For US Healthcare Professionals
I am a
Rheumatology Specialist
For US Healthcare Professionals
Full Prescribing Information
DISCOVER 2 (ACR20): Continued improvement in joint symptoms# at 2 years†
Open-label active treatment, NRI post hoc analysis (Weeks 24-100)
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‡§ǁ††
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.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
ǁAfter 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*†‡
DISCOVER 1 and DISCOVER 2: Pooled ACR20 response rates through 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 estimates, 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. Poster presented at: Innovations in Dermatology 2021; Virtual; March 16-20, 2021. 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. 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. Poster 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†
Open-label active treatment, NRI post hoc analysis (Weeks 24-100)
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 sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.
NRI=nonresponder imputation.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
ǁAfter 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, randomised, 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. Poster presented at: Innovations in Dermatology 2021; Virtual; March 16-20, 2021. 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.
DISCOVER 2 (ACR70): Continued improvement in joint symptoms# at 2 years†
Open-label active treatment, NRI post hoc analysis (Weeks 24-100)
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‡§ǁ††
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.
*The same patients may not have responded at each time point.
†Year 2 represents Week 100.
‡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.
ǁAfter 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, randomised, 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. Poster presented at: Innovations in Dermatology 2021; Virtual; March 16-20, 2021. 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.
Have a discussion with a Janssen representative
Talk with a Janssen representative
