Tanezumab may effectively improve pain and physical function in patients with severe hip or knee osteoarthritis pain who are not responsive to commonly used analgesics, according to research presented at the 2019 European League Against Rheumatism (EULAR) Congress, held June 12-15, in Madrid, Spain.
This randomized double-blind placebo-controlled study conducted in Japan and Europe aimed to examine the safety and efficacy of tanezumab — a monoclonal antibody raised against nerve growth factor — in individuals reporting moderate to severe pain associated with osteoarthritis of the hip or knee who had indicated intolerance to or inefficacy of nonsteroidal anti-inflammatory drugs, acetaminophen, and tramadol or opioids.
Patients were given subcutaneous injections of 2.5 mg or 5 mg tanezumab, or placebo (n=282) at baseline, and at weeks 8 and 16, and followed-up for 24 weeks. The study’s primary outcomes were changes at week 24 compared with baseline in pain (evaluated with the Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] Pain), physical function (assessed with the WOMAC Physical Function), and in patient global assessment (PGA; evaluated with the PGA of osteoarthritis [PGA-OA]).
Treatment with tanezumab 2.5 mg (n=283) was found to improve pain (P ≤.01) and function (P ≤.001), but not PGA-OA at 24 weeks compared with placebo, and therefore was not deemed efficacious. Tanezumab administered at 5 mg (n=284) was found to improve pain and physical function (P ≤.001), as well as PGA-OA (P ≤.01) compared with placebo at the 24-week follow-up.
The prevalence of adverse events and related treatment discontinuations was comparable between groups, although a greater number of serious adverse events were reported by participants treated with tanezumab (2.5 mg, n=8; 5 mg, n=9) compared with placebo (n=3).
Two of the patients treated with tanezumab 5 mg died, but these deaths were deemed unrelated to the medication.
A total of 2, 5, and 1 study participants treated with placebo, tanezumab 2.5 mg, and tanezumab 5 mg, respectively, left the study because of adverse events. The most common adverse events (ie, reported by ≥3% of participants from any of the 3 groups) included arthralgia (placebo, 12%; tanezumab 2.5 mg, 9.5%; tanezumab 5 mg, 8.1%), nasopharyngintis (placebo, 8.9%; tanezumab 2.5 mg, 10.9%; tanezumab 5 mg, 7.7%), back pain, headache, and osteoarthritis. Among those adverse events, osteoarthritis was the only one occurring more frequently (ie, with a difference >1%) in patients treated with tanezumab at either dose vs placebo.
A total of 6.7%, 7.8%, and 7.0% of participants who received placebo, tanezumab 2.5 mg and 5 mg, respectively, required total joint replacements. These interventions, as well as other joint safety events, were considered part of the expected progression of the disease for 73.4% of participants who experienced them.
A total of 1.8% and 3.2% of participants treated with tanezumab 2.5 mg and 5 mg, respectively, experienced joint safety events pre-specified in this study (including rapidly progressive osteoarthritis, subchondral insufficiency fracture, and primary osteonecrosis), with none reported in the placebo group.
Disclosures: Multiple study authors report financial disclosures. Please refer to original abstract for comprehensive list.
Berenbaum F, Blanco FJ, Guermazi A, Vignon E, Miki K, Yamabe T, et al. Subcutaneous tanezumab for osteroarthritis pain: A 24-week phase 3 study with a 24-week follow-up. Presented at: European League Against Rheumatism (EULAR) Congress 2019; June 12-15, 2019; Madrid, Spain. Abstract LB0007.