SUPPLEMENTARY MATERIALS
Supplementary Methods Description of PASI and IGA
The Psoriasis Area and Severity Index (PASI) is scored on a continuous scale from 0–72 calculated based on scores of 0–4 in redness, thickness and scaliness in four areas of the body. Scores ≥12 are considered to represent severe disease.
1The Investigator’s Global Assessment (IGA) is a 5-point scale scored from 0–4, where a score of 4 indicates “severe” disease, 3 “moderate”, 2 “mild”, 1 “almost clear” and 0 “clear”.
Reference: 1. Feldman SR. A quantitative definition of severe psoriasis for use in
clinical trials. J Dermatolog Treat. 2004;15:27-9.
Supplementary Figure 1. eCDF curves of observed changes from baseline in P-SIM item scores by PGAP change score category
Figure 1a. P-SIM Item 1 (Itching) from baseline to Week 16
Figure 1b. P-SIM Item 1 (Itching) from baseline to Week 48
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Figure 1c. P-SIM Item 3 (Skin pain) from baseline to Week 16
Figure 1d. P-SIM Item 3 (Skin pain) from baseline to Week 48
Figure 1e. P-SIM Item 5 (Scaling) from baseline to Week 16
Figure 1f. P-SIM Item 3 (Scaling) from baseline to Week 48
Negative changes from baseline in P-SIM item scores indicate improvement. Horizontal dashed line represents the median percentage of patients. Vertical dashed lines represent improvements from baseline. eCDF: empirical cumulative distribution function; PGAP: Patient Global Assessment of Psoriasis; P-SIM: Psoriasis Symptoms and Impacts Measure.
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Supplementary Figure 2. eCDF curves of observed changes from baseline in P-SIM item scores by DLQI Item 1 score category
Figure 2a. P-SIM Item 1 (Itching) from baseline to Week 16
Figure 2b. P-SIM Item 1 (Itching) from baseline to Week 48
Figure 2c. P-SIM Item 3 (Skin pain) from baseline to Week 16
Figure 2d. P-SIM Item 3 (Skin pain) from baseline to Week 48
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Figure 2e. P-SIM Item 5 (Scaling) from baseline to Week 16
Figure 2f. P-SIM Item 5 (Scaling) from baseline to Week 48
Negative changes from baseline in P-SIM item scores indicate improvement. Horizontal dashed line represents the median percentage of patients. Vertical dashed lines represent improvements from baseline. eCDF: empirical cumulative distribution function; DLQI: Dermatology Life Quality Index;
P-SIM: Psoriasis Symptoms and Impacts Measure.
Supplementary Table 1. Compliance rates of P-SIM over time (N=743)
P-SIM Item
N BL
n (%)
Wk 4 n (%)
Wk 8 n (%)
Wk 12 n (%)
Wk 16 n (%)
Wk 32 n (%)
Wk 48 n (%)
Overall n (%) Item 1
– Itching
743 735/743 (98.92%)
729/738 (98.78%)
733/734 (99.86%)
724/725 (99.86%)
709/716 (99.02%)
687/692 (99.28%)
405/418 (96.89%)
4722/4766 (99.08%) Item 3
– Skin pain
743 735/743
(98.92%) 729/738
(98.78%) 733/734
(99.86%) 724/725
(99.86%) 709/716
(99.02%) 687/692
(99.28%) 405/418
(96.89%) 4722/4766 (99.08%) Item 5
– Scaling
743 735/743
(98.92%) 729/738
(98.78%) 733/734
(99.86%) 724/725
(99.86%) 709/716
(99.02%) 687/692
(99.28%) 405/418
(96.89%) 4722/4766 (99.08%) All randomised study participants within BE RADIANT are included. The compliance rates (%) were
calculated as the number of study participants who were compliant at a given visit divided by the number of study participants in the randomised set who were still ongoing in the study at that visit. The overall compliance rate was estimated by summing up all numerators across all visits presented and dividing by the sum of all denominators across all visits presented derived from the compliance calculations mentioned above. BL: baseline; P-SIM: Psoriasis Symptoms and Impacts Measure;
Wk: week.
Supplementary Table 2. Completion rates of P-SIM over time (N=743)
P-SIM Item
N BL
n (%)
Wk 4 n (%)
Wk 8 n (%)
Wk 12 n (%)
Wk 16 n (%)
Wk 32 n (%)
Wk 48 n (%)
Overall n (%) Item 1
– Itching
743 735
(98.92%)
729 (98.12%)
733 (98.65%)
724 (97.44%)
709 (95.42%)
687 (92.46%)
405 (54.51%)
4722/5201 (90.79%) Item 3
– Skin
pain 743 735
(98.92%) 729
(98.12%) 733
(98.65%) 724
(97.44%) 709
(95.42%) 687
(92.46%) 405
(54.51%) 4722/5201 (90.79%) Item 5
– Scalin g
743 735
(98.92%) 729
(98.12%) 733
(98.65%) 724
(97.44%) 709
(95.42%) 687
(92.46%) 405
(54.51%) 4722/5201 (90.79%) All randomised study participants within BE RADIANT are included. Study participants were considered
completers at a given visit if they had a non-missing item score at that visit. The completion rates (%) were calculated as the number of study participants who completed the considered item at a given week divided by the sample size of the randomised set. The overall completion rate was estimated by summing up all numerators across all weeks presented and dividing by the sum of all denominators across all visits presented derived from the completion calculations mentioned above. BL: baseline;
P-SIM: Psoriasis Symptoms and Impacts Measure; Wk: week.
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Supplementary Table 3. Spearman correlations between P-SIM and selected outcome measures (N=743)
P-SIM Item Anchor Baseline n, r, p
Week 16 n, r, p
Week 32 n, r, p
Week 48 n, r, p Item 1 - Itching PGAP Score 732, 0.49,
<0.001 707, 0.57,
<0.001 682, 0.61,
<0.001 400, 0.63,
<0.001 DLQI Item 1
Score 732, 0.67,
<0.001 707, 0.72,
<0.001 682, 0.76,
<0.001 400, 0.80,
<0.001 DLQI Total
Score
732, 0.49,
<0.001
707, 0.67,
<0.001
682, 0.74,
<0.001
400, 0.77,
<0.001 PASI Total
Score 732, 0.10,
0.006 703, 0.40,
<0.001 677, 0.44,
<0.001 400, 0.43,
<0.001 IGA Score 732, 0.11,
0.003 703, 0.41,
<0.001 677, 0.43,
<0.001 400, 0.41,
<0.001 Item 3 – Skin
pain PGAP Score 732, 0.44,
<0.001 707, 0.41,
<0.001 682, 0.50,
<0.001 400, 0.49,
<0.001 DLQI Item 1
Score 732, 0.60,
<0.001 707, 0.53,
<0.001 682, 0.52,
<0.001 400, 0.57,
<0.001 DLQI Total
Score 732, 0.57,
<0.001 707, 0.56,
<0.001 682, 0.55,
<0.001 400, 0.53,
<0.001 PASI Total
Score 732, 0.10,
0.010 703, 0.28,
<0.001 677, 0.37,
<0.001 400, 0.38,
<0.001 IGA Score 732, 0.10,
0.007
703, 0.27,
<0.001
677, 0.35,
<0.001
400, 0.37,
<0.001 Item 5 - Scaling PGAP Score 732, 0.56,
<0.001 707, 0.59,
<0.001 682, 0.69,
<0.001 400, 0.72,
<0.001 DLQI Item 1
Score 732, 0.49,
<0.001 707, 0.53,
<0.001 682, 0.54,
<0.001 400, 0.67,
<0.001 DLQI Total
Score
732, 0.46,
<0.001
707, 0.54,
<0.001
682, 0.57,
<0.001
400, 0.68,
<0.001 PASI Total
Score 732, 0.10,
0.005 703, 0.45,
<0.001 677, 0.62,
<0.001 400, 0.65,
<0.001 IGA Score 732, 0.12,
0.001 703, 0.43,
<0.001 677, 0.59,
<0.001 400, 0.63,
<0.001 n, r, p = number of study participants included in the analysis, correlation coefficients, and corresponding p value, respectively. Grey shading indicates a weak correlation (≤0.30), light green shading indicates a moderate correlation (0.30 < r ≤0.50), and the absence of shading indicates a strong correlation (>0.50). DLQI: Dermatology Life Quality Index; IGA: Investigator’s Global Assessment; PASI: Psoriasis Area and Severity Index; PGAP: Patient Global Assessment of Psoriasis;
P-SIM: Psoriasis Symptoms and Impacts Measure.
