Introduction/Objective
 ■ Guselkumab is a fully human monoclonal antibody that binds and blocks interleukin-23 function

 ■ VOYAGE 1 is an ongoing, Phase 3, double-blinded, placebo- and active comparator-controlled study that 
evaluates the efficacy and safety of guselkumab in patients with moderate-to-severe plaque psoriasis1,2 

 ■ Here, efficacy results following up to 4 years of continuous guselkumab treatment are presented

Methods
 ■ In VOYAGE 1 (n=837), patients were randomized as follows (Figure 1):

 — Guselkumab 100 mg administered by subcutaneous (SC) injection at Weeks 0, 4, and 12, then 
every 8 weeks (q8wk)

 — Placebo at Weeks 0, 4, and 12, followed by guselkumab 100 mg SC at Weeks 16 and 20,  
then q8wk

 — Adalimumab 80 mg SC at Week 0, 40 mg at Week 1, then 40 mg q2wk through Week 47
 — Starting at Week 52, all patients received open-label guselkumab treatment through Week 204

 ■ Efficacy assessments included proportions of patients achieving Psoriasis Area and Severity Index (PASI) 
90, PASI 100, Investigator’s Global Assessment (IGA) score of cleared (0) or minimal (1), and IGA score 
of 0

 ■ Patient-reported outcomes included proportions of patients achieving a Dermatology Life Quality Index 
(DLQI) score of 0 or 1 (no effect on a patient’s health-related quality of life) and Psoriasis Symptoms and 
Signs Diary (PSSD) summary scores of 0 (no symptoms or signs of psoriasis)

 ■ Efficacy was analyzed using prespecified treatment failure rules (TFR), nonresponder imputation (NRI), 
and As Observed (OBS) methodology

 — For TFR, patients who discontinued due to lack of efficacy, worsening of psoriasis, or use of a 
protocol-prohibited psoriasis treatment were considered nonresponders

 — For NRI, patients with missing efficacy data (regardless of the reason) after application of TFR 
were counted as nonresponders

 — For OBS, only patient data from each visit were used; missing data were not imputed

 ■ Data for patients randomized to guselkumab and for those originally randomized to placebo who then 
crossed over to guselkumab at Week 16 were combined (guselkumab group) and presented in this 
analysis

Figure 1. VOYAGE 1 Study Design Through 204 Weeks

Placebo-
controlled

Guselkumab 100 mg at Weeks 0 
and 4, then q8w

Guselkumab 100 mg at Week 52, then q8wAdalimumab 80 mg at Week 0, 
40 mg at Week 1, then q2w

Guselkumab 100 mg at 
Weeks 16 and 20, then q8w

Placebo

Placebo-
crossover

Active-comparator
Period

Open-label

Guselkumab
(n=329)

Placebo
(n=174)

Adalimumab 
(n=334)

Weeks 0 4 16
PE
SE

= Randomization

q2w= every 2 weeks q8w= every 8 weeks

PE = Primary endpoint SE = Secondary endpoint

24
SE

204
4 Year
DBL

R

R

48
SE

52

Results
 ■ PASI 90 responses were well-maintained with up to 4 years of continuous guselkumab treatment (Figure 2)

 ■ At Week 204, PASI 90 response rates were 82.2%, 68.4%, and 84.3%, respectively, based on TFR, NRI, 
and OBS analyses (Figure 2)

 ■ Similarly,  PASI 100, IGA score of 0 or 1, and IGA score of 0 responses were stably maintained from Week 
52 through Week 204 (Figures 3-5)

Figure 2. Proportion of Patients Who Achieved PASI 90 Response From Week 52 Through Week 204 
(TFR, NRI, OBS)*

0

20

40

60

80

100

P
e
rc

e
n
ta

g
e
 o

f 
P

a
ti
e
n
ts 82.1

75.5
82.279.7

74.5
68.4

80.6 83.3 84.3

82.9

72.5

84.0

52 60 68 76 84 92 100 108 116 124 132 140 148 156 164 172 180 188 196 204

TFR:
NRI:

448
494
442n=463

n=494
n=468 411

494
401

432
494
425OBS:

Weeks

Guselkumab (TFR) Guselkumab (NRI) Guselkumab (OBS)

*Includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with guselkumab at Week 16.

Figure 3. Proportion of Patients Who Achieved PASI 100 Response From Week 52 Through Week 204 
(TFR, NRI, OBS)*

0

20

40

60

80

100

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Weeks

TFR:
NRI:

448
494
442n=463

n=494
n=468 411

494
401

432
494
425OBS:

52 60 68 76 84 92 100 108 116 124 132 140 148 156 164 172 180 188 196 204

Guselkumab (TFR) Guselkumab (NRI) Guselkumab (OBS)

46.4

49.7

44.546.6

51.8 51.8
49.1 51.1 50.9

46.4

57.1

55.7

*Includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with guselkumab at Week 16.

Figure 4. Proportion of Patients Who Achieved IGA Score of 0 or 1 From Week 52 Through Week 204 
(TFR, NRI, OBS)*

0

20

40

60

80

100

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab (TFR) Guselkumab (NRI) Guselkumab (OBS)

52 60 68 76 84 92 100 108 116 124 132 140 148 156 164 172 180 188 196 204

TFR:
NRI:

448
494
442n=463

n=494
n=468 410

494
400

430
494
423OBS:

Weeks

84.4 83.5

83.3 82.1
75.5

71.5

85.5
84.6
80.2

83.8

81.7

67.8

*Includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with guselkumab at Week 16.

Figure 5. Proportion of Patients Who Achieved IGA Score of 0 From Week 52 Through Week 204  
(TFR, NRI, OBS)*

0

20

40

60

80

100

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

TFR:
NRI:

448
494
442n=463

n=494
n=468 410

494
400

430
494
423OBS:

52 60 68 76 84 92 100 108 116 124 132 140 148 156 164 172 180 188 196 204
Weeks

Guselkumab (TFR) Guselkumab (NRI) Guselkumab (OBS)

56.3

46.4

55.6
54.1

50.4 53.3

54.2
53.6
50.8

47.4

58.5

57.1

*Includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with guselkumab at Week 16.

 ■ Proportions of patients with PSSD summary scores of 0 and DLQI score of 0 or 1 were sustained from 
Week 76 through Week 204 (Figures 6-8) 

Figure 6. PSSD Symptom Score=0 From Weeks 76-204 (TFR)*

39.2 40.2
42.8 39.8

45.4 42.543.6 41.8
45.9 44.0

49.1
43.0

0

20

40

60

80

100

Week 76 Week 156 Week 172 Week 204Week 100 Week 124

P
er

ce
nt

ag
e 

of
 P

at
ie

nt
s

347 343 339 327 315 313227 225 222 218 212 207n =

Guselkumab Adalimumab→Guselkumab

*Patients with baseline PSSD symptom score >0. 
Weeks 76-204: Guselkumab – includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with 
guselkumab at Week 16; Adalimumab→Guselkumab – includes patients randomized to adalimumab at baseline and crossed over and were 
treated with guselkumab at or after Week 52.

Figure 7. PSSD Sign Score=0 From Weeks 76-204 (TFR)*

29.4 32.9
33.0

28.7
34.9 33.231.1 29.2

35.9
31.5

39.4

29.3

0

20

40

60

80

100

Week 76 Week 156 Week 172 Week 204Week 100 Week 124

P
er

ce
nt

ag
e 

of
 P

at
ie

nt
s

347 343 339 327 315 313228 226 223 219 213 208n =

Guselkumab Adalimumab→Guselkumab

*Patients with baseline PSSD sign score >0. 
Weeks 76-204: Guselkumab – includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with 
guselkumab at Week 16; Adalimumab→Guselkumab – includes patients randomized to adalimumab at baseline and crossed over and were 
treated with guselkumab at or after Week 52.

Figure 8. DLQI Score of 0 or 1 From Weeks 76-204 (TFR)*

75.7 75.2 74.5 73.3 76.2 75.375.0 74.0 76.1 74.5
78.0

72.5

0

20

40

60

80

100

Week 76 Week 156 Week 172 Week 204Week 100 Week 124

P
er

ce
nt

ag
e 

of
 P

at
ie

nt
s

445 436 431 420 404 396264 262 259 255 250 244n =

Guselkumab Adalimumab→Guselkumab

*Patients with baseline DLQI score >1. 
Weeks 76-204: Guselkumab – includes patients randomized to guselkumab at baseline and to placebo who crossed over and were treated with 
guselkumab at Week 16; Adalimumab→Guselkumab – includes patients randomized to adalimumab at baseline and crossed over and were 
treated with guselkumab at or after Week 52.

Table 1. Adverse Events (AEs) Through Weeks 48, 100, 156, and 204 Among Patients Randomized to 
Guselkumab and Placebo Crossover Patients 

Guselkumab

Weeks 0-48 Weeks 0-100 Weeks 0-156 Weeks 0-204

Treated patients, n 494 494 494 494

Average duration of 
follow-up, weeks

41.6 89.4 139.2 179.0

≥1 AE, n (%) 350 (70.9%) 395 (80.0%) 426 (86.2%) 437 (88.5%)

Discontinued due to ≥1 
AE, n (%)

10 (2.0%) 14 (2.8%) 21 (4.3%) 29 (5.9%)

≥1 SAE, n (%) 21 (4.3%) 45 (9.1%) 66 (13.4%) 82 (16.6%)

Infections, n (%) 248 (50.2%) 302 (61.1%) 335 (67.8%) 347 (70.2%)

Requiring antibiotics 79 (16.0%) 124 (25.1%) 154 (31.2%) 169 (34.2%)

Serious infections 3 (0.6%) 6 (1.2%) 11 (2.2%) 15 (3.0%)

Malignancies other than 
NMSC, n (%)

2 (0.4%) 6 (1.2%) 9 (1.8%) 13 (2.6%)

NMSC, n (%) 2 (0.4%) 2 (0.4%) 3 (0.6%) 8 (1.6%)

MACE, n (%) 1 (0.2%) 1 (0.2%) 2 (0.4%) 3 (0.6%)

Deaths, n (%) 0 2 (0.4%) 4 (0.8%) 4 (0.8%)

MACE=Major adverse cardiovascular event; NMSC=Nonmelanoma skin cancer; SAE=Serious adverse event

Other Safety Events
 ■ No opportunistic infections were reported

 ■ No anaphylactic or serum sickness-like reactions were reported

 ■ Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 in blood hematology and chemistry 
laboratory values were uncommon

Conclusions
 ■ High efficacy response rates were maintained with up to 4 years of continuous guselkumab treatment in 

VOYAGE 1, regardless of the analysis method (TFR, NRI, and OBS)

 ■ No new safety signals were identified

References
1. Blauvelt A., et al. J Am Acad Dermatol. 2017;76(3):405-417.

2. Griffiths C.E.M., et al. J Drugs Dermatol. 2018;17(8):826-832.

This poster was supported by Janssen Research & Development, LLC

Maintenance of Response With up to 4 Years of Continuous 
Guselkumab Treatment: Results From the VOYAGE 1 Phase 3 Trial

C.E.M. Griffiths,1 K.A. Papp,2 M. Song,3 M. Miller,3 Y. You,3 Y-K. Shen,3 C. Han,3 A. Blauvelt4
1Dermatology Centre, University of Manchester, Manchester, UK; 2K. Papp Clinical Research and Probity Research Inc., Waterloo, Ontario, Canada; 3Janssen Research & Development, LLC, Spring House, PA, USA; 
4Oregon Medical Research Center, Portland, OR, USA