13075_2021_2590_MOESM1_ESM.docx (1023.04 kB)
Download file

Additional file 1 of Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis

Download (1023.04 kB)
journal contribution
posted on 25.08.2021, 03:36 authored by Yoshiya Tanaka, Tsutomu Takeuchi, Hiroyuki Izutsu, Yuichiro Kaneko, Daisuke Kato, Musashi Fukuda, Mitsuhiro Rokuda, Neil M. Schultz
Additional file 1: Supplementary Methods. Supplementary Figure 1. Correlations between WPAI domain scores and CDAI at Week 12/ET. Except for ‘daily activity impairment’, only full-time paid workers and part-time paid workers were included (not homemakers). At Week 12/ET, last observation carried forward was used for missing WPAI scores. The Pearson (r) correlation coefficients assessed the relationships between WPAI domains (absenteeism, presenteeism, loss of work productivity, and daily impairment) and clinical response (CDAI). A 95% prediction ellipse is displayed on each plot. CDAI, Clinical Disease Activity Index. ET early termination, WPAI Work Productivity and Activity Impairment. Supplementary Figure 2. Mean changes from baseline at Week 12/ET for WPAI domains by employment status. Full-time paid workers and part-time paid workers were employed for ≥35 or <35 hours/week, respectively. Homemakers were unemployed, or employed in a capacity other than paid workers, and able to perform basic activities of daily life. Only daily activity impairment data were obtained for homemakers. Higher WPAI scores indicate greater activity impairment and less productivity. At Week 12/ET, last observation carried forward was used for missing WPAI scores. p-values calculated using analysis of covariance, with no adjustment made for multiplicity. *p<0.05; **p<0.01; ***p<0.001, peficitinib versus placebo. ET early termination, WPAI Work Productivity and Activity Impairment. Supplementary Figure 3. Proportion of patients achieving MCID in WPAI at Week 12/ET by employment status. MCID for WPAI was defined as ≥7% decrease from baseline. Full-time paid workers and part-time paid workers were employed for ≥35 or <35 hours/week, respectively. Homemakers were unemployed, or employed in a capacity other than paid workers, and able to perform basic activities of daily life. Only daily activity impairment data were obtained for homemakers. All time points except for Week 12/ET are observed data. At Week 12/ET, last observation carried forward was used for missing WPAI scores. p-values calculated using the chi-squared test (RAJ3) or Fisher’s Exact test (RAJ4), with no adjustment made for multiplicity. *p<0.05; **p<0.01, peficitinib versus placebo. ET early termination, MCID minimal clinically important difference, NE not estimable, WPAI Work Productivity and Activity Impairment.

Funding

Astellas Pharma Inc.

History