Skin Clearance Data: Moderate to Severe Plaque PsO

PASI results IGA results

Patients saw clearer skin at Week 16^1,2

VOYAGE 1: Major secondary endpoints at Weeks 16, 24, and 48 (NRI)*

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

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

VOYAGE 1—PASI 90: TREMFYA^® 73% (241/329), placebo 3% (5/174) (P<0.001). IGA 0/1: TREMFYA^® 85% (280/329), placebo 7% (12/174) (P<0.001). VOYAGE 2—PASI 90: TREMFYA^® 70% (347/496), placebo 2% (6/248) (P<0.001). IGA 0/1: TREMFYA^® 84% (417/496), placebo 8% (21/248) (P<0.001).

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

VOYAGE 2: Major secondary endpoint at Week 16 (NRI)^1,2*^†

64% (102/160) of patients receiving TREMFYA^® achieved PASI 90 vs 42% (34/81) of patients receiving Humira^®

VOYAGE 2: Major secondary endpoint at Week 24 (NRI)^1,2*^‡

71% (113/160) of patients receiving TREMFYA^® achieved PASI 90 vs 51% (41/81) of patients receiving Humira^®

*Results from North American sites only, which used US-licensed Humira^®.

^†P<0.001 vs Humira^®.

^‡P=0.003 vs Humira^®.

Humira is a registered trademark of Abbvie Biotechnology Ltd. Corporation.

NRI=nonresponder imputation.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

48% of patients were completely clear* at Week 48¹

VOYAGE 1: Prespecified exploratory endpoint at Weeks 24 and 48 (NRI)*^†

*PASI 100 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P values were considered nominal.

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

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

^†Results from North American sites only, which used US-licensed Humira^®.

Humira is a registered trademark of Abbvie Biotechnology Ltd. Corporation.

NRI=nonresponder imputation; PASI 100=proportion of patients who achieved 100% reduction (or improvement) in PASI score from baseline.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

Consistent efficacy, dose to dose

VOYAGE 1: Prespecified secondary analysis—PASI 90 response rates
were evaluated between doses from Week 20 through Week 48^1,2*

Data shown include patients randomized at Week 0 to the TREMFYA^® arm.

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

Placebo and active-comparator data are not shown in chart.

VOYAGE co-primary endpoints at Week 16 (NRI)^2,3:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).³

VOYAGE 2: PASI 90 at Weeks 16 and 24 (major secondary endpoints, NRI)^3†

64% (102/160) of patients receiving TREMFYA^® achieved PASI 90 response at Week 16
71% (113/160) of patients receiving TREMFYA^® achieved PASI 90 response at Week 24

*NRI methods were used for analysis.

^†Results from North American sites only, which used a US-licensed active comparator. Active-comparator data not shown.

Dosing and administration

100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter³

References: 1. Blauvelt A, Papp KA, Griffiths CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417. 2. Data on file. Janssen Biotech, Inc. 3. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

93% mean PASI improvement at Week 48¹

VOYAGE 1: Prespecified other secondary analysis—mean PASI improvement from baseline*

In the controlled period, mean PASI improvement was a prespecified other secondary analysis that was not adjusted for multiplicity; P values were considered nominal.

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

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

In VOYAGE 2¹

Mean PASI improvement from baseline at Week 4 was 54% (n=496) with TREMFYA^® vs 16% (n=248) with placebo
Mean PASI improvement from baseline at Week 16 was 89% (n=496) with TREMFYA^® vs 20% (n=248) with placebo

Treatment failure rules method: Patients who discontinued study agent due to lack of efficacy or an adverse event of worsening of psoriasis, or who started a protocol-prohibited medication, including conventional and biologic systemic therapy, phototherapy, and/or topical therapies for psoriasis, were considered treatment failures. Patients were considered to have no improvement (percent improvement=0) after meeting treatment failure criteria.

After treatment failure rules were applied, last observation carried forward was applied for any missing data.

*Mean PASI improvement is an assessment of the average percentage improvement from baseline in psoriatic signs of redness, thickness, scale, and body surface area of involvement.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

Retreatment with TREMFYA^® after withdrawal
and loss of ≥50% of PASI response at Week 28¹

VOYAGE 2: Prespecified exploratory endpoint—proportion of patients with ≥PASI 75 or ≥PASI 90 after retreatment

Limitations:

The criterion for retreatment was patient-specific (ie, based on the patient’s baseline value and amount of improvement) and therefore includes a range of PASI scores
The same patients may not have responded at each time point

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

At Week 0 of VOYAGE 2, patients were randomized to TREMFYA^® 100 mg at Weeks 0, 4, 12, and 20. At Week 28, PASI 90 responders were re-randomized to either continue TREMFYA^® or to receive placebo. Upon loss of ≥50% of the improvement in PASI achieved at Week 28, patients in the placebo arm were re-treated with TREMFYA^® and evaluated for PASI 75 and PASI 90 response. This analysis includes patients who lost ≥50% of the improvement in PASI achieved at Week 28 by Week 32, 36, 40, 44, 48, or 52.

Patients were re-treated with 100 mg, then 100 mg 4 weeks later, and then 100 mg every 8 weeks.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

The majority of patients saw clearer skin with TREMFYA^®1,2

VOYAGE 1: Major secondary endpoints at Weeks 16, 24, and 48 (NRI)*

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

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

VOYAGE 2: Major secondary endpoint at Week 16 (NRI)^1,2*^‡

74% (119/160) of patients receiving TREMFYA^® achieved IGA 0/1 vs 62% (50/81) of patients receiving Humira^®

VOYAGE 2: Major secondary endpoint at Week 24 (NRI)^1,2*^§

74% (119/160) of patients receiving TREMFYA^® achieved IGA 0/1 vs 57% (46/81) of patients receiving Humira^®

Humira is a registered trademark of Abbvie Biotechnology Ltd. Corporation.

Nonresponder imputation (NRI) methods were used for analysis.

*Results from North American sites only, which used US-licensed Humira^®.

^†P<0.001 vs Humira^®.

^‡P<0.027 vs Humira^®.

^§P=0.005 vs Humira^®.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

More than half of patients were completely clear at Week 24^1,2

VOYAGE 1: Major secondary endpoints at Weeks 24 and 48*^†

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

VOYAGE co-primary endpoints at Week 16 (NRI)^1,2:

Psoriasis Symptoms and Signs Diary (Week 16): Greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness).²

VOYAGE 2: Major secondary endpoint at Week 24^1,2*^†

48% (76/160) of patients receiving TREMFYA^® achieved IGA 0 compared with 28% (23/81) of patients receiving Humira^®
(P =0.005)

*NRI methods were used for analysis.

^†Results from North American sites only, which used a US-licensed active comparator.

^‡P<0.001 vs Humira^®.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

Clearer skin
is possible

Clearer skin
is possible

Clearer skin is possible

Clearer skin is possible

Clearer skin
is possible

Clearer skin
is possible