Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis

Jeffrey R. Curtis; Iain B. McInnes; Proton Rahman; Dafna D. Gladman; Steven Peterson; Feifei Yang; Oluwakayode Adejoro; Alexa P. Kollmeier; Natalie J. Shiff; Chenglong Han; May Shawi; William Tillett; Philip J. Mease

doi:10.1007/s40744-024-00642-9

Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis

Jeffrey R. Curtis, Iain B. McInnes, Proton Rahman, Dafna D. Gladman, Steven Peterson, Feifei Yang, Oluwakayode Adejoro, Alexa P. Kollmeier, Natalie J. Shiff, Chenglong Han, May Shawi, William Tillett, Philip J. Mease

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial.

Methods: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Results: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (− 23.8% to − 28.0%) and nonwork daily activity impairment (– 26.6% to − 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1–16.4% were not employed at week 100, and 20.0–25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409.

Conclusion: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Trial Registration: Clinicaltrials.gov identifier: NCT03158285.

Original language	English
Pages (from-to)	425-441
Number of pages	17
Journal	Rheumatology and therapy
Volume	11
Issue number	2
DOIs	https://doi.org/10.1007/s40744-024-00642-9
Publication status	Published - 5 Apr 2024

Funding

Medical writing support was provided by Teresa Tartaglione, PharmD, of Certara Synchrogenix (funded by Janssen Scientific Affairs, LLC) and Rebecca Clemente, PhD, of Janssen Scientific Affairs, LLC, under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med. 2022; https://doi.org/10.7326/M22-1460 ). The authors thank Cynthia Guzzo, MD (consultant funded by Janssen Scientific Affairs, LLC) for substantive manuscript review.

Funders	Funder number
Certara Synchrogenix
Janssen Scientific Affairs LLC

Keywords

Guselkumab
Health-related quality of life
Psoriatic arthritis
Work productivity

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy

Access to Document

10.1007/s40744-024-00642-9Licence: CC BY-NC

Cite this

Curtis, J. R., McInnes, I. B., Rahman, P., Gladman, D. D., Peterson, S., Yang, F., Adejoro, O., Kollmeier, A. P., Shiff, N. J., Han, C., Shawi, M., Tillett, W., & Mease, P. J. (2024). Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis. Rheumatology and therapy, 11(2), 425-441. https://doi.org/10.1007/s40744-024-00642-9

Curtis, JR, McInnes, IB, Rahman, P, Gladman, DD, Peterson, S, Yang, F, Adejoro, O, Kollmeier, AP, Shiff, NJ, Han, C, Shawi, M, Tillett, W & Mease, PJ 2024, 'Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis', Rheumatology and therapy, vol. 11, no. 2, pp. 425-441. https://doi.org/10.1007/s40744-024-00642-9

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title = "Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis",

abstract = "Introduction: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-na{\"i}ve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. Methods: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Results: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (− 23.8% to − 28.0%) and nonwork daily activity impairment (– 26.6% to − 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1–16.4% were not employed at week 100, and 20.0–25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. Conclusion: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Trial Registration: Clinicaltrials.gov identifier: NCT03158285.",

keywords = "Guselkumab, Health-related quality of life, Psoriatic arthritis, Work productivity",

author = "Curtis, {Jeffrey R.} and McInnes, {Iain B.} and Proton Rahman and Gladman, {Dafna D.} and Steven Peterson and Feifei Yang and Oluwakayode Adejoro and Kollmeier, {Alexa P.} and Shiff, {Natalie J.} and Chenglong Han and May Shawi and William Tillett and Mease, {Philip J.}",

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AU - McInnes, Iain B.

AU - Rahman, Proton

AU - Gladman, Dafna D.

AU - Peterson, Steven

AU - Yang, Feifei

AU - Adejoro, Oluwakayode

AU - Kollmeier, Alexa P.

AU - Shiff, Natalie J.

AU - Han, Chenglong

AU - Shawi, May

AU - Tillett, William

AU - Mease, Philip J.

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N2 - Introduction: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. Methods: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Results: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (− 23.8% to − 28.0%) and nonwork daily activity impairment (– 26.6% to − 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1–16.4% were not employed at week 100, and 20.0–25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. Conclusion: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Trial Registration: Clinicaltrials.gov identifier: NCT03158285.

AB - Introduction: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. Methods: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. Results: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (− 23.8% to − 28.0%) and nonwork daily activity impairment (– 26.6% to − 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1–16.4% were not employed at week 100, and 20.0–25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. Conclusion: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. Trial Registration: Clinicaltrials.gov identifier: NCT03158285.

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KW - Health-related quality of life

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Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis

Abstract

Funding

Keywords

ASJC Scopus subject areas

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The Impact of Biologic and Targeted Synthetic Disease Modifying Drugs in Psoriatic Arthritis

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Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

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The Impact of Biologic and Targeted Synthetic Disease Modifying Drugs in Psoriatic Arthritis

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