TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS MORE THAN 7 OUT OF 10 PATIENTS ACHIEVED PASI 90 RESPONSE AFTER JUST 3 DOSES1,2


Voyage 1

RESULTS AT WEEK 16
TREMFYA® (guselkumab) Clinical Study Results: PASI 90 and IGA 0/1 at Week 16

Based on the results of an analysis of the 101 global sites from VOYAGE 1 (including North American sites [ie, US and Canada]).

View Study Design
  • *PASI 90=Proportion of patients who achieved 90% or more reduction (or improvement) in PASI score from baseline; IGA 0/1=Proportion of patients who achieved an IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).

  • P<0.001 vs placebo.

More Than 9 Out of 10 Patients Achieved a 75% Improvement in Skin Clearance at Week 161,4

VOYAGE 1: Major Secondary Endpoint at Week 16 (North American Analysis)

PASI 75
TREMFYA® (guselkumab) Efficacy at Weeks 24 and 48: PASI 75

PASI 75 at Weeks 24 and 48 were prespecified exploratory endpoints that were not adjusted for multiplicity; P values are considered nominal.

Based on the results of an analysis of 38 North American sites (US=27, Canada=11) from VOYAGE 1 that used US-licensed Humira®.

The same patients may not have responded at each time point.

View Study Design
  • PASI 75=Proportion of patients who achieved 75% or more reduction (or improvement) in PASI score from baseline.

Therapeutic Longevity: Consistent PASI 90 Response Rates Demonstrated With TREMFYA®1,4

VOYAGE 1: Major Secondary Endpoint at Weeks 16, 24, and 48 (North American Analysis)

PASI 90
Efficacy of TREMFYA® (guselkumab) vs Humira®: PASI 90

Based on the results of an analysis of 38 North American sites (US=27, Canada=11) from VOYAGE 1 that used US-licensed Humira®.

The same patients may not have responded at each time point.

View Study Design

Nearly 1 Out of Every 2 Patients Were Rated as Cleared (IGA 0)# at Weeks 24 and 481,4

VOYAGE 1: Major Secondary Endpoint at Weeks 24 and 48 (North American Analysis)

IGA 0
Efficacy of TREMFYA® (guselkumab) vs Humira®: IGA 0

Based on the results of an analysis of 38 North American sites (US=27, Canada=11) from VOYAGE 1 that used US-licensed Humira®.

The same patients may not have responded at each time point.

View Study Design
  • #IGA 0=Proportion of patients who achieved an IGA score of cleared (0) using a 5-point scale where overall lesions are graded for induration, erythema, and scaling and rated as cleared except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).

TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS VOYAGE 2 RESULTS VS PLACEBO AND HUMIRA® (adalimumab) REFLECTED THOSE ACHIEVED IN VOYAGE 1


voyage 2: co-primary
endpoints AT WEEK 161,8††
(global Analysis)

TREMFYA® (guselkumab) PASI 90 and IGA 0/1 at Week 16

voyage 2: Major Secondary
Endpoint at Week 161,4‡‡
(north american Analysis)

TREMFYA® (guselkumab) PASI 75 at Week 16

voyage 2: Major Secondary
Endpoints at Week 241,4‡‡
(north american Analysis)

TREMFYA® (guselkumab) PASI 90, IGA 0/1 and IGA 0 at Week 24
  • ††Based on the results of an analysis of the 115 global sites from VOYAGE 2 (including North American sites [ie, US and Canada]).

  • ‡‡Based on the results of an analysis of 41 North American sites (US=31, Canada=10) from VOYAGE 2 that used US-licensed Humira®.

  • §§P<0.001 vs placebo.

  • || ||P<0.001 vs Humira®.

  • ¶¶ P=0.003.

  • ##P=0.005.

Nearly 9 out of 10 Patients Who Achieved PASI 90 at Week 28 Maintained This Response at Week 481***

VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1,4,8

Efficacy with TREMFYA® (guselkumab) through Week 48: PASI 90

‡‡‡Maintenance and durability of PASI 90 response at Week 48 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P values are considered nominal.

  • Major secondary endpoint: Median time to loss of PASI 90 response was 15 weeks (23 weeks after last TREMFYA® dose) for patients at Week 28 who were re-randomized to placebo and withdrawn from TREMFYA®1

Based on the results of an analysis of the 115 global sites from VOYAGE 2 (including North American sites [ie, US and Canada]).

The same patients may not have responded at each time point.

View Study Design
  • ***Subjects randomized to TREMFYA® at Week 0 and who were PASI 90 responders at Week 28 were re-randomized to either continue treatment with TREMFYA® q8w (maintenance group) or receive placebo (withdrawal group).

Skin Clearance Captured for an Actual VOYAGE 2 Patient4§§§

Age: 36 - BMI: 31.1 - Psoriasis duration: 12 years - Baseline BSA involvement: 54% - Previous therapies: topicals, biologics
Week 0
Week 0

PASI=32.8

Week 16
Week 16

PASI=8.4

Week 48
Week 48

PASI=2.8

  • §§§Individual results may vary. Photos are of a real patient from VOYAGE 2 (North American site) who received TREMFYA® 100 mg at Weeks 0, 4, and every 8 weeks thereafter through Week 48. Other areas affected (not shown) yielded similar results to those depicted here. Images are for illustrative purposes only and are used with permission from Janssen Biotech, Inc.