Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

Summary

The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.

Timeline

Start

2015-07-21

Primary completion

2018-10-05

Completion

2019-02-27

Outcome

Mixed primary results

registry Tanezumab 5 mg vs NSAID; p = 0.0148; LS Mean Difference -0.26 (95% CI -0.46 to -0.05); ANCOVA NCT02528188 ↗

registry Tanezumab 5 mg vs NSAID; p = 0.0030; LS Mean Difference -0.31 (95% CI -0.52 to -0.11); ANCOVA NCT02528188 ↗

registry Tanezumab 5 mg vs NSAID; p = 0.3431; LS Mean Difference -0.04 (95% CI -0.11 to 0.04); ANCOVA NCT02528188 ↗

registry Tanezumab 2.5 mg vs NSAID; p = 0.1597; LS Mean Difference -0.15 (95% CI -0.36 to 0.06); ANCOVA NCT02528188 ↗

Publications

• Schnitzer TJ, Conaghan PG, Berenbaum F, Abraham L, Cappelleri JC, Bushmakin AG, Viktrup L, Yang R, Brown MT. Effect size varies based on calculation method and may affect interpretation of treatment effect: an illustration using randomised clinical trials in osteoarthritis. Adv Rheumatol. 2024 Apr 22;64(1):31. doi: 10.1186/s42358-024-00358-y.
• Guermazi A, Roemer FW, Kompel AJ, Diaz LE, Crema MD, Brown MT, Hickman A, Pixton GC, Viktrup L, Fountaine RJ, Burr A, Sherlock SP, West CR. Inter-Reader Consistency and Exclusionary Findings During Radiographic Screening for Phase 3 Trials of Tanezumab in Patients With Osteoarthritis. Osteoarthr Imaging. 2022 Sep-Dec;2(3-4):100082. doi: 10.1016/j.ostima.2022.100082. Epub 2022 Nov 15.
• Carrino JA, McAlindon TE, Schnitzer TJ, Guermazi A, Hochberg MC, Conaghan PG, Brown MT, Burr A, Fountaine RJ, Pixton GC, Viktrup L, Verburg KM, West CR. Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab. Osteoarthritis Cartilage. 2023 Dec;31(12):1612-1626. doi: 10.1016/j.joca.2023.08.010. Epub 2023 Aug 29.
• Shoji S, Suzuki A, Nouri P, Cai CH, Gaitonde P, Marshall S. Prediction of relative change in free nerve growth factor following subcutaneous administration of tanezumab, a novel monoclonal antibody to nerve growth factor. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1358-1370. doi: 10.1002/psp4.13015. Epub 2023 Jul 31.
• Hunter DJ, Schnitzer TJ, Hall J, Semel D, Davignon I, Cappelleri JC, Bushmakin AG, Abraham L. Time to first and sustained improvement in WOMAC domains among patients with osteoarthritis receiving tanezumab. Osteoarthr Cartil Open. 2022 Jul 2;4(3):100294. doi: 10.1016/j.ocarto.2022.100294. eCollection 2022 Sep.
• Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.
• Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.
• Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.
• Neogi T, Hunter DJ, Churchill M, Shirinsky I, White A, Guermazi A, Omata M, Fountaine RJ, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Observed efficacy and clinically important improvements in participants with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study. Arthritis Res Ther. 2022 Mar 29;24(1):78. doi: 10.1186/s13075-022-02759-0.
• Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.
• Brown MT, Sandroni P, Low PA, Gorson KC, Hunter DJ, Pixton GC, Fountaine RJ, Viktrup L, West CR, Verburg KM. Neurological safety of subcutaneous tanezumab versus NSAID in patients with osteoarthritis. J Neurol Sci. 2022 Mar 15;434:120184. doi: 10.1016/j.jns.2022.120184. Epub 2022 Feb 14.
• Hochberg MC, Carrino JA, Schnitzer TJ, Guermazi A, Walsh DA, White A, Nakajo S, Fountaine RJ, Hickman A, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Long-Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial. Arthritis Rheumatol. 2021 Jul;73(7):1167-1177. doi: 10.1002/art.41674. Epub 2021 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	100 mg	Oral
Comparator	Diclofenac	Other / unclassified	75 mg	Oral
Comparator	Naproxen	Small molecule	500 mg	Oral
Subject	Tanezumab	Monoclonal antibody	2.5 mg	Subcutaneous
Subject	Tanezumab	Monoclonal antibody	5 mg	Subcutaneous

Indications