Session Information
Session Title: AA 2021 Virtual Posters - Pain and Spine Medicine
Session Time: None. Available on demand.
Disclosures: John Carrino, MD, MPH: Covera (Products/Services: No) (Consultant/Advisory Board)Globus (Products/Services: No) (Consultant/Advisory Board)Image Analysis Group (Products/Services: No) (Consultant/Advisory Board)Pfizer (Products/Services: Yes) (Consultant/Advisory Board)Simplify Medical (Products/Services: No) (Consultant/Advisory Board)
Objective: Describe baseline population characteristics, adjudicated joint safety outcomes and subgroup analyses in 3 osteoarthritis (OA) tanezumab studies.
Design: Combined analysis of data from 3 randomized, phase 3 studies.Setting : Multicenter clinical trials.Participants : Patients with moderate to severe OA.
Interventions: NCT02697773: subcutaneous placebo, tanezumab 2.5 mg, or 2.5 mg then 5 mg (tanezumab 2.5/5 mg) every 8 weeks for 16 weeks. NCT02709486: subcutaneous placebo, tanezumab 2.5 mg, or tanezumab 5 mg every 8 weeks for 24 weeks. NCT02528188: subcutaneous tanezumab 2.5 mg or 5 mg every 8 weeks, or twice-daily oral nonsteroidal anti-inflammatory drug (NSAID), for 56 weeks.
Main Outcome Measures: Joint safety outcomes were adjudicated by a blinded external Adjudication Committee. The adjudicated composite joint safety endpoint (CJSE) included primary osteonecrosis (ON), rapidly progressive OA type 1 (RPOA1) or type 2 (RPOA2), subchondral insufficiency fracture (SIF), or pathological fracture. Subgroups were cross-tabulated to investigate potential associations with outcomes descriptively with no formal statistical analysis.
Results: At baseline, maximum Kellgren-Lawrence (KL) grade of any joint and number of joints with KL grade ≥2 were similar across treatment groups. A total of 451 patients were evaluated by the blinded adjudication committee; 145 were adjudicated to have a primary outcome that comprised the CJSE: RPOA1 (69% 100/145), RPOA2 (17% 24/145), SIF (12% 18/145), and ON (2% 3/145). The proportion of patients with adjudicated CJSE was higher in tanezumab-treated patients relative to placebo or NSAID and the incidence increased with increasing dose of tanezumab. Subgroup investigations of CJSE showed possible associations for baseline disease severity and adverse events of arthralgia and joint swelling.Conclusions: The proportion of patients with adjudicated CJSE was higher in tanezumab-treated patients relative to placebo or NSAID and the incidence increased with increasing dose of tanezumab. Subgroup analyses did not reveal an association of CJSE with efficacy response. Funded by Pfizer/Eli Lilly & Co.
Level of Evidence: Level II
To cite this abstract in AMA style:
Carrino J, Verburg K, Burr A, Pixton G, Viktrup L, West C, Brown M. Joint Safety with Subcutaneous Tanezumab: Integrated Analyses from Randomized Controlled Phase 3 Studies in Patients with Osteoarthritis [abstract]. PM R. 2021; 13(S1)(suppl 1). https://pmrjabstracts.org/abstract/joint-safety-with-subcutaneous-tanezumab-integrated-analyses-from-randomized-controlled-phase-3-studies-in-patients-with-osteoarthritis/. Accessed May 11, 2025.« Back to AAPM&R Annual Assembly 2021
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/joint-safety-with-subcutaneous-tanezumab-integrated-analyses-from-randomized-controlled-phase-3-studies-in-patients-with-osteoarthritis/