Abstract Details

Title Peripheral Neurological Safety of Subcutaneous Tanezumab versus Placebo or NSAIDs in Patients with Osteoarthritis.

Topic Pain

Presentation(s) S24 - Pain and Palliative Care: Targeted Therapy in Chronic Pain Disorders (4:00 PM-4:08 PM)

Poster/Presentation
Number 001

Background

Tanezumab, an analgesic monoclonal antibody against nerve growth factor, has been associated with abnormal peripheral sensation (APS) in prior studies.

Objective

To evaluate the peripheral nerve safety of subcutaneous (SC) tanezumab versus placebo or nonsteroidal anti-inflammatory drugs (NSAIDs).

Design/Methods Safety of SC tanezumab versus placebo was assessed using pooled data from 3 osteoarthritis trials (NCT01089725, NCT02697773 and NCT02709486). Treatments (every 8-weeks for 16-24 weeks with an 8-24 week follow-up) included placebo, tanezumab 2.5mg, 2.5mg at baseline and 5mg at week 8, 5mg and 10mg. Safety of SC tanezumab versus oral NSAIDs was evaluated in an osteoarthritis trial with a 56-week treatment period and a 24-week follow-up (NCT02528188). Patients received tanezumab 2.5mg or 5mg every 8 weeks, or twice-daily NSAIDs. Peripheral nerve safety assessments included use of a group of 27 adverse events (AEs) of APS.

Results

In the pooled SC placebo-controlled studies, AEs of APS were reported for 2.2%, 5.1%, 3.2%, 6.1% and 12.8% of patients during the treatment period in the placebo (n=586), tanezumab 2.5mg (n=602), 2.5/5mg (n=219), 5mg (n=347) and 10mg (n=86) groups, respectively. All AEs of APS were mild/moderate in severity. Up to end of the studies, 1 patient (0.3%) in the tanezumab 5mg group discontinued due to an AE of APS (hypoesthesia).

In the NSAID-controlled study, AEs of APS were reported for 6.2%, 9.0% and 4.6% of patients during the treatment period in the tanezumab 2.5mg (n=1002), 5mg (n=998) and NSAID (n=996) groups, respectively. Severe AEs of APS were reported for 0.1%, 0.3% and 0.1% of patients, respectively. Discontinuations due to AEs of APS up to end of study were reported for 0.4%, 1.5% and 0.4% of patients, respectively.

Conclusions

Compared with placebo or NSAID, a higher proportion of patients in tanezumab groups had AEs of APS; these were typically mild/moderate in severity and rarely resulted in discontinuation.

Authors/Disclosures
Mark T. Brown, MD (Pfizer Inc.) PRESENTER	Dr. Brown has received personal compensation for serving as an employee of Pfizer Inc. Dr. Brown has received stock or an ownership interest from Pfizer Inc.
Paola Sandroni, MD, PhD, FAAN (Mayo Clinic)	Dr. Sandroni has nothing to disclose.
Kenneth C. Gorson, MD (Kenneth Gorson, MD)	Dr. Gorson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Annexon. Dr. Gorson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Dr. Gorson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ArgenX. Dr. Gorson has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer.
Phillip A. Low, MD, FAAN (Mayo Clinic)	Dr. Low has nothing to disclose.
	No disclosure on file
	No disclosure on file
Robert Fountaine	No disclosure on file
Lars Viktrup	No disclosure on file
Elizabeth Johnston	Elizabeth Johnston has stock in Eli Lilly.
	No disclosure on file
	No disclosure on file