Tanezumab in Osteoarthritis at the ACR 2015 Meeting in San Francisco

There has been one publication on tanezumab in osteoarthritis at the ACR 2015 Annual Meeting in San Francisco. After 2013 we didn’t hear much about tanezumab, because the US FDA had imposed a partial clinical hold on studies due to unexpected adverse events. Pfizer announced earlier this year to resume phase 3 studies on chronic pain for tanezumab (see link below). “Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity.”

P.G. Conaghan talked on: “What is new: osteoarthritis” at the 2013 EULAR Annual Meeting in Madrid. “New evidence supporting the analgesic efficacy of anti-nerve growth factor monoclonal antibodies has been provided with another RCT employing tanezumab; managing potential side effects of this class remains problematic.”

Leslie Tive and colleagues, who worked in the original studies, presented: “Pooled Efficacy and Safety from Phase 3 Controlled Studies of Tanezumab in Patients with Osteoarthritis”. Methods: “Four, phase 3 placebo (PBO)-controlled clinical trials of TNZ in patients with moderate-to-severe OA of the knee or hip completed before the clinical hold were pooled to evaluate efficacy and 9 phase 3 controlled OA studies were pooled to evaluate safety. […]”. Pooled data from older studies … “Patients received 1 to 3 injections of intravenous TNZ 2.5, 5, or 10 mg every 8 weeks, naproxen 500 mg twice daily (BID), celecoxib 100 mg BID, oxycodone controlled release 10-40 mg BID, or PBO.” In Results we read: “TNZ 10 mg but not 2.5 or 5 mg was associated with a higher rate of rapidly progressive OA than active comparator.” Conclusion: “TNZ provides significant improvement of pain, physical function, and PGA of OA. Non-joint-related safety was similar in patients treated with TNZ 2.5-10 mg versus active comparator but increased versus PBO-treated patients.”

I have my problems with the reappearance of tanezumab in osteoarthritis. A monoclonal autoantibody in osteoarthritis pain (not to treat structural deterioration)! The studies didn’t last long enough to evaluate long term safety. This evaluation doesn’t tell us, if tanezumab is better than naproxen, celecoxib, or oxycodone. It tells us that it’s better than placebo. Hooray! But let’s see if the phase 3 program comes up with stressable data.

References:

Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab http://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_lilly_preparing_to_resume_phase_3_chronic_pain_program_for_tanezumab

P.G. Conaghan: “WHAT IS NEW: OSTEOARTHRITIS”. Abstract No. SP0098. DOI: 10.1136/annrheumdis-2015-eular.6817 / http://ard.bmj.com/cgi/content/long/74/Suppl_2/25-c

Tive L, Radin D, Bello A, Nguyen H, Brown MT, West CR, Verburg KM. Pooled Efficacy and Safety from Phase 3 Controlled Studies of Tanezumab in Patients with Osteoarthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/pooled-efficacy-and-safety-from-phase-3-controlled-studies-of-tanezumab-in-patients-with-osteoarthritis/. Accessed December 7, 2015.

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