TREMFYA® EFFICACY DATA IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS CONSISTENT PASI 75, PASI 90, AND IGA 0 RESPONSE RATES AT WEEKS 52 AND 100 IN AN OPEN-LABEL EXTENSION4,9

VOYAGE 1 POST HOC ANALYSIS: RESULTS THROUGH WEEK 100 (AS OBSERVED, GLOBAL ANALYSIS)*

WEEK 100
TREMFYA® (guselkumab) 100 Week Data VOYAGE 1, POST HOC ANALYSIS: RESULTS THROUGH WEEK 100 (AS OBSERVED, GLOBAL ANALYSIS)*
  • *Available data at each visit were used; missing data were not included in the analysis.

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The same patients may not have responded at each time point.

Post hoc, as-observed analysis: Data from patients randomized at Week 0 to receive TREMFYA® 100 mg at Weeks 0, 4, and q8w thereafter during the blinded treatment period (Week 0 through Week 48) and through an open-label extension (from end of blinded treatment period through Week 100).

During clinical trials, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.

In the active-comparator–controlled portion of VOYAGE 1: PASI 75 was a major secondary endpoint at Week 16 vs Humira® (adalimumab); PASI 90 was a co-primary endpoint at Week 16 vs placebo and a major secondary endpoint at Weeks 16, 24, and 48 vs Humira®; IGA 0 was a major secondary endpoint at Weeks 24 and 48 vs Humira®.

In a prespecified analysis of efficacy after Week 48 applying treatment failure rules4,9:

  • At Week 52, 93% (284/307) achieved PASI 75, 80% (246/307) achieved PASI 90, and 54% (165/307) achieved IGA 0
  • At Week 100, 95% (275/290) achieved PASI 75, 82% (238/290) achieved PASI 90, and 54% (156/290) achieved IGA 0
  • Treatment failure analysis=After Week 48, subjects who discontinued study agent due to lack of efficacy or an adverse event of worsening of psoriasis, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy and/or ultra-high–potency corticosteroids were considered treatment failures. Other topical agents for psoriasis were permitted.

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