Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab
Authors' conclusion
In placebo- and NSAID controlled studies of SC tanezumab for OA, adjudicated CJSE, RPOA, and TJR most commonly occurred in patients treated with tanezumab and with more severe radiographic or symptomatic OA.
Study context
- Population
- Patients with moderate to severe hip or knee osteoarthritis (OA) in the phase III studies of SC tanezumab
- Participants
- 4,541 patients3 phase III studies
- Comparison
- SC tanezumab 2.5 mg or 5 mg vs placebo or NSAID
- Outcome
- Adjudicated composite joint safety endpoint (CJSE):
- RPOA1
- RPOA2
- Primary osteonecrosis
- Subchondral insufficiency fracture
- Pathological fracture
Methodological detailsplacebo-controlled (2 studies), NSAID-controlled (1 study), blinded external adjudication committee
- Placebo-controlled (2 studies)
- NSAID-controlled (1 study)
- Blinded external adjudication committee
Pooled result
As reported in the abstract
Adjudicated CJSE
- Overall adjudicated composite joint safety endpoint (CJSE): 145/4541 patients
- 3.2%
Further pooled results
Risk factors for adjudicated RPOA and total joint replacement (TJR)
- Adjudicated RPOA associated with more severe radiographic/symptomatic (joint pain, swelling, physical limitation) OA
- Risk of adjudicated RPOA1 highest with Kellgren-Lawrence (KL) grade 2 or 3 OA at baseline
- Risk of adjudicated RPOA2 or TJR highest with KL grade 4 joints at baseline
Joints with TJR, by adjudicated RPOA type
- Joints with adjudicated RPOA2 that had a TJR
- 14/26
- Joints with adjudicated RPOA1 that had a TJR
- 16/106
Original publication
Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab. Osteoarthritis Cartilage. Published 29 August 2023. doi:10.
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