For US Healthcare Professionals
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
ENTHESITIS AND DACTYLITIS
EMERGE TREMFYANT® : Complete resolution of enthesitis at Week 241-5
LEI=Leeds Enthesitis Index; NRI=nonresponder imputation.
*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.
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.
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.
EMERGE TREMFYANT® : Complete resolution of dactylitis at Week 241-5
NRI=nonresponder imputation.
*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.
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.
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.
EMERGE TREMFYANT® : Complete resolution of enthesitis at Week 241-5
LEI=Leeds Enthesitis Index; NRI=nonresponder imputation.
*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.
§P=0.0301 vs placebo.
||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.
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
*Among patients with LEI enthesitis score >0 at baseline.
‡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.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
EMERGE TREMFYANT® : Complete resolution of dactylitis at Week 241-5
NRI=nonresponder imputation.
*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.
§P=0.0301 vs placebo.
||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.
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
*Among patients with dactylitis at baseline.
‡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.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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.