IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)ADDITIONAL ENDPOINTS

TREATMENT WITH TREMFYA® RESULTED IN AN IMPROVEMENT IN THE SKIN MANIFESTATIONS OF PSORIASIS1-4

In patients with ≥3% BSA of psoriatic involvment and IGA score ≥2 at baseline

IGA=Investigator’s Global Assessment; NRI=nonresponder imputation.

*IGA 0/1=Proportion of patients who achieved an IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).
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<0.0001 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 DISCOVER 2 prespecified as-observed analysis from Weeks 24 to 52 is not shown.

*IGA 0/1=Proportion of patients who achieved an IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4).
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<0.0001 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 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. 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. 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. 6. Ritchlin CT, Helliwell PS, Boehncke WH, et al. Guselkumab, an inhibitor of the IL-23-p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results from a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced. RMD Open. 2021;7(1):e001457.

EMERGE TREMFYANT®: IMPROVEMENT IN PHYSICAL FUNCTION1,3

Mean change from baseline in HAQ-DI at Week 24

HAQ-DI=Health Assessment Questionnaire-Disability Index; NRI=nonresponder imputation.
*Multiple imputation was used to impute missing data.
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 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.

d1_haq_score_wk24_mobile2x-1

*Multiple imputation was used to impute missing data.
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 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.
P<0.0001 vs placebo.

HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing:

  • Dressing
  • Arising
  • Eating
  • Walking
  • Hygiene
  • Reaching
  • Gripping
  • Activities of daily living

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. 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.

IMPROVEMENT IN SF-36 PHYSICAL COMPONENT SUMMARY (PCS) SCORE AT WEEK 241,2

LS=least squares; NRI=nonresponder imputation; SF-36=36-item short-form health survey.
*Multiple imputation was used to impute missing data.
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 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.

In DISCOVER 1 at Week 24

  • LS mean change from baseline in SF-36 PCS was 6.10 for patients taking TREMFYA® q8w (n=127) vs 1.96 for patients taking placebo (n=126) (P<0.0001)1,3*†

There was not a statistically significant improvement observed in the SF-36 mental component summary score.

References: 1. Data on file. Janssen Biotech, Inc. 2. 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. 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;395(10230):1115-1125.

TREMFYA® IS THE FIRST AND ONLY ALT-MOA* BIOLOGIC TO INCLUDE FACIT-F IN THE LABEL FOR ACTIVE PsA1,2

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.2
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 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.
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 change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.

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

facit-f-d1

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 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.
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 change from baseline, if missing, was considered to have no improvement (change=0) after patients discontinued study treatment due to any reason.
The DISCOVER 1 prespecified, as-observed analysis from Weeks 24 to 52 is not shown.

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

 
facit-f4pt-d2-mobile_d2_facit_f_improvement_from_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 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 FACIT-F endpoint in DISCOVER 2 was not adjusted for multiplicity. Therefore, statistical significance has not been established.

#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

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

facit-f4pt-d1

**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 1 prespecified, as-observed analysis from Weeks 24 to 52 is not shown.

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

#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

References: 1. TREMFYA® (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. 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.

BASDAI RESPONSE AT WEEK 24 IN PsA PATIENTS WITH IMAGING-CONFIRMED SACROILIITIS1

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.

*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 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.
Patients with BASDAI 0 at baseline.

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.

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

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