Results at Week 16
Results at Week 16
†P<0.001 vs placebo.
TREMFYA® vs placebo analysis is based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [ie, United States and Canada]).
Study Designs: In VOYAGE 1 and VOYAGE 2, 837 and 992 patients were randomized to placebo (n=174, n=248), TREMFYA® 100-mg subcutaneous (SC) injection every 8 weeks (q8w) after Weeks 0 and 4 (n=329, n=496), or Humira® (adalimumab) 80-mg SC at Week 0, 40 mg at Week 1, and 40 mg every 2 weeks thereafter (n=334, n=248), respectively. Eligible patients (≥18 years of age) had moderate to severe plaque psoriasis (ie, Investigator’s Global Assessment [IGA] score ≥3, Psoriasis Area and Severity Index [PASI] score ≥12, and body surface area [BSA] involvement ≥10%) for at least 6 months and were candidates for systemic therapy or phototherapy. The studies comprised a placebo-controlled period (Weeks 0-16) after which patients taking placebo crossed over to receive TREMFYA® at Weeks 16 and 20. In VOYAGE 1, patients continued TREMFYA® q8w thereafter through Week 48, and there was an active–comparator-controlled period when TREMFYA® was compared with Humira® from Week 0 through Week 48. The VOYAGE 2 study also included an active–comparator-controlled period with Humira® (Weeks 0-24). In VOYAGE 2, at Week 28, patients who were randomized to TREMFYA® 100-mg SC q8w at Week 0 and those who were PASI 90 responders were re-randomized either to placebo or TREMFYA® 100-mg SC q8w in a 1:1 ratio.
*PASI 90=Proportion of patients who achieved 90% or more reduction (or improvement) in PASI score from baseline; IGA 0/1=Proportion of patients who achieved an 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).