Dataset Information

Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry.

ABSTRACT:

Introduction

In clinical trials, treatment with the interleukin-23 inhibitor guselkumab was associated with significantly improved disease severity and patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis. However, limited information is available regarding the real-world effectiveness of guselkumab among patients with psoriasis of mild, moderate, and severe Investigator's Global Assessment (IGA) severities living in the USA and Canada.

Methods

Patients participating in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 July 2019 who met the following criteria were included: IGA ≥ 2 (mild or greater disease severity), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after persistent guselkumab treatment for 9 to 12 months. Data were collected for patient demographics, disease characteristics, treatment history, disease activity, and PROMs. At follow-up, outcome measure response rates and mean changes from the index visit were calculated.

Results

Among 130 patients, the mean age was 50.2 years, 39.2% were female, and 56.9% had a body mass index ≥ 30 kg/m². Mean psoriasis duration was 17.5 years and 79.2% of patients had previously received one or more biologic therapy. At the index visit, mean IGA, Psoriasis Area Severity Index (PASI), and Dermatology Life Quality Index (DLQI) scores were 3.0, 9.9, and 8.0, respectively. At follow-up, IGA 0/1 and IGA 0 were achieved by 64.6% and 36.2% of patients, respectively. PASI 75, 90, and 100 were achieved by 61.5%, 46.9%, and 36.9% of patients; 55.4% had maintained or achieved DLQI 0/1. Mean improvements were observed in all evaluated disease activity outcomes and PROMs, with all differing significantly from zero except for the percent of work hours missed due to psoriasis.

Conclusion

In this real-world study, patients with a baseline IGA score ≥ 2 experienced improvements in disease activity and PROMs after 9-12 months of persistent guselkumab treatment.

SUBMITTER: Armstrong AW

PROVIDER: S-EPMC9884726 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry.

Armstrong April W AW Fitzgerald Timothy T McLean Robert R RR Teeple Amanda A Uy Jonathan P JP Olurinde Mobolaji M Rowland Katelyn K Guo Lin L Shan Ying Y Callis Duffin Kristina K

Dermatology and therapy 20221209 2

<h4>Introduction</h4>In clinical trials, treatment with the interleukin-23 inhibitor guselkumab was associated with significantly improved disease severity and patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis. However, limited information is available regarding the real-world effectiveness of guselkumab among patients with psoriasis of mild, moderate, and severe Investigator's Global Assessment (IGA) severities living in the USA and Canada.<h4>Met ...[more]

PMID: 36484917

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Project description:IntroductionThe aim of this work is to evaluate treatment persistence and clinical 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.MethodsParticipants with PsA who initiated and persisted with on-label guselkumab use post-Food and Drug Administration (FDA) approval for active PsA (7/13/2020; subcutaneous 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (occurring through 3/31/2023) comprised the primary analysis population (On-Label Persisters). Hierarchical, multiplicity-controlled primary and secondary outcomes were mean (95% confidence interval) changes from baseline at 6 months in clinical Disease Activity Index for PsA (cDAPSA; primary), Physician Global Assessment (PGA) of arthritis and psoriasis (visual analog scale [VAS] 0-100), patient-reported pain (VAS 0-100), and percent body surface area with psoriasis (%BSA). Paired t tests determined changes that were statistically significantly different from 0 (α = 0.05).ResultsAmong 114 patients who initiated on-label guselkumab and had eligible baseline and 6-month visits, 90 (78.9%) had persistent use. Among these On-Label Persisters at baseline, mean duration of PsA symptoms = 13.6 years; mean cDAPSA, PGA, and patient-reported pain = 22.0, 42.3, and 57.0, respectively; 94.4% had a history of psoriasis (mean BSA 7.6%); and 18.9% and 73.3%, respectively, previously received 1 or ≥ 2 biologic/targeted synthetic disease-modifying antirheumatic drugs. The mean change (improvement) in cDAPSA was - 5.4 (- 8.5, - 2.3; p < 0.001) at 6 months. Significant mean improvements in PGA (- 19.0 [- 24.2, - 13.8]), patient-reported pain (- 9.1 [- 14.4, - 3.8]), and %BSA (- 5.1 [- 7.6, - 2.7]) were also observed (all p < 0.001).ConclusionsIn this real-world PsA population, generally characterized by longstanding, treatment-resistant, active disease at baseline, persistent guselkumab use in nearly 80% of patients with on-label use was accompanied by significant improvements in joint and skin symptoms and patient-reported pain at 6 months. These registry data support results from randomized clinical trials demonstrating the efficacy of guselkumab in improving PsA signs and symptoms.Trial registrationclinicaltrials.gov: NCT02530268.

Dataset Information

Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry.

Introduction

Methods

Results

Conclusion

Publications

Effectiveness of Guselkumab Therapy among Patients with Plaque Psoriasis with Baseline IGA Score ≥ 2 in the CorEvitas Psoriasis Registry.

Similar Datasets

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