A 16-week phase 3 study in patients with osteoarthritis pain evaluating subcutaneous administration of Tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints.
The study has demonstrated that patients who received two doses of Tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their osteoarthritis, compared to those receiving placebo.
Tanezumab is part of an investigational class of pain medications known as nerve growth factor ( NGF ) inhibitors and in addition to osteoarthritis pain, is being evaluated for chronic low back pain ( CLBP ) and cancer pain ( due to bone metastases ).
Preliminary safety data showed that Tanezumab was generally well tolerated, with approximately 1% of patients discontinuing treatment due to adverse events. Rapidly progressive osteoarthritis was observed in Tanezumab-treated patients at a frequency of less than 1.5%, and was not observed in the placebo arm.
There were no events of osteonecrosis observed in the trial. No new safety signals were identified.
The phase 3 OA ( osteoarthritis ) study was a 16-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trial evaluating the efficacy and safety of subcutaneous administration of Tanezumab compared to placebo in patients with osteoarthritis of the knee or hip.
The trial included a 24-week safety follow-up period. In the study, patients were enrolled with moderate to severe osteoarthritis pain who had experienced inadequate pain relief with other treatment options for osteoarthritis pain or were unable to take other pain medications.
A total of 698 patients were randomized to three treatment groups in a 1:1:1 ratio to receive two injections over the 16-week study, once every eight weeks. One group received two doses of placebo, the second group received two doses of Tanezumab 2.5 mg, and the third group received one dose of Tanezumab 2.5 mg followed by one dose of Tanezumab 5 mg eight weeks later.
The efficacy of Tanezumab versus placebo was measured by changes from baseline at 16 weeks in the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) Pain subscale, the WOMAC Physical Function subscale, and the patient’s Global Assessment of osteoarthritis. ( Xagena )
Source: Pfizer & Lilly, 2018