About

Alexis Ogdie, MD, MSCE, is a Professor of Medicine (Rheumatology) at the Hospital of the University of Pennsylvania. He serves as the Director of the Penn Psoriatic Arthritis Clinic and is a Senior Scholar at the Penn Center for Clinical Epidemiology and Biostatistics. His clinical expertise includes psoriatic arthritis, ankylosing spondylitis, spondyloarthropathies, and other inflammatory arthritis such as rheumatoid arthritis. His research focuses on psoriatic arthritis, axial spondyloarthritis, epidemiology, and pharmacoepidemiology. Ogdie is affiliated with the Graduate Group in Epidemiology and Biostatistics and is based at the University of Pennsylvania in Philadelphia, PA.

Research topics

• Internal medicine
• Medicine
• Dermatology
• Sociology
• Environmental health
• Psychology
• Physical therapy
• Intensive care medicine
• Immunology
• Demography

Selected publications

• Impact of Deucravacitinib on Scalp Psoriasis in a Real-world Prospective Cohort Study in the United States

  SKIN The Journal of Cutaneous Medicine · 2025-03-17

  articleOpen access1st authorCorresponding

  Background: Real-world data indicate that patients with psoriasis (PsO) affecting the scalp, nails, palms, soles, and genitals report worse patient-reported outcomes (PROs) than those without PsO involvement in these special areas, despite having the same level of disease severity. Deucravacitinib is the first oral tyrosine kinase 2 inhibitor approved by the US Food and Drug Administration (FDA) for moderate-to-severe plaque psoriasis. Phase IV scalp-specific clinical trials have shown that deucravacitinib was efficacious across multiple efficacy endpoints. However, real-world evidence is limited for patients with psoriasis in difficult-to-treat areas, such as the scalp. Objective: The goal of this PRO study is to understand the impact of deucravacitinib on improvement of PsO signs and symptoms among patients with scalp PsO in the real world. Methods: Patients were recruited from dermatology offices of a U.S practice group, through a patient support program for deucravacitinib, and online from the FORWARD registry website. Patients were enrolled between August 2023 and November 2024. Inclusion criteria were adult patients initiating deucravacitinib ≤14 days of survey enrollment and continuation of deucravacitinib at 6-month follow up. We descriptively report demographics, disease characteristics, and comorbidities for participants at enrollment as well as mean change in key PROs and patient-reported psoriasis severity at 6 months in the subset of patients with scalp psoriasis. Psoriasis Symptoms and Signs Diary (PSSD) score was the primary outcome (range 0-100). All patients also completed a Dermatology Life Quality Index (DLQI) and patients with scalp PsO completed scalp-specific questions including the Scalp Specific Itch (SS-itch) numeric rating scale (NRS), scalp specific pain (SS-pain) NRS, and the scalp specific flaking (SS-flaking, NRS). Results: Among 306 patients with psoriasis initiating deucravacitinib, 219 (71.6%) reported scalp psoriasis. Of these, sixty patients (27.4%) completed a 6-month follow up, and 39 of these (65.0%) were persistent on therapy at 6 months. At baseline, the mean PSSD was higher among those with scalp psoriasis compared to those without reported scalp psoriasis (34.1 vs 25.8). At 6-month follow up, the mean change in PSSD among those with scalp psoriasis was -19.2 (SD: 27.6). Mean DLQI at enrollment among those with scalp psoriasis was 8.5 (SD: 4.7) and change in DLQI at 6 month follow up was -4.5 (SD: 5.4). Scalp itch (0-10) at baseline was 4.1 (SD: 3.0) and mean change was -1.9 (SD: 2.7). Mean scalp flaking (0-10) at baseline was 4.7 (SD: 3.0) and mean change was -2.0 (SD: 3.2). Mean scalp pain at baseline was 1.8 (SD: 2.8) and mean change was -0.3 (SD: 2.2). Conclusions: Deucravacitinib was associated with improvements in scalp psoriasis and patient-reported outcomes of disease impact and quality of life in a real-world setting.

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• Psychometrics of inflammatory back pain criteria in the US population

  EULAR Rheumatology Open · 2025-05-16

  articleOpen access

  Objectives: Evaluation of axial spondyloarthritis relies on capturing various inflammatory back pain (IBP) features represented in different criteria. These criteria are likely to be interpreted differently across demographic subpopulations. We examined IBP criteria dimensionality and differential item functioning (DIF) among different age, gender, and race groups using a nationally representative sample. Methods: We utilised the National Health and Nutrition Examination Survey (NHANES) 2009-2010 dataset, a US nationally representative data collection with demographic weighting. The Arthritis Questionnaire (ARQ) within NHANES included questions from published Calin, European Spondyloarthropathy Study Group, and Berlin criteria (8a and 7b). Confirmatory factor analysis (CFA) was performed to assess the dimensionality of IBP criteria. DIF analysis based on Item Response Theory was applied to evaluate differences in criterion performance across age (20-49 years vs >50 years), gender (men vs women), and race (white vs non-white) groups. Results: The study included 1511 patients with complete ARQ IBP questionnaires. CFA indicated that 1-factor models were generally preferred for all IBP criteria. DIF analysis revealed age-related differences in several IBP items, with non-uniform DIF observed except in the Berlin 8a criteria. In contrast, gender differences were noted primarily in the Berlin 8a lower back pain item, and racial differences were minimal. Conclusions: Findings support the predominant use of a single underlying construct in IBP criteria, validating their clinical application. However, demographic factors, especially age and gender, introduce significant variability in responses, necessitating tailored approaches in clinical assessment and further research to confirm these findings across broader populations.

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• Patient Experiences with Psoriatic Disease in the USA: Results from the Psoriasis and Beyond Global Study

  Drugs - Real World Outcomes · 2025-08-29

  articleOpen accessSenior author

  BACKGROUND: Psoriatic disease (PsD) is a chronic, multisystem, inflammatory disorder encompassing psoriasis, psoriatic arthritis (PsA), and their associated comorbidities. OBJECTIVE: The aim of this subanalysis of the global "Psoriasis and Beyond" study was to evaluate patients' experiences of living with PsD in the USA. METHODS: The study included a cross-sectional, quantitative, 25-min online survey of adults with self-reported, healthcare professional-diagnosed, moderate-to-severe psoriasis, with or without PsA. USA-based patients were recruited through online panels by the Institut de Publique Sondage D'Opinion Secteur and The National Psoriasis Foundation. RESULTS: This analysis included 793 US patients with psoriasis; 43% also had PsA. Overall, 75% of patients knew that their disease was systemic, and 65% had heard the term "psoriatic disease." Of patients without diagnosed PsA, 50% screened positive for PsA using the Psoriasis Epidemiology Screening Tool. Psoriasis negatively affected emotional well-being and quality of life (QoL) in the majority of patients (87% and 91%, respectively). Overall, 29% of patients reported that they could not work or study in the week prior to the survey; of these, 98% responded that psoriasis had a very or extremely large impact on their QoL. Mean diagnostic delays of 3.7 and 3.3 years for psoriasis and PsA, respectively, were reported. CONCLUSIONS: This analysis of USA-based patients with PsD highlights the profound impact of PsD on emotional well-being and QoL and suggests potential underdiagnosis of PsA. There is a need to ensure early PsD diagnosis and to provide holistic treatment, including mental health support.

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• Impact of Delay of Treatment With Disease‐Modifying Antirheumatic Drugs in Psoriatic Arthritis: The <scp>CorEvitas</scp> Psoriatic Arthritis/Spondyloarthritis Registry

  ACR Open Rheumatology · 2025-06-01 · 2 citations

  articleOpen accessSenior author

  OBJECTIVE: Our objective was to describe characteristics and compare clinical and patient-reported outcomes (PROs) for disease-modifying antirheumatic drug (DMARD)-naive patients with psoriatic arthritis (PsA) who initiate DMARD therapy early versus late. METHODS: Patients with PsA from the CorEvitas PsA/Spondyloarthritis Registry were classified by reported time between diagnosis and DMARD initiation. Early and late initiators were patients whose first DMARD treatment occurred ≤1 year or >1 year, respectively, following PsA diagnosis. Change in disease activity and PRO measures from initiation to the six-month follow-up was calculated for each group; mean change for each continuous outcome and proportion achieving binary outcomes were reported for early and late initiators. Associations of early versus late DMARD initiation with disease activity and PROs at six months were calculated using adjusted linear and Poisson regressions. RESULTS: The mean patient age was 53 years, more than half of patients were female, and 90% of patients were White. Mean time from diagnosis to DMARD initiation was 0.2 years in early initiators (n = 229, 79%) and 8.6 years in late initiators (n = 62, 21%). In adjusted analyses, achievement of minimal disease activity (adjusted risk ratio 2.01, 95% confidence interval [CI] 1.03-4.40) and mean change in Clinical Disease Activity Index (β -3.4, 95% CI -6.2 to -0.49) were statistically different between early and late initiators. CONCLUSION: Among patients from the PsA registry, those who had both early and late initiation of DMARD therapy experienced improvements throughout all disease activity and PROs across six months of treatment. Minimal disease activity, a key treatment target, was more likely observed in early initiators, highlighting the value of early identification and treatment. Delay of Treatment With Disease-Modifying Antirheumatic Drugs in Psoriatic Arthritis: The CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

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• OP0375 Incidence of non-infectious anterior uveitis among adult patients with immune-mediated inflammatory diseases treated with tofacitinib and other advanced therapies

  Annals of the Rheumatic Diseases · 2025-06-01

  articleOpen access1st authorCorresponding

  <h2>Abstract</h2><h3>Background:</h3> Non-infectious anterior uveitis (NIAU) is a common manifestation in several immune-mediated inflammatory diseases (IMIDs), which poses a significant potential health burden if left untreated [1]. Data on the comparative effectiveness of tofacitinib and other advanced therapies in reducing occurrence of NIAU is limited. <h3>Objectives:</h3> To estimate crude incidence rates (IRs) and adjusted hazard ratios (aHRs) of NIAU, stratified by history of NIAU, among adult patients with IMID (ulcerative colitis [UC], psoriatic arthritis [PsA], axial spondylarthritis [axSpA]) receiving tofacitinib and other advanced therapies. <h3>Methods:</h3> This was a population-based retrospective cohort study of United States (US) claims data (Komodo Health; January 2016-Februray 2024) from patients aged ≥18 with UC, PsA or axSpA initiating a new advanced therapy. Disease cohorts, outcome of interest (NIAU), and drugs prescribed were identified using International Classification of Diseases-Tenth Revision (ICD-10) codes, current procedure terminology and prescribing codes in the patients' records. Exposure to advanced therapies was classified according to mechanism of action (MoA): monoclonal tumor necrosis factor inhibitor (mTNFi), TNFi-soluble receptor (TNFi-rec), interleukin-17 inhibitors (IL-17i), and interleukins 12/23 inhibitors (IL-12/23i). Patients could contribute to multiple observations if they had been treated with different MoAs. Individuals with more than one simultaneous advanced therapy prescription, pregnancy within 9 months, or Crohn's disease (UC only) code within 365 days prior to date of the advanced therapy initiation (index date) were excluded. Patients were followed from index date to the earliest of end of study period, the event of interest (NIAU), treatment switch, treatment discontinuation (+ 90 days), or end of enrolment in the database. For each cohort, crude IRs per 100 person-years, and aHRs using a mixed effects standardized mortality ratio weighted Cox proportional hazards model, were calculated with 95% confidential intervals (CI). Inverse probability of treatment weighting was applied to adjust for potential confounding variables. Meta-analysis of individual-level data for each indication was performed to produce cross-indication estimates for each relevant MoA. Resulting IRs and aHRs were stratified by previous history of NIAU. <h3>Results:</h3> Across all IMIDs, 13,918, 82,939, 21,959, 43,030, and 17,217 subjects on tofacitinib, mTNFi, TNFi-rec, IL-17i, and IL-12/23i, respectively, were included in the analysis. Mean (standard deviation [SD]) of follow-up time ranged from 177 (SD 174) days for tofacitinib in axSpA to 414 (SD 443) days for mTNFi in UC. Across all indications, mean number of prior advanced therapies was higher in patients initiating tofacitinib versus other MoAs. Crude IRs of NIAU were numerically higher in axSpA compared to PsA and UC and in patients with previous history of NIAU versus patients without history of NIAU for all indications. Crude IRs (95% CI) in the cross-indication analysis were 1.69 (1.45-1.95), 2.66 (2.55-2.78), 1.54 (1.35-1.74), 1.32 (1.21-1.44), and 0.93 (0.78-1.09) for tofacitinib, mTNFi, TNFi-rec, IL-17i, and IL-12/23i, respectively. There were no statistically significant differences in incidence of NIAU for the various MoAs compared to tofacitinib (aHR [95% CI] mTNFi: 1.11 [0.94-1.32], TNFi-rec: 0.88 [0.68-1.13], IL-17i: 0.97 [0.79-1.18], and IL12/23-i: 0.96 [0.69-1.35]). Among patients without previous history of NIAU, no significant differences were observed in aHRs for NIAU for the various MoAs versus tofacitinib in the cross-indication analysis or in any of the individual IMIDs (Figure 1). In patients with previous NIAU, mTNFi were associated with a significant higher incidence of NIAU compared to tofacitinib in the cross-indication analysis and in PsA, while IL-12/23i were associated with a lower incidence of NIAU versus tofacitinib in the cross-indication analysis and in UC (Figure 2). <h3>Conclusion:</h3> In this large retrospective US cohort, there were no differences in the overall adjusted incidence of NIAU between tofacitinib and other advanced therapies among adult patients with UC, PsA and axSpA. In patients with previous history of NIAU, mTNFi may be associated with a higher incidence of NIAU compared to tofacitinib, but sample size was small and confounding by indication could not be excluded. Additional limitations include short period of exposure and relatively low number of events in patients without history of NIAU. <h3>REFERENCES:</h3> [1] Rothova A et al. Br J Ophthalmol 1996; 80: 332-336. <h3>Acknowledgements:</h3> Genesis Research Group, CMC Connect. <h3>Disclosure of Interests:</h3> Alexis Ogdie receives consulting fees from AbbVie, Amgen, BMS, Celgene, Corrona, Gilead, GSK, Janssen, Lilly, Novartis, Takeda, TREG, Pfizer, UCB, Spyre, receives grants/research support from Abbvie (to Penn), Amgen (to Forward), BMS (to Forward), Janssen (to Penn), Novartis (to Penn), Pfizer (to Penn), Forward/National Databank for Rheumatic Diseases, NIH/NIAMS, Rheum Research Foundation, Milena A Gianfrancesco owns Pfizer's stock shares, is a Pfizer's employee, Katherine A Falloon served on an advisory panel for Janssen and is providing content for Takeda IBDIQ, receives grant funding from the Crohn's and Colitis Foundation (916943) and Pfizer (90146787), Xiang Guo owns Pfizer's stock shares, is a Pfizer's employee, David C Gruben owns Pfizer's stock shares, is a Pfizer's employee, Lidia Sanchez-Riera owns Pfizer's stock shares, is a Pfizer's employee. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

  PublisherDOI

• Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA

  RMD Open · 2025-07-01 · 1 citations

  articleOpen access

  OBJECTIVES: To assess vaccine effectiveness (VE) and safety of the recombinant zoster vaccine (RZV) in adults with systemic lupus erythematosus (SLE). METHODS: This retrospective study using administrative claims data collected between 1 January 2018 and 30 September 2023 from the USA included two cohorts of adults aged ≥18 years with SLE insured by (1) Medicare (parts A/B/D) or (2) one of five commercial partners (including Medicare Advantage plans). In VE analyses, adults receiving two RZV doses ≥28 days apart were matched 1:4 to unvaccinated comparators on insurer, sex and age (±5 years); the outcome was incident herpes zoster (HZ) after 31 days. In safety analyses, adults receiving RZV dose 1 or 2 were matched to unvaccinated comparators as above; the outcome was severe SLE flare within 90 days. Adjusted hazard ratios (HRs) were estimated using Cox models with inverse probability of treatment weighting (IPTW). RESULTS: VE cohorts included 2284 Medicare and 1308 commercially insured RZV-vaccinated patients; mean weighted follow-up was 1.4-1.6 person-years. Safety cohorts included 6602 RZV vaccinations (dose 1 or 2) in Medicare and 4196 in commercial insurers. Vaccinated versus unvaccinated patient characteristics were balanced after IPTW. VE was 70% (95% CI: 50% to 82%) in Medicare and 54% (95% CI: 18% to 74%) in commercially insured patients. The HR of severe SLE flare in vaccinated versus unvaccinated patients was 0.91 (95% CI: 0.75 to 1.11) in Medicare and 0.94 (95% CI: 0.72 to 1.24) in commercially insured patients. CONCLUSIONS: RZV prevented a majority of HZ cases in individuals with SLE without increasing the risk of severe SLE flare.

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• Empowering Clinical Trial Design through AI: A Randomized Evaluation of PowerGPT

  ArXiv.org · 2025-09-15

  preprintOpen access

  Sample size calculations for power analysis are critical for clinical research and trial design, yet their complexity and reliance on statistical expertise create barriers for many researchers. We introduce PowerGPT, an AI-powered system integrating large language models (LLMs) with statistical engines to automate test selection and sample size estimation in trial design. In a randomized trial to evaluate its effectiveness, PowerGPT significantly improved task completion rates (99.3% vs. 88.9% for test selection, 99.3% vs. 77.8% for sample size calculation) and accuracy (94.1% vs. 55.4% in sample size estimation, p &lt; 0.001), while reducing average completion time (4.0 vs. 9.3 minutes, p &lt; 0.001). These gains were consistent across various statistical tests and benefited both statisticians and non-statisticians as well as bridging expertise gaps. Already under deployment across multiple institutions, PowerGPT represents a scalable AI-driven approach that enhances accessibility, efficiency, and accuracy in statistical power analysis for clinical research.

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• Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials

  Rheumatology and Therapy · 2025-12-15 · 2 citations

  articleOpen access

  INTRODUCTION: Psoriatic arthritis (PsA) is a heterogeneous disease, and clinical manifestations can differ between sexes. Sex-disaggregated baseline characteristics, guselkumab efficacy, and radiographic progression were assessed in a pooled cohort of randomized controlled trial (RCT) participants with active PsA. METHODS: Post hoc analyses of DISCOVER-1 (N = 381), DISCOVER-2 (N = 739), and COSMOS (N = 285) assessed sex-related baseline characteristics differences. Week (W) 24 clinical response rates with guselkumab 100 mg at W0/W4/every 8W (Q8W) were compared between sexes using multivariate logistic regression. In DISCOVER-2, multivariate repeated-measures mixed models evaluated associations between sex and radiographic progression with guselkumab Q4W + Q8W through W100, and between early (W8) response in joint disease activity with guselkumab Q4W + Q8W and radiographic progression, stratifying by sex. RESULTS: Females were older; had higher body mass index; longer PsA duration; less severe psoriasis; more prevalent enthesitis; and reported more fatigue, pain, and functional impairment. Analyses adjusting for sex-specific differences in baseline characteristics showed no significant sex impact on guselkumab clinical response. Through W100, males exhibited significantly greater radiographic progression than females in unadjusted and adjusted models. Early clinical improvement in joint disease activity with guselkumab afforded significantly less radiographic progression through W100 in males (p = 0.0288) and numerically less in females. CONCLUSIONS: Despite being associated with significant differences in characteristics at baseline, sex had no independent effect on guselkumab clinical efficacy in this RCT cohort. The known independent association between male sex and radiographic progression was confirmed; males exhibited a stronger relationship between early improvement in joint disease activity and lower long-term rates of radiographic progression. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03162796, NCT03158285, NCT03796858.

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• POS1314 ICOTROKINRA, A NOVEL TARGETED ORAL PEPTIDE, IN PATIENTS WITH PSORIATIC DISEASE: EXPLORATORY ASSESSMENTS FROM A PHASE 2 PSORIASIS STUDY INFORMING A PHASE 3 CLINICAL PROGRAM IN PSORIATIC ARTHRITIS

  Annals of the Rheumatic Diseases · 2025-06-01

  articleOpen access

  <h2>Abstract</h2><h3>Background:</h3> Psoriatic arthritis (PsA) affects ~20-30% of patients with psoriasis (PsO) [1, 2, 3]. PsA causes articular inflammation and damage, fatigue, pain, and impaired physical function, leading to profound negative impacts on health-related quality of life (HRQoL) [4]. The IL-23 pathway plays a pivotal role in the pathogenesis of PsO and PsA [5]. Injectable biologics inhibiting the IL-23p19 subunit have demonstrated a favorable benefit-risk profile with durable efficacy. While oral therapies are available for the treatment of PsA, a substantial unmet need remains for highly efficacious and safe oral therapy options. Icotrokinra, a novel targeted oral peptide that binds directly to the IL-23R and inhibits proximal IL-23R signaling and downstream effector functions (eg, cytokine secretion), showed greater clinical response rates vs placebo (PBO) and a favorable safety profile in participants with moderate-to-severe plaque PsO in the Phase 2b FRONTIER 1&2 studies [6, 7]. Icotrokinra is being evaluated in Phase 3 studies in participants with moderate-to-severe PsO and in a Phase 2 study of participants with moderately-to-severely active ulcerative colitis. <h3>Objectives:</h3> To leverage exploratory serum biomarker, Patient Reported Outcomes Measurement Information Systems (PROMIS-29), and Psoriasis Area and Severity Index 75% improvement (PASI75) data from a subset of FRONTIER 1 participants with PsO and a medical history of PsA (PsO+PsA) in support of conducting the Phase 3 ICONIC-PsA 1 and ICONIC-PsA 2 studies. <h3>Methods:</h3> Mean log fold-changes (logFC) in serum levels of β-Defensin-2 (BD-2), IL-22, IL-17A, and IL-17F were summarized for FRONTIER participants with PsO only and those with PsO+PsA. Participants completed the PROMIS-29 questionnaire to assess their HRQoL across distinct domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity). Improvements ≥5-points in PROMIS-29 domain scores (or ≥2-points for pain), and in the physical/mental component summary (PCS/MCS) scores to which they contribute, are considered clinically meaningful [8]. Sample sizes for the Phase 3 PsA studies were informed both by ample safety data to support a regulatory submission and estimates derived from model-based analyses. Specifically, a meta-analysis employed FRONTIER 1 PASI75 response rates to bridge to expected ACR20 response at Week (W) 16 (primary endpoint), and meta-regression modeling bridged between ACR20 response and secondary endpoints of interest, including more stringent joint disease activity (ACR50/70), skin (PASI90/100), and multi-domain (Minimal Disease Activity) outcomes. <h3>Results:</h3> Of the 91 FRONTIER 1 participants, 23 (25%) had PsO+PsA (20 icotrokinra, 3 PBO). Among those with evaluable biomarker data, mean logFC in serum BD-2, IL-22, IL-17A (Figure 1A-C<b>),</b> and IL-17F (data not shown) over time indicated consistent pharmacodynamic (PD) effect of icotrokinra between participants with PsO only and those with PsO+PsA. Numerically greater changes from baseline (BL) at W16 were seen in icotrokinra vs PBO-treated PsO+PsA participants across PROMIS-29 domains relevant to PsA, i.e., improvements in physical function (7.7 vs 1) and reductions in fatigue (-7.4 vs 2.3 [worsening]), pain interference (-10.7 vs -1.3), and pain intensity (-3.5 vs -1.5). Among the 20 icotrokinra-treated participants with PsO+PsA, 45% and 70%, respectively, reported ≥5-point improvement from BL in the PROMIS-29 PCS and MCS scores vs no participants receiving PBO. For both ICONIC-PsA 1 (biologic-naïve) and ICONIC-PsA 2 (biologic-experienced), the primary endpoint is ACR20 response at W16, and sample size estimation employed model-based meta-analyses. Respective sample sizes of 540 (randomized 5:5:5:3 to icotrokinra Dose 1 or 2, PBO, or active reference arm [no formal statistical comparisons]; Figure 2A) and 750 (1:1:1 to icotrokinra Dose 1 or 2 or PBO; Figure 2B) were estimated to provide ≥90% power to detect a significant difference between icotrokinra and PBO. Given that minorities are often under-recruited in PsA trials, this Phase 3 PsA program plans to assess a diverse patient population, including representation of individuals with different racial/ethnic backgrounds. This will be achieved through multiple strategies, including targeted outreach to under-represented communities to enhance recruitment, as well as collaboration with patient advocacy groups to increase awareness and support the enrollment of these populations. Both studies will continue through 2 years. <h3>Conclusion:</h3> Exploratory assessments from the Phase 2 FRONTIER 1 study showed icotrokinra PD effects were comparable between participants with PsO only and those with PsO who also had PsA, and numerically greater patient-reported improvements in PROMIS-29 domains relevant to PsA with icotrokinra vs PBO. Informed by these post hoc analyses and model-based meta-analyses that bridged data from PsO to PsA, the multicenter, double-blind, PBO-controlled ICONIC-PsA 1 and ICONIC-PsA 2 studies will comprehensively evaluate the novel targeted oral peptide icotrokinra in a diverse population of participants with active PsA. <h3>REFERENCES:</h3> [1] Lemke S. doi:10.1093/rheumatology/keae198. [2] Ocampo D. doi:10.12688/f1000research.19144.1. [3] Merola J. doi:10.1016/j.jaad.2021.09.019. [4] Gladman D. doi:10.1136/rmdopen-2019-000928. [5] Qin-Yi S. doi:10.1080/14712598.2024.2401148. [6] Bissonnette R. doi: 10.1056/NEJMoa2308713. [7] Ferris L. doi:10.1016/j.jaad.2024.10.076. [8] Terwee C. doi:10.1007/s11136-021-02925-y. <h3>Acknowledgements:</h3> <b>NIL</b>. <h3>Disclosure of Interests:</h3> Joseph F. Merola: Consultant - AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, Leo Pharma, Moonlake, Novartis, Pfizer, Sanofi-Regeneron, Sun Pharma, and UCB, Philip J. Mease: Speaker - AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant - AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Immagene, Janssen, Novartis, Pfizer, UCB, and Ventyx, Grants - AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, and UCB, Laura C. Coates: Speaker - AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medac, Novartis, Pfizer, and UCB, Consultant - AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB, Grants - AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Iain B. McInnes: Shareholder - Causeway and Evelo Compugen, NHS GGC Board Member, Evelo Board of Directors, and Versus Arthritis Trustee, Consultant - AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Cabaletta, Compugen, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, Sanofi, and UCB, Grants - Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Roche, and UCB, Peter Nash: Consultant - AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun, and UCB, Grants - AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun, and UCB, Alexis Ogdie: Consultant - AbbVie, Amgen, BMS, Celgene, CorEvitas, Gilead, GSK, Janssen, Eli Lilly, Novartis, Pfizer, and UCB, Grants - AbbVie to Penn, Pfizer to Penn, Novartis to Penn, Amgen to Forward/NDB, NIAMS, Rheumatology Research Foundation, National Psoriasis Foundation, and University of Pennsylvania, Lihi Eder: Consultant - AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, and UCB, Grants - AbbVie, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer, Sandoz, and UCB, Mitsumasa Kishimoto: Speaker - AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Tanabe-Mitsubishi, and UCB, Consultant - AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Tanabe-Mitsubishi, and UCB, Anna Beutler: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Konstantina Psachoulia: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Shana Hamm: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Shihong Sheng: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Bei Zhou: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Mehrdad Javidi: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Chandni Valiathan: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Charles Iaconangelo: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Ya-Wen Yang: Shareholder - Johnson & Johnson, Employee - Janssen Pharmaceutical Companies of Johnson & Johnson, Arun Kannan: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Chetan S Karyekar: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson, Tasneam Shagroni: Shareholder - Johnson & Johnson, Employee - Johnson & Johnson. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

  PublisherDOI

• Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial

  Trials · 2025-03-19 · 1 citations

  articleOpen access1st authorCorresponding

  BACKGROUND: Psoriatic arthritis (PsA) is a multi-domain, inflammatory disease impacting joints, soft tissues, and skin; tumor necrosis factor inhibitors (TNFi) are typically the first biologic following inadequate response (IR) to conventional therapies. Although guidance is lacking on therapy selection after initial TNFi failure, data suggest TNFi-IR PsA patients may benefit from switching to a different mechanism of action (MOA) vs. cycling to another TNFi. Guselkumab is a fully human monoclonal antibody targeting the interleukin-23p19 subunit. Emphasizing practicality and applicability to routine clinical practice, EVOLUTION will pragmatically evaluate whether switching to guselkumab is more effective than cycling to a second TNFi (subcutaneous [SC] golimumab) in TNFi-IR PsA patients. METHODS: The multicenter, longitudinal, prospective, observational Psoriatic Arthritis Research Consortium study guided eligibility criteria, outcome measures, and sample size estimates. Adults seen in clinical practice with active PsA (≥ 1 swollen joint) while receiving TNFi treatment will be eligible. Participants will be randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week 0, Week 4, and Q8W; or SC golimumab 50 mg Q4W (no washout period). The novel primary composite endpoint is achievement of clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (≤ 13) and an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 (scale: 0-4) at Month12. Secondary endpoints include cDAPSA + IGA 0/1 at Month 6; achievement of minimal disease activity, resolution of enthesitis and dactylitis (among patients affected at baseline) at Months 6/12; and mean changes at Months 6/12 in the 12-item PsA Impact of Disease, Dermatology Life Quality Index, Patient-Reported Outcomes Measurements Information System fatigue and depression questionnaires, and Bath Ankylosing Spondylitis Disease Activity Index (patients with physician-determined axial disease). The target sample size is 150 participants (50/treatment group); all analyses are considered exploratory. DISCUSSION: EVOLUTION will employ a pragmatic approach, including a novel primary endpoint relevant to clinical practice, to assess whether switching to an alternate MOA biologic with guselkumab is more effective than cycling to a second TNFi among TNFi-IR PsA patients. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov, NCT05669833, on 3 January 2023, https://www. CLINICALTRIALS: gov/study/NCT05669833?term=%20NCT05669833&rank=1.

  PublisherOA PDFDOI

Recent grants

• Identification of Early Psoriatic Arthritis

  NIH · $751k · 2013–2019

• Refining Outcome Measurement in Psoriatic Arthritis: Preparation for Pragmatic Trials

  NIH · $709k · 2017–2021

Frequent coauthors

• Philip J. Mease

  637 shared

• Dafna D. Gladman

  512 shared

• Oliver FitzGerald

  University College Dublin

  426 shared

• Laura C. Coates

  Nuffield Orthopaedic Centre

  411 shared

• Niti Goel

  Duke University

  389 shared

• William Tillett

  385 shared

• Lihi Eder

  University of Toronto

  368 shared

• Ana‐Maria Orbai

  Johns Hopkins University

  363 shared

Education

• B.S.

  University of Minnesota

  2002

• M.D.

  Georgetown University School of Medicine

  2006

• Other

  University of Pennsylvania

  2012