The following article is a part of conference coverage from the 2019 American College of Rheumatology/The Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the 2019 ACR/ARP Annual Meeting.
ATLANTA — Patients with osteoarthritis (OA) who are switched from nonsteroidal anti-inflammatory drugs (NSAIDs) to tanezumab experience improvement in pain and physical functioning, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia. Investigators also found that the safety and tolerability profile of tanezumab was consistent with prior studies.
Researchers examined the general efficacy, safety, and tolerability of switching from NSAID use to subcutaneous tanezumab, instead of further oral NSAID treatment in patients with OA and moderate to severe pain.
Data from patients with either hip or knee OA were included, according to the ACR criteria with x-ray confirmation, baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function subscale scores of ≥5, baseline Patient’s Global Assessment of OA (PGA-OA) of “fair,” “poor,” or “very poor, and a history of inadequate pain relief with acetaminophen or tramadol, or unwillingness to take an opioid.
Patients were randomly assigned to receive either tanezumab (2.5 mg or 5 mg subcutaneously every 8 weeks) or an NSAID (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended-release 75 mg orally twice daily).
A total of 3021 patients (mean age, 60.3±61.2 years) were randomly assigned to a treatment group, of whom 2996 were included in both the safety and efficacy analyses. Overall, 1312 patients completed the treatment period (45%, 42%, and 45% of the tanezumab 2.5 mg, tanezumab 5 mg, and NSAID groups, respectively); 2227 patients completed the safety period (74%, 76%, and 73%, respectively). Duration of OA was 8.5 to 9.1 years; for 85% to 86% of patients, the knee was the OA index joint.
At 16 weeks, compared with patients in the NSAID group, patients in the tanezumab 5 mg group demonstrated a statistically significant improvement in WOMAC Pain and WOMAC Physical Function. Compared with the NSAID group, improvement in co-primary efficacy end points (change from baseline to week 16 in WOMAC Pain and Physical Function, and PGA-OA scores) in the tanezumab 2.5 mg group was not significantly different. At week 56, neither dose of tanezumab was significantly different than in the NSAID group.
Overall incidence of treatment-emergent adverse events and serious treatment-emergent adverse events were highest in the tanezumab 5 mg group, but were similar among the tanezumab 2.5 mg and NSAID groups. Eight deaths were recorded in the tanezumab-treated groups, but none of them were considered treatment-related.
“Patients who switched from NSAID to tanezumab 5 mg…had greater improvement in OA pain and physical function…at week 16 than patients who continued NSAID therapy,” the researchers concluded. “Differences in efficacy end points between tanezumab 2.5 mg subcutaneous and NSAID did not reach statistical significance.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Hochberg MC, Carrino J, Schnitzer T, et al. Subcutaneous tanezumab vs NSAID for the treatment of osteoarthritis: efficacy and general safety results from a randomized, double-blind, active-controlled, 80-week, phase-3 study. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 1302.