A study presented at the in Atlanta evaluated the efficacy and long-term risk of joint safety events with subcutaneous tanezumab vs NSAIDs in patients with osteoarthritis.
In this exclusive 鶹ý video, , principal and consultant at SDG, discusses .
Following is a transcript of his remarks:
Simon: This has been around for some time, there's been a lot of controversy associated with this biologic therapy. It is an extremely helpful drug to decrease pain in these various different disease states. In fact, at the initial studies, there was about a 70% to 80% benefit with IV only every eight weeks. It is now a subcutaneous drug, but unfortunately associated with a very significant pain relief, there is a very high rate of difficult problems associated with destruction of joints as a side effect. Therefore, the FDA and EMA have required the companies to study this in large trials.
There is now a trial finished of over 2,000 patients comparing two different doses of the anti-NGF therapy as a subcutaneous drug given every eight weeks and followed for 80 weeks total compared to non-steroidal anti-inflammatory drugs as standard of care associated with osteoarthritis. This study surprisingly demonstrated that the two doses of the anti-NGF had a dose response relationship for destruction of the joints, which was not reflected in the use of non-steroidal anti-inflammatory drugs, thus suggesting this is clearly related to the analgesic effects of the anti-NGF. But we still do not know the exact etiology of it. The pain relief was adequate and the same as achieved with a non-steroidal, but now the real question will be whether or not we can identify a patient population that is appropriate for the benefit associated with the risk. That remains to be determined both by the regulatory bodies as well as the academic and clinical community.
In understanding who to use this drug for, we would probably need to do another study and understand the exact way to deliver the drug. It clearly has very significant importance, especially in this day and age of the opioid crisis. To be able to come up with another therapy that is actually not available yet, that could actually lead to substantive pain improvement, we have to identify exactly who those patients would be and who would be served by being given this drug, even with the inherent risk associated with the drug. Then, furthermore, to really understand the dose and how to use it.