Clinical Studies – Hyalgan for Healthcare Professionals

Studied in 100+ clinical trials globally¹

The most active comparator trials in its class¹

Provides long-lasting pain relief up to 6 months²

A possible option to treat knee OA pain in early OA⁴

Demonstrated pain relief with repeat treatment up to 30 months³

An important part of multimodal therapies for early stages of knee OA

Long-lasting pain relief up to 6 months

2 out of 3 patients receiving HYALGAN^® reported pain relief that lasted 6 months in the pivotal trial²

HYALGAN^® significantly reduced mean VAS pain scores from baseline compared with placebo over 26 weeks²

N=495
Mean pain score for completed patients during a 50-foot walk recorded on a 100-mm-visual analog scale (VAS) adjusted for baseline severity

Study Summary: Altman, 1998

Demonstrated pain reduction with repeat treatment up to 30 months³

Reduced pain from baseline at 30 months with 5 treatment cycles of 5 injections each³

HYALGAN^® reduced mean VAS pain scores from baseline

N=75
Adapted from Scali JJ. J Rheumatol Inflamm. 1995; 15(1):57-62.

Study Summary: Scali, 1995

A possible option to treat knee OA pain in early OA⁴

Patients with Kellgren-Lawrence grade 2-3 demonstrated greater clinical improvement⁴

Clinical improvement

Use of analgesics or assisted walking devices

N=76 patients (92 knees)

Study Summary: Neustadt, 2003

Multimodal Treatment

Viscosupplementation—An important part of knee OA pain treatment after conservative therapies⁵

Multimodal treatment that includes hyaluronic acid (HA) may deliver…

53% to 55% improvement in mean WOMAC pain scores in patients with Kellgren-Lawrence (K-L) grades I to III⁶
46% improvement in mean WOMAC pain scores in patients with K-L grade IV⁶
Very low rates of total knee replacement at 1 and 2 years, post treatment⁷
Sustained cost-effectiveness at 2 years, well below the established cost-effectiveness threshold⁷

Indication

HYALGAN^® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, eg, acetaminophen.

Important Safety Information

HYALGAN^® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of present infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.

Transient increases in inflammation in the injected knee following HYALGAN^® injection have been reported in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis. Physicians should evaluate whether HYALGAN^® treatment should be initiated when objective signs of inflammation are present.

The effectiveness of a single treatment cycle of less than 3 injections has not been established.

Patients should be advised to avoid any strenuous or prolonged weight-bearing activities within 48 hours following intra-articular injection.

Use caution when injecting HYALGAN^® into patients who are allergic to avian proteins, feathers, and egg products.

Joint effusion, if present, should be removed prior to injection.

The safety and effectiveness of HYALGAN^® has not been established in children or in pregnant or lactating women. It is unknown whether HYALGAN^® is excreted in human milk.

In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain. Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN^®-treated and placebo groups. In other clinical studies, the frequency and severity of adverse events occurring during the repeat treatment cycles did not increase over that reported for a single treatment cycle.

Please see package insert for full prescribing information including indications, contraindications, warnings, precautions, and adverse events.

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Please see Full Prescribing Information.

The most trusted HA treatment worldwide

Studied in 100+ clinical trials globally1

The most active comparator trials in its class1

Long-lasting pain relief up to 6 months

2 out of 3 patients receiving HYALGAN® reported pain relief that lasted 6 months in the pivotal trial2

HYALGAN® significantly reduced mean VAS pain scores from baseline compared with placebo over 26 weeks2

Demonstrated pain reduction with repeat treatment up to 30 months3

Reduced pain from baseline at 30 months with 5 treatment cycles of 5 injections each3

HYALGAN® reduced mean VAS pain scores from baseline

A possible option to treat knee OA pain in early OA4

Patients with Kellgren-Lawrence grade 2-3 demonstrated greater clinical improvement4

Clinical improvement

Use of analgesics or assisted walking devices

Multimodal Treatment

Viscosupplementation—An important part of knee OA pain treatment after conservative therapies5

References

STUDY SUMMARY: ALTMAN, 1998

Intra-articular sodium hyaluronate (HYALGAN®) in the treatment of patients with osteoarthritis of the knee: A randomized clinical trial2

Study design

Results

STUDY SUMMARY: SCALI, 1995

Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study3

Study design

Results

STUDY SUMMARY: NEUSTADT, 2003

Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN®) in patients with osteoarthritis of the knee4

Study design

Results

Studied in 100+ clinical trials globally¹

The most active comparator trials in its class¹

2 out of 3 patients receiving HYALGAN^® reported pain relief that lasted 6 months in the pivotal trial²

HYALGAN^® significantly reduced mean VAS pain scores from baseline compared with placebo over 26 weeks²

Demonstrated pain reduction with repeat treatment up to 30 months³

Reduced pain from baseline at 30 months with 5 treatment cycles of 5 injections each³

HYALGAN^® reduced mean VAS pain scores from baseline

A possible option to treat knee OA pain in early OA⁴

Patients with Kellgren-Lawrence grade 2-3 demonstrated greater clinical improvement⁴

Viscosupplementation—An important part of knee OA pain treatment after conservative therapies⁵

Intra-articular sodium hyaluronate (HYALGAN^®) in the treatment of patients with osteoarthritis of the knee: A randomized clinical trial²

Intra-articular hyaluronic acid in the treatment of osteoarthritis of the knee: A long-term study³

Long-term efficacy and safety of intra-articular sodium hyaluronate (HYALGAN^®) in patients with osteoarthritis of the knee⁴