. 2024 Mar 18;11(3):617–632. doi: 10.1007/s40744-024-00654-5

Table 1.

Efficacy assessments

Parameter	Week 24 (period 1)^a	Week 52 (period 1 and 2)^b	Week 100 (period 1 and 2)
Change from baseline PsA-mTSS,^c mean [n/N] (95% CI)	0.23 [451/458] (0.02, 0.44)	0.32 [451/457] (0.11, 0.53)	0.21 [375/377] (0.04, 0.38)	0.27 [385/390] (0.10, 0.44)	0.34 [372/377] (0.17, 0.52)	0.45 [383/390] (0.28, 0.62)
PsA-mTSS ≤ 0,^c,d % [n/N] (95% CI)	92.4 [423/458] (89.9, 94.8)*	87.7 [401/457] (84.7, 90.8)	91.7 [344/375] (88.9, 94.5)	89.9 [346/385] (86.9, 92.9)	90.6 [337/372] (87.6, 93.6)	86.9 [333/383] (83.6, 90.3)
PsA-mTSS ≤ 0.5,^c,d % [n/N] (95% CI)	93.7 [429/458] (91.4, 95.9)	90.4 [413/457] (87.7, 93.1)	93.6 [351/375] (91.1, 96.1)	92.5 [356/385] (89.8, 95.1)	91.9 [342/372] (89.2, 94.7)	89.3 [342/383] (86.2, 92.4)
Change from baseline in PGA-F,^e mean (95% CI)	− 0.8 (− 1.0, − 0.7)***	− 0.4 (− 0.5, − 0.3)	− 1.2 (− 1.3, − 1.1)	− 1.1 (− 1.2, − 1.0)	− 1.4 (− 1.5, − 1.3)	− 1.3 (− 1.4, − 1.2)
Clinically meaningful reduction from baseline in HAQ-DI (≥ 0.35),^f % [n/N] (95% CI)	50.3 [208/414] (45.5, 55.1)***	27.9 [117/419] 23.5, 32.2)	57.9 [240/414] (53.1, 62.6)	46.4 [194/419] (41.6, 51.2)	54.9 [227/414] (50.0, 59.7)	48.4 [203/419] (43.5, 53.3)
Change from baseline in Patient’s Assessment of Pain VAS,^g mean (95% CI)	− 21.0 (− 23.2, − 18.8)***	− 10.2 (− 12.5, − 8.0)	− 26.5 (− 28.6, − 24.5)	− 22.6 (− 24.7, − 20.6)	− 26.9 (− 29.0, − 24.9)	− 25.0 (− 27.1, − 22.9)
Change from baseline in SF-36 PCS, mean [n/N] (95% CI)	6.5 [474/482] (5.8, 7.2)***	3.2 [470/477] (2.5, 3.9)	8.4 [443/476] (7.8, 9.1)	7.3 [437/473] (6.7, 8.0)	8.4 [403/476] (7.7, 9.1)	7.5 [398/473] (6.8, 8.2)
Change from baseline in FACIT-Fatigue, mean (95% CI)	6.5 (5.6, 7.3)***	3.9 (3.1, 4.7)	8.0 (7.2, 8.8)	6.5 (5.7, 7.3)	7.8 (6.9, 8.6)	6.9 (6.0, 7.7)

Parameter

Week 24 (period 1)^a

Week 52 (period 1 and 2)^b

Week 100 (period 1 and 2)

RZB (n = 483)

PBO (n = 481)

Continuous RZB (n = 483)

PBO/RZB (n = 481)

Continuous RZB (n = 483)

PBO/RZB (n = 481)

Change from baseline PsA-mTSS,^c mean [n/N] (95% CI)

0.23 [451/458]

(0.02, 0.44)

0.32 [451/457]

(0.11, 0.53)

0.21 [375/377]

(0.04, 0.38)

0.27 [385/390]

(0.10, 0.44)

0.34 [372/377]

(0.17, 0.52)

0.45 [383/390]

(0.28, 0.62)

PsA-mTSS ≤ 0,^c,d % [n/N] (95% CI)

92.4 [423/458]

(89.9, 94.8)*

87.7 [401/457]

(84.7, 90.8)

91.7 [344/375]

(88.9, 94.5)

89.9 [346/385]

(86.9, 92.9)

90.6 [337/372]

(87.6, 93.6)

86.9 [333/383]

(83.6, 90.3)

PsA-mTSS ≤ 0.5,^c,d % [n/N] (95% CI)

93.7 [429/458]

(91.4, 95.9)

90.4 [413/457]

(87.7, 93.1)

93.6 [351/375]

(91.1, 96.1)

92.5 [356/385]

(89.8, 95.1)

91.9 [342/372]

(89.2, 94.7)

89.3 [342/383]

(86.2, 92.4)

Change from baseline in PGA-F,^e mean (95% CI)

− 0.8

(− 1.0, − 0.7)***

− 0.4

(− 0.5, − 0.3)

− 1.2

(− 1.3, − 1.1)

− 1.1

(− 1.2, − 1.0)

− 1.4

(− 1.5, − 1.3)

− 1.3

(− 1.4, − 1.2)

Clinically meaningful reduction from baseline in HAQ-DI (≥ 0.35),^f % [n/N] (95% CI)

50.3 [208/414]

(45.5, 55.1)***

27.9 [117/419]

23.5, 32.2)

57.9 [240/414]

(53.1, 62.6)

46.4 [194/419]

(41.6, 51.2)

54.9 [227/414]

(50.0, 59.7)

48.4 [203/419]

(43.5, 53.3)

Change from baseline in Patient’s Assessment of Pain VAS,^g mean (95% CI)

− 21.0

(− 23.2, − 18.8)***

− 10.2

(− 12.5, − 8.0)

− 26.5

(− 28.6, − 24.5)

− 22.6

(− 24.7, − 20.6)

− 26.9

(− 29.0, − 24.9)

− 25.0

(− 27.1, − 22.9)

Change from baseline in SF-36 PCS, mean [n/N] (95% CI)

6.5 [474/482]

(5.8, 7.2)***

3.2 [470/477]

(2.5, 3.9)

8.4 [443/476]

(7.8, 9.1)

7.3 [437/473]

(6.7, 8.0)

8.4 [403/476]

(7.7, 9.1)

7.5 [398/473]

(6.8, 8.2)

Change from baseline in FACIT-Fatigue, mean (95% CI)

6.5

(5.6, 7.3)***

3.9

(3.1, 4.7)

8.0

(7.2, 8.8)

6.5

(5.7, 7.3)

7.8

(6.9, 8.6)

6.9

(6.0, 7.7)

The continuous RZB cohort was randomized to RZB 150 mg (period 1) and remained on RZB (period 2). The PBO/RZB cohort was randomized to placebo (period 1) and switched to RZB 150 mg (period 2). All changes are least squares mean change from baseline. Results are based on the full analysis set and use NRI-C at week 24, where missing data due to COVID-19 were imputed by multiple imputation, and NRI-MI at weeks 52 and 100, where missing data due to COVID-19 and geopolitical conflict were handled by multiple imputation and all other missing data were treated as nonresponders, including missing data and patients who received rescue therapy; MMRM was used for continuous endpoints, excluding mTSS

CI confidence interval, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue, HAQ-DI Health Assessment Questionnaire–Disability Index, MMRM mixed-effect model for repeated measures, NRI-C nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19, NRI-MI nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19 and geopolitical conflict, and all other missing data treated as nonresponders, including missing data and patients who received rescue therapy, PBO placebo, PGA-F Physician’s Global Assessment of Fingernail Psoriasis, PsA-mTSS psoriatic arthritis-modified Total Sharp Score, RZB risankizumab, SF-36 PCS 36-item Short Form Physical Component Summary, VAS Visual Analog Scale

^aData previously reported [11]

^bBinary endpoint data previously reported using nonresponder imputation [14]

^cResults for PsA-mTSS were recorded from the third reading session (weeks 52 and 100)

^dResults for PsA-mTSS ≤ 0 and ≤ 0.5 were reported using as observed data with no imputation for missing data

^eAmong patients with nail psoriasis at baseline (RZB, n = 309; PBO/RZB, n = 338)

^fIn patients with baseline HAQ-DI ≥ 0.35. Number of responders (n) is calculated on the basis of the total number of patients and estimated response rate, rounding to the nearest integer

^gAmong patients with a baseline Patient’s Assessment of Pain (VAS) score (RZB, n = 482; PBO/RZB, n = 479)

*Nominal p < 0.05

***Nominal p < 0.001