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Rheumatology Specialist
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Full Prescribing Information
Lasting skin clearance at 2 years1-6*†‡
Treatment with TREMFYA® resulted in an improvement in the skin manifestations of psoriasis in patients with ≥3% BSA of psoriatic involvement and IGA score ≥2 at baseline
DISCOVER 2: IGA 0/1† response rates with a ≥2 grade improvement at
Weeks 24, 52, and 100§ǁ¶#
Blinded, placebo-
controlled phase
(Week 24; NRI)
Open-label
active
treatment,
NRI post hoc
analysis
Open-label
active
treatment,
NRI post hoc
analysis
In DISCOVER 1
Week 24: 57% of patients receiving TREMFYA® q8w (47/82) had an IGA score 0 (cleared) or 1 (minimal) and ≥2 grade reduction from baseline vs 15% of patients receiving placebo (12/78) (P<0.0001)1,2,7ǁ¶
Week 52 (NRI post hoc analysis): 63% of patients receiving TREMFYA® q8w (52/82) had an IGA score of 0 (cleared) or 1 (minimal) and ≥2 grade reduction from baseline1,8§ǁ¶††
BSA=body surface area; IGA=Investigator’s Global Assessment; NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†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).
‡Year 2 represents Week 100.
§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.
||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.
#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.
PASI 90 response rates1-5
In patients with ≥3% BSA of psoriatic involvement and IGA score ≥2 at baseline
DISCOVER 2: PASI 90 response rates at Week 24, Week 52, and Week 100*†‡
Blinded, placebo-
controlled phase
(Week 24; NRI)
Open-label
active
treatment,
NRI post hoc
analysis§||
Open-label
active
treatment,
NRI post hoc
analysis§||
In DISCOVER 1
Week 24: 50% of patients receiving TREMFYA® q8w (41/82) achieved a PASI 90 response vs 12% of patients receiving placebo (9/78)1,2,7†‡
Week 52 (NRI post hoc analysis): 61% of patients receiving TREMFYA® q8w (50/82) achieved a PASI 90 response1,8*†‡§¶
PASI 90 endpoints were not adjusted for multiplicity. Therefore, statistical significance has not been established.
*The same patients may not have responded at each time point.
†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.
ǁThe 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. 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. 6. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485. 7. 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. 8. Ritchlin CT, Helliwell PS, Boehncke W-H, 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.
Complete resolution of enthesitis that lasts at 2 years1-6*†‡
DISCOVER 1 AND DISCOVER 2 (pooled data): Resolution of enthesitis (LEI score=0) at Week 24 and Week 52§ǁ¶
Blinded, placebo-controlled
phase
(Week 24; NRI)
Open-label
active treatment,
NRI post hoc
analysis‡#
DISCOVER 2 only: Resolution of enthesitis (LEI score=0) at Week 100§¶
Open-label active treatment,
NRI post hoc analysis‡#
DISCOVER 1 AND DISCOVER 2 (pooled data): Resolution of enthesitis (LEI score=0) at Week 24 and Week 52§ǁ¶
DISCOVER 2 only: Resolution of enthesitis (LEI score=0) at Week 100§¶
Blinded, placebo-
controlled phase
(Week 24; NRI)
Open-label
active
treatment,
NRI post hoc
analysis‡#
Open-label
active
treatment,
NRI post hoc
analysis‡#
LEI=Leeds Enthesitis Index; NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
§Among patients with LEI enthesitis score >0 at baseline.
ǁThrough 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.
#The prespecified as-observed analyses at Week 52 and Week 100 are 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. 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. 6. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.
Complete resolution of dactylitis that lasts at 2 years1-5*†‡
DISCOVER 1 AND DISCOVER 2 (pooled data): Resolution of dactylitis (dactylitis score=0) at Week 24 and Week 52§ǁ¶
Blinded, placebo-controlled
phase (Week 24; NRI)
Open-label
active treatment,
NRI post hoc
analysis‡#
DISCOVER 2 only: Resolution of dactylitis (dactylitis score=0) at Week 100§¶
Open-label active treatment, NRI post hoc analysis‡#
DISCOVER 1 AND DISCOVER 2 (pooled data): Resolution of dactylitis (dactylitis score=0) at Week 24 and Week 52§ǁ¶
DISCOVER 2 only: Resolution of dactylitis (dactylitis score=0) at Week 100§¶
Blinded, placebo-controlled phase
(Week24; NRI)
Open-label active treatment,
NRI post hoc analysis‡#
Open-label active treatment,
NRI post hoc analysis‡#
NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
§Among patients with LEI enthesitis score >0 at baseline.
ǁThrough 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.
#The prespecified as-observed analyses at Week 52 and Week 100 are 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. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.
Improvement in physical function at Week 241-6
Mean change from baseline in HAQ-DI score through Week 100
DISCOVER 2: LS mean change from baseline in HAQ-DI score
through Week 100*†‡§||
Blinded, placebo-
controlled
phase
(Weeks 0-24; NRI)
Open-label active treatment
NRI post hoc analysis
(Weeks 24-100)
In DISCOVER 1
Week 24: The LS mean change from baseline for HAQ-DI score was -0.32 for patients receiving TREMFYA® q8w (n=127) vs -0.07 for patients receiving placebo (n=126) (P<0.0001).1,2,7‡§
Week 52 (NRI post hoc analysis): The LS mean change from baseline for HAQ-DI score was -0.40 for patients receiving TREMFYA® q8w (n=127).1,8†‡§¶
Change from baseline in HAQ-DI score at Week 16 was not adjusted for multiplicity. Therefore, statistical significance has not been established.
HAQ-DI=Health Assessment Questionnaire-Disability Index; NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†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.
‡Multiple imputation was used to impute missing data.
§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.
||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. 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. 6. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485. 7. Deodhar A, Helliwell PS, Boehncke W-H, et al; DISCOVER-1 Study Group. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomized, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125. 8. Ritchlin CT, Helliwell PS, Boehncke W-H, et al. Guselkumab, an inhibitor of the IL23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomized study of patients who were biologic-naive or TNFα inhibitor-experienced. RMD Open. 2021;7(1):e001457.
HAQ-DI is a 20-question instrument that assesses
the degree of difficulty a
person has in accomplishing:
- dressing
- arising
- hygiene
- reaching
- eating
- walking
- gripping
- activities of
daily living
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
Minimal disease activity (MDA) that lasts at 2 years1-5*†
At Week 24, Week 52, and Week 100
DISCOVER 2: Minimal disease activity at Week 24, Week 52, and Week 100‡§||
Blinded, placebo-
controlled
phase
(Week 24; NRI)
Open-label
active
treatment,
NRI post hoc
analysis‡¶
Open-label
active
treatment,
NRI post hoc
analysis‡¶
In DISCOVER 1
Week 24: 23% of patients receiving TREMFYA® q8w (29/127) had MDA compared with 11% of patients receiving placebo (14/126).6§||
Week 52 (NRI post hoc analysis): 30% of patients receiving TREMFYA® q8w (38/127) had MDA.1,7‡#
MDA was not adjusted for multiplicity. Therefore, statistical significance has not been established.
HAQ-DI=Health Assessment Questionnaire-Disability Index; NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
§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.
¶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.
A patient has achieved MDA when they meet 5
of 7 of the following
criteria:
- tender joint count ≤1
- swollen joint count ≤1
- PASI ≤1 or BSA ≤3
- patient pain visual analogue scale (VAS) ≤15
- patient’s global activity VAS ≤20
- HAQ ≤0.5
- tender enthesial points ≤18
A patient has achieved MDA when they meet 5 of 7 of the following criteria:
- tender joint count ≤1
- swollen joint count ≤1
- PASI ≤1 or BSA ≤3
- patient pain visual
analogue scale (VAS) ≤15 - patient’s global activity VAS ≤20
- HAQ ≤0.5
- tender
enthesial points ≤18
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. 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. 4. 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. 5. McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485. 6. 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. 7. Ritchlin CT, Helliwell PS, Boehncke W-H, et al. Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced. RMD Open. 2021;7(1):e001457. 8. Mease PJ, et al. Measures of Psoriatic Arthritis. Arthritis Care & Res. 2011;63(S11):S64-S85.
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