Non-Opioid Therapy Significantly Reduces Pain in Patients with Osteoarthritis

A non-opioid pain therapy, tanezumab (Eli Lilly and Pfizer), significantly improved pain and function in patients with osteoarthritis (OA), according to new data from a phase 3 study.

Treatments for OA, a progressive disease that can cause ongoing debilitating pain, are currently limited and many patients are unable to find relief from available options. If approved, tanezumab would be a first-in-class non-opioid treatment for OA pain and chronic low back pain, for which it is also being studied, according to Pfizer.

The phase 3 OA study evaluated changes from baseline to 16 weeks for 3 co-primary endpoints of pain intensity and physical function, which was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale and the patient’s overall assessment of their OA.

For the study, subcutaneous administration of tanezumab was compared with placebo in 698 patients with OA of the knee or hip. Patients who were enrolled had moderate-to-severe OA pain and had experienced inadequate pain relief with other treatment options or were unable to take pain medications.

Over the 16-week treatment period, patients received 2 injections once every 8 weeks. One group received 2 doses of placebo, the second group received 2 doses of tanezumab 2.5 mg, and the third group received 1 dose of tanezumab 2.5 mg followed by 1 dose of tanezumab 5 mg 8 weeks later.

Compared with a placebo, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function, and patients’ global assessment of their OA at 16 weeks of treatment. More than half of patients treated with both dosing regimens experienced a 50% or greater reduction in OA pain, according to the data.

“The results demonstrated by tanezumab in this study are particularly meaningful, given that patients had moderate-to-severe pain and were unable to achieve adequate pain relief with other treatment options, including opioids and [non-steroidal anti-inflammatory drugs],” Ken Verburg, tanezumab development team leader, Pfizer Global Product Development, said in a statement. “Our goal is to be able to offer tanezumab as a potential non-opioid treatment option for these patients suffering from osteoarthritis pain.”

The most common adverse effects reported in the study were nasopharyngitis, pain in extremities, and paresthesia, which had a higher frequency in both tanezumab treatment groups compared with placebo. Overall, tanezumab was well-tolerated, with 0.4% and 1.3% of patients in the tanezumab 2.5 mg and 2.5/5 mg arms, respectively, discontinuing treatment due to adverse effects compared with 1.3% of patients in the placebo arm.

The study data were presented at the 2018 American College of Rheumatology/Association of Rheumatology for Health Professionals Annual Meeting in Chicago.

Reference

Complete results from first study in ongoing phase 3 program for tanezumab demonstrated significant improvement in pain and function in osteoarthritis patients [news release]. Pfizer’s website. https://bit.ly/2yKvqmh. Accessed October 24, 2018.