ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0583

Impact of Prior Tumor Necrosis Factor Inhibitor Treatment and Baseline Psoriatic Arthritis Disease Activity on Minimal Clinically Important Improvement Thresholds for Efficacy Outcomes: Post Hoc Analysis of Three Phase 3 Studies of Guselkumab in Patients with Active Psoriatic Arthritis

Alexis Ogdie1, Philip Mease2, Francois Nantel3, Frederic Lavie4, Mohamed Sharaf5, Emmanouil Rampakakis6, Helena Marzo-Ortega7 and Laure Gossec8, 1Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 2Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, 3Nantel MedSci Consult, Montreal, QC, Canada, 4Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 5Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, 6McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, 7NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 8Sorbonne Université, Paris, France

Meeting: ACR Convergence 2024

Keywords: , , ,

Session Information

Date: Saturday, November 16, 2024

Title: SpA Including PsA – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: PsA disease activity (DA) and impact on patients (pts) are measured with clinical and pt-reported outcomes1. Minimal clinically important improvement (MCII), the smallest improvement perceived by pts as clinically meaningful2, has been defined for multiple PsA outcome measures, mainly using observational data3,4. We determined MCII thresholds for PsA outcomes in subsets of PsA pts from randomized controlled trials (RCTs) stratified by treatment history and baseline (BL) DA.

Methods: Data from 3 Phase 3 RCTs of 1405 PsA pts receiving guselkumab (GUS) every 4 weeks (Q4W) or at W0, W4 and Q8W, or placebo (PBO) were pooled: DISCOVER-1 (NCT03162796); DISCOVER-2 (NCT03158285); COSMOS (NCT03796858). MCII thresholds were assessed in bio-naïve and TNF inhibitor (i)‑experienced cohorts for clinical DA Index for PsA (cDAPSA), PsA DA Score (PASDAS), pt global assessment (PtGA) Arthritis, PtGA Psoriasis, Pt Pain, HAQ-Disability Index (DI), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT‑F) using 3 BL distribution-based methods (Table 1). MCII achievement at W8 (1st timepoint common to all outcomes) was compared in GUS Q8W (regimen common to all studies) vs PBO via logistic regression (Fig 1). To assess impact of BL PsA DA on measures of joint and overall DA, MCII thresholds were estimated in the pooled population stratified by PsA DA (15/16% and 84/84% of pts had moderate and high DA by cDAPSA/PASDAS, respectively) using a method based on standard deviation (SD) of change from BL to W24.

Results: Mean BL scores in TNFi-experienced (N=403) vs bio-naïve (N=1002) cohorts for cDAPSA, PASDAS, PtGA Arthritis, PtGA Psoriasis, Pt Pain, HAQ-DI, and FACIT‑F of 43.7/44.4, 6.4/6.5, 65.0/63.6, 61.4/60.5, 63.7/60.8, 1.3/1.2, and 29.0/30.1, respectively, indicated high overall BL PsA DA. Although some variation was observed between methods, mean MCII thresholds for outcomes were generally consistent across cohorts, representing 16-39% mean improvement from BL (Table 1). At W8, GUS Q8W pts were significantly more likely to achieve estimated MCII cutoffs vs PBO for all outcomes (except FACIT‑F in TNFi‑experienced pts), with odds ratios (ORs) ranging from 1.5 to 3.7 (Fig 1). Relative to previous reports3,4, mean cDAPSA MCII thresholds were higher in these RCT cohorts (both 14.7) and mean HAQ-DI MCII cutoffs were somewhat higher than reported5 (0.4/0.5 in bio-naïve/TNFi‑experienced pts; Table 1). When stratifying by BL joint and PsA DA in the pooled RCT population, estimated MCII thresholds were higher in pts with high (MCII cDAPSA: 9.1; PASDAS: 0.8) than moderate (cDAPSA: 4.1; PASDAS: 0.7) DA (Table 2).

Conclusion: In a pooled RCT population of pts with active PsA, estimated MCII thresholds were consistent across bio-naïve and TNFi-experienced pts. Pts receiving GUS Q8W were significantly more likely to achieve early (W8) MCII vs PBO. MCII cutoffs were greater for pts with higher BL cDAPSA and PASDAS, indicating BL DA impacts MCII and assessment of response achievement.

References:

  1. Ogdie. Arthritis Care Res 2020;72:82
  2. Kvien. Ann Rheum Dis 2007;66:iii40
  3. Ogdie. Ann Rheum Dis 2020;79:1173
  4. Karmacharya. Arthritis Care Res 2022;75:2182
  5. Mease. J Rheumatol 2011;38:2461

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Disclosures: A. Ogdie: AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb(BMS), 5, Celgene, 2, CorEvitas, 2, Eli Lilly, 2, Gilead, 2, GlaxoSmithKlein(GSK), 5, Happify Health, 2, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2; P. Mease: AbbVie, 2, 5, Aclaris Therapeutics, 2, 5, Aclyrin, 2, 5, Amgen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, CorEvitas, 2, 5, Galápagos, 2, 5, Gilead, 2, 5, Inmagene, 2, 5, Janssen, 2, 5, Lilly, 2, 5, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, Sun Pharma, 2, 5, UCB, 2, 5; F. Nantel: Janssen, 2, Johnson & Johnson, 11; F. Lavie: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 3, Johnson & Johnson, 11; M. Sharaf: Janssen Pharmaceutical Companies of Johnson & Johnson, 3, Johnson & Johnson, 11; E. Rampakakis: Janssen, 2, JSS Medical Research, 3; H. Marzo-Ortega: AbbVie, 2, 6, Amgen, 2, 6, Biogen, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 5, 6, MoonLake, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Takeda, 2, 6, UCB Pharma, 2, 5, 6; L. Gossec: AbbVie, 2, 5, Amgen, 2, Biogen, 5, Bristol-Myers Squibb (BMS), 2, Celltrion, 2, Eli Lilly, 2, 5, Galapagos, 2, Janssen, 2, MSD, 2, Novartis, 2, 5, Pfizer, 2, Sandoz, 2, UCB, 2, 5.

To cite this abstract in AMA style:

Ogdie A, Mease P, Nantel F, Lavie F, Sharaf M, Rampakakis E, Marzo-Ortega H, Gossec L. Impact of Prior Tumor Necrosis Factor Inhibitor Treatment and Baseline Psoriatic Arthritis Disease Activity on Minimal Clinically Important Improvement Thresholds for Efficacy Outcomes: Post Hoc Analysis of Three Phase 3 Studies of Guselkumab in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/impact-of-prior-tumor-necrosis-factor-inhibitor-treatment-and-baseline-psoriatic-arthritis-disease-activity-on-minimal-clinically-important-improvement-thresholds-for-efficacy-outcomes-post-hoc-analy/. Accessed .

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