Tanezumab in Patients with Knee or Hip Osteoarthritis at the 2017 ACR Annual Meeting in San Diego

You might recall that I had been very critical about tanezumab in osteoarthritis [1]. There has been one abstract/poster on tanezumab at the 2017 ACR Annual Meeting in San Diego. Let’s have a closer look!

C.A. Birbara and colleagues presented [2]: “Efficacy and Safety of Subcutaneous Tanezumab in Patients with Knee or Hip Osteoarthritis (NCT01089725)”. The authors concluded: “SC TNZ [subcutaneous tanezumab] provided improvements in Pain, Physical Function, and PGAOA [Patient’s Global Assessment of Osteoarthritis] at all doses. Efficacy and safety of SC TNZ were generally similar to IV [intravenous] in patients with OA [osteoarthritis] pain.”

If you look up NCT01089725 [3], you’ll find a study with this title: “Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee”. Moreover you find this: “This study was terminated on 08 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.” Last update on this study had been on July 3, 2013. Am I missing something?

In the study that C.A. Birbara presented we find under methods: “Patients (N=379) with knee or hip OA were randomized and treated with placebo (n=72), TNZ 2.5 mg SC (n=74), 5 mg SC (n=63), 10 mg SC (n=86) or 10 mg IV (n=84) every 8 weeks.” In Clinical Trials we find: “Actual Enrollment: 385 participants”. Do we look at hitherto unpublished data of an older study? I’m growing even more skeptical about tanezumab.

So, we’ve got some patient-reported outcome measures. Where are structural outcome measures? Why aren’t we told if tanezumab is better than naproxen, celecoxib, or oxycodone?

Until further notice I’ll stay skeptical about tanezumab in osteoarthritis.

Links: 

[1] http://rheumatologe.blogspot.de/2015/12/tanezumab-in-osteoarthritis-at-acr-2015.html

[2] Birbara CA, Dabezies EJ, Burr AM, Fountaine RJ, Smith MD, Brown MT, West CR, Arends RH, Verburg KM. Efficacy and Safety of Subcutaneous Tanezumab in Patients with Knee or Hip Osteoarthritis (NCT01089725) [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-subcutaneous-tanezumab-in-patients-with-knee-or-hip-osteoarthritis-nct01089725/. Accessed March 16, 2018.

[3] https://clinicaltrials.gov/ct2/show/NCT01089725

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