TREMFYA^® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
TREMFYA^® HAS SET THE BAR AT PASI 90 AS A PRIMARY ENDPOINT IN PHASE 3 TRIALS

VOYAGE 1 AND VOYAGE 2 STUDY DESIGNS

PHASE 3 Multicenter, Double-blind Trials

PATIENT ELIGIBILITY

• ≥18 years of age
• Moderate to severe plaque psoriasis (IGA score ≥3; PASI score ≥12, BSA involvement ≥10%) for at least 6 months
• Candidates for phototherapy and/or systemic treatment

VOYAGE 1 (n=837)^1,2,4

VOYAGE 2 (n=992)^1,3,4

Before Week 48, patients who discontinued study agent because of lack of efficacy or an adverse event (AE) of psoriasis worsening, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or topical therapies for psoriasis were considered nonresponders (binary endpoints). Other patients with missing data were considered nonresponders for binary endpoints and nonresponder imputation (NRI) was applied. After Week 48, with the exception of ultra–high-potency corticosteroids, other topical agents for psoriasis were permitted.

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.