Clinical implications and predictive values of early PASI responses to tildrakizumab in patients with moderate-to-severe plaque psoriasis

Figures & data

Figure 1. Percent PASI improvements from baseline to week 28 by week 28 PASI response subgroup. Percent values by the end of each line represent the percentage of patients in each week 28 PASI category. PASI responders were defined as patients with PASI ≥75, super responders as patients with PASI ≥90, partial responders as patients with PASI 50–74, and nonresponders as patients with PASI <50 improvement at week 28. CI: confidence interval; PASI: Psoriasis Area and Severity Index.

Table 1. Baseline demographic and clinical characteristics.

	Week 28 PASI Categories
	PASI 90–100	PASI 75–89	PASI 50–74	PASI <50
Number of Patients	308	137	82	48
Age, mean (SD)	44.4 (13.3)	46.5 (13.1)	46.9 (12.9)	49.2 (13.8)
Male, %	67.9%	68.6%	70.7%	81.3%
Race, %
White	82.9%	84.7%	73.2%	83.3%
Black	2.3%	3.7%	0.0%	0.0%
Asian	11.5%	9.5%	25.6%	10.4%
Other Races	3.3%	2.2%	1.2%	6.3%
Body Weight, kg, mean (95% CI)	86.9 (84.4, 89.3)	94.3^a (90.2, 98.4)	84.4 (79.4, 89.3)	99.5^a (92.1, 106.9)
BMI, kg/m^2, mean (95% CI)	29.4 (28.6, 30.1)	31.8^b (30.5, 33.1)	29.0 (27.4, 30.6)	32.0 (30.1, 33.8)
% BSA, mean (95% CI)	30.6 (28.7, 32.6)	30.7 (27.7, 33.6)	35.7 (31.3, 40.1)	34.3 (29.4, 39.2)
Psoriasis, years, mean (95% CI)	15.3 (14.0, 16.6)	18.3 (16.0, 20.6)	18.6 (15.4, 21.9)	22.8^b (18.3, 27.3)
PASI Scores, mean (95% CI)	19.7 (18.9, 20.5)	20.1 (18.7, 21.4)	21.8 (19.7, 23.9)	20.2 (18.3, 22.0)
Comorbidities, %
Psoriatic Arthritis	16.9%	15.3%	17.1%	14.6%
Cardiovascular Diseases	22.4%	29.2%	31.7%	37.5%
Diabetes	8.1%	11.0%	7.3%	14.6%
Previously on Biologics	16.2%	16.1%	15.9%	31.3%

^aStatistically significant difference vs PASI 90–100 and PASI 50–74.

^bSignificant difference vs PASI 90–100.

BMI: body mass index; BSA: body surface area; CI: confidence interval; PASI: Psoriasis Area and Severity Index; SD: standard deviation.

Figure 2. Week 16 PASI responses are predictive of week 28 nonresponders/partial responders (PASI <75). PASI responders were defined as patients with PASI ≥75, super responders as patients with PASI ≥90, partial responders as patients with PASI 50–74, and nonresponders as patients with PASI <50 improvement at week 28. PASI: Psoriasis Area and Severity Index.

Table 2. Predictive value of week 16 PASI improvement for predicting week 28 partial responders/nonresponders (PASI <75).

	Week 28 PASI Category
	PASI <75	PASI ≥75
Week 16 PASI < 50 (N)	56^a	10^b
Week 16 PASI ≥ 50 (N)	73^c	432^d
PPV	84.8%
NPV	85.5%

NPV: negative predictive value; PASI: Psoriasis Area and Severity Index; PPV: positive predictive value.

^aPatients with PASI <50 at week 16 and PASI <75 at week 28.

^bPatients with PASI <50 at week 16 and PASI ≥75 at week 28.

^cPatients with PASI ≥50 at week 16 and PASI <75 at week 28.

^dPatients with PASI ≥50 at week 16 and PASI ≥75 at week 28.

PPV = a/(a + b) × 100; NPV = d/(c + d) × 100.

Figure 3. Week 4 PASI responses are predictive of week 28 super responders (PASI ≥90) and responders (PASI ≥75). PASI responders were defined as patients with PASI ≥75, super responders as patients with PASI ≥90, partial responders as patients with PASI 50–74, and nonresponders as patients with PASI <50 improvement at week 28. PASI: Psoriasis Area and Severity Index.

Table 3. Predictive value of week 4 PASI improvement for predicting week 28 responders (PASI ≥75) and super responders (PASI ≥90).

	Week 28 PASI Category
	PASI ≥75	PASI <75	PASI ≥90	PASI <90
Week 4 PASI ≥ 50 (N)	201^a	30^c	154^b	77^d
Week 4 PASI < 50 (N)	243^e	100^g	154^f	189^h
PPV	87.0%		66.7%
NPV	29.2%		55.1%

NPV: negative predictive value; PASI: Psoriasis Area and Severity Index; PPV: positive predictive value.

^aPatients with PASI ≥50 at week 4 and PASI ≥75 at week 28.

^bPatients with PASI ≥50 at week 4 and PASI ≥90 at week 28.

^cPatients with PASI ≥50 at week 4 and PASI <75 at week 28.

^dPatients with PASI ≥50 at week 4 and PASI <90 at week 28.

^ePatients with PASI <50 at week 4 and PASI ≥75 at week 28.

^fPatients with PASI <50 at week 4 and PASI ≥90 at week 28.

^gPatients with PASI <50 at week 50 and PASI <75 at week 28.

^hPatients with PASI <50 at week 50 and PASI <90 at week 28.

PPV = a/(a+c) × 100 and b/(b+d) 100; NPV = g/(e+g) × 100 and h/(f+h) × 100.