Dermatology Xagena

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ECLIPSE trial has demonstrated superiority of Guselkumab versus Secukinumab in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48

ECLIPSE trial has demonstrated that Guselkumab ( Tremfya ) was superior to Secukinumab ( Cosentyx ) in treating adults with moderate to severe plaque psoriasis for the primary endpoint assessed at week 48.
Data from the multi-center, randomized, double-blind head-to-head phase 3 study have demonstrated that 84.5% of patients treated with Guselkumab has achieved at least 90% improvement in their baseline Psoriasis Area Severity Index ( PASI ) score at week 48, compared with 70.0% of patients treated with Secukinumab ( p less than 0.001 ).

ECLIPSE is a head-to-head study comparing an interleukin-23-targeted biologic therapy ( Guselkumab ) with an IL-17 inhibitor ( Secukinumab ).

ECLIPSE has incorporated six major secondary endpoints that used a fixed statistical sequence procedure to control for multiple comparisons and included both shorter and longer-term analyses.

Guselkumab has demonstrated non-inferiority to Secukinumab in the first major secondary endpoint, with 84.6% of patients on Guselkumab achieving a PASI75 response at both weeks 12 and 48 versus 80.2% of those on Secukinumab ( p less than 0.001 ), however, it did not demonstrate superiority ( p=0.062 ).
Because superiority was not demonstrated for the first major secondary endpoint, p-values for all the subsequent major secondary endpoints were considered nominal.
Three of the remaining major secondary endpoints evaluated efficacy at week 48, including achievement of a PASI100 response and Investigator’s Global Assessment ( IGA ) scores of 0 ( cleared ), or 0 or 1 ( cleared or minimal disease ).
At week 48, 58.2% of patients receiving Guselkumab has achieved a PASI100 response, compared with 48.4% of patients receiving Secukinumab; 62.2% of patients receiving Guselkumab has achieved an IGA score of 0 compared to 50.4% of patients receiving Secukinumab; and 85.0% of patients receiving Guselkumab has achieved an IGA score of 0 or 1 compared to 74.9% of patients receiving Secukinumab ( all comparisons with nominal p less than or equal to 0.001 ).

The remaining major secondary endpoints assessed non-inferiority of Guselkumab versus Secukinumab at week 12.
The percentage of patients achieving a PASI75 response at week 12 was 89.3% for Guselkumab and 91.6% for Secukinumab ( p less than 0.001 for non-inferiority ); the percentage of patients achieving a PASI 90 response at week 12 was 69.1% for Guselkumab and 76.1% for Secukinumab ( p=0.127 for non-inferiority ).

The response-over-time curves show that maximum response rates with Guselkumab are achieved after six months and are maintained over time through one year, achieving superiority at the primary endpoint of the study.
Results of the study have confirmed a slightly more rapid onset of response with Secukinumab.

Through week 44, 27 patients ( 5.1% ) randomized to the Guselkumab arm discontinued treatment compared with 48 patients ( 9.3% ) randomized to the Secukinumab arm.

The safety profiles observed for Guselkumab and Secukinumab in ECLIPSE were consistent with the known safety profiles seen in the respective registration trials and current prescribing information.
Similar percentages of patients receiving Guselkumab ( 77.9% ), and Secukinumab ( 81.6% ) have reported at least one adverse event.
Serious adverse effects were reported in 6.2% of patients receiving Guselkumab and 7.2% of patients receiving Secukinumab.
Serious infections occurred in six patients receiving Guselkumab and five patients receiving Secukinumab. ( Xagena )

Source: Janssen Pharmaceutical, 2018