TREMFYA® vs COSENTYX® Data | TREMFYA® (guselkumab) | HCP

IN MODERATE TO SEVERE PLAQUE PSORIASIS
ECLIPSE HEAD-TO-HEAD STUDY DESIGN: TREMFYA® AND COSENTYX® (secukinumab)

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

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 POPULATION1,2

TREMFYA® (guselkumab) ECLIPSE 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.

STATISTICAL METHODS: PRIMARY AND SECONDARY ENDPOINTS
ENDPOINT TESTED TESTING PLAN
PRIMARY ENDPOINT
PASI 90 at Week 48
Noninferiority
Superiority
MAJOR SECONDARY ENDPOINTS
PASI 75 at both Week 12 and 48*
Noninferiority
Superiority
PASI 90 at Week 12
Noninferiority
PASI 75 at Week 12
Noninferiority
PASI 100 at Week 48
Noninferiority
Superiority
IGA 0 at Week 48
Noninferiority
Superiority
IGA 0/1 at Week 48
Noninferiority
Superiority
Significant
Not statistically significant
Statistical tests are not applied due to the step-down approach, so there are no statistically significant results

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

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ECLIPSE: PRIMARY ENDPOINT AT WEEK 48

PASI 90

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

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.

NRI methods were used for analysis.

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

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

Due to the results of the step-down approach to control for multiple testing, nominal P  value for PASI 90 at Week 12 is not presented and efficacy comparisons cannot be made.

View Study Design

ECLIPSE Primary Endpoint: PASI 90 at Week 48

PASI 90

Efficacy of TREMFYA® (guselkumab) vs Cosentyx® at Week 48: PASI 90 Over Time

 

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

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

NRI methods were used for analysis.

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.

View Study Design

ECLIPSE: MAJOR SECONDARY ENDPOINTS AT WEEK 48

Results at Week 48

Secondary Endpoint at Week 48

  • IGA 0/1: TREMFYA® 85% (454/534), Cosentyx® 75% (385/514)

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.

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.