For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
VOYAGE 2
VOYAGE 2: CO-PRIMARY
ENDPOINTS AT WEEK 161,2*
(GLOBAL ANALYSIS)
PASI 90
IGA 0/1
VOYAGE 2: MAJOR SECONDARY
ENDPOINT AT WEEK 162,3*
(GLOBAL ANALYSIS)
ss-IGA 0/1
VOYAGE 2: MAJOR SECONDARY
ENDPOINTS AT WEEK 241,2‡
(NORTH AMERICAN ANALYSIS)
PASI 90
IGA 0/1
IGA 0
VOYAGE 2: MAJOR SECONDARY
ENDPOINT AT WEEK 161,3‡
(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®.
VOYAGE 2: PRESPECIFIED EXPLORATORY ENDPOINT—MAINTENANCE AND DURABILITY OF PASI 90 RESPONSE1-3
††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.
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.
Analyses were nonresponder imputation (NRI).
*At Week 28, patients treated with TREMFYA® achieving PASI 90 (responders) were re-randomized in a 1:1 ratio to continue TREMFYA® 100 mg every 8 weeks (q8w) or placebo. Patients treated with placebo were re-treated with TREMFYA® and received another dose 4 weeks later, then q8w thereafter upon loss of 50% or more of Week 28 PASI response. TREMFYA® nonresponders continued TREMFYA® treatment.
† Placebo→TREMFYA® responders received placebo q8w beginning at Week 28. Upon loss of ≥50% Week 28 PASI response, patients were re-treated with TREMFYA®, another dose 4 weeks later, then q8w thereafter. Placebo→TREMFYA® nonresponders at Week 28 continued TREMFYA® q8w.
‡ Humira® responders received placebo and upon loss of 50% or more of Week 28 PASI response, initiated TREMFYA®, then received another dose 4 weeks later, then q8w thereafter. Humira® nonresponders initiated TREMFYA® at Week 28, then received another dose 4 weeks later, then q8w thereafter.