Introduction/Objective
 ■ Guselkumab is a fully human monoclonal antibody that binds and blocks 

interleukin-23
 ■ VOYAGE 1 is a phase 3, double-blind, placebo- and active comparator-controlled 

trial that showed significantly higher proportions of patients with moderate 
to severe plaque psoriasis achieving several outcome measures, including 
Psoriasis Area and Severity Index (PASI) 90 response and Investigator’s Global 
Assessment (IGA) of cleared (0) or minimal (1) scores, with guselkumab versus 
placebo at Week 16 and guselkumab versus adalimumab at Week 24.1 

 ■ Study results through up to 3 years of continuous treatment with guselkumab 
were examined

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 (PBO) 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 100 mg 
SC q8wk through Week 156

 ■ Efficacy was assessed using prespecified analyses: non-responder imputation 
(NRI) through Week 48 (patients with missing efficacy data after application 
of treatment failure rules [TFR] were counted as non-responders, without 
regard to the reason for missing data) and TFR starting at Week 52 (patients 
were considered non-responders after discontinuing due to lack of efficacy or 
worsening of psoriasis, or after use of a prohibited treatment)

 ■ Data for patients randomized to gusekumab and for those originally randomized 
to placebo and then crossed over to guselkumab at Week 16 were combined 
(guselkumab group)

Figure 1. VOYAGE 1 Study Design Through 156 Weeks

Active-Comparator Period

PBO-
Controlled

Guselkumab
(n=329)

Placebo
(n=174)

Adalimumab
(n=334)

PBO-
Crossover

Open-Label

Weeks 0 16
PE
SE

24
SE

48
SE

156
3 Year
DBL

4

R

R

52

Guselkumab 100 mg at 
Weeks 0 and 4, then q8w

Guselkumab 100 mg at Week 52, then q8w

Guselkumab 100 mg
at Weeks 16 and 20,
then q8w

Adalimumab 80 mg at Week 0, 
40 mg at Week 1, then q2w

= Randomization PE = Primary endpoint
q2w = every 2 weeks q8w = every 8 weeks

SE = Secondary endpoint

Placebo

Results
Figure 2. Proportion of Patients Who Achieved IGA Score of 0 or 1 Through 
Week 156, Primary Analysis†

0

20

40

60

80

100

0 4 8 12 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100 108 116 124 132 140 148 156

Guselkumab PBO→Guselkumab Guselkumab* Adalimumab→Guselkumab 
Weeks

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

334

84.0

83.3 82.1

84.8

269

84.6

Guselkumab n=

448 429468
PBO→Gus n=

Guselkumab* n=
Ada→Gus n=

174
329

165
329

278 275

60.4

80.5

89.1

†NRI through Week 48, then TFR beyond Week 48.
*Includes patients randomized to guselkumab at baseline and to placebo who crossed over to guselkumab 
at Week 16.

Figure 3. Proportion of Patients Who Achieved IGA Score of 0 Through Week 156,  
Primary Analysis†

Guselkumab PBO→Guselkumab Guselkumab* Adalimumab→Guselkumab 

0 4 8 12 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100 108 116 124 132 140 148 156

Weeks

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab n=
PBO→Gus n=

Guselkumab* n=
Ada→Gus n=

0

20

40

60

80

100

55.6

55.6 53.1

53.553.6

334 269
448 429468

174
329

165
329

278 275

56.4

27.3

50.5

†NRI through Week 48, then TFR beyond Week 48.
*Includes patients randomized to guselkumab at baseline and to placebo who crossed over to guselkumab 
at Week 16.

Figure 4. Proportion of Patients Who Achieved PASI 75 Response Through Week 156,  
Primary Analysis†

Guselkumab PBO→Guselkumab Guselkumab* Adalimumab→Guselkumab 

0 4 8 12 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100 108 116 124 132 140 148 156

Weeks

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab n=
PBO→Gus n=

Guselkumab* n=
Ada→Gus n=

0

20

40

60

80

100
94.9

95.8 95.8

93.7

72.4

96.4

87.8

93.8

334 269
448 431468

174
329

165
329

279 275

†NRI through Week 48, then TFR beyond Week 48.
*Includes patients randomized to guselkumab at baseline and to placebo who crossed over to guselkumab 
at Week 16.

Figure 5. Proportion of Patients Who Achieved PASI 90 Response Through Week 156,  
Primary Analysis†

Guselkumab PBO→Guselkumab Guselkumab* Adalimumab→Guselkumab 

0 4 8 12 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100 108 116 124 132 140 148 156

Weeks

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab n=
PBO→Gus n=

Guselkumab* n=
Ada→Gus n=

0

20

40

60

80

100

81.1

82.1 84.4

82.8

50.5

81.8 79.7

76.3

334 269
448 431468

174
329

165
329

279 275

†NRI through Week 48, then TFR beyond Week 48.
*Includes patients randomized to guselkumab at baseline and to placebo who crossed over to guselkumab 
at Week 16.

Figure 6. Proportion of Patients Who Achieved PASI 100 Response Through 
Week 156, Primary Analysis†

Guselkumab PBO→Guselkumab Guselkumab* Adalimumab→Guselkumab 

0 4 8 12 16 20 24 28 32 36 40 44 48 52 60 68 76 84 92 100 108 116 124 132 140 148 156

Weeks

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab n=
PBO→Gus n=

Guselkumab* n=
Ada→Gus n=

0

20

40

60

80

100

51.6

51.1 50.8

50.9

24.0

50.3

47.4

334 269
448 431468

174
329

165
329

279 275

49.1

†NRI through Week 48, then TFR beyond Week 48.
*Includes patients randomized to guselkumab at baseline and to placebo who crossed over to guselkumab 
at Week 16.

Figure 7. Proportion of Patients Who Achieved PASI 90 Response From Week 52  
Through Week 156 (TFR, NRI, Observed Data)*

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

0

20

40

60

80

100

52 60 68 76 84 92 100 108 116 124 132 140 148 156

Guselkumab (TFR) Guselkumab (NRI) Guselkumab (Observed Data)
Weeks

82.1
75.5

82.879.7

TFR: Gus n=468
NRI: Gus n=494

Observed: Gus n=463
Data

448
494
442

431
494
424

74.5 72.3

80.6 83.3
84.0

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

Figure 8. Proportion of Patients Who Achieved PASI 75, PASI 90, PASI 100, 
IGA Score of 0 or 1, and IGA Score of 0 (Weeks 52-156), As Observed

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

52 60 68 76 84 92 100 108 116 124 132 140 148 156
Weeks

0

20

40

60

80

100

PASI 75 PASI 90 PASI 100 IGA 0 or 1 IGA 0

97.1 97.494.8

424463PASI: Guselkumab* n=

83.3

84.0

80.6

51.8 51.749.7

84.4

83.4

85.5

56.3 54.054.2

IGA: Guselkumab* n= 463
442

422442

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

Figure 9. DLQI Score of 0 or 1 at Weeks 76-156 (TFR)*

75.7 75.2 74.5 74.7

0

20

40

60

80

100

Guselkumab

Week 76 Week 100 Week 124 Week 156

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

n=431n=445 n=436 n=411

DLQI=Dermatology Life Quality Index
*Patients with baseline DLQI score >1.
Weeks 76-156: Includes patients randomized to guselkumab at baseline and to placebo who crossed over 
to guselkumab at Week 16.

Figure 10. PSSD Symptom Score=0 at Weeks 76-156 (TFR)*

39.2 40.2 42.8 40.4

0

20

40

60

80

100

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

n=339n=347 n=343 n=319

Guselkumab

Week 76 Week 100 Week 124 Week 156

PSSD=Psoriasis Symptom and Sign Diary
*Patients with baseline PSSD symptom score >0.
Weeks 76-156: Includes patients randomized to guselkumab at baseline and to placebo who crossed over 
to guselkumab at Week 16.

Figure 11. PSSD Sign Score=0 at Weeks 76-156 (TFR)*

P
e
rc

e
n

ta
g

e
 o

f 
P

a
ti
e
n

ts

Guselkumab

Week 76 Week 100 Week 124 Week 156

29.4 32.9 33.0 29.2

0

20

40

60

80

100

n=339n=347 n=343 n=319

PSSD=Psoriasis Symptom and Sign Diary
*Patients with baseline PSSD sign score >0.
Weeks 76-156: Includes patients randomized to guselkumab at baseline and to placebo who crossed over 
to guselkumab at Week 16.

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

Guselkumab 
(Weeks 0-48)

Guselkumab 
(Weeks 0-100)

Guselkumab 
(Weeks 0-156)

Treated patients, n 494 494 494

Avg. duration of follow-up, weeks 41.6 89.4 139.2

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

Discontinued due to ≥1 AE, n (%) 10 (2.0%) 14 (2.8%) 21 (4.3%)

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

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

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

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

Malignancies other than NMSC, n (%) 2 (0.4%) 6 (1.2%) 9 (1.8%)

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

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

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

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

Conclusions
 ■ High levels of response were stably maintained through up to 3 years of 

continuous guselkumab treatment in patients with moderate to severe plaque 
psoriasis, regardless of the data handling rules utilized

 ■ Treatment with guselkumab was well-tolerated

Reference
1. Blauvelt A., et al. J Am Acad Dermatol. 2017;76(3):405-17. 

This poster was supported by Janssen Research & Development, LLC

Maintenance of Response With Guselkumab for up to 3 Years’ Treatment in the Phase 3 VOYAGE 1 Trial of 
Patients With Plaque Psoriasis
C.E.M. Griffiths,1 K.A. Papp,2 M. Song,3 B. Randazzo,3 S. Li,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, ON, CA; 3Janssen Research & Development, LLC, Spring House, PA, USA; 4Oregon Medical Research Center, Portland, OR, USA