The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Jeffrey R Curtis; Iain B McInnes; Proton Rahman; Dafna D Gladman; Steven Peterson; Prasheen Agarwal; Feifei Yang; Alexa P Kollmeier; Elizabeth C Hsia; Natalie J Shiff; Bei Zhou; Chenglong Han; May Shawi; William Tillett; Philip J Mease

doi:10.1007/s12325-022-02270-7

The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Jeffrey R Curtis, Iain B McInnes, Proton Rahman, Dafna D Gladman, Steven Peterson, Prasheen Agarwal, Feifei Yang, Alexa P Kollmeier, Elizabeth C Hsia, Natalie J Shiff, Bei Zhou, Chenglong Han, May Shawi, William Tillett, Philip J Mease

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

3 Citations (SciVal)

105 Downloads (Pure)

Abstract

INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).

METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.

RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.

CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.

Original language	English
Pages (from-to)	4613-4631
Number of pages	19
Journal	Advances in therapy
Volume	39
Issue number	10
Early online date	10 Aug 2022
DOIs	https://doi.org/10.1007/s12325-022-02270-7
Publication status	Published - 31 Oct 2022

Bibliographical note

Funding Information:
Medical writing support was provided by Holly Capasso-Harris of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461–4) and was funded by Janssen Scientific Affairs, LLC.

Funding Information:
This manuscript was supported by Janssen Global Services, LLC, and Janssen Research & Development, LLC, Spring House, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA funded the rapid service fee.

Keywords

Guselkumab
Psoriatic arthritis
Work productivity

ASJC Scopus subject areas

Pharmacology (medical)

Access to Document

10.1007/s12325-022-02270-7

DISCOVER_2_WPAI_manuscript_revised_Final.PDF
This is a post-peer-review, pre-copyedit version of an article published in Advances in Therapy. The final authenticated version is available online at: https://doi.org/10.1007/s12325-022-02270-7
Accepted author manuscript, 1.09 MB

Cite this

Curtis, J. R., McInnes, I. B., Rahman, P., Gladman, D. D., Peterson, S., Agarwal, P., Yang, F., Kollmeier, A. P., Hsia, E. C., Shiff, N. J., Zhou, B., Han, C., Shawi, M., Tillett, W., & Mease, P. J. (2022). The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. Advances in therapy, 39(10), 4613-4631. https://doi.org/10.1007/s12325-022-02270-7

The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. / Curtis, Jeffrey R; McInnes, Iain B; Rahman, Proton et al.
In: Advances in therapy, Vol. 39, No. 10, 31.10.2022, p. 4613-4631.

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

Curtis, JR, McInnes, IB, Rahman, P, Gladman, DD, Peterson, S, Agarwal, P, Yang, F, Kollmeier, AP, Hsia, EC, Shiff, NJ, Zhou, B, Han, C, Shawi, M, Tillett, W & Mease, PJ 2022, 'The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial', Advances in therapy, vol. 39, no. 10, pp. 4613-4631. https://doi.org/10.1007/s12325-022-02270-7

@article{e1f1b7f189a0459394e3e9a59367b738,

title = "The Effect of Guselkumab on Work Productivity in Biologic-Na{\"i}ve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial",

abstract = "INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-na{\"i}ve patients with psoriatic arthritis (PsA).METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.",

keywords = "Guselkumab, Psoriatic arthritis, Work productivity",

author = "Curtis, {Jeffrey R} and McInnes, {Iain B} and Proton Rahman and Gladman, {Dafna D} and Steven Peterson and Prasheen Agarwal and Feifei Yang and Kollmeier, {Alexa P} and Hsia, {Elizabeth C} and Shiff, {Natalie J} and Bei Zhou and Chenglong Han and May Shawi and William Tillett and Mease, {Philip J}",

note = "Funding Information: Medical writing support was provided by Holly Capasso-Harris of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461–4) and was funded by Janssen Scientific Affairs, LLC. Funding Information: This manuscript was supported by Janssen Global Services, LLC, and Janssen Research & Development, LLC, Spring House, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA funded the rapid service fee. ",

year = "2022",

month = oct,

day = "31",

doi = "10.1007/s12325-022-02270-7",

language = "English",

volume = "39",

pages = "4613--4631",

journal = "Advances in therapy",

issn = "0741-238X",

publisher = "Springer International Publishing",

number = "10",

}

TY - JOUR

T1 - The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

AU - Curtis, Jeffrey R

AU - McInnes, Iain B

AU - Rahman, Proton

AU - Gladman, Dafna D

AU - Peterson, Steven

AU - Agarwal, Prasheen

AU - Yang, Feifei

AU - Kollmeier, Alexa P

AU - Hsia, Elizabeth C

AU - Shiff, Natalie J

AU - Zhou, Bei

AU - Han, Chenglong

AU - Shawi, May

AU - Tillett, William

AU - Mease, Philip J

N1 - Funding Information: Medical writing support was provided by Holly Capasso-Harris of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461–4) and was funded by Janssen Scientific Affairs, LLC. Funding Information: This manuscript was supported by Janssen Global Services, LLC, and Janssen Research & Development, LLC, Spring House, PA, USA. Janssen Research & Development, LLC, Spring House, PA, USA funded the rapid service fee.

PY - 2022/10/31

Y1 - 2022/10/31

N2 - INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.

AB - INTRODUCTION: The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).METHODS: Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.RESULTS: In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.CONCLUSION: Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03158285.

KW - Guselkumab

KW - Psoriatic arthritis

KW - Work productivity

UR - http://www.scopus.com/inward/record.url?scp=85135831464&partnerID=8YFLogxK

U2 - 10.1007/s12325-022-02270-7

DO - 10.1007/s12325-022-02270-7

M3 - Article

C2 - 35947349

SN - 0741-238X

VL - 39

SP - 4613

EP - 4631

JO - Advances in therapy

JF - Advances in therapy

IS - 10

ER -

The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

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

Cite this

The Effect of Guselkumab on Work Productivity in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Projects

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

Cite this