 26 weeks
STUDY SUMMARY: BENAZZO F, 2016
A Multi-centre, Open-label, Long-term Follow-up Study to Evaluate The Benefits of a New Viscoelastic Hydrogel (HYMOVIS®) in The Treatment of Knee Osteoarthritis7
Study design
Prospective, multi-center, open-label, clinical study with 52-week follow-up
Objective
To evaluate the long-term efficacy and safety of HYMOVIS® in the treatment of symptomatic osteoarthritis (OA) of the knee
Study population
Patients (age >40 years) with clinically and radiologically confirmed knee OA and a complaint of pain in the target knee (N = 49)
Intervention
- Treatment involved 2 injection cycles:
- Patients were given 2 intra-articular (IA) injections (3 mL each) of HYMOVIS® (8 mg/mL HYADD® 4) 1 week apart (day 0 and day 7)
- Injections were repeated 6 months from baseline (on days 182 and 189)
- Patients were followed up for 52 weeks
Primary endpoint
Knee OA pain, measured by WOMAC A (pain) over 52 weeksa
Secondary endpoints
- 39% of patients did not complain any pain when walking on a flat surface, 43% had slight pain, and 18% complained of moderate pain
- 86% demonstrated improvement in OMERACT-OARSI responder rates (demonstrated 88% responder rates at 52 weeks)
STUDY SUMMARY: PRIANO F, 2017
Post-market retrospective study evaluating real-world use of HYMOVIS®
Early Efficacy of Intra-articular HYADD® 4 (HYMOVIS®) Injections for Symptomatic Knee Osteoarthritis6
- Real-world clinical practice, retrospective study of 937 eligible patients from the ANTIAGE National Registrya
- Demonstrates safety and efficacy of HYMOVIS® in patients with mild to severe (Kellgren-Lawrence grades II to IV) symptomatic knee osteoarthritis (OA)
Study objective
The aim of the study was to evaluate the clinical efficacy and safety of HYMOVIS® (HYADD® 4), a hydrogel based on a hyaluronic acid derivative, in patients with symptomatic knee osteoarthritis
Study design
- A retrospective observational study to evaluate the clinical efficacy and tolerability of two intra-articular (IA) HYMOVIS® injections (24 mg/3 mL) administered 1 week apart in everyday clinical practice, for the treatment of symptomatic knee OA
- Data obtained from the ANTIAGE national registry, a nonprofit database of clinical data on the effects of ultrasound-guided IA viscosupplementation
- Patients were evaluated for VAS pain at rest and on movement at 1, 3, 6, 9, and 12 months from baseline
- Total WOMAC scores, NSAIDs/acetaminophen use, and patient satisfaction with therapy were evaluated at 1, 3, and 6 months from baseline
- A total of 937 eligible patients (age range 41–80 years old) with Kellgren-Lawrence grade II–IV were included at baseline
- Symptomatic knee arthritis was diagnosed according to the American College of Rheumatology (ACR) criteria
aData obtained from the ANTIAGE National Registry (Italy): Associazione Nazionale por la Terapia Intra Articcolare con Guida Ecografica (ANTIAGE) - A nonprofit database of clinical data on effects of ultrasound-guided intra-articular viscosupplementation