For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
JOINT IMPROVEMENT PROVEN TO LAST AT 2 YEARS1-5*†‡§II¶
JOINT IMPROVEMENT PROVEN TO LAST AT 2 YEARS1-5*†‡§II¶
DISCOVER 2 (ACR20): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (primary endpoint): 52% of patients receiving TREMFYA® q8w (66/127) achieved an ACR20 response vs 22% of patients receiving placebo (28/126) (P<0.0001)1,2,6‡§
Week 16: 52% of patients receiving TREMFYA® q8w (66/127) achieved an ACR20 response vs 25% of patients receiving placebo (32/126) (P<0.0001)1,2‡§
Week 52 (NRI post hoc analysis): 60% of patients receiving TREMFYA® q8w (76/127) achieved an ACR20 response1,7‡§||††
ACR20 response in DISCOVER 1 and DISCOVER 2 at Week 16 was not part of the sequential testing procedure but was prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††The DISCOVER 1 prespecified as-observed analysis from Weeks 24 to 52 is not shown.
ACR20 RESPONSE RATES ASSESSED AS EARLY AS WEEK 48
NRI POST HOC ANALYSIS FROM WEEK 4 TO WEEK 24*†‡
*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.
‡All the efficacy analyses through Week 24 were based on composite estimate, and missing data were considered nonresponders.
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. 8. Nash P, McInnes IB, Ritchlin CT, et al. Guselkumab treatment shows rapid onset of effect on American College of Rheumatology components: results of 2 randomized phase 3 trials. Presented at: European Alliance of Associations for Rheumatology (EULAR) Congress; Virtual; June 2-5, 2021.
DISCOVER 2 (ACR50): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (major secondary endpoint): 30% of patients receiving TREMFYA® q8w (38/127) achieved an ACR50 response compared with 9% of patients receiving placebo (11/126) (P<0.0001)1,2,6‡§
Week 16: 23% of patients receiving TREMFYA® q8w (29/127) achieved an ACR50 response vs 13% of patients receiving placebo (16/126) (P=0.036)1,2‡§
Week 52 (NRI post hoc analysis): 39% of patients receiving TREMFYA® q8w (49/127) achieved an ACR50 response1,7‡§||††
ACR50 response in DISCOVER 1 and DISCOVER 2 at Weeks 16 and 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††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-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.
DISCOVER 2 (ACR70): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (major secondary endpoint): 12% of patients receiving TREMFYA® q8w (15/127) achieved an ACR70 response compared with 6% of patients receiving placebo (7/126) (P=0.069)1,2,6‡§
Week 16: 8% of patients receiving TREMFYA® q8w (10/127) achieved an ACR70 response vs 6% of patients receiving placebo (7/126)1,2‡§
Week 52 (NRI post hoc analysis): 26% of patients receiving TREMFYA® q8w (33/127) achieved an ACR70 response1,7‡§||††
ACR70 response in DISCOVER 1 and DISCOVER 2 at Week 24 were not part of sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
ACR70 response in DISCOVER 1 and DISCOVER 2 at Week 16 was not controlled for multiplicity. Therefore, statistical significance has not been established.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††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-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.
DISCOVER 2 (ACR20): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (primary endpoint): 52% of patients receiving TREMFYA® q8w (66/127) achieved an ACR20 response vs 22% of patients receiving placebo (28/126) (P<0.0001)1,2,6‡§
Week 16: 52% of patients receiving TREMFYA® q8w (66/127) achieved an ACR20 response vs 25% of patients receiving placebo (32/126) (P<0.0001)1,2‡§
Week 52 (NRI post hoc analysis): 60% of patients receiving TREMFYA® q8w (76/127) achieved an ACR20 response1,7‡§||††
ACR20 response in DISCOVER 1 and DISCOVER 2 at Week 16 was not part of the sequential testing procedure but was prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††The DISCOVER 1 prespecified as-observed analysis from Weeks 24 to 52 is not shown.
ACR20 RESPONSE RATES ASSESSED AS EARLY AS WEEK 48
NRI POST HOC ANALYSIS FROM WEEK 4 TO WEEK 24*†‡
*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.
‡All the efficacy analyses through Week 24 were based on composite estimate, and missing data were considered nonresponders.
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. 8. Nash P, McInnes IB, Ritchlin CT, et al. Guselkumab treatment shows rapid onset of effect on American College of Rheumatology components: results of 2 randomized phase 3 trials. Presented at: European Alliance of Associations for Rheumatology (EULAR) Congress; Virtual; June 2-5, 2021.
DISCOVER 2 (ACR50): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (major secondary endpoint): 30% of patients receiving TREMFYA® q8w (38/127) achieved an ACR50 response compared with 9% of patients receiving placebo (11/126) (P<0.0001)1,2,6‡§
Week 16: 23% of patients receiving TREMFYA® q8w (29/127) achieved an ACR50 response vs 13% of patients receiving placebo (16/126) (P=0.036)1,2‡§
Week 52 (NRI post hoc analysis): 39% of patients receiving TREMFYA® q8w (49/127) achieved an ACR50 response1,7‡§||††
ACR50 response in DISCOVER 1 and DISCOVER 2 at Weeks 16 and 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††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-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.
DISCOVER 2 (ACR70): CONTINUED IMPROVEMENT IN JOINT SYMPTOMS# AT 2 YEARS†
IN DISCOVER 1:
Week 24 (major secondary endpoint): 12% of patients receiving TREMFYA® q8w (15/127) achieved an ACR70 response compared with 6% of patients receiving placebo (7/126) (P=0.069)1,2,6‡§
Week 16: 8% of patients receiving TREMFYA® q8w (10/127) achieved an ACR70 response vs 6% of patients receiving placebo (7/126)1,2‡§
Week 52 (NRI post hoc analysis): 26% of patients receiving TREMFYA® q8w (33/127) achieved an ACR70 response1,7‡§||††
ACR70 response in DISCOVER 1 and DISCOVER 2 at Week 24 were not part of sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
ACR70 response in DISCOVER 1 and DISCOVER 2 at Week 16 was not controlled for multiplicity. Therefore, statistical significance has not been established.
NRI=nonresponder imputation.
*Year 2 represents Week 100.
†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.
#Based on ACR response rates.
††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-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.
