The Effect of Guselkumab on General Health State 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; Feifei Yang; Steven Peterson; Prasheen Agarwal; Alexa P Kollmeier; Elizabeth C Hsia; Chenglong Han; Natalie J Shiff; May Shawi; William Tillett; Philip J Mease

doi:10.1007/s12325-022-02269-0

The Effect of Guselkumab on General Health State 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, Feifei Yang, Steven Peterson, Prasheen Agarwal, Alexa P Kollmeier, Elizabeth C Hsia, Chenglong Han, Natalie J Shiff, May Shawi, William Tillett, Philip J Mease

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Abstract

INTRODUCTION: In DISCOVER-2, guselkumab, an interleukin-23 p19 subunit inhibitor, was efficacious in biologic-naïve psoriatic arthritis (PsA) patients. We report the effect of guselkumab on health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and Visual Analog Scale (EQ-VAS) through Week 52.

METHODS: Adults with active PsA were randomized to guselkumab 100 mg every 4 weeks (Q4W) or Weeks 0, 4, then every 8 weeks (Q8W), or placebo (crossover to guselkumab Q4W at Week 24). Least squares (LS) mean changes in EQ-5D-5L Index (0-1, US-based value set) and EQ-VAS (0-100) from baseline through Week 52 were assessed. Proportions of patients achieving minimally important differences (MIDs) were assessed through Week 52. Associations between patient clinical features and EQ-5D-5L Index and EQ-VAS scores were examined cross-sectionally with pooled data through Week 24.

RESULTS: The analysis included 738 patients (Q4W n = 245; Q8W n = 248; placebo n = 245). At Week 24, LS mean changes from baseline in the Q4W, Q8W, and placebo groups were 0.12, 0.12, and 0.05, respectively, for EQ-5D-5L Index, and 18.2, 18.4, and 6.8, respectively, for EQ-VAS. At Week 52, improvement was maintained in the guselkumab groups and increased in the placebo crossover group. EQ-5D-5L Index MID was achieved by 56.0% in each guselkumab group at Week 24 and 66.2% in Q4W, 68.5% in Q8W, and 66.1% in placebo crossover group at Week 52. Higher C-reactive protein level, Psoriasis Area and Severity Index score, fatigue, and pain were correlated with worse EQ-5D-5L Index and EQ-VAS, based on pooled data through Week 24. Higher tender joint count was correlated with worse EQ-5D-5L, while higher swollen joint count was correlated with worse EQ-VAS.

CONCLUSIONS: Guselkumab improved HRQoL through 52 weeks in patients with active PsA. Impairment in HRQoL was correlated with increased inflammation, fatigue, pain, and measures of skin and joint symptom severity.

CLINICALTRIALS: GOV: NCT03158285.

Original language	English
Pages (from-to)	4632-4644
Number of pages	13
Journal	Advances in therapy
Volume	39
Issue number	10
Early online date	10 Aug 2022
DOIs	https://doi.org/10.1007/s12325-022-02269-0
Publication status	Published - Oct 2022

Bibliographical note

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.

Funding Information:
Medical writing support was provided by Cheryl Jones of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med. 2015;163:461–64) and was funded by Janssen Scientific Affairs, LLC.

Keywords

Guselkumab
Health-related quality of life
Psoriatic arthritis

ASJC Scopus subject areas

Pharmacology (medical)

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10.1007/s12325-022-02269-0

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Cite this

Curtis, J. R., McInnes, I. B., Rahman, P., Gladman, D. D., Yang, F., Peterson, S., Agarwal, P., Kollmeier, A. P., Hsia, E. C., Han, C., Shiff, N. J., Shawi, M., Tillett, W., & Mease, P. J. (2022). The Effect of Guselkumab on General Health State 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), 4632-4644. https://doi.org/10.1007/s12325-022-02269-0

The Effect of Guselkumab on General Health State 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, 10.2022, p. 4632-4644.

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

Curtis, JR, McInnes, IB, Rahman, P, Gladman, DD, Yang, F, Peterson, S, Agarwal, P, Kollmeier, AP, Hsia, EC, Han, C, Shiff, NJ, Shawi, M, Tillett, W & Mease, PJ 2022, 'The Effect of Guselkumab on General Health State 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. 4632-4644. https://doi.org/10.1007/s12325-022-02269-0

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title = "The Effect of Guselkumab on General Health State 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: In DISCOVER-2, guselkumab, an interleukin-23 p19 subunit inhibitor, was efficacious in biologic-na{\"i}ve psoriatic arthritis (PsA) patients. We report the effect of guselkumab on health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and Visual Analog Scale (EQ-VAS) through Week 52.METHODS: Adults with active PsA were randomized to guselkumab 100 mg every 4 weeks (Q4W) or Weeks 0, 4, then every 8 weeks (Q8W), or placebo (crossover to guselkumab Q4W at Week 24). Least squares (LS) mean changes in EQ-5D-5L Index (0-1, US-based value set) and EQ-VAS (0-100) from baseline through Week 52 were assessed. Proportions of patients achieving minimally important differences (MIDs) were assessed through Week 52. Associations between patient clinical features and EQ-5D-5L Index and EQ-VAS scores were examined cross-sectionally with pooled data through Week 24.RESULTS: The analysis included 738 patients (Q4W n = 245; Q8W n = 248; placebo n = 245). At Week 24, LS mean changes from baseline in the Q4W, Q8W, and placebo groups were 0.12, 0.12, and 0.05, respectively, for EQ-5D-5L Index, and 18.2, 18.4, and 6.8, respectively, for EQ-VAS. At Week 52, improvement was maintained in the guselkumab groups and increased in the placebo crossover group. EQ-5D-5L Index MID was achieved by 56.0% in each guselkumab group at Week 24 and 66.2% in Q4W, 68.5% in Q8W, and 66.1% in placebo crossover group at Week 52. Higher C-reactive protein level, Psoriasis Area and Severity Index score, fatigue, and pain were correlated with worse EQ-5D-5L Index and EQ-VAS, based on pooled data through Week 24. Higher tender joint count was correlated with worse EQ-5D-5L, while higher swollen joint count was correlated with worse EQ-VAS.CONCLUSIONS: Guselkumab improved HRQoL through 52 weeks in patients with active PsA. Impairment in HRQoL was correlated with increased inflammation, fatigue, pain, and measures of skin and joint symptom severity.CLINICALTRIALS: GOV: NCT03158285.",

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

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

note = "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. Funding Information: Medical writing support was provided by Cheryl Jones of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med. 2015;163:461–64) and was funded by Janssen Scientific Affairs, LLC. ",

year = "2022",

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doi = "10.1007/s12325-022-02269-0",

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T1 - The Effect of Guselkumab on General Health State 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 - Yang, Feifei

AU - Peterson, Steven

AU - Agarwal, Prasheen

AU - Kollmeier, Alexa P

AU - Hsia, Elizabeth C

AU - Han, Chenglong

AU - Shiff, Natalie J

AU - Shawi, May

AU - Tillett, William

AU - Mease, Philip J

N1 - 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. Funding Information: Medical writing support was provided by Cheryl Jones of Certara Synchrogenix under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med. 2015;163:461–64) and was funded by Janssen Scientific Affairs, LLC.

PY - 2022/10

Y1 - 2022/10

N2 - INTRODUCTION: In DISCOVER-2, guselkumab, an interleukin-23 p19 subunit inhibitor, was efficacious in biologic-naïve psoriatic arthritis (PsA) patients. We report the effect of guselkumab on health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and Visual Analog Scale (EQ-VAS) through Week 52.METHODS: Adults with active PsA were randomized to guselkumab 100 mg every 4 weeks (Q4W) or Weeks 0, 4, then every 8 weeks (Q8W), or placebo (crossover to guselkumab Q4W at Week 24). Least squares (LS) mean changes in EQ-5D-5L Index (0-1, US-based value set) and EQ-VAS (0-100) from baseline through Week 52 were assessed. Proportions of patients achieving minimally important differences (MIDs) were assessed through Week 52. Associations between patient clinical features and EQ-5D-5L Index and EQ-VAS scores were examined cross-sectionally with pooled data through Week 24.RESULTS: The analysis included 738 patients (Q4W n = 245; Q8W n = 248; placebo n = 245). At Week 24, LS mean changes from baseline in the Q4W, Q8W, and placebo groups were 0.12, 0.12, and 0.05, respectively, for EQ-5D-5L Index, and 18.2, 18.4, and 6.8, respectively, for EQ-VAS. At Week 52, improvement was maintained in the guselkumab groups and increased in the placebo crossover group. EQ-5D-5L Index MID was achieved by 56.0% in each guselkumab group at Week 24 and 66.2% in Q4W, 68.5% in Q8W, and 66.1% in placebo crossover group at Week 52. Higher C-reactive protein level, Psoriasis Area and Severity Index score, fatigue, and pain were correlated with worse EQ-5D-5L Index and EQ-VAS, based on pooled data through Week 24. Higher tender joint count was correlated with worse EQ-5D-5L, while higher swollen joint count was correlated with worse EQ-VAS.CONCLUSIONS: Guselkumab improved HRQoL through 52 weeks in patients with active PsA. Impairment in HRQoL was correlated with increased inflammation, fatigue, pain, and measures of skin and joint symptom severity.CLINICALTRIALS: GOV: NCT03158285.

AB - INTRODUCTION: In DISCOVER-2, guselkumab, an interleukin-23 p19 subunit inhibitor, was efficacious in biologic-naïve psoriatic arthritis (PsA) patients. We report the effect of guselkumab on health-related quality of life (HRQoL) using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and Visual Analog Scale (EQ-VAS) through Week 52.METHODS: Adults with active PsA were randomized to guselkumab 100 mg every 4 weeks (Q4W) or Weeks 0, 4, then every 8 weeks (Q8W), or placebo (crossover to guselkumab Q4W at Week 24). Least squares (LS) mean changes in EQ-5D-5L Index (0-1, US-based value set) and EQ-VAS (0-100) from baseline through Week 52 were assessed. Proportions of patients achieving minimally important differences (MIDs) were assessed through Week 52. Associations between patient clinical features and EQ-5D-5L Index and EQ-VAS scores were examined cross-sectionally with pooled data through Week 24.RESULTS: The analysis included 738 patients (Q4W n = 245; Q8W n = 248; placebo n = 245). At Week 24, LS mean changes from baseline in the Q4W, Q8W, and placebo groups were 0.12, 0.12, and 0.05, respectively, for EQ-5D-5L Index, and 18.2, 18.4, and 6.8, respectively, for EQ-VAS. At Week 52, improvement was maintained in the guselkumab groups and increased in the placebo crossover group. EQ-5D-5L Index MID was achieved by 56.0% in each guselkumab group at Week 24 and 66.2% in Q4W, 68.5% in Q8W, and 66.1% in placebo crossover group at Week 52. Higher C-reactive protein level, Psoriasis Area and Severity Index score, fatigue, and pain were correlated with worse EQ-5D-5L Index and EQ-VAS, based on pooled data through Week 24. Higher tender joint count was correlated with worse EQ-5D-5L, while higher swollen joint count was correlated with worse EQ-VAS.CONCLUSIONS: Guselkumab improved HRQoL through 52 weeks in patients with active PsA. Impairment in HRQoL was correlated with increased inflammation, fatigue, pain, and measures of skin and joint symptom severity.CLINICALTRIALS: GOV: NCT03158285.

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

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

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

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Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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

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