Compared with patients with osteoarthritis (OA) receiving nonsteroidal anti-inflammatory drugs (NSAIDs), those receiving subcutaneous tanezumab were found to have clinically significant pain improvement at 16 weeks, according to study results presented at the American College of Rheumatology (ACR) Convergence 2020, held virtually from November 5 to 9, 2020.
Tanezumab is a monoclonal antibody shown to inhibit nerve growth factor. Researchers assessed the long-term safety and efficacy of tanezumab in OA (ClinicalTrials.gov Identifier: NCT02528188). The current analysis was aimed at evaluating the effect of tanezumab vs NSAIDs on clinically important improvements in patients with OA.
Eligible participants met certain ACR criteria, including hip or knee OA with x-ray confirmation; baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Physical Function subscale scores of 5 or more; baseline Patient Global Assessment of OA of “fair,” “poor,” or “very poor”; a history of inadequate pain relief with acetaminophen; and a history of inadequate pain relief with opioids, intolerance to opioids, or unwillingness to take opioids. All patients were receiving a stable dose of NSAIDs prior to study entry. Participants were randomly assigned to receive subcutaneous tanezumab (2.5 or 5.0 mg every 8 weeks) or oral NSAIDs twice daily over a treatment period of 56 weeks. The percentage of patients who achieved clinically important pain improvement (≥30%) from baseline WOMAC Pain subscale score was evaluated at weeks 16 and 56.
A total of 2996 patients received at least 1 dose of the blinded study drug and were included in analyses. Overall, 1312 patients (63.6%-66.5% women) completed the 56-week treatment period (42%-45% across groups). Baseline characteristics were similar across treatment groups; mean age ranged from 60.3 to 61.2 years and duration of OA in the index joint ranged from 7.9 to 8.1 years.
A greater percentage of patients in the tanezumab 2.5 mg and 5.0 mg groups vs the NSAID group achieved 30% or more, 50% or more, and 90% or more reductions in pain by week 16. Specifically, 56.3% and 57.6% of the tanezumab 2.5 mg and 5 mg groups, respectively, compared with 51.5% of the NSAID group (P ≤.05 for all) achieved 30% or more reduction in baseline pain by 16 weeks. In addition, 8.2% of the tanezumab 5 mg group compared with 4.9% of the NSAID group achieved 90% or more reduction in baseline pain at week 16 (P ≤.05 for all).
By week 56, the percentage of patients with clinically important pain reduction was comparable between the tanezumab and NSAID groups. In addition, there were no significant between-group differences in the number of patients achieving Minimum Clinically Important Improvement and/or Patient Acceptable Symptom State at weeks 16 and 56.
Overall, a majority of patients who received tanezumab vs NSAIDs had significantly more clinically important pain improvements at week 16. However, “The composite pain and function improvement and acceptable severity level after treatment was similar for tanezumab and NSAID,” the study authors wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. This study was supported by Pfizer and Eli Lilly & Company.
Hunter D, Neogi T, Churchill M, et al. Clinically important improvements in patients with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 1641.
This article originally appeared on Rheumatology Advisor