TREMFYA^® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

DATA vs HUMIRA^® (adalimumab)

Superior Skin Clearance vs Humira^®: PASI 75* at Week 16^1,2

VOYAGE 1: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)

^†P<0.001 vs Humira®.

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

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

VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)

^§P<0.001 vs Humira^®.

Based on the results of an analysis of 38 North American sites (United States=27, Canada=11) from VOYAGE 1 and 41 North American ‭sites (United States=31, Canada=10) from VOYAGE 2 that used US-licensed Humira®.‬‬‬‬‬‬‬‬‬‬‬

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

TREMFYA^®—Consistent PASI 90 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)

View Study Designs

*P<0.001 vs Humira®.

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

VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)

^†P<0.001 vs Humira®.

^‡P=0.003 vs Humira®.

TREMFYA^®—Consistent IGA 0/1 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)

View Study Designs

*P<0.001 vs Humira®.

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

VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)

^†P<0.027 vs Humira^®.

^‡P=0.005 vs Humira^®.

Nearly Twice as Many Patients Were Rated as Cleared (IGA 0) With TREMFYA^® vs Humira^® at Weeks 24 and 48^1,2

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 24 AND 48 (NORTH AMERICAN ANALYSIS)

View Study Designs

*P<0.001 vs Humira®.

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

VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 24 (NORTH AMERICAN ANALYSIS)

^†P=0.005 vs Humira^®.

PASI 100* Response Rates at Weeks 24 and 48‬‬^{1,2‬‬‬‬‬‬‬‬‬}

VOYAGE 1: PRESPECIFIED EXPLORATORY ENDPOINT AT WEEKS 24 AND 48 (NORTH AMERICAN ANALYSIS)

View Study Designs

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.

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

*PASI 100=Proportion of patients who achieved 100% reduction (or improvement) in PASI score from baseline.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬

PASI 75

Superior Skin Clearance vs Humira^®: PASI 75* at Week 16^1,2

View Study Designs

VOYAGE 1: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)

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

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

VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 16 (NORTH AMERICAN ANALYSIS)

^§P<0.001 vs Humira®.

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

PASI 90

TREMFYA^®—Consistent PASI 90 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

View Study Designs

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)

View Study Designs

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

VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)

^†P<0.001 vs Humira®.

^‡P=0.003 vs Humira®.

IGA 0/1

TREMFYA^®—Consistent IGA 0/1 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

View Study Designs

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 16, 24, AND 48 (NORTH AMERICAN ANALYSIS)

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

VOYAGE 2: MAJOR SECONDARY ENDPOINTS AT WEEKS 16 AND 24 (NORTH AMERICAN ANALYSIS)

^†P<0.027 vs Humira®.

^‡P=0.005 vs Humira®.

IGA 0

Nearly Twice as Many Patients Were Rated as Cleared (IGA 0) With TREMFYA^® vs Humira^® at Weeks 24 and 48^1,2

View Study Designs

VOYAGE 1: MAJOR SECONDARY ENDPOINTS AT WEEKS 24 AND 48 (NORTH AMERICAN ANALYSIS)

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

VOYAGE 2: MAJOR SECONDARY ENDPOINT AT WEEK 24 (NORTH AMERICAN ANALYSIS)

^†P=0.005 vs Humira®.

PASI 100

PASI 100* Response Rates at Weeks 24 and 48‬‬^{1,2‬‬‬‬‬‬‬‬‬}

View Study Designs

VOYAGE 1: PRESPECIFIED EXPLORATORY ENDPOINT AT WEEKS 24 AND 48 (NORTH AMERICAN ANALYSIS)

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.

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

*PASI 100=Proportion of patients who achieved 100% reduction (or improvement) in PASI score from baseline.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬

Humira® is a registered trademark of AbbVie Inc.

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

CONTRAINDICATIONS
TREMFYA^® is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of TREMFYA^®. Some cases required hospitalization. If a serious hypersensitivity reaction occurs, discontinue TREMFYA^® and initiate appropriate therapy.

Infections
TREMFYA^® may increase the risk of infection. Treatment with TREMFYA^® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.

Consider the risks and benefits of treatment prior to prescribing TREMFYA^® in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving TREMFYA^® to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue TREMFYA^® until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis (TB)
Evaluate patients for TB infection prior to initiating treatment with TREMFYA^®. Initiate treatment of latent TB prior to administering TREMFYA^®. Monitor patients for signs and symptoms of active TB during and after TREMFYA^® treatment. Do not administer TREMFYA^® to patients with active TB infection.

Immunizations
Prior to initiating TREMFYA^®, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TREMFYA^®.

ADVERSE REACTIONS
Most common (≥1%) adverse reactions associated with TREMFYA^® include upper respiratory infections, headache, injection site reactions, arthralgia, bronchitis, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

The overall safety profile observed in patients with psoriatic arthritis is generally consistent with the safety profile in patients with plaque psoriasis, with the addition of bronchitis and neutrophil count decreased.

Please read the full Prescribing Information and Medication Guide for TREMFYA^®. Provide the Medication Guide to your patients and encourage discussion.

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DATA vs HUMIRA^® (adalimumab)

Superior Skin Clearance vs Humira^®: PASI 75* at Week 16^1,2

TREMFYA^®—Consistent PASI 90 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

TREMFYA^®—Consistent IGA 0/1 Response Rates That Were Superior to Humira^® at Weeks 16, 24, and 48^1,2

Nearly Twice as Many Patients Were Rated as Cleared (IGA 0) With TREMFYA^® vs Humira^® at Weeks 24 and 48^1,2