Thomas J. Schnitzer
TORONTO — A monoclonal antibody directed against nerve growth factor, tanezumab, was associated with improvements in both WOMAC pain and function in a cohort of patients with knee and hip OA, according to findings presented here.
Thomas J. Schnitzer, MD, PhD, professor of physical medicine and rehabilitation, anesthesiology, and rheumatology at the Northwestern University Feinberg School of Medicine, presented primary efficacy data for the current trial. “Tanezumab has been shown in previous studies done some years ago in an IV formulation to have very significant efficacy in musculoskeletal pain,” he said. “This is the first of two phase 3 studies. The goal was to look at two different dose approaches.”
The study included 231 patients who received two doses of tanezumab (Pfizer, Eli Lilly) at 2.5 grams 8 weeks apart, 233 patients treated with a 2.5-mg dose that was titrated up to 5 mg for the second dose, and 232 patients treated with placebo.
Tanezumab was associated with improvements in both WOMAC pain and function in a cohort of patients with knee and hip OA, according to findings.
Knee OA was reported in 85% of the patient population. The remaining 15% had hip OA.
WOMAC pain and KL grade 2 or higher comprised the basis of the inclusion criteria, according to Schnitzer. “The inclusion criteria were fairly standard for knee and hip OA trials,” he said. “However, what makes this trial a little different from previous trials is that patients had to have had a documented inadequate response to at least three previous drugs, such as acetaminophen, NSAIDS, or opioids, or a contraindication to those drugs.”
Efficacy endpoints included WOMAC pain and function, along with safety. Schnitzer added that benchmarks of 30%, 50%, or 70% reduction in WOMAC pain were assessed at each clinic visit. Patients measured pain using a daily diary. “This was a population of people with a fairly severe degree of pain,” he said.
Results showed a statistically significant reduction in WOMAC pain and function, Schnitzer reported. He noted that the onset of response usually required just 3 to 5 days, with the optimal response reported 4 weeks after the dose.
The strongest best responses occurred at 12 weeks, which Schnitzer pointed out was 4 weeks after the second dose. “This suggests an immediate effect of the antibody that tends to wane,” Schnitzer said.
“WOMAC physical function mirrored pain, as it usually does,” he added.
Self-reported results from the pain diary were comparable to the WOMAC findings, according to Schnitzer. However, he said that patients who continued to have pain tended to have that pain through the full 16 weeks. “For patients who responded, with continued dosing, there continues to be a maintenance benefit through the 16 weeks,” he concluded. – by Rob Volansky
Bessette L, et al. Abstract #88. Presented at: OARSI 2019 World Congress on Osteoarthritis; May 2-5; Toronto.
Disclosure: Schnitzer reports associations with AbbVie, Aptinyx, Astellas Pharma, Fidia Pharma USA, Health Advances, Pfizer, Regeneron Pharmaceuticals, Sanofi-Aventis US, and TLC Biopharmaceuticals.