For US Healthcare Professionals
For US Healthcare Professionals
For US Healthcare Professionals
IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS (PsA)
ACR RESPONSE RATES
Over 50% of Patients Achieved ACR20 Response at Week 24, After Just 4 Injections1,2
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NONRESPONDER IMPUTATION [NRI])*†
ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
†Patients with missing data were considered nonresponders.
DISCOVER 1: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NRI)*†
ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
NS=not significant.
†Patients with missing data were considered nonresponders.
NS=not significant.
References: 1. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11. 2. 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;20(30265):1-11.
Sustained Joint Response Rates at 2 Years: ACR Response Rates From Week 52 to Week 1001*
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSE RATES FROM WEEK 52 THROUGH WEEK 100 (AS-OBSERVED ANALYSIS)1†‡§II¶#**
*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.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
**Includes all randomized subjects still on study treatment at Week 52.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
**Includes all randomized subjects still on study treatment at Week 52.
IN DISCOVER 1: ACR RESPONSES AT WEEK 52 (AS-OBSERVED)1‡#††:
- ACR20: 68% (76/112) of patients receiving TREMFYA® q8w had an ACR20 response
- ACR50: 43% (49/113) of patients receiving TREMFYA® q8w had an ACR50 response
- ACR70: 29% (33/114) of patients receiving TREMFYA® q8w had an ACR70 response
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSE RATES FROM WEEK 52 THROUGH WEEK 100 (NRI POST HOC ANALYSIS)1-3*†‡II¶#
IN DISCOVER 1: ACR RESPONSES AT WEEK 52 (NRI POST HOC ANALYSIS)1,4*§††‡‡:
- ACR20: 60% (76/127) of patients receiving TREMFYA® q8w had an ACR20 response
- ACR50: 39% (49/127) of patients receiving TREMFYA® q8w had an ACR50 response
- ACR70: 26% (33/127) of patients receiving TREMFYA® q8w had an ACR70 response
*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.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
††Includes all randomized subjects still on study treatment at Week 24.
‡‡Patients with missing data were considered nonresponders.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
††Includes all randomized subjects still on study treatment at Week 24.
‡‡Patients with missing data were considered nonresponders.
References: 1. Data on file. Janssen Biotech, Inc. 2. McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, an interleukin-23p19-specific monoclonal antibody, through one year in biologic-naive patients with psoriatic arthritis. Arthritis Rheumatol. 2021;73(4):604-616. 3. 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. 4. 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.
Similar ACR20 Response Rates Regardless of Prior Anti-TNFα Exposure1,2*†
ACR20 RESPONSE BY PRIOR ANTI-TNFα EXPOSURE WAS A SUBGROUP ANALYSIS OF THE PRIMARY ENDPOINT (ACR20 RESPONSE AT WEEK 24) (NRI ANALYSIS)
DISCOVER 1: ACR20 RESPONSE RATES—NO PRIOR ANTI-TNFα EXPOSURE
ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.
DISCOVER 1: ACR20 RESPONSE RATES—PRIOR ANTI-TNFα EXPOSURE
ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
†Patients with missing data were considered nonresponders.
References: 1. Data on File. Janssen Biotech, Inc. 2. 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;20(30265):1-11.
Over 50% of Patients Achieved ACR20 Response at Week 24, After Just 4 Injections1,2
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NONRESPONDER IMPUTATION [NRI])*†
ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
†Patients with missing data were considered nonresponders.
DISCOVER 1: ACR20, ACR50, AND ACR70 RESPONSES AT WEEK 24 (NRI)*†
ACR50 response and ACR70 response at Week 24 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 response.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
NS=not significant.
†Patients with missing data were considered nonresponders.
NS=not significant.
References: 1. Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER 2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;20(30263):1-11. 2. 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;20(30265):1-11.
Sustained Joint Response Rates at 2 Years: ACR Response Rates From Week 52 to Week 1001*
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSE RATES FROM WEEK 52 THROUGH WEEK 100 (AS-OBSERVED ANALYSIS)1†‡§II¶#**
*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.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
**Includes all randomized subjects still on study treatment at Week 52.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
**Includes all randomized subjects still on study treatment at Week 52.
IN DISCOVER 1: ACR RESPONSES AT WEEK 52 (AS-OBSERVED)1‡#††:
- ACR20: 68% (76/112) of patients receiving TREMFYA® q8w had an ACR20 response
- ACR50: 43% (49/113) of patients receiving TREMFYA® q8w had an ACR50 response
- ACR70: 29% (33/114) of patients receiving TREMFYA® q8w had an ACR70 response
DISCOVER 2: ACR20, ACR50, AND ACR70 RESPONSE RATES FROM WEEK 52 THROUGH WEEK 100 (NRI POST HOC ANALYSIS)1-3*†‡II¶#
IN DISCOVER 1: ACR RESPONSES AT WEEK 52 (NRI POST HOC ANALYSIS)1,4*§††‡‡:
- ACR20: 60% (76/127) of patients receiving TREMFYA® q8w had an ACR20 response
- ACR50: 39% (49/127) of patients receiving TREMFYA® q8w had an ACR50 response
- ACR70: 26% (33/127) of patients receiving TREMFYA® q8w had an ACR70 response
*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.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
††Includes all randomized subjects still on study treatment at Week 24.
‡‡Patients with missing data were considered nonresponders.
†Year 2 represents Week 100.
‡Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.
§After Week 24, patients and healthcare providers knew that all patients were on TREMFYA® (open label with a blinded dosing interval), which may have affected the results.
||The same patients may not have responded at each time point.
¶The prespecified as-observed analysis from Weeks 24 to 52 is not shown, but the prespecified as-observed analysis at Week 52 is shown.
#Available data at each visit were used; missing data were not included in the analysis.
††Includes all randomized subjects still on study treatment at Week 24.
‡‡Patients with missing data were considered nonresponders.
References: 1. Data on file. Janssen Biotech, Inc. 2. McInnes IB, Rahman P, Gottlieb AB, et al. Efficacy and safety of guselkumab, an interleukin-23p19-specific monoclonal antibody, through one year in biologic-naive patients with psoriatic arthritis. Arthritis Rheumatol. 2021;73(4):604-616. 3. 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. 4. 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.
Similar ACR20 Response Rates Regardless of Prior Anti-TNFα Exposure1,2*†
ACR20 RESPONSE BY PRIOR ANTI-TNFα EXPOSURE WAS A SUBGROUP ANALYSIS OF THE PRIMARY ENDPOINT (ACR20 RESPONSE AT WEEK 24) (NRI ANALYSIS)
DISCOVER 1: ACR20 RESPONSE RATES—NO PRIOR ANTI-TNFα EXPOSURE
ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.
DISCOVER 1: ACR20 RESPONSE RATES—PRIOR ANTI-TNFα EXPOSURE
ACR20 response by prior anti-TNFα exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.
*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent due to 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.
†Patients with missing data were considered nonresponders.
References: 1. Data on File. Janssen Biotech, Inc. 2. 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;20(30265):1-11.
