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Introduction <p>The aim of this study was to evaluate guselkumab efficacy through week&#xa0;100 in participants with psoriatic arthritis (PsA) and severe disease activity or patient global assessment (PtGA).</p> Methods <p>This post hoc analysis utilized DISCOVER-2 (NCT03158285) data from 739&#xa0;biologic-naïve adults with active PsA (≥ 5 swollen/tender joints, C-reactive protein  ≥ 0.6&#xa0;mg/dL) randomized to guselkumab every 4&#xa0;weeks (Q4W) or at weeks&#xa0;0 and 4, then every 8&#xa0;weeks (Q8W); or placebo with crossover to guselkumab Q4W at week&#xa0;24. Severe disease activity was defined as clinical Disease Activity Index for Psoriatic&#xa0;Arthritis (cDAPSA) &gt; 27, Psoriatic&#xa0;Arthritis Disease Activity Score (PASDAS) ≥ 5.4, and PtGA Arthritis + Psoriasis ≥ 80&#xa0;mm. Least squares mean (LSM) changes in cDAPSA, PASDAS, and PtGA were estimated with mixed models for repeated measures adjusted for baseline factors.</p> Results <p>Baseline characteristics among 648 (88%), 639 (86%), and 218 (29%) participants meeting the cDAPSA, PASDAS, and PtGA criteria for severe disease activity, respectively, were generally balanced across cohorts. LSM improvements from baseline with guselkumab Q4W/Q8W vs. placebo were −5.9 (<i>p</i> = 0.3905)/−7.2 (<i>p</i> = 0.0379) for cDAPSA at week&#xa0;2; −1.5/−1.5 for PASDAS&#xa0;(both p &lt; 0.0001); and −30.0/−32.1 for PtGA at week&#xa0;8 (both <i>p</i> &lt; 0.01). Differences vs. placebo increased through week&#xa0;24 in the respective cohorts with guselkumab Q4W/Q8W: −9.8/−9.0, −1.1/−1.1, −24.0/−20.2 (all <i>p</i> &lt; 0.0001). Through week&#xa0;100 of guselkumab Q4W/Q8W treatment, LSM improvements of 69/74%, 52/54%, and 64/63% from baseline in cDAPSA (−35.9/−35.6), PASDAS (−3.6/−3.7), and PtGA (−56.8, −55.5), respectively, were observed. Regardless of severe disease activity definition, approximately 80% of guselkumab-randomized participants who achieved low disease activity at week&#xa0;24 maintained this response at week&#xa0;100.</p> Conclusion <p>In biologic-naïve participants with PsA and severe disease activity, guselkumab demonstrated early and durable clinically meaningful improvements in key PsA domains through 2&#xa0;years.</p> Trial Registration <p>ClinicalTrials.gov, NCT03158285.</p>

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Guselkumab Efficacy in Biologic-Naïve Participants with Psoriatic Arthritis and Severe Disease Activity: Post Hoc Analysis of a Phase 3 Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月21日

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  • Christopher T. Ritchlin,
  • Ennio Lubrano,
  • Maria Sole Chimenti,
  • Evan Leibowitz,
  • Mohamed Sharaf,
  • Emmanouil Rampakakis,
  • Francois Nantel,
  • Frederic Lavie,
  • Atul Deodhar

摘要

Introduction

The aim of this study was to evaluate guselkumab efficacy through week 100 in participants with psoriatic arthritis (PsA) and severe disease activity or patient global assessment (PtGA).

Methods

This post hoc analysis utilized DISCOVER-2 (NCT03158285) data from 739 biologic-naïve adults with active PsA (≥ 5 swollen/tender joints, C-reactive protein  ≥ 0.6 mg/dL) randomized to guselkumab every 4 weeks (Q4W) or at weeks 0 and 4, then every 8 weeks (Q8W); or placebo with crossover to guselkumab Q4W at week 24. Severe disease activity was defined as clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) > 27, Psoriatic Arthritis Disease Activity Score (PASDAS) ≥ 5.4, and PtGA Arthritis + Psoriasis ≥ 80 mm. Least squares mean (LSM) changes in cDAPSA, PASDAS, and PtGA were estimated with mixed models for repeated measures adjusted for baseline factors.

Results

Baseline characteristics among 648 (88%), 639 (86%), and 218 (29%) participants meeting the cDAPSA, PASDAS, and PtGA criteria for severe disease activity, respectively, were generally balanced across cohorts. LSM improvements from baseline with guselkumab Q4W/Q8W vs. placebo were −5.9 (p = 0.3905)/−7.2 (p = 0.0379) for cDAPSA at week 2; −1.5/−1.5 for PASDAS (both p < 0.0001); and −30.0/−32.1 for PtGA at week 8 (both p < 0.01). Differences vs. placebo increased through week 24 in the respective cohorts with guselkumab Q4W/Q8W: −9.8/−9.0, −1.1/−1.1, −24.0/−20.2 (all p < 0.0001). Through week 100 of guselkumab Q4W/Q8W treatment, LSM improvements of 69/74%, 52/54%, and 64/63% from baseline in cDAPSA (−35.9/−35.6), PASDAS (−3.6/−3.7), and PtGA (−56.8, −55.5), respectively, were observed. Regardless of severe disease activity definition, approximately 80% of guselkumab-randomized participants who achieved low disease activity at week 24 maintained this response at week 100.

Conclusion

In biologic-naïve participants with PsA and severe disease activity, guselkumab demonstrated early and durable clinically meaningful improvements in key PsA domains through 2 years.

Trial Registration

ClinicalTrials.gov, NCT03158285.