First biologic for osteoarthritis triggered tough talk about trade-offs

Drug name: tanezumab
Manufacturer: Pfizer/Lilly
Condition: Osteoarthritis

In March 2021, a joint FDA advisory committee rejected a risk mitigation proposal for Pfizer and Eli Lilly’s osteoarthritis (OA) drug tanezumab, concluding that the drug’s safety risk to patients is too high.

Condition overview

Osteoarthritis (OA) is a common form of arthritis. About 27 million Americans have OA; 11 million have moderate-to-severe OA. OA occurs most frequently in the hands, hips, and knees. As cartilage breaks down in a joint, the underlying bone is damaged, causing pain, stiffness, and swelling. As OA progresses, patients may experience disability and reduced function. They may no longer be able to work or do daily tasks.1

Depending on the patient, physical and occupational therapy, and/or a program of regular, gentle exercise can strengthen areas surrounding the weakened joint, improve flexibility and reduce pain. This may extend the patient’s ability to participate in daily living activities.2

Treatment / Medications

There are many medications available for the pain associated with OA including:1

• Topical and oral nonsteroidal anti-inflammatory drugs (NSAIDs
• Oral cyclooxygenase-2 selective inhibitors (COX-2s)
• Acetaminophen
• Intra-articular corticosteroids or viscosupplements
• Tramadol
• Duloxetine
• Glycosaminoglycans
• Opioids

Each drug therapy option has its own side effects that need to be weighed against the potential for pain relief. None of these treatments can slow or reverse the destruction of joint structures.

About one third of patients with moderate-to-severe OA pain will have an inadequate response to these treatments. And surgical replacements for hips and knees have become commonplace. Nearly 800,000 knee replacement surgeries, for example, are performed every year in the U.S.3

Tanezumab

Tanezumab is a monoclonal antibody nerve growth factor (NGF) inhibitor.2 NGF levels increase in the body as a result of injury, inflammation or chronic pain states. Tanezumab works by targeting, binding to and inhibiting NGF. By stopping NGF, tanezumab helps to keep pain signals from reaching the spinal cord and brain. This is different than the way other typical pain relievers work, like opioids and analgesics. And in studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.4,5

In trials, Tanezumab was taken as a bimonthly subcutaneous injection administered by a health care professional.

Comparable pain relief that risks faster disease progression

Studies have shown that tanezumab provides similar pain relief when compared with NSAIDS. But patients who used tanezumab increased their risk of rapidly progressive OA. These patients would then had an earlier need for total joint replacement compared to other treatment options and placebo.

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Drug names are the property of their respective owners.

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References

1. Uptodate.com Search term: osteoarthritis. Accessed in September 2020.

2. https://www.mayoclinic.org/diseases-conditions/osteoarthritis/diagnosis-treatment/drc-20351930

3. https://orthoinfo.aaos.org/en/treatment/total-knee-replacement#:~:text=Total%20knee%20replacements%20are%20one,year%20in%20the%20United%20States.

4. Lilly.com Tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis. Accessed in September 2020: https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-regulatory-submission-tanezumab-potential-first

5. https://www.drugs.com/clinical_trials/pfizer-lilly-announce-positive-top-line-results-phase-3-trial-tanezumab-osteoarthritis-oa-pain-17872.html

6. https://www.the-rheumatologist.org/article/fda-considers-tanezumab-application-for-chronic-oa-pain/

https://www.pharmaceutical-technology.com/news/fda-pfizer-tanezumab-safety/