Table 4

Summary of adjudicated joint safety findings (baseline to week 48)

Placebo
(n=282)
Tanezumab 2.5 mg
(n=283)
Tanezumab 5 mg
(n=284)
Patients adjudicated for joint safety, n (%)19 (6.7%)27 (9.5%)33 (11.6%)
 Patients with adjudicated joint safety end point05 (1.8%)9 (3.2%)
  RPOA04 (1.4%)8 (2.8%)
   Type 103 (1.1%)5 (1.8%)
   Type 201 (0.4%)3 (1.1%)
  Primary osteonecrosis001 (0.4%)
  Pathological fracture000
  Subchondral insufficiency fracture01 (0.4%)0
Patients with normal OA progression*17 (6.0%)22 (7.8%)19 (6.7%)
Patients with other joint outcome*2 (0.7%)05 (1.8%)
Total joint replacement
 Patients with ≥1 total joint replacement, n (%)19 (6.7%)†22 (7.8%)20 (7.0%)
 Number of joints212220
  Index/non-index16/521/117/3
  Elective/non-elective‡15/616/69/11
  Knee/hip/shoulder/other8/13/0/013/9/0/010/9/1/0
  Baseline Kellgren-Lawrence grade 0/1/2/3/40/1/1/13/60/0/1/5/160/0/1/8/9
  • RPOA type 1 was defined as a significant loss of joint space width ≥2 mm (predicated on optimal joint positioning) within approximately 1 year, without gross structural failure; RPOA type 2 was defined as abnormal bone loss or destruction, including limited or total collapse of at least one subchondral surface, that is not normally present in conventional end-stage osteoarthritis.18

  • *Excludes any patient who had one or more of the outcomes included in the adjudicated joint safety end point.

  • †In the placebo group, two patients had two joint replacements.

  • ‡Elective when not associated with an AE or an adjudicated joint safety end point.

  • AE, adverse event; OA, osteoarthritis; RPOA, rapidly progressive osteoarthritis.