Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Mease, Philip J.; Ogdie, Alexis; Tesser, John; Shiff, Natalie J.; Lin, Iris; Chakravarty, Soumya D.; Kelleman, Michael; Dodge, Rhiannon; McLean, Robert R.; Broadwell, Aaron; Kavanaugh, Arthur; Merola, Joseph F.

doi:10.1007/s40744-023-00582-w

Cited by 8 publications

(10 citation statements)

References 41 publications

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“…experienced statistically significant improvements in peripheral joint arthritis, pain, and skin symptoms at 6 months, with 22% of this generally treatment-resistant cohort achieving the stringent response criteria of minimal or very low disease activity. 12 The primary analysis also showed meaningful improvements in exploratory outcomes, including enthesitis, nail disease, and overall disease activity. 12 The high persistence rate (approximately 80%) in this study supports the robustness of the data and indicates that real-world retention rates among on-label guselkumab users are consistent with rates in guselkumab PsA RCTs (≥88% in patients treated through 1 or 2 years).…”

Section: Discussionmentioning

confidence: 84%

“…12 The primary analysis also showed meaningful improvements in exploratory outcomes, including enthesitis, nail disease, and overall disease activity. 12 The high persistence rate (approximately 80%) in this study supports the robustness of the data and indicates that real-world retention rates among on-label guselkumab users are consistent with rates in guselkumab PsA RCTs (≥88% in patients treated through 1 or 2 years). 10,24,25 Robust real-world long-term persistence with guselkumab has also been observed in biologic-naive (median persistence >32 months) and biologic-experienced (median persistence = 26 months) patients with psoriasis; these persistence rates were approximately two times higher than with secukinumab or ixekizumab.…”

Section: Discussionmentioning

confidence: 84%

“…Initiated in March 2013, the CorEvitas PsA/SpA Registry ( ClinicalTrials.gov : NCT02530268) is a prospective, multicenter, noninterventional study of adults who have been diagnosed with PsA or SpA and are under the care of a US‐based rheumatologist. 12 , 13 Longitudinal data are collected from patients and their treating rheumatologist during routine follow‐up visits occurring every 6 months (180 days from the last registry visit, within −30 to +90 days). At each visit, patients and providers complete questionnaires on patient demographics, disease characteristics, PsA medication history, medical and lifestyle history, disease activity, and adverse events.…”

Section: Methodsmentioning

confidence: 99%

“…At each visit, patients and providers complete questionnaires on patient demographics, disease characteristics, PsA medication history, medical and lifestyle history, disease activity, and adverse events. 12 , 13 Data are available from CorEvitas, LLC, through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.…”

Section: Methodsmentioning

confidence: 99%

“…11 Analyses of treatment persistence and clinical outcomes in 114 registry participants who initiated on‐label treatment with guselkumab (100 mg administered subcutaneously at weeks 0, 4, then every 8 weeks after FDA approval for PsA) showed that nearly 80% of patients had persistent use for at least 6 months (On‐Label Persisters) and that treatment with guselkumab was associated with significant improvements from baseline at the 6‐month visit in health care provider‐assessed joint and skin symptoms. 12 Here we report secondary results from these analyses assessing changes in PROs among these On‐Label Persisters.…”

Section: Introductionmentioning

confidence: 99%

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Improvements in Patient‐Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real‐World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Mease,

Ogdie,

Tesser

et al. 2024

ACR Open Rheumatology

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ObjectiveEvaluate patient‐reported outcomes after 6 months of on‐label guselkumab use in patients with rheumatologist‐diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.MethodsThis analysis includes registry participants who initiated and persisted with on‐label guselkumab (after US Food and Drug Administration approval for PsA; 100 mg at weeks 0, 4, and every 8 weeks) at their 6‐month follow‐up visit (On‐Label Persisters). Among patients not meeting response criteria at baseline, responses at 6 months were determined for patient‐reported outcomes, including patient‐reported pain (0–100 mm visual analog scale), patient global assessment of arthritis + psoriasis (PtGA; 0–100 visual analog scale), and Health Assessment Questionnaire‐Disability Index (HAQ‐DI; 0‐3). Unadjusted, nominal P values were calculated via single‐proportion, one‐sided test (H0 = 0%; α = 0.05).ResultsOf 90 On‐Label Persisters, most had treatment‐resistant PsA (92.2% and 73.3% previously received ≥1 and ≥2 biologic/targeted synthetic disease‐modifying antirheumatic drugs, respectively), with mean (SD) baseline patient‐reported pain, PtGA, and HAQ‐DI scores of 57.0 (24.6), 50.3 (24.4), and 0.9 (0.6), respectively. Among those with patient‐reported pain and PtGA scores of at least 15 at baseline, 40.2% (33/82) and 46.8% (36/77), respectively, achieved at least 15‐mm reductions at 6 months; among those with HAQ‐DI scores of at least 0.35 and more than 0.5 at baseline, respectively, 30.4% (21/69) achieved improvements of at least 0.35 and 10.3% (6/58) achieved scores of 0.5 or lower at 6 months (all nominal P < 0.001).ConclusionPain and physical function are important contributors to health‐related quality of life. In this real‐world population of patients with treatment‐resistant PsA and 6 months of persistent guselkumab treatment, clinically meaningful improvements in pain and physical function were achieved by approximately 40% and 30% of patients, respectively.

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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 84%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Improvements in Patient‐Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real‐World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Mease,

Ogdie,

Tesser

et al. 2024

ACR Open Rheumatology

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Persistent Patient‐Level Effect of Guselkumab at Consecutive 8‐Week Dosing Visits and Over Time in Patients With Active Psoriatic Arthritis: Post Hoc Analysis of a 2‐Year, Phase 3, Randomized, Controlled Study

Mease,

Baraliakos,

Chandran

et al. 2024

ACR Open Rheumatology

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ObjectiveGroup‐level analyses from the phase 3 DISCOVER‐2 trial of guselkumab demonstrated robust and durable improvements across psoriatic arthritis (PsA) domains. To specifically evaluate continuous disease control in individual patients, persistence of clinically relevant improvements was assessed, both at consecutive guselkumab dosing visits and over time.MethodsPost hoc analyses included biologic‐naïve patients randomized to 100 mg of guselkumab at week 0, week 4, and then every 8 weeks (Q8W). Improvements in joint (minimal clinically important improvement [MCII] in Disease Activity Index for PsA [DAPSA; ≥7.25], clinical DAPSA [cDAPSA; ≥5.7]), skin (Investigator's Global Assessment [IGA] 0/1), and overall disease activity (patient global assessment of arthritis and psoriasis [PtGA Arthritis+Psoriasis; MCII ≥ 15 mm], PsA Disease Activity Score [PASDAS; MCII ≥ 0.8]) were assessed. Proportions of patients with maintenance of DAPSA and cDAPSA MCII at consecutive Q8W guselkumab dosing visits (ie, at weeks 4 and 12, weeks 12 and 20, etc through week 52) and patient‐level durability of response through week 100 (Kaplan‐Meier) were determined.ResultsAmong 248 patients randomized to guselkumab Q8W, 93% to 99% maintained clinical improvement in joint disease at consecutive Q8W dosing visits through week 52 across time periods. Among guselkumab patients achieving MCII by week 24, estimated probabilities of maintenance of clinical improvement 100 weeks post achievement ranged from 68% (IGA 0/1) to 89% (PASDAS MCII). Median times to loss of improvement were not reached; estimated mean weeks of maintenance of improvement were 58.6, 52.4, 75.7, 83.6, and 76.7, respectively, for DAPSA, cDAPSA, IGA, PtGA Arthritis+Psoriasis, and PASDAS.ConclusionGuselkumab provided highly durable patient‐level improvements, both at consecutive Q8W dosing visits for joint disease activity and over time across PsA domains according to physician‐ and patient‐driven assessments.

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Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study

Ritchlin,

Mease,

Boehncke

et al. 2024

Clin Rheumatol

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Objectives Evaluate patterns of stringent disease control with 2 years of guselkumab across key disease-identified domains and patient-reported outcomes (PROs) in subgroups of patients with psoriatic arthritis (PsA) defined by baseline characteristics. Method This post hoc analysis of DISCOVER-2 (Clinicaltrials.gov NCT03158285) evaluated biologic-naïve PsA patients (≥ 5 swollen/ ≥ 5 tender joints, C-reactive protein [CRP] ≥ 0.6 mg/dL) randomized to guselkumab every 4 weeks (Q4W); guselkumab at Weeks 0 and 4, then Q8W; or placebo with crossover to guselkumab Q4W at Week 24. Achievement of American College of Rheumatology 50/70% improvement (ACR50/70), Investigator’s Global Assessment (IGA) 0, dactylitis/enthesitis resolution, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue response (≥ 4-point improvement), HAQ-Disability Index (HAQ-DI) response (≥ 0.35-point improvement), PsA Disease Activity Score (PASDAS) low disease activity (LDA), and minimal disease activity (MDA) was assessed at Weeks 24, 52, and 100 in subgroups defined by sex and baseline medication use, body mass index, PsA duration, swollen/tender joints, CRP, and psoriasis severity/extent. Patients with missing categorical response data were considered nonresponders. Results 442/493 (90%) guselkumab-randomized patients completed treatment through Week 100. Significant multi-domain efficacy of guselkumab versus placebo was shown across adequately sized patient subgroups. A pattern of continuous improvement was observed across key PsA domains and PROs within patient subgroups: 65%–85% of guselkumab-randomized patients had enthesitis/dactylitis resolution, 50%–70% achieved complete skin clearance, 60%–80% reported meaningful improvements in function/fatigue, 40%–65% achieved PASDAS LDA, and 35%–50% achieved MDA at Week 100. Conclusion Patients with active PsA receiving guselkumab demonstrated durable achievement of stringent endpoints associated with disease control across key PsA domains and PROs, regardless of baseline characteristics. Key Points• Among biologic-naïve patients with highly active psoriatic arthritis (PsA), efficacy of guselkumab across stringent disease endpoints and patient-reported outcomes (PROs) at Week 24 was consistent regardless of baseline demographics and disease characteristics.• Within guselkumab-randomized PsA patient subgroups, major improvements in joint disease activity, complete skin clearance, dactylitis/enthesitis resolution, clinically meaningful improvements in PROs, and achievement of low overall disease activity were maintained through Week 100.• Durable stringent endpoint achievement indicating disease control was observed with guselkumab, regardless of baseline patient or disease characteristics. Graphical Abstract

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Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Cited by 8 publications

References 41 publications

Improvements in Patient‐Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real‐World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Improvements in Patient‐Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real‐World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry

Persistent Patient‐Level Effect of Guselkumab at Consecutive 8‐Week Dosing Visits and Over Time in Patients With Active Psoriatic Arthritis: Post Hoc Analysis of a 2‐Year, Phase 3, Randomized, Controlled Study

Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study

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