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Abstract Number: 1644

Radiographic Exclusionary Findings During Screening for Three Phase III Trials of Subcutaneous Tanezumab in Patients with Moderate to Severe Hip or Knee Osteoarthritis

Ali Guermazi1, Frank Roemer2, Andrew Kompel1, Luis Diaz3, Michel Crema4, Mark Brown5, Anne Hickman5, Glenn Pixton6, Lars Viktrup7, Robert Fountaine5, Aimee Burr5, Sarah Sherlock5 and Christine West8, 1Boston University School of Medicine, Boston, MA, 2Boston University School of Medicine, Boston, MA, and Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany, Erlangen, Germany, 3Boston Veteran Affairs Healthcare System, Boston, MA, 4Boston University School of Medicine, Paris, France, 5Pfizer Inc., Groton, CT, 6Pfizer Inc., Morrisville, NC, 7Eli Lilly and Company, Indianapolis, IN, 8Pfizer Inc, Groton, CT

Meeting: ACR Convergence 2020

Keywords: clinical trial, Osteoarthritis, pain, radiography, X-ray

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Session Information

Date: Monday, November 9, 2020

Session Title: Osteoarthritis – Clinical Poster II

Session Type: Poster Session D

Session Time: 9:00AM-11:00AM

Background/Purpose: Tanezumab is a nerve growth factor monoclonal antibody in development for osteoarthritis (OA). Following a clinical hold due to concerns around adverse joint events, the tanezumab clinical trial program implemented comprehensive radiographic eligibility criteria. We describe the frequencies of exclusionary radiographic findings during screening in three Phase III randomized studies of subcutaneous tanezumab.

Methods: NCT026977731 was a 40-week placebo-controlled study (16-week treatment). NCT027094862 was a 48-week placebo-controlled study (24-week treatment). NCT025281883,4 was an 80-week active-controlled (oral NSAID) study (56-week treatment). Bilateral shoulder, hip and knee screening radiographs were taken by trained imaging technologists and read by one of five central musculoskeletal radiology experts (central readers). Central readers were trained using a program-specific imaging atlas and underwent periodic re-calibration sessions.5 Eligibility criteria for all studies included an OA diagnosis in the index hip or knee based on ACR criteria and a Kellgren Lawrence (KL) grade of ≥2 on radiograph as diagnosed by the central reader. Radiographic exclusion criteria included a KL grade of 0 or 1 in a non-index knee or hip with patient reported pain of ≥7 on a 0-10 numerical rating scale, without other exclusionary radiographic findings (discordant pain to X-ray), confounding joint or systemic conditions (severe malalignment of the knee, inflammatory joint disease etc.), presence of rapidly progressive OA type 2 (RPOA2), or potential risk factors for RPOA (such as osteonecrosis, subchondral insufficiency fracture, or atrophic OA; Figure 1) in any joint. 

Results: In the three studies, conducted at >480 international sites, 23,079 patients were screened and 13,797 proceeded to radiography (producing 81,055 knee, hip or shoulder screening radiographs read by the central reader). Overall, 8024 patients (58.2%) were declared radiographically eligible. Among the 5773 (41.8%) patients declared ineligible, exclusionary radiographic findings were noted in 1 (4116 [29.8%]), 2 (1268 [9.2%]), 3 (279 [2.0%]), 4 (108 [0.8%]), or 6 joints (2 [0.01%]). The most common exclusionary radiographic finding in both knees and hips was discordant pain to X-ray (Table 1; ~1 in 10 screening X-rays), with other findings being much rarer (≤~1 in 35), particularly in the hip (≤~1 in 100). Exclusionary radiographic findings were rare in the shoulder ─ the most common was osteonecrosis (~1 in 325, vs ~1 in 250 and 100 in the knee and hip, respectively).

Conclusion: Conclusion: The Phase III tanezumab trial program included comprehensive radiographic screening. The most common exclusionary finding in knees and hips was pain discordant to X-ray (~1 in 10 screening X-rays).

Disclosures: Studies sponsored by Pfizer and Eli Lilly and Company.

References:

  1. Schnitzer T., JAMA. 2019. 322(1):37-48.
  2. Berenbaum F., et al. Ann Rheum Dis. 2020. 79:800-10.
  3. Hochberg M., et al. ACR/ARHP Annual Scientific Meeting. 2019. 71(s10):2243.
  4. Hochberg M., et al. ACR/ARHP Annual Scientific Meeting. 2019. 71(S10):4888.
  5. Roemer F., et al. Semin Arthritis Rheum. 2017. 47(3):323-30.

Table 1: Most common exclusionary radiographic findings from three Phase III trials of subcutaneous tanezumab

Figure 1: Examples of exclusionary radiographic findings


Disclosure: A. Guermazi, AstraZeneca, 1, Pfizer, 1, MerckSerono, 1, Galapagos, 1, Roche, 1, TissueGene, 1, Boston Imaging Core Lab, 1; F. Roemer, Boston Imaging Core Lab (BICL), LLC, 1, Calibr - California Institute for Biomedical Research, 1; A. Kompel, Boston Imaging Core Lab (BICL), LLC, 1; L. Diaz, None; M. Crema, Boston Imaging Core Lab, 1; M. Brown, Pfizer, 1, 3; A. Hickman, Pfizer Inc., 1, 3; G. Pixton, Pfizer Inc., 3, 4; L. Viktrup, Eli Lilly and Company, 1, 3; R. Fountaine, Pfizer Inc., 1, 3, 4; A. Burr, Pfizer Inc., 1, 2; S. Sherlock, Pfizer Inc., 1, 2; C. West, Pfizer Inc., 1, 3.

To cite this abstract in AMA style:

Guermazi A, Roemer F, Kompel A, Diaz L, Crema M, Brown M, Hickman A, Pixton G, Viktrup L, Fountaine R, Burr A, Sherlock S, West C. Radiographic Exclusionary Findings During Screening for Three Phase III Trials of Subcutaneous Tanezumab in Patients with Moderate to Severe Hip or Knee Osteoarthritis [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/radiographic-exclusionary-findings-during-screening-for-three-phase-iii-trials-of-subcutaneous-tanezumab-in-patients-with-moderate-to-severe-hip-or-knee-osteoarthritis/. Accessed June 30, 2022.
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