Similar ACR20 response seen regardless of prior anti-TNFα exposure1,2

ACR20 response rates by prior anti-TNFα exposure (DISCOVER 1)

DISCOVER 1 (subgroup analysis) at Week 24 and Week 52: ACR20 response in patients with no prior anti-TNFα exposure*†‡

Blinded, placebo-controlled phase (Week 24; NRI)

Open-label active treatment,
NRI post hoc analysis (Week 52)§II

DISCOVER 1 ACR20 response rates chart
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DISCOVER 1 ACR20 response rates

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

NRI=nonresponder imputation; TNF=tumor necrosis factor.

*ACR20 response by prior anti-TNFα exposure was a subgroup analysis of the primary endpoint (ACR20 response at Week 24).

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.

IIThe prespecified as-observed analysis at Week 52 is not shown.

DISCOVER 1 (subgroup analysis) at Week 24 and Week 52: ACR20 response in patients with prior anti-TNFα exposure*†‡

Blinded, placebo-controlled phase (Week 24; NRI)

Open-label active treatment,
NRI post hoc analysis (Week 52)§II

DISCOVER 1 ACR20 response rate chart
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DISCOVER 1 ACR20 response chart

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

*ACR20 response by prior anti-TNFα exposure was a subgroup analysis of the primary endpoint (ACR20 response at Week 24).

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.

IIThe prespecified as-observed analysis at Week 52 is not shown.

References: 1. Data on file. Janssen Biotech, Inc. 2. Deodhar A, Helliwell PS, Boehncke W-H, 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;395(10230):1115-1125.

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TREMFYA® is the first ALT-MOA* biologic to include FACIT-F in the label for active PsA1,2

Treatment with TREMFYA® resulted in improvement in fatigue as measured by FACIT-F

DISCOVER 2: Mean change from baseline FACIT-F score
at Week 24, Week 52, and Week 100

Blinded, placebo-controlled phase
(Week 24; NRI)†‡§

Blinded, placebo-controlled
phase (Week 24; NRI)ǁ¶

Open-label active treatment, NRI post hoc analysis (Week 100)ǁ¶

TREMFYA® DISCOVER 2  improvements in fatigue chart measured by FACIT-F
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DISCOVER 2 improvements in fatigue chart measured by FACIT-F

In DISCOVER 1

Week 24: The mean change from baseline in FACIT-F score was 5.76 for patients receiving TREMFYA® q8w (n=127) vs 2.15 for patients receiving placebo (n=126).1†‡§

Week 52 (NRI post hoc analysis): The mean change from baseline in FACIT-F score was 6.88 for patients receiving TREMFYA® q8w (n=124).1II#

The FACIT-F endpoint in DISCOVER 1 and DISCOVER 2 was not adjusted for multiplicity. Therefore, statistical significance has not been established.

FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; NRI=nonresponder imputation.

*Alt-MOA is a biologic not classified as a tumor necrosis factor (TNF) blocker. TREMFYA® is an interleukin-23 blocker.

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.

Change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.

§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 DISCOVER 2 prespecified as-observed analysis from Weeks 24 to 100 is not shown.

#The DISCOVER 1 prespecified as-observed analysis from Weeks 24 to 52 is not shown.

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FACIT-Fatigue (FACIT-F) measures a patient’s level of fatigue and tiredness over the last 7 days through a questionnaire consisting of 13 questions. Lower scores reflect more severe fatigue.2

DISCOVER 2: Patients with ≥4-point improvement from baseline in FACIT-F*

Blinded, placebo-controlled phase (Week 24; NRI)

Blinded, placebo-controlled phase (Week 52; NRI)‡§

TREMFYA® DISCOVER 2 improvement chart by percentage in FACIT-F
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DISCOVER 2 improvement chart in FACIT-F

In DISCOVER 1

Week 24: The percentage of patients with ≥4-point improvement from baseline in FACIT-F score was 54% (68/127) for patients receiving TREMFYA® q8w vs 35% (44/126) for patients receiving placebo.1*

Week 52 (NRI post hoc analysis): The percentage of patients with ≥4-point improvement from baseline in FACIT-F score was 55% (70/127) for patients receiving TREMFYA® q8w.1‡II

The FACIT-F endpoint in DISCOVER 1 and DISCOVER 2 was not adjusted for multiplicity. Therefore, statistical significance has not been established.

In DISCOVER 1 and DISCOVER 2, the threshold for clinically meaningful improvement when assessing fatigue using FACIT-F in clinical trials was based on literature that supports a change of ≥4.3

*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 DISCOVER 2 prespecified as-observed analysis from Weeks 24 to 100 is not shown.

||The DISCOVER 1 prespecified as-observed analysis from Weeks 24 to 52 is not shown.

References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 3. Cella D, Wilson H, Shalhoub H, et al. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire. Support Care Cancer Outcomes. 2019;3(30):1-12.

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Improvement in axial disease symptoms1

Change from baseline in BASDAI in patients with PsA with imaging-confirmed sacroiliitis

Post hoc analysis-pooled data from DISCOVER 1 and DISCOVER 2: LS mean change from baseline in BASDAI at Week 24 and Week 52*†‡

Data from DISCOVER 2 only: LS mean change from baseline in BASDAI at Week 100

Blinded, placebo-controlled phase (Week 24; NRI)§ǁ

Open-label active treatment, NRI post hoc analysis (Week 52)¶#

Open-label active treatment, NRI post hoc analysis (Week 100)†‡§II¶#

DISCOVER 1 and DISCOVER 2 improvement in axial disease symptoms chart
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DISCOVER 1 and DISCOVER 2 Week 24 and Week 52 improvement in axial disease symptoms chart

Data from DISCOVER 2 only: LS mean change from baseline in BASDAI at Week 100

Open-label active treatment, NRI post hoc analysis (Week 100)†‡§ǁ¶#

DISCOVER 1 and DISCOVER 2 Week 100 improvement in axial disease symptoms chart

These endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.

BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; LS=least squares.

*Included patients with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening based on investigators’ judgment of presence/absence of sacroiliitis.

BASDAI is a subject self-assessment of axial disease, which asks patients to rate their symptoms on a scale of 0 to 10, with higher scores indicating greater disease severity.

Through Week 24, patients were considered to have no improvement (change=0) after meeting treatment failure criteria. After Week 24, treatment failure rules were not applied.

§LS mean change for BASDAI scores was calculated using Mixed-Effect Repeated Measures.

||After subjects discontinued study agent due to any reason, the change from baseline, if missing, was considered to have no improvement (change=0).

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.

BASDAI50 response in patients with PsA with imaging-confirmed sacroiliitis

Post hoc analysis-pooled data from DISCOVER 1 and DISCOVER 2: BASDAI50 at Week 24 and Week 52*†‡§ǁ¶#

Post hoc analysis—data from DISCOVER 2 only: BASDAI50 at
Week 100¶#

Blinded, placebo-controlled phase (Week 24; NRI)

Open-label active treatment, NRI post hoc analysis (Week 52)

Open-label active treatment, NRI post hoc analysis (Week 100)

DISCOVER 1 and DISCOVER 2 BASDAI50 response in PsA patients chart
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DISCOVER 1 and DISCOVER 2 BASDAI50 response at Weeks 24 and 52

Post hoc analysis—data from DISCOVER 2 only: BASDAI 50 at Week 100¶#

Open-label active treatment, NRI post hoc analysis (Week 100)†‡§ǁ¶#

DISCOVER 2 BASDAI50 response at Week 100

These endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*Included patients with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening based on investigators’ judgment of presence/absence of sacroiliitis.

BASDAI is a subject self-assessment of axial disease, which asks patients to rate their symptoms on a scale of 0 to 10, with higher scores indicating greater disease severity.

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 Weeks 52 and 100 are not shown.

||Patients with BASDAI >0 at baseline.

Patients with missing data were considered nonresponders.

#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.

BASDAI response by component scores at Week 24 in patients with PsA with imaging-confirmed sacroiliitis

Post hoc analysis—pooled data from DISCOVER 1 and DISCOVER 2: BASDAI component scores at Week 24*†‡

DISCOVER 1 and DISCOVER 2 BASDAI response at Week 24
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DISCOVER 1 and DISCOVER 2 BASDAI response at Week 24

The BASDAI endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*Included patients with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening based on investigators’ judgment of presence/absence of sacroiliitis.

BASDAI is a subject self-assessment of axial disease, which asks patients to rate their symptoms on a scale of 0 to 10, with higher scores indicating greater disease severity.

Through Week 24, patients were considered to have no improvement (change=0) after meeting treatment failure criteria. After Week 24, treatment failure rules were not applied.

Reference: 1. Data on file. Janssen Biotech, Inc.

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