Enthesitis & Dactylitis Efficacy: Active PsA | TREMFYA® (guselkumab) HCP

IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

COMPLETE RESOLUTION OF ENTHESITIS THAT LASTS AT 2 YEARS1-5*

ENTHESITIS

POOLED DATA FROM DISCOVER 1 AND DISCOVER 2: RESOLUTION OF ENTHESITIS (LEI SCORE=0) AT WEEKS 24 AND 52 (NRI ANALYSIS)‡§||

DISCOVER 2 ONLY: RESOLUTION OF ENTHESITIS (LEI SCORE=0) AT WEEK 100 (NRI ANALYSIS)‡||

View Study Design

Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.

Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.

LEI=Leeds Enthesitis Index; NRI=nonresponder imputation.

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

Year 2 represents Week 100.

Among patients with LEI enthesitis score >0 at baseline.

§Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased the dose of disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.

||Patients with missing data were considered nonresponders.

After Week 24, patients and doctors knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.

#The prespecified as-observed analyses at Week 52 and Week 100 are not shown.

IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
COMPLETE RESOLUTION OF DACTYLITIS THAT LASTS AT 2 YEARS1-5*

DACTYLITIS

POOLED DATA FROM DISCOVER 1 AND DISCOVER 2: 
RESOLUTION OF DACTYLITIS (DACTYLITIS SCORE=0) 
AT WEEKS 24 AND 52 (NRI ANALYSIS)‡§||​

DISCOVER 2 ONLY: RESOLUTION OF DACTYLITIS (DACTYLITIS SCORE=0) AT WEEK 100 (NRI ANALYSIS)‡||

View Study Design

Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.

Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.

NRI=nonresponder imputation.

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

†​Year 2 represents Week 100.

Among patients with dactylitis at baseline.

§Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased the dose of disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.

||Patients with missing data were considered nonresponders.

After Week 24, patients and doctors knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.

#The prespecified as-observed analyses at Week 52 and Week 100 are not shown.

 

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 3. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naïve patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomized, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136. 4. McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, an interleukin-23p19-specific monoclonal antibody, through one year in biologic-naïve patients with psoriatic arthritis. Arthritis Rheumatol. 2021;73(4):604-616. 5. McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, a monoclonal antibody specific to the p-19 subunit of interleukin-23, through 2 years: results from a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Presented at: Innovations in Dermatology 2021; Virtual; March 16-20, 2021.