For US Healthcare Professionals
GIVE YOUR ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA) THE OPPORTUNITY TO EMERGE WITH...EXTENSIVE RELIEF
Improvement in IGA 0/1 at Weeks 24 and 100, with additional data including PASI 90, enthesitis, dactylitis, HAQ-DI, and MDA
LASTING SKIN CLEARANCE AT 2 YEARS1-5*†‡
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
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)1,2,6ǁ¶
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 baseline1,7§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 52 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
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)1,2,6†‡
Week 52 (NRI post hoc analysis): 61% of patients receiving TREMFYA® q8w (50/82) achieved a PASI 90 response1,7*†‡§¶
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. 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. 7. 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.
COMPLETE RESOLUTION OF ENTHESITIS THAT LASTS AT 2 YEARS1-5*†‡
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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.
||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 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.
COMPLETE RESOLUTION OF DACTYLITIS THAT LASTS AT 2 YEARS1-5*†‡
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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 dactylitis at 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 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.
IMPROVEMENT IN PHYSICAL FUNCTION AT WEEK 241-5
Mean change from baseline in HAQ-DI score through Week 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)1,2,6‡§
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)1,7†‡§¶
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 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 tor PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.
||The DISCOVER 2 prespecified analysis from Weeks 24 to 100 is not shown.
¶The DISCOVER 1 prespecified analysis from Weeks 24 to 52 is not shown.
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. 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. 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. 7. Ritchlin CT, Helliwell PS, Boehncke WH, 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.
MINIMAL DISEASE ACTIVITY (MDA) THAT LASTS AT 2 YEARS1-4*†
At Week 24, Week 52, and Week 100
IN DISCOVER 1:
Week 24: 23% of patients receiving TREMFYA® q8w (29/127) had MDA compared with 11% of patients receiving placebo (14/126)5§||
Week 52 (NRI post hoc analysis): 30% of patients receiving TREMFYA® q8w (38/127) had MDA1,6‡#
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 ≤1.7
MDA was not adjusted for multiplicity. Therefore, statistical significance has not been established.
*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.
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. 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-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. 7. Mease PJ, et al. Measures of Psoriatic Arthritis. Arthritis Care & Res. 2011;63(S11):S64-S85.
LASTING SKIN CLEARANCE AT 2 YEARS1-5*†‡
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
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)1,2,6ǁ¶
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 baseline1,7§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
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)1,2,6†‡
Week 52 (NRI post hoc analysis): 61% of patients receiving TREMFYA® q8w (50/82) achieved a PASI 90 response1,7*†‡§¶
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.
||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. 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. 7. 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.
COMPLETE RESOLUTION OF ENTHESITIS THAT LASTS AT 2 YEARS1-5*†‡
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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.
llThrough 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 analysis 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.
COMPLETE RESOLUTION OF DACTYLITIS THAT LASTS AT 2 YEARS1-5*†‡
Week 24 and Week 52 data are based on DISCOVER 1 and DISCOVER 2 pooled data.
Week 100 data are based on data from the open-label active treatment, NRI post hoc analysis of DISCOVER 2 only.
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 dactylitis at 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 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 analysis from Weeks 24 and 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.
IMPROVEMENT IN PHYSICAL FUNCTION AT WEEK 241-5
Mean change from baseline in HAQ-DI score through Week 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)1,2,6‡§
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)1,7†‡§¶
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 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.
||The DISCOVER 2 prespecified analysis from Weeks 24 to 100 is not shown.
¶The DISCOVER 1 prespecified analysis from Weeks 24 to 52 is not shown.
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. 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. 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. 7. Ritchlin CT, Helliwell PS, Boehncke WH, 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.
MINIMAL DISEASE ACTIVITY (MDA) THAT LASTS AT 2 YEARS1-4*†
At Week 24, Week 52, and Week 100
IN DISCOVER 1:
Week 24: 23% of patients receiving TREMFYA® q8w (29/127) had MDA compared with 11% of patients receiving placebo (14/126)5§||
Week 52 (NRI post hoc analysis): 30% of patients receiving TREMFYA® q8w (38/127) had MDA1,6‡#
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 ≤1.7
MDA was not adjusted for multiplicity. Therefore, statistical significance has not been established.
*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.
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. 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-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. 7. Mease PJ, et al. Measures of Psoriatic Arthritis. Arthritis Care & Res. 2011;63(S11):S64-S85.