The only 2-injection
hyaluronic acid regimen for
osteoarthritis knee pain

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 weeks^a

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 Registry^a
• 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