Mylène Jansen

SF biomarker changes upon KJD 329 16 Table 1 : Assay characteristics of panel of 10 candidate markers Analyte Assay Manufacturer (Catalog No.) Intra- Assay CV Inter- Assay CV Lower Limit of Normal (SF) Upper Limit of Normal (SF) Dil n Factor (SF) (%) (%) (pg/ml) (pg/ml) Activin A Human/Mouse/Rat Activ- in A Quantikine ELISA R&D (DAC00B) 3.9 11.7 1028 5253 50 MCP-1 V-PLEX Human MCP-1 MSD (K151N- ND-1) 3.1 5.1 60 493 5 FGF-2 V-PLEX Human (basic) FGF-2 MSD (K151MDD-1) 4.0 6.1 2 411 4 IL-6 V-PLEX Custom Human Cytokine MSD (K151A0H-1) 4.1 9.7 1 20 5 IL-8 V-PLEX Custom Human Cytokine MSD (K151A0H-1) 3.5 8.9 2 39 5 LTBP2 Human LTBP2 ELISA Abbexa (abx 152242) 6.6 17.3 1887 13630 4 MMP3 Human MMP3 Ul- tra-Sensitive MSD (K151FZC-1) 4.7 13.6 3742 231000 50 TGF β -1 Human TGF β -1 Quanti- kine ELISA R&D (DB100B) 3.7 13.0 257.3 1545 4 TIMP - 1 Human TIMP-1 Ul- tra-sensitive MSD (K151JFC-1) 9.1 10.3 143000 744700 200 TSG-6 In-house, self-coated MSD MSD (L15XA-1) 4.5 7.1 6479 19060 6 Inter- and intra-assay coefficients of variation (CVs) were calculated for all assays. Lower and upper limits were also calculated for all assays for normal ranges using the geometric mean ± 2 standard deviations. CV: coefficient of variation; Dil n : Dilution; MSD: Mesoscale Discovery. Statistical analysis All available data were analyzed on all participants with sufficient SF at each of the 3 time points (and 1 patient with samples at baseline and 3 weeks). All SF analytes were above LLOQ (allowing attribution of endpoint measurements) except for 1 sample each for TGF β 1 at baseline, FGF-2 at midpoint and activin A at endpoint. These values were considered as 50% of the LLOQ. Sample and KOOS completeness are shown in Figure 1A. Missing data were not imputed. Change in KOOS 4 over time Median differences between paired observations of KOOS 4 at baseline and either 3, 6 or 12 months were compared by Wilcoxon Signed Rank test. Change in analyte levels over time Median differences between paired observations (baseline versus 3 or 6 weeks) of analyte levels were compared by Wilcoxon signed rank test. Effect size (ES) was reported as the difference