Background: In a previous claims-based analysis of patients (pts) with psoriatic arthritis (PsA), those receiving guselkumab (GUS; a fully human IL-23p19-subunit inhibitor) were ~3x more likely to remain persistent through 12 months (M) versus those initiating their first subcutaneous (SC) tumor necrosis factor (TNF) inhibitor (SC TNFi) [1]. Real-world data comparing long-term on-label persistence beyond 12M with GUS and SC TNFi are lacking.

Objectives: To compare the long-term on-label treatment persistence beyond 12M with GUS and SC TNFi in pts with active PsA, using real-world data.

Methods: Using claims from the IQVIA PharMetrics ^® Plus database (1/1/2011-6/30/2023), adults with active PsA and ≥1 claim for either GUS or SC TNFi (i.e., adalimumab, certolizumab pegol, etanercept, SC golimumab) were identified (first claim = index date; Figure 1a). Pts had ≥12M insurance eligibility and no rheumatic diseases or study drug exposure pre-index. On-label persistence was defined as no discontinuation or dose modification per US FDA-approved labeling. Demographic and disease characteristics (12M pre-index) were balanced between the GUS and SC TNFi cohorts using propensity score-weighting (overlap weights). On-label persistence through 24M was assessed via weighted Kaplan-Meier curves and compared between treatment cohorts (Cox proportional hazards model adjusted for biologic [b] and conventional synthetic [cs] disease-modifying anti-rheumatic drug [DMARD] use).

Results: 804 GUS pts (unweighted: mean age: 50.2 years; 60.6% female; 55.1% bio-experienced) and 2,490 SC TNFi pts (unweighted: mean age: 48.3 years; 60.1% female; 12.8% bio-experienced) were identified. Weighted baseline characteristics were similar between cohorts, except for prior bDMARD or csDMARD use. Median times to discontinuation were 22.0M for GUS vs 9.2M for the SC TNFi cohort (Figure 1b). Weighted on-label persistence rates by 6, 12, 18, and 24M, respectively, were 82.1%, 65.9%, 58.1%, and 45.5% (GUS) and 63.8%, 43.8%, 35.4%, 28.5% (SC TNFi; all log-rank p<0.001). Pts initiating GUS were ~2.2 times more likely to be persistent on-label through 24M than pts initiating an SC TNFi (hazard ratio: 2.24; 95% confidence interval: 1.90, 2.64; p<0.001).

Conclusion: GUS was associated with a significantly greater likelihood (~2x) of on-label persistence through 24M vs SC TNFi among pts with PsA, despite a higher prevalence of biologic-experienced pts in the GUS cohort.

REFERENCES: [1] Walsh JA, et al. Drugs - Real World Outcomes . 2024; 11(3):487-499.

Figure 1.

a. Data Source and Study Design. Figure 1b. Kaplan-Meier Analysis of On-label Persistence in Weighted Guselkumab and SC TNFi Cohorts ^f,g

^a The IQVIA PharMetrics® Plus data is comprised of fully adjudicated claims for inpatient and outpatient services, and outpatient prescription drugs, offering a diverse representation of geographic zones, employers, payers, providers and therapy areas. ^b A validated algorithm for identifying patients with PsA in US claims data was used: ≥2 claims with a PsA diagnosis (ICD-10-CM: L40.5x) ≥30 days apart and ≥1 prescription claim for a PsA-related medications (i.e., guselkumab or SC TNFi). ^c Patients could be bio-naïve or bio-experienced during baseline but were naïve to treatment with guselkumab or SC TNFi agents. ^d Patients in the SC TNFi cohort were newly initiated within the class. ^e Diagnoses for PsA include claims on the index date. ^f Discontinuation was defined as a gap in treatment of > twice the duration of days of supply for a claim (i.e., 2 x 56 = 112 days for guselkumab or 2 x 28 = 56 days for SC TNFi). ^g Patients with dose changes inconsistent with the FDA-approved dosing were censored as of the first dose change. ^h A weighted Cox proportional hazards model, further adjusted for baseline bDMARD and csDMARD use, was used to compare on-label persistence between cohorts

bDMARD = biologic disease-modifying anti-rheumatic drug; CI = confidence interval; csDMARD = conventional synthetic disease-modifying drug; FDA = Food and Drug Administration; ICD-10-CM = International Classification of Disease, 10th revision, Clinical Modification.

Acknowledgements: NIL.

Disclosure of Interests: Philip J. Mease Speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Novartis, Pfizer, SUN, UCB, and Ventyx, Received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Jessica A. Walsh Consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, and UCB, Received research funding from AbbVie, Merck, and Pfizer, Timothy Fitzgerald Shareholder of Johnson & Johnson, Employee of Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Soumya D. Chakravarty Shareholder of Johnson & Johnson, Employee of Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Bruno Emond Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Carmine Rossi Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Samuel Schwartzbein Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Kana Yokoji Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Yuxi Wang Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Patrick Lefebvre Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Dominic Pilon Employee of Analysis Group, Inc., a consulting company that has received research funding from Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Linda Hou Shareholder of Johnson & Johnson, Employee of Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Shikha Singla Received consulting fees from AbbVie, Janssen, and UCB, Received research funding from Eli Lilly, Joseph F. Merola Consultant and/or investigator for AbbVie, Amgen, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Leo Pharma, Moonlake, Novartis, Pfizer, Sanofi-Regeneron, Sun Pharma, and UCB.

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