Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World...

Area of Science:

• Orthopedics
• Rheumatology
• Pharmacovigilance

Background:

• Severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been reported.
• The specific causes and product-related risks of SALR remain incompletely understood.

Purpose of the Study:

• To compare surrogate measures of SALR between patients receiving hylan G-F 20 and other non-hylan G-F 20 hyaluronic acid (HA) products for knee osteoarthritis.
• To investigate potential correlations between product characteristics (avian-derived, cross-linked) and SALR.

Main Methods:

• Retrospective cohort study using the Optum Clinformatics dataset (January 2006 to June 2016).
• Identified knee OA patients receiving IA HA injections, stratified into hylan G-F 20 and non-hylan G-F 20 groups.
• Matched patients based on single or multiple injection products and evaluated surrogate SALR measures within 3 days post-injection, including inflammation/infection, corticosteroid injections, arthrocentesis, arthrotomy, and arthroscopy.

Main Results:

• Across 694,404 HA injections, the overall rate of inflammation/infection within 3 days was low (up to 0.03%) with no significant difference between hylan G-F 20 and non-hylan G-F 20 groups.
• Specific procedural risks varied: hylan G-F 20 (2 mL, 3 weekly injections) showed lower SALR rates than Hyalgan/Supartz and Orthovisc but higher rates than Euflexxa.
• Among single injection products, hylan G-F 20 (6 mL) had lower SALR rates than Monovisc and Gel-One.

Conclusions:

• The study found no clear correlation between avian-derived or cross-linked HA products and SALR.
• Evidence suggests that the source (avian-derived) or cross-linking method of HA products are unlikely to be the primary drivers of SALR.