RAPID 2 PRO supplementary online material

Supplementary online material

METHODS

Statistical analyses

Response to treatment

Changes from baseline in PRO scores were analysed using Analysis of Covariance (ANCOVA) with region and treatment as factors, and baseline scores as covariates. Missing values, because of patient withdrawal, or because of data exclusion after the use of rescue medication, were imputed by carrying forward the last efficacy measurement (LOCF imputation).

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RAPID 2 PRO supplementary online material

Supplementary Table S1 Correlations between PROs, DAS28, mTSS, CDAI and SDAI at week 24 following treatment with CZP 200 mg plus MTX

HRQoL (SF-36)
Pain (VAS) / Global assess-ment (PtGA) / Physical function (HAQ-DI) / Fatigue (FAS) / PCS / MCS / PF / RP / BP / GH / VT / SF / RE / MH / DAS28 / mTSS / CDAI / SDAI
Pain (VAS) / 1.00 / 0.97 / 0.64 / 0.76 / –0.58 / –0.38 / –0.54 / –0.48 / –0.67 / –0.36 / –0.53 / –0.51 / –0.37 / –0.40 / 0.65 / 0.03 / 0.63 / 0.64
Global assessment (PtGA) / 0.97 / 1.00 / 0.62 / 0.77 / –0.57 / –0.41 / –0.55 / –0.48 / –0.66 / –0.39 / –0.57 / –0.52 / –0.38 / –0.43 / 0.65 / 0.04 / 0.63 / 0.64
Physical function (HAQ-DI) / 0.64 / 0.62 / 1.00 / 0.54 / –0.63 / –0.32 / –0.66 / –0.45 / –0.60 / –0.32 / –0.48 / –0.56 / –0.35 / –0.31 / 0.55 / 0.21 / 0.54 / 0.54
Fatigue (FAS) / 0.76 / 0.77 / 0.54 / 1.00 / –0.51 / –0.49 / –0.46 / –0.47 / –0.63 / –0.42 / –0.68 / –0.56 / –0.41 / –0.47 / 0.52 / –0.05 / 0.51 / 0.51
HRQoL
(SF-36)
PCS / –0.58 / –0.57 / –0.63 / –0.51 / 1.00 / 0.12 / 0.82 / 0.68 / 0.76 / 0.58 / 0.51 / 0.49 / 0.21 / 0.21 / –0.54 / –0.17 / –0.55 / –0.55
MCS / –0.38 / –0.41 / –0.32 / –0.49 / 0.12 / 1.00 / 0.27 / 0.50 / 0.46 / 0.37 / 0.69 / 0.75 / 0.83 / 0.85 / –0.29 / 0.02 / –0.31 / –0.31
PF / –0.54 / –0.55 / –0.66 / –0.46 / 0.82 / 0.27 / 1.00 / 0.51 / 0.63 / 0.35 / 0.49 / 0.55 / 0.36 / 0.35 / –0.46 / –0.19 / –0.49 / –0.50
RP / –0.48 / –0.48 / –0.45 / –0.47 / 0.68 / 0.50 / 0.51 / 1.00 / 0.59 / 0.38 / 0.50 / 0.55 / 0.63 / 0.42 / –0.44 / –0.09 / –0.44 / –0.44
BP / –0.67 / –0.66 / –0.60 / –0.63 / 0.76 / 0.46 / 0.63 / 0.59 / 1.00 / 0.46 / 0.62 / 0.64 / 0.48 / 0.46 / –0.57 / –0.13 / –0.53 / –0.54
GH / –0.36 / –0.39 / –0.32 / –0.42 / 0.58 / 0.37 / 0.35 / 0.38 / 0.46 / 1.00 / 0.53 / 0.44 / 0.25 / 0.44 / –0.34 / –0.01 / –0.37 / –0.36
VT / –0.53 / –0.57 / –0.48 / –0.68 / 0.51 / 0.69 / 0.49 / 0.50 / 0.62 / 0.53 / 1.00 / 0.67 / 0.44 / 0.69 / –0.47 / –0.01 / –0.48 / –0.49
SF / –0.51 / –0.52 / –0.56 / –0.56 / 0.49 / 0.75 / 0.55 / 0.55 / 0.64 / 0.44 / 0.67 / 1.00 / 0.56 / 0.67 / –0.46 / –0.12 / –0.51 / –0.51
RE / –0.37 / –0.38 / –0.35 / –0.41 / 0.21 / 0.83 / 0.36 / 0.63 / 0.48 / 0.25 / 0.44 / 0.56 / 1.00 / 0.53 / –0.30 / 0.00 / –0.27 / –0.28
MH / –0.40 / –0.43 / –0.31 / –0.47 / 0.21 / 0.86 / 0.35 / 0.42 / 0.46 / 0.44 / 0.69 / 0.67 / 0.53 / 1.00 / –0.27 / –0.01 / –0.31 / –0.31
DAS28 / 0.65 / 0.65 / 0.55 / 0.52 / –0.54 / –0.29 / –0.46 / –0.44 / –0.57 / –0.34 / –0.47 / –0.46 / –0.30 / –0.27 / 1.00 / 0.01 / 0.91 / 0.92
mTSS / 0.03 / 0.04 / 0.21 / –0.05 / –0.17 / 0.02 / –0.19 / –0.09 / –0.13 / –0.01 / –0.01 / –0.12 / 0.00 / –0.01 / 0.01 / 1.00 / –0.01 / 0.01
CDAI / 0.63 / 0.63 / 0.54 / 0.51 / –0.55 / –0.31 / –0.49 / –0.44 / –0.53 / –0.37 / –0.48 / –0.51 / –0.27 / –0.31 / 0.91 / –0.01 / 1.00 / 0.99
SDAI / 0.64 / 0.64 / 0.54 / 0.51 / –0.55 / –0.31 / –0.50 / –0.44 / –0.54 / –0.36 / –0.49 / –0.51 / –0.28 / –0.31 / 0.92 / 0.01 / 0.99 / 1.00

BP, Bodily Pain; CDAI, Clinical Disease Activity Index; CZP, certolizumab pegol; GH, General Health; MCS, mental component summary; MH, Mental Health, MTX, methotrexate; PCS, physical component summary; PF, Physical Functioning; PROs, patient-reported outcomes; PtGA, patient’s global assessment of disease activity; RE, Role Emotional; RP, Role Physical; SDAI, Simplified Disease Activity Index; SF-36, short-form 36-item health survey; SF, Social Functioning; VT, Vitality

White, grey and black shading indicate low (≥–0.3 to ≤0.3); moderate (>–0.6 to <–0.3 or >0.3–<0.6), and high (–1.0 to ≤–0.6 or ≥0.6 to 1.0) degrees of correlation, respectively.

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RAPID 2 PRO supplementary online material

Supplementary Figure S1 Improvements in PROs at first assessment (ITT population, LOCF). The first post-baseline assessment was at week 1 for pain VAS, PtGA, HAQ-DI (physical function) and FAS (fatigue), and week 12 for SF-36 (HRQoL). *p≤0.001 for the CZP groups vs placebo. BL, baseline; CZP, certolizumab pegol; ITT, intent to treat; LOCF, last observation carried forward; MCID, minimum clinically important difference; MCS, mental component summary; MTX, methotrexate; PBO, placebo; PCS, physical component summary; PtGA, patient’s global assessment of disease activity; SD, standard deviation; SE, standard error; SF-36, short-form 36-item health survey.

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