For US Healthcare Professionals
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
ADDITIONAL DATA
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
ADDITIONAL DATA
SIMILAR ACR20 RESPONSE SEEN REGARDLESS OF PRIOR ANTI-TNFα EXPOSURE1,2
ACR20 response rates by prior anti-TNFα exposure (DISCOVER 1)
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.
||The prespecified as-observed analysis at Week 52 is not shown.
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.
||The prespecified as-observed analysis at Week 52 is not shown.
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;395(10230):1115-1125.
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
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 have no improvement (change=0) 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.
‡Change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.
§Patients with data missing 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.
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
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 placebo1*†
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® q8w1‡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 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 52 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.
IMPROVEMENT IN AXIAL DISEASE SYMPTOMS1
CHANGE FROM BASELINE IN BASDAI IN PATIENTS WITH PSA WITH IMAGING-CONFIRMED SACROILIITIS
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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
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
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.
SIMILAR ACR20 RESPONSE SEEN REGARDLESS OF PRIOR ANTI-TNFα EXPOSURE1,2
ACR20 response rates by prior anti-TNFα exposure (DISCOVER 1)
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.
||The prespecified as-observed analysis at Week 52 is not shown.
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.
||The prespecified as-observed analysis at Week 52 is not shown.
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;395(10230):1115-1125.
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
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)1||#
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 have no improvement (change=0) 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.
‡Change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.
§Patients with data missing 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.
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
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 placebo1*†
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® q8w1‡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 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 52 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.
IMPROVEMENT IN AXIAL DISEASE SYMPTOMS1
CHANGE FROM BASELINE IN BASDAI IN PATIENTS WITH PSA WITH IMAGING-CONFIRMED SACROILIITIS
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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
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
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.