A Phase IIIb, Multicentre, Interventional, Randomised, Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Guselkumab for the Treatment of Nonpustular Palmoplantar Psoriasis (G-PLUS)
Table 4
Treatment-emergent adverse events through week 16 and week 56.
Treatment-emergent AEs through week 16 (double-blind)
Treatment-emergent AEs on guselkumab through week 56
Placebo
Guselkumab 100 mg q8w
Placebo-crossover†
Guselkumab 100 mg q8w
Guselkumab combined q8w
Analysis set: safety analysis set, n
39
78
39
78
117
Participants with one or more of the following, n (%):
AEs
24 (61.5)
50 (64.1)
22 (56.4)
68 (87.2)
90 (76.9)
Nasopharyngitis
—
—
9 (23.1)
35 (44.9)
44 (37.6)
Arthralgia
—
—
0
7 (9.0)
7 (6.0)
Back pain
—
—
3 (7.7)
3 (3.8)
6 (5.1)
Headache
—
—
4 (10.3)
6 (7.7)
10 (8.5)
Diarrhoea
—
—
2 (5.1)
13 (16.7)
15 (12.8)
Injury, poisoning, and procedural complications
—
—
3 (7.7)
12 (15.4)
15 (12.8)
Psoriasis
—
—
0
4 (5.1)
4 (3.4)
Fatigue
—
—
0
5 (6.4)
5 (4.3)
C-reactive protein increased
—
—
2 (5.1)
0
2 (1.7)
Metabolism and nutrition disorder
—
—
1 (2.6)
6 (7.7)
7 (6.0)
Respiratory, thoracic, and mediastinal disorders
—
—
1 (2.6)
6 (7.7)
7 (6.0)
Hypertension
—
—
0
5 (6.4)
5 (4.3)
SAEs
2 (5.1)
4 (5.1)
2 (5.1)
5 (6.4)
7 (6.0)
AEs leading to discontinuation of trial intervention
0
2 (2.6)
0
3 (3.8)
3 (2.6)
AEs with severe intensity
1 (2.6)
1 (1.3)
1 (2.6)
3 (3.8)
4 (3.4)
Infections
8 (20.5)
27 (34.6)
9 (23.1)
35 (44.9)
44 (37.6)
Serious infections
1 (2.6)
1 (1.3)
1 (2.6)
1 (1.3)
2 (1.7)
Injection site reactions
1 (2.6)
0
2 (5.1)
0
2 (1.7)
Anaphylactic reactions or serum sickness
0
0
0
0
0
Events of psoriasis
0
0
0
4 (5.1)
4 (3.4)
Events leading to death
0
0
0
0
0
Events of malignancy
0
0
0
0
0
Events of active tuberculosis
0
0
0
0
0
Note. Subjects were counted once only for any given event, regardless of the number of times they experienced the event. AEs are coded using Medical Dictionary for Regulatory Activities Version 21.1 for AEs through week 16 and 24.1 for AEs through week 56. †For placebo-randomised subjects, only those AEs with start date at or after crossover to guselkumab (i.e., week 16) are included in this column. AE, adverse event; q8w, every 8 weeks; SAE, serious adverse event.
