Table 2.
One‐year changes from baseline in cartilage thickness in patients treated with 100 μg sprifermin compared with matched placebo‐treated patients, according to thinning and thickening scores, OVs of the magnitude of change, and anatomic subregionsa
| One‐year change from baseline | Between‐group difference, mean (95% CI) μm | |||
|---|---|---|---|---|
| 100 μg sprifermin (n = 57) | Matched placebo (n = 18) | P | ||
| ThCTnS | −590.5 ± 616.8 (−360) | −921.1 ± 776.8 (−745) | 330.6 (−23.7, 684.9) | 0.0304 |
| ThCTkS | 744.2 ± 360.4 (710) | 507.2 ± 429.0 (380) | 237.0 (33.6, 440.4) | 0.0286 |
| ThCTnS:ThCTkS ratio | −3.1 ± 9.0 (−0.55) | −9.4 ± 16.1 (−2.1) | 6.3 (0.3, 12.3) | 0.0143 |
| OVs | ||||
| OV1 | −178.6 ± 151.1 | −217.2 ± 158.1 | 38.6 (−43.7, 121.0) | 0.1208 |
| OV2 | −122.8 ± 121.6 | −153.3 ± 114.7 | 30.5 (−34.2, 95.2) | 0.1758 |
| OV3 | −85.6 ± 92.9 | −121.1 ± 88.2 | 35.5 (−14.0, 85.0) | 0.0699 |
| OV4 | −53.5 ± 64.7 | −97.2 ± 77.4 | 43.7 (7.1, 80.3) | 0.0297 |
| OV5 | −36.0 ± 61.0 | −81.1 ± 67.6 | 45.1 (11.4, 78.9) | 0.0086 |
| OV6 | −22.3 ± 55.8 | −66.7 ± 63.2 | 44.4 (13.4, 75.4) | 0.0074 |
| OV7 | −8.1 ± 54.7 | −46.1 ± 57.7 | 38.0 (8.2, 67.9) | 0.0226 |
| OV8 | 5.4 ± 50.2 | −27.2 ± 59.8 | 32.7 (4.3, 61.0) | 0.0429 |
| OV9 | 17.5 ± 49.5 | −8.3 ± 60.1 | 25.9 (−2.2, 54.0) | 0.0786 |
| OV10 | 31.8 ± 46.7 | 6.7 ± 63.8 | 25.1 (−2.5, 52.7) | 0.0747 |
| OV11 | 47.0 ± 45.6 | 15.0 ± 62.9 | 32.0 (5.0, 59.1) | 0.0343 |
| OV12 | 63.3 ± 42.0 | 25.0 ± 64.6 | 38.3 (12.4, 64.3) | 0.0280 |
| OV13 | 81.8 ± 46.2 | 43.3 ± 63.5 | 38.4 (11.1, 65.8) | 0.0332 |
| OV14 | 103.2 ± 49.9 | 68.3 ± 71.0 | 34.8 (4.9, 64.7) | 0.0450 |
| OV15 | 131.4 ± 59.1 | 93.9 ± 74.1 | 37.5 (3.6, 71.4) | 0.0274 |
| OV16 | 179.1 ± 70.9 | 152.2 ± 101.5 | 26.9 (−15.7, 69.5) | 0.1644 |
| Cartilage subregion thicknessb | ||||
| cMT | −2.6 ± 144.9 | −22.8 ± 193.3 | 20.1 (−64.7, 105.0) | 0.6595 |
| eMT | −10.9 ± 129.5 | −25.0 ± 101.3 | 14.1 (−52.4, 80.7) | 0.1925 |
| iMT | 10.5 ± 82.0 | −22.8 ± 92.7 | 33.3 (−12.3, 78.9) | 0.2587 |
| aMT | 18.2 ± 103.2 | 22.8 ± 110.4 | −4.5 (−61.1, 52.0) | 0.9950 |
| pMT | 27.0 ± 85.8 | −21.7 ± 85.0 | 48.7 (2.5, 94.8) | 0.0463 |
| ccMF | −29.6 ± 176.2 | −86.1 ± 145.8 | 56.5 (−34.9, 147.8) | 0.0750 |
| ecMF | 4.4 ± 146.3 | −28.3 ± 115.6 | 32.7 (−42.6, 108.0) | 0.4128 |
| icMF | −5.6 ± 110.1 | −57.8 ± 106.2 | 52.2 (−6.7, 111.0) | 0.0463 |
| cLT | −0.4 ± 129.7 | −53.9 ± 184.8 | 53.5 (−24.3, 131.4) | 0.1646 |
| eLT | 21.8 ± 103.3 | −26.7 ± 86.1 | 48.4 (−5.2, 102.1) | 0.0205 |
| iLT | 3.5 ± 73.2 | −15.0 ± 98.5 | 18.5 (−24.5, 61.5) | 0.5267 |
| aLT | 8.4 ± 91.6 | −7.8 ± 102.4 | 16.2 (−34.6, 67.0) | 0.4641 |
| pLT | 22.6 ± 108.5 | −14.4 ± 91.5 | 37.1 (−19.4, 93.6) | 0.2940 |
| ccLF | 32.3 ± 116.4 | −12.2 ± 172.7 | 44.5 (−26.5, 115.5) | 0.2287 |
| ecLF | 43.5 ± 89.7 | −29.4 ± 108.0 | 73.0 (22.1, 123.8) | 0.0088 |
| icLF | 10.5 ± 109.1 | −12.8 ± 105.7 | 23.3 (−35.0, 81.7) | 0.2310 |
Values are the mean ± SD (median) μm. ThCTnS = total femorotibial subregional cartilage thinning summary score of negative change; ThCTkS = total femorotibial subregional cartilage thinning summary score of positive change; OVs = ordered values of subregional change in cartilage thickness (ranging from OV1, representing greatest cartilage loss, to OV16, representing greatest cartilage thickening).
Thickness of cartilage from the medial tibia (MT), central part of the medial weight‐bearing femur (cMF), lateral tibia (LT), and central part of the lateral weight‐bearing femur (cLF) was determined in the central (c), external (e), internal (i), anterior (a), and posterior (p) subregions.