Comparator Data: Moderate to Severe Plaque PsO | TREMFYA® (guselkumab) HCP

TREMFYA® ADDITIONAL ACTIVE COMPARATOR STUDIES

ECLIPSE Study Design: TREMFYA® vs Cosentyx® (secukinumab)

ECLIPSE: PHASE 3, DOUBLE-BLIND TRIAL (N=1048)1,2

ECLIPSE: PHASE 3 DOUBLE-BLIND TRIAL (N=1048)

Cosentyx® is a registered trademark of Novartis AG.

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

OVERALL STUDY POPULATION1

OVERALL STUDY POPULATION

ECLIPSE STATISTICAL METHODS

This study utilized a step-down approach to control for multiple testing. The first major secondary endpoint did not achieve statistical significance for superiority, therefore the remaining P values are nominal and not included in the presentation.

NRI methods were used for analysis.

*Superiority for the first major secondary endpoint, PASI 75 at both Week 12 and 48, was not achieved (TREMFYA® 84.6% vs Cosentyx® 80.2%; P=0.062); therefore, the remaining P values are nominal and not included in the presentation.

TREMFYA® DEMONSTRATED SUPERIORITY vs COSENTYX® FOR PASI 90* RESPONSE AT WEEK 481,2

ECLIPSE: PRIMARY ENDPOINT AT WEEK 48

PASI 90

ECLIPSE: PRIMARY ENDPOINT AT WEEK 48

 

PASI 75 AND IGA 0/1 AT WEEK 12

Secondary Endpoints at Week 12

  • PASI 75: TREMFYA® 89% (477/534), Cosentyx® 92% (471/514)
  • IGA 0/1§: TREMFYA® 86% (457/534), Cosentyx® 86% (444/514)

Due to the results of the step-down approach to control for multiple testing, nominal P  values for PASI 75 at Week 12 are not presented and efficacy comparisons cannot be made.

IGA 0/1 at Week 12 was a prespecified exploratory endpoint that was not adjusted for multiplicity; P  value was considered nominal.

View Study Design

Results based on ECLIPSE, a single study of TREMFYA® vs Cosentyx®.

NRI methods were used for analysis.

There were no new safety findings observed for either TREMFYA® or Cosentyx® in this study.

*PASI 90=Proportion of patients who achieved 90% or more reduction (or improvement) in PASI score from baseline.

PASI 75=Proportion of patients who achieved 75% 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 discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).

TREMFYA®: IGA 0* AND PASI 100 AT WEEK 481,2

Due to the results of the step-down approach to control for multiple testing, nominal P values for IGA 0, PASI 100, and IGA 0/1 at Week 48 are not presented and efficacy comparisons cannot be made.

ECLIPSE: MAJOR SECONDARY ENDPOINTS AT WEEK 48

Results at Week 48

View Study Design

NRI methods were used for analysis.

Results based on ECLIPSE: a single study of TREMFYA® vs Cosentyx®.

*IGA 0=Proportion of patients who achieved an IGA score of cleared (0) 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 discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).

PASI 100=Proportion of patients who achieved 100% or more reduction (or improvement) in PASI score from baseline.

PASI 90 RESPONSE WITH TREMFYA® AT WEEK 48 BY BASELINE BODY WEIGHT QUARTILE1

ECLIPSE: POST HOC ANALYSIS OF BODY WEIGHT—PASI 90 AT WEEK 48

BODY WEIGHT

View Study Design

NRI methods were used.

This is a post hoc analysis; statistical significance has not been established.

The quartile cutoffs are based on the overall population (not by treatment group).

PASI 90 RESPONSE WITH TREMFYA® AT WEEK 48 BY BASELINE BMI CATEGORY1

ECLIPSE: PRESPECIFIED SUBGROUP ANALYSIS OF BMI CATEGORY—PASI 90 AT WEEK 48

BMI

View Study Design

NRI methods were used.

This is a prespecified subgroup analysis; statistical significance has not been established.

References: 1. Data on file. Janssen Biotech, Inc. 2. Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.