Clinical Data | TREMFYA® (guselkumab) HCP

TREATMENT CONSIDERATIONS INDIFFICULT TO TREAT PATIENT TYPES

IN MODERATE TO SEVERE PLAQUE PsO

CO-PRIMARY ENDPOINTS: PASI 90 AND IGA 0/1 AT WEEK 16

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

In VOYAGE 1 and VOYAGE 2 at Week 16, patients had greater improvements in symptoms of psoriasis (itch, pain, stinging, burning, and skin tightness) compared to placebo as measured by the Psoriasis Symptoms and Signs Diary (PSSD).¹

*Nonresponder imputation (NRI) methods were used for analysis.

^†Based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American site [ie, United States and Canada]).

VIEW STUDY DESIGN

IGA=Investigator Global Assessment; IGA 0/1=Proportion of patients who achieved 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); PASI=Psoriasis Area and Severity Index; PASI 90=Proportion of patients who achieved 90% or more reduction (or improvement) in PASI score from baseline.

IN MODERATE TO SEVERE PLAQUE PsO

TREATMENT CONSIDERATIONS IN

DIFFICULT TO TREAT PATIENT TYPES

SCALP

VOYAGE 1: ss-IGA 0/1 and ≥2-Grade Improvement From Baseline^1,2*

VIEW STUDY DESIGN

^*In a subpopulation of patients with ss-IGA score ≥2 at baseline.

^†Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.

Active comparator at Week 48 not shown.

VOYAGE 2: Major Secondary Endpoint at Week 16^3*

81% (329/408) of patients receiving TREMFYA^® achieved ss-IGA 0/1 vs 11% (22/202) of patients receiving placebo (P<0.001)

NRI methods were used for analysis.

Based on the results of an analysis of the 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [ie, United States and Canada]).

ss-IGA=scalp-specific Investigator Global Assessment; ss-IGA 0/1=Proportion of patients who achieved an ss-IGA score of absence of disease (0) or very mild (1) using a 5-point scale where scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness on a scale of 0 to 4: absence of disease (0), very mild (1), mild (2), moderate (3), or severe (4).

NAIL

VOYAGE 1: Mean Percent Improvement From Baseline NAPSI (Target Nail)^2*^†‡

VIEW STUDY DESIGN

^*In a subpopulation of patients with NAPSI (target nail) score >0 at baseline.

^†Fingernail psoriasis was assessed using NAPSI, in which the nail most affected by psoriasis (target nail) is divided into quadrants and graded for psoriasis of the nail matrix (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis) on a scale of 0 to 4 for a total score ranging from 0 to 8; a higher score indicates more severe disease.

^‡Limitation: All 10 fingernails may also be evaluated using NAPSI.

^§Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.

Active comparator at Week 48 not shown.

NRI methods were used for analysis.

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

NAPSI=Nail Psoriasis Severity Index.

PALMS/SOLES

VOYAGE 1: hf-PGA 0/1 and ≥2-Grade Improvement From Baseline^2*

VIEW STUDY DESIGN

^*In a subpopulation of patients with hf-PGA score ≥2 at baseline.

^†Prespecified other secondary analysis that was not adjusted for multiplicity; therefore, statistical significance has not been established.

Active comparator at Week 48 not shown.

NRI methods were used for analysis.

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

hf-PGA=Physician Global Assessment of hands and/or feet; hf-PGA 0/1=Patients who achieved hf-PGA score of clear (0) or almost clear (1) using a 5-point scale based on the category that best describes the severity of psoriasis on the palms and soles on a scale of 0 to 4: clear, post inflammatory hyperpigmentation may be present (0), almost clear (1), mild (2), moderate (3), or severe (4).

BODY WEIGHT

VOYAGE 1: PASI 90 Response With TREMFYA^® by Baseline BMI⁴

VIEW STUDY DESIGN

BMI=body mass index (calculated as weight in kilograms divided by height in meters squared).

*This is a post hoc analysis; statistical significance has not been established and efficacy comparisons cannot be made.

Active comparator at Week 48 not shown.

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

VOYAGE 1: Major Secondary Endpoint at Week 48^1,4

73% (84/115) of patients receiving TREMFYA^® achieved PASI 90 vs 46% (53/115) of patients receiving an active comparator (P<0.001)

Based on the results of an analysis of 38 North American sites (United States=27, Canada=11) from VOYAGE 1 that used an active comparator.

NRI methods were used for analysis.

References: 1. TREMFYA^® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. 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. 3. 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. 4. Data on file. Janssen Biotech, Inc.

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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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TREMFYA^® IS INDICATED FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS (PsO) WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY AS WELL AS ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

TREATMENT CONSIDERATIONS INDIFFICULT TO TREAT PATIENT TYPES

IN MODERATE TO SEVERE PLAQUE PsO

CO-PRIMARY ENDPOINTS: PASI 90 AND IGA 0/1 AT WEEK 16

IN MODERATE TO SEVERE PLAQUE PsO

TREATMENT CONSIDERATIONS IN

DIFFICULT TO TREAT PATIENT TYPES

SCALP

VOYAGE 1: ss-IGA 0/1 and ≥2-Grade Improvement From Baseline^1,2*

VOYAGE 2: Major Secondary Endpoint at Week 16^3*

NAIL

VOYAGE 1: Mean Percent Improvement From Baseline NAPSI (Target Nail)^2*^†‡

PALMS/SOLES

VOYAGE 1: hf-PGA 0/1 and ≥2-Grade Improvement From Baseline^2*

BODY WEIGHT

VOYAGE 1: PASI 90 Response With TREMFYA^® by Baseline BMI⁴

VOYAGE 1: Major Secondary Endpoint at Week 48^1,4

IMPORTANT SAFETY INFORMATION

INDICATIONS

DOSAGE AND ADMINISTRATION

Do you want to continue to [extlink:external-url]?

TREMFYA® IS INDICATED FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS (PsO) WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY AS WELL AS ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

TREATMENT CONSIDERATIONS INDIFFICULT TO TREAT PATIENT TYPES

IN MODERATE TO SEVERE PLAQUE PsO

CO-PRIMARY ENDPOINTS: PASI 90 AND IGA 0/1 AT WEEK 16

IN MODERATE TO SEVERE PLAQUE PsO

TREATMENT CONSIDERATIONS IN

DIFFICULT TO TREAT PATIENT TYPES

SCALP

VOYAGE 1: ss-IGA 0/1 and ≥2-Grade Improvement From Baseline1,2*

VOYAGE 2: Major Secondary Endpoint at Week 163*

NAIL

VOYAGE 1: Mean Percent Improvement From Baseline NAPSI (Target Nail)2*†‡

PALMS/SOLES

VOYAGE 1: hf-PGA 0/1 and ≥2-Grade Improvement From Baseline2*

BODY WEIGHT

VOYAGE 1: PASI 90 Response With TREMFYA® by Baseline BMI4

VOYAGE 1: Major Secondary Endpoint at Week 481,4

DOSAGE AND ADMINISTRATION

Do you want to continue to [extlink:external-url]?

TREMFYA^® IS INDICATED FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS (PsO) WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY AS WELL AS ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

VOYAGE 1: ss-IGA 0/1 and ≥2-Grade Improvement From Baseline^1,2*

VOYAGE 2: Major Secondary Endpoint at Week 16^3*

VOYAGE 1: Mean Percent Improvement From Baseline NAPSI (Target Nail)^2*^†‡

VOYAGE 1: hf-PGA 0/1 and ≥2-Grade Improvement From Baseline^2*

VOYAGE 1: PASI 90 Response With TREMFYA^® by Baseline BMI⁴

VOYAGE 1: Major Secondary Endpoint at Week 48^1,4