Tanezumab Effective OA Treatment

A new study published in the Journal of Pain Research found that tanezumab successfully treated patients with osteoarthritis (OA), even those with severe disease, diabetes, and older age.

“Despite a number of treatment options and guidelines for the management of pain associated with OA, many patients report dissatisfaction with or the need to change medications because adequate pain control is not achieved,” the researchers wrote. “[Nonsteroidal anti-inflammatory drugs] and opioids are standard pharmacologic treatments for OA pain, but these are often associated with increased risk of adverse events (AEs), including gastrointestinal and cardiovascular AEs, multiorgan failure, and potential for dependence or addiction.” Older patients and patients who have diabetes have a greater risk for AEs, the study authors added.

The researchers gathered data from 13 trials pertaining to patients with moderate-to-severe hip or knee OA. Four trials assessed the efficacy of tanezumab, while nine evaluated its safety. Treatments included intravenous tanezumab, tanezumab plus an oral NSAID (naproxen, celecoxib, or diclofenac), active comparator (naproxen, celecoxib, diclofenac, or oxycodone), and placebo. Efficacy was measured by change from baseline to week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores; Patient’s Global Assessment (PGA) of OA; and percentage of patients with ≥30%, ≥50%, ≥70%, and ≥90% improvement in WOMAC pain. Subgroup analyses measured the aforementioned outcomes in at-risk patients with diabetes, severe OA symptoms, and age ≥65 years.

An experimental non-opioid drug shows promise in treating low #backpain. But is it safe to use? #Pfizer #EliLilly #tanezumab #osteoarthritis #FDA #chronicpain #arthritis https://t.co/4XmMzf13lO

— Pain News Network (@PainNewsNetwork) February 23, 2019

Tanezumab Safety

The nine phase III studies measuring safety included a total of 7,491 patients; 1,171 (15.6%) had diabetes, 1,674 (22.3%) had severe OA symptoms, and 2,695 (36.0%) were aged ≥65 years at baseline.

Among the safety studies, “incidence rates of AEs, withdrawals due to AEs, and serious AEs in patients treated with tanezumab were similar to patients receiving active comparator but higher compared with placebo-treated patients,” according to the study authors. “Combination of tanezumab with NSAIDs was associated with slightly higher rates of these AEs than with tanezumab monotherapy, placebo, or active comparator.” Subgroup safety was generally similar to safety in the overall assessment.

In the overall analysis, arthralgia, headache, pain in extremity, paresthesia, peripheral edema, OA, nasopharyngitis, and hypoesthesia were the most commonly reported AEs, and occurred at similar rates in all treatment arms and subgroups.

Just reading about thenphase III trial of tanezumab-what several reputable news sources deemed “the new Lternative to opioids. It’s a monoclonal. If marketed, will this cost more or less than$50 k/yr? How many insurers would pay? Joint Pfizer-Lilly trial

— Jonathan Mayer, PhD (@jmayer0716) January 5, 2019

Tanezumab Efficacy

Among the four trials evaluating efficacy, there were 744 placebo patients, 327 tanezumab 2.5 mg patients, 743 tanezumab 5 mg patients, 748 tanezumab 10 mg patients, and 417 naproxen patients; the number of patients with diabetes for each group was 88, 50, 90, 75, and 60, respectively; the number of severe OA symptom patients in each group was 192, 88, 179, 170, and 113, respectively; and the number of patients with older age in each group was 275, 124, 269, 268, and 151, respectively.

At 16 weeks, tanezuamb 2.5–10 mg and twice daily naproxen 500 mg were associated with significantly improved WOMAC pain, WOMAC physical function, and PGA of OA versus placebo; for these same outcomes, higher tanezumab doses (5 and 10 mg) were superior to naproxen. Tanezumab was associated with improvement across all subgroups, notably at 5 and 10 mg, while tanezumab 2.5 mg was not largely different from placebo for WOMAC pain in diabetic patients and patients with severe OA symptoms; for WOMAC physical function in patients with severe OA symptoms; and for PGA of OA in patients with severe OA symptoms. The difference between tanezumab 5 and 10 mg and naproxen in subgroup analyses was not always significant, notably among smaller patient populations.

There is a potential new treatment for knee/hip pain. If #tanezumab garners FDA approval, it will become the first in a new class of medications called nerve growth factor (NGF) inhibitors: https://t.co/qap5u6ZAqS #Arthritis365 #spoonie pic.twitter.com/p40bfZfOzw

— CreakyJoints.org (@CreakyJoints) December 4, 2018

“In the overall analysis, tanezumab 2.5–10 mg provided significantly greater improvement in the percentage of patients with WOMAC pain reduction ≥30%, ≥50%, ≥70%, and ≥90% compared with placebo,” the study authors wrote. “Treatment with tanezumab 5 or 10 mg also resulted in higher percentage of improvement in patients across all categories compared with naproxen, except tanezumab 10 mg at ≥30% response.” The naproxen patients only saw greater improvement compared to placebo in the ≥30% and ≥50% response categories.

The researchers concluded that tanezumab is a safe, effective choice for OA patients, including high-risk patients.

“This profile indicates that tanezumab has significant potential to be a treatment option that will add to the management of chronic OA pain in diverse patient populations,” the authors concluded.

Pfizer, Eli Lilly report positive late-stage data for tanezumab in chronic low back pain https://t.co/Im0UM8jsPX

— FirstWord Pharma (@fwpharma) February 19, 2019