Efficacy Data in Active PsA | TREMFYA® (guselkumab) HCP

IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)

ACR RESPONSE RATES IN DISCOVER 1 AND DISCOVER 2

Over 50% of Patients Achieved ACR20 Response at Week 24, After Just 4 Injections1,2

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DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NONRESPONDER IMPUTATION [NRI])*

ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.

*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to any reason, terminated study participation for any reason, initiated or increased the dose of 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.

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DISCOVER 1: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NRI)*

ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.

*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to any reason, terminated study participation for any reason, initiated or increased the dose of 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.
NS=not significant.

References: 1. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11. 2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30265):1-11.

75% of Patients Receiving TREMFYA® Had an ACR20 Response at Week 521-3*†‡

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DISCOVER 2: ACR20 RESPONSE THROUGH WEEK 52

52-WEEK DATA

*The same patients may not have responded at each timepoint.

DISCOVER 1: ACR20 RESPONSE AT WEEK 24 AND WEEK 52

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 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.
§The prespecified as-observed analysis from Weeks 24 to 52 is not shown.
||After 24 weeks, patients and doctors knew that all patients were on TREMFYA® (open-label with a blinded dosing interval), which may have affected the results.

References: 1. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11. 2. Data on File. Janssen Biotech, Inc. 3. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30265):1-11.

Similar ACR20 Response Rates Regardless of Prior Anti-TNFα Exposure1,2*

ACR20 RESPONSE BY PRIOR ANTI-TNFα EXPOSURE WAS A SUBGROUP ANALYSIS OF THE PRIMARY ENDPOINT (ACR20 RESPONSE AT WEEK 24) (NRI ANALYSIS)

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DISCOVER 1: ACR20 RESPONSE RATES—NO PRIOR ANTI-TNFα EXPOSURE

ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.

DISCOVER 1: ACR20 RESPONSE RATES—PRIOR ANTI-TNFα EXPOSURE

ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.

*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to any reason, terminated study participation for any reason, initiated or increased the dose of 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.

References: 1. Data on File. Janssen Biotech, Inc. 2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER 1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30265):1-11.