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

VOYAGE 2: CO-PRIMARY
ENDPOINTS AT WEEK 16^1,2*
(GLOBAL ANALYSIS)

PASI 90

IGA 0/1

VOYAGE 2: MAJOR SECONDARY
ENDPOINT AT WEEK 16^2,3*
(GLOBAL ANALYSIS)

ss-IGA 0/1

VOYAGE 2: MAJOR SECONDARY
ENDPOINTS AT WEEK 24^{1,2^‡}
(NORTH AMERICAN ANALYSIS)

PASI 90

IGA 0/1

IGA 0

VOYAGE 2: MAJOR SECONDARY
ENDPOINT AT WEEK 16^{1,3^‡}
(NORTH AMERICAN ANALYSIS)

PASI 75

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

^†P<0.001 vs placebo.

^‡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=0.003.

^llP=0.005.

^¶P<0.001 vs Humira®.

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

^†P<0.001 vs placebo.

^‡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=0.003.

^llP=0.005.

^¶P<0.001 vs Humira®.

Nearly 9 Out of 10 Patients Who Achieved PASI 90 at Week 28 Maintained This Response at Week 48^1#

VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE^1-3

View Study Design

^††Maintenance and durability of PASI 90 response at Week 48 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P value is 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response was 15 weeks (23 weeks after last TREMFYA® dose) for patients at Week 28 who were re-randomized to placebo and withdrawn from TREMFYA^®1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.

^#Patients 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).

References: 1. TREMFYA® (guselkumab) [prescribing information]. Horsham, PA: Janssen Biotech, Inc. 2. Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. 3. 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.

cp-82625v3

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

Nearly 9 Out of 10 Patients Who Achieved PASI 90 at Week 28 Maintained This Response at Week 48^1#

IMPORTANT SAFETY INFORMATION

INDICATIONS

DOSAGE AND ADMINISTRATION

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TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASISVOYAGE 2 RESULTS VS PLACEBO AND HUMIRA® (adalimumab)

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

DOSAGE AND ADMINISTRATION

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

Nearly 9 Out of 10 Patients Who Achieved PASI 90 at Week 28 Maintained This Response at Week 48^1#