Knee osteonecrosis incidence from two real-world data sources.

Area of Science:

• Orthopedics
• Rheumatology
• Pharmacovigilance

Background:

• Anti-nerve growth factor (NGF) therapies show promise for osteoarthritis (OA) pain.
• A joint safety signal, including osteonecrosis, was observed in clinical trials.
• The contribution of OA natural history versus anti-NGF agents to these events is unclear.

Purpose of the Study:

• To determine the incidence of knee osteonecrosis in real-world osteoarthritis (OA) populations.
• To contextualize the risk of osteonecrosis observed in anti-nerve growth factor (NGF) trials.

Main Methods:

• Utilized UK IQVIA Medical Research Data (IMRD) for incident knee OA (2000-2018).
• Assessed knee osteonecrosis incidence using various definitions in IMRD.
• Evaluated knee osteonecrosis incidence in US Medicare beneficiaries undergoing knee replacement (2011-2014).

Main Results:

• In IMRD (122,343 OA patients), knee osteonecrosis incidence was 0.006-0.10%.
• Prior to knee replacement in IMRD (81,807 patients), incidence was 0.004-0.06%.
• In US Medicare (316,593 knee replacements), incidence was 0.24-0.7%.

Conclusions:

• Knee osteonecrosis is a rare event in patients with knee osteoarthritis.
• Incidence remains low even in the year preceding knee replacement surgery.
• These findings provide crucial context for interpreting safety data from anti-NGF trials.