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Abstract Number: L20

Efficacy and Safety of Subcutaneous Tanezumab for the Treatment of Osteoarthritis of the Hip or Knee

Thomas J. Schnitzer1, Richard Easton2, Shirley Pang3, Dennis Levinson4, Glenn Pixton5, Lars Viktrup6, Isabelle Davignon7, Mark T. Brown7, Kenneth M. Verburg7 and Christine R. West7, 1Northwestern University, Chicago, IL, 2Michigan Orthopaedic & Spine Surgeons, Rochester Hills, MI, 3St. Jude Medical Center, Fullerton, CA, 4Chicago Clinical Research Institute, Chicago, IL, 5Pfizer, Inc., Morrisville, NC, 6Eli Lilly and Company, Indianapolis, IN, 7Pfizer, Inc., Groton, CT

Meeting: 2018 ACR/ARHP Annual Meeting

Date of first publication: October 4, 2018

Keywords: Late-Breaking 2018, monoclonal antibodies, OA, osteoarthritis and pain management

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Session Information

Date: Tuesday, October 23, 2018

Session Title: 5T113 Abstracts: Late-Breaking Abstract Session

Session Type: ACR Late-breaking Abstract Session

Session Time: 4:00PM-6:00PM

Background/Purpose: Tanezumab is a humanized mAb that blocks nerve growth factor (NGF) and is in clinical development for chronic pain treatment. Tanezumab administered intravenously has proven efficacy in previous studies of osteoarthritis (OA) pain.

Methods: A randomized, double-blind, placebo-controlled, multicenter, parallel-group, 40-week study (16-week treatment period; 24-week safety follow-up) was conducted to examine the efficacy and safety of subcutaneous (SC) tanezumab administered in two treatment regimens over 16 weeks: fixed-dosing (2.5 mg administered at Baseline and Week 8) and step-up dosing (2.5 mg administered at Baseline and 5 mg at Week 8). This study enrolled OA patients who had not responded to or could not tolerate standard pain treatments. Patients (N = 696) had: OA of the hip or knee based on clinical and radiographic ACR criteria, baseline WOMAC Pain and Physical Function scores of ≥5 (11-point numerical rating scale), baseline Patient’s Global Assessment of OA (PGA-OA) of “fair,” “poor,” or “very poor”, and a history of insufficient pain relief or intolerance to acetaminophen, NSAIDs, and either tramadol or opioids (or were unwilling to take opioids). Co-primary endpoints were change from Baseline to Week 16 in WOMAC Pain subscale, WOMAC Physical Function subscale, and PGA-OA. Safety assessments included adverse event (AE) reporting, physical and neurological examinations, joint x-rays, electrocardiogram, and laboratory tests.   

Results: At Week 16, patients treated with tanezumab 2.5 mg or 2.5/5 mg experienced statistically significant improvement in WOMAC Pain, WOMAC Physical Function, and PGA-OA compared with patients receiving placebo (Table 1). Both tanezumab dosing regimens met the study co-primary endpoints. The most common AEs (≥3% in any treatment group and more frequent in each tanezumab treatment group than in the placebo treatment group) were nasopharyngitis, pain in extremity, and paresthesia. The incidence of serious AEs or withdrawals due to AEs was similar between treatment groups (Table 2). Adjudicated rapidly progressive OA occurred in 1.3% of tanezumab-treated subjects during the 40-week study.

Conclusion: Tanezumab 2.5 mg SC provided significant pain relief and improved both function and PGA-OA versus placebo in OA patients. Increasing the dose to 5 mg at Week 8 was associated with modest additional benefit versus continuation on tanezumab 2.5 mg. This study demonstrates that SC tanezumab may be an effective option for patients who have demonstrated intolerance or incomplete response to standard treatments for OA.

 

Table 1. Change in Baseline to Week 16 in WOMAC Pain subscale, WOMAC Physical Function subscale, and Patient’s Global Assessment of OA.

 

 

placebo

 

tanezumab

2.5 mg

tanezumab

2.5/5 mg

 

N = 232

N = 231

N = 233

WOMAC Paina

 

 

 

Mean (Range) Baseline Pain Score

7.30 (4.2, 10.0)

7.08 (4.8, 10.0)

7.33 (5.0, 10.0)

LS Mean (SE) Change from Baseline

-2.64 (0.23)

-3.23 (0.23)

-3.37 (0.22)

Diff of LS Means (SE)

 

-0.60 (0.24)

-0.73 (0.24)

p-value

 

0.0129

0.0023

 

 

 

 

WOMAC Physical Functionb

 

 

 

Mean (Range) Baseline Physical Function Score

7.38 (4.4, 10.0)

7.18 (5.1, 9.9)

7.39 (3.2, 9.9)

LS Mean (SE) Change from Baseline

-2.56 (0.22)

-3.22 (0.22)

-3.45 (0.22)

Diff of LS Means (SE)

 

-0.66 (0.24)

-0.89 (0.24)

p-value

 

 0.0065

 0.0002

 

 

 

 

PGA-OAc

 

 

 

Mean (Range) Baseline Score

3.46 (3, 5)

3.42 (2, 5)

3.53 (3, 5)

LS Mean (SE) Change from Baseline

-0.65 (0.08)

-0.87 (0.08)

-0.90 (0.08)

Diff of LS Means (SE)

 

-0.22 (0.09)

-0.25 (0.09)

p-value

 

0.0109 

0.0038

  

aWOMAC Pain subscale on an 11-point numerical rating scale; higher score indicates higher pain levels

bWOMAC Physical Function subscale on an 11-point numerical rating scale; higher score indicates worse function

cPGA-OA scale ranges from 1 = “very good” to 5 = “very poor”

 

Table 2. Summary of adverse events and those reported in ≥3% of patients in any treatment group during the Treatment Period.

 

 

placebo

 

tanezumab

2.5 mg

tanezumab

2.5/5 mg

 

N = 232

N = 231

N = 233

Adverse events

 

 

 

Any adverse event, n (%)

115 (49.6)

128 (55.4)

109 (46.8)

Any treatment-related adverse event, n (%)

24 (10.3)

29 (12.6)

22 (9.4)

Any treatment discontinuation due to adverse events, n (%)a

2 (0.9)

0

1 (0.4)

Any study withdrawal due to adverse events, n (%)

2 (0.9)

1 (0.4)

2 (0.9)

Any serious adverse event, n (%)

4 (1.7)

4 (1.7)

4 (1.7)

Adverse event, n (%)

 

 

 

Arthralgia

Nasopharyngitis

Musculoskeletal pain

Back pain

Headache

Fall

Upper respiratory tract infection

Joint swelling

Pain in extremity

Paresthesia

29 (12.5)

8 (3.4)

8 (3.4)

7 (3.0)

7 (3.0)

6 (2.6)

6 (2.6)

4 (1.7)

2 (0.9)

1 (0.4)

19 (8.2)

12 (5.2)

7 (3.0)

10 (4.3)

6 (2.6)

11 (4.8)

7 (3.0)

8 (3.5)

4 (1.7)

8 (3.5)

22 (9.4)

11 (4.7)

2 (0.9)

6 (2.6)

7 (3.0)

5 (2.1)

3 (1.3)

4 (1.7)

7 (3.0)

3 (1.3)

  

aPatients with adverse events leading to treatment discontinuation, but not study withdrawal during the treatment period

 


Disclosure: T. J. Schnitzer, AbbVie Inc., 5, 9,Aptinyx, 5,Genzyme, 5,Eli Lilly and Co., 5, 9,Pfizer, Inc., 5, 9,Regeneron, 5, 9,Vertex, 5,Grunenthal, 9,Radius, 9; R. Easton, Pfizer, Inc., 2; S. Pang, Pfizer, Inc., 5; D. Levinson, None; G. Pixton, Pfizer, Inc., 1, 3; L. Viktrup, Eli Lilly and Company, 1, 3; I. Davignon, Pfizer, Inc., 1, 3; M. T. Brown, Pfizer, Inc., 1, 3; K. M. Verburg, Pfizer, Inc., 1, 3; C. R. West, Pfizer, Inc., 1, 3.

To cite this abstract in AMA style:

Schnitzer TJ, Easton R, Pang S, Levinson D, Pixton G, Viktrup L, Davignon I, Brown MT, Verburg KM, West CR. Efficacy and Safety of Subcutaneous Tanezumab for the Treatment of Osteoarthritis of the Hip or Knee [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-subcutaneous-tanezumab-for-the-treatment-of-osteoarthritis-of-the-hip-or-knee/. Accessed July 3, 2022.
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