Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-24DOI: 10.1007/s40744-024-00714-w
Xiao Xu, Christopher Edmonds, YongJin Kim, Michael Stokes, Heide A Stirnadel-Farrant, Justin Kwiatek, Rohit Katial
{"title":"Disease Overlap, Healthcare Resource Utilization, and Costs in Patients with Eosinophilic Granulomatosis with Polyangiitis: A REVEAL Sub-study.","authors":"Xiao Xu, Christopher Edmonds, YongJin Kim, Michael Stokes, Heide A Stirnadel-Farrant, Justin Kwiatek, Rohit Katial","doi":"10.1007/s40744-024-00714-w","DOIUrl":"10.1007/s40744-024-00714-w","url":null,"abstract":"<p><strong>Introduction: </strong>Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophil-associated disease (EAD) characterized by inflammation in small- to medium-sized blood vessels. In the REal-world inVestigation of Eosinophilic-Associated disease overLap (REVEAL) study, overlap among 11 EADs was assessed. In the present sub-study, we evaluated EGPA overlap with other EADs, all-cause EAD- and EGPA-related healthcare resource utilization (HCRU) and costs, and their relationship with blood eosinophil count and treatments received.</p><p><strong>Methods: </strong>REVEAL, a retrospective study, used Optum's de-identified Clinformatics<sup>®</sup> Data Mart Database. In this sub-study, eligibility criteria included an age of ≥ 12 years, ≥ 1 EAD, continuous health-plan eligibility, and compliance with the EGPA/GPA case definition per International Classification of Diseases Ninth/Tenth Revision diagnostic codes between 1 January 2015 and 30 June 2018. Patients were grouped based on whether they had received immunomodulators/cyclophosphamide/mepolizumab (ICM) or not (non-ICM).</p><p><strong>Results: </strong>Of 701 patients with EGPA, 29.5% were in the ICM group. Overall, 72.2% had ≥ 1 overlapping EAD. The number of overlaps was similar for the ICM and non-ICM groups. In patients with blood eosinophil counts ≥ 300 cells/µL, 22.8% had ≥ 1 overlapping EAD. The mean annual all-cause cost was $98,644, 54.1% of which was from outpatients and 33.6% from inpatients. The mean annual EAD- and EGPA-related costs were $23,820 and $9,306, respectively. Patients in the non-ICM group versus the ICM group had higher all-cause ($101,560 vs $91,684) but lower EAD-related ($22,733 vs $26,412) and EGPA-related ($6,171 vs $16,786) costs. All-cause HCRU and costs increased with increasing overlap.</p><p><strong>Conclusions: </strong>EGPA was associated with substantial HCRU and costs, driven by outpatient and inpatient settings. More overlapping EADs were associated with higher HCRU and costs, highlighting the need for treatment to reduce healthcare expenditure in these patients. Infographic available for this article.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1611-1628"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142506886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-30DOI: 10.1007/s40744-024-00720-y
Francisco Castro-Dominguez, Carsten Tibesku, Timothy McAlindon, Rita Freitas, Stefan Ivanavicius, Prashanth Kandaswamy, Amy Sears, Augustin Latourte
{"title":"Literature Review to Understand the Burden and Current Non-surgical Management of Moderate-Severe Pain Associated with Knee Osteoarthritis.","authors":"Francisco Castro-Dominguez, Carsten Tibesku, Timothy McAlindon, Rita Freitas, Stefan Ivanavicius, Prashanth Kandaswamy, Amy Sears, Augustin Latourte","doi":"10.1007/s40744-024-00720-y","DOIUrl":"10.1007/s40744-024-00720-y","url":null,"abstract":"<p><strong>Introduction: </strong>To conduct a literature review exploring the humanistic burden, costs, and guideline recommendations for non-surgical management of moderate-severe pain in knee osteoarthritis (KOA).</p><p><strong>Methods: </strong>Published studies (2018-25 April 2023) assessing the burden of moderate-severe pain in KOA were identified by searching Medline, Embase, EconLit, and Cochrane database, supplemented with grey literature hand searches and reference list snowballing. Treatment guidelines were also identified for key countries.</p><p><strong>Results: </strong>This review included 106 publications and 37 treatment guidelines. Patients with moderate-severe pain were found to experience a low quality of life (QoL) and an impaired ability to perform daily tasks. The economic burden of KOA was substantial, including cost of medical visits, non-operative treatment (physical therapy and hyaluronic acid [HA] being key drivers) and productivity losses. Non-steroidal anti-inflammatory drugs (NSAIDs) were among the most frequently used pharmacological treatments, with intra-articular (IA) injections used to varying degrees. Opioid use was also frequently reported. Guidelines universally recommended NSAIDs, albeit with limited dose and duration for oral NSAIDs. IA-corticosteroids were conditionally/moderately recommended for short-term use by most guidelines, while IA-HA and opioids were rarely recommended. Guidelines are not specific to patients with moderate-severe pain and do not distinguish between different KOA phenotypes.</p><p><strong>Conclusions: </strong>KOA with moderate-severe pain is associated with substantial humanistic and economic burden. Real-world data suggest that some treatments are regularly used at high cost regardless of the lack of evidence-based recommendations. There remains a need for new treatment options that successfully relieve pain, improve QoL and delay the need for surgery. Graphical abstract available for this article.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1457-1499"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-09-25DOI: 10.1007/s40744-024-00711-z
Alexis Ogdie, Lars E Kristensen, Enrique R Soriano, Servet Akar, Yanhui Sun, David Gruben, Lara Fallon, Cassandra D Kinch, Dafna D Gladman
{"title":"Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status.","authors":"Alexis Ogdie, Lars E Kristensen, Enrique R Soriano, Servet Akar, Yanhui Sun, David Gruben, Lara Fallon, Cassandra D Kinch, Dafna D Gladman","doi":"10.1007/s40744-024-00711-z","DOIUrl":"10.1007/s40744-024-00711-z","url":null,"abstract":"<p><strong>Introduction: </strong>Routine care studies of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) demonstrated attenuated responses to tumor necrosis factor inhibitors in current/past versus never smokers. This post hoc analysis assessed tofacitinib efficacy and safety in patients with PsA or AS by cigarette smoking status at trial screening.</p><p><strong>Methods: </strong>Pooled data from phase 3 and long-term extension (safety only) PsA trials and phase 2 and 3 AS trials were assessed by current/past versus never smoker status. Analysis included efficacy and safety data for tofacitinib 5 (PsA/AS) and 10 (PsA only) mg twice daily (BID) or placebo, and safety data in AS for tofacitinib 2 and 10 mg BID. Efficacy outcomes included American College of Rheumatology ≥ 50% responses (ACR50) and minimal disease activity (MDA) responses to month (M)6/M3 (tofacitinib/placebo) in PsA; and ≥ 40% improvement in Assessment of SpondyloArthritis international Society responses (ASAS40) and AS Disease Activity Score (ASDAS) < 2.1 responses to week (W)16 in AS. Safety was assessed to M48/W48 (PsA/AS), adjusted for treatment/smoking status/median body mass index (BMI) status/sex/trial/treatment-smoking status interaction.</p><p><strong>Results: </strong>PsA/AS cohorts included 342/178 current/past and 572/194 never smokers. Tofacitinib efficacy was generally greater versus placebo to M3/W6 (PsA/AS), and comparable in current/past and never smokers to M6/W16 (PsA/AS). In patients receiving ≥ 1 tofacitinib dose, adjusted treatment-emergent adverse event (TEAE)/serious AE (SAE)/discontinuation due to AE incidence rates (IRs) to M48 in PsA were higher in current/past versus never smokers; adjusted IRs to W48 in AS were higher in current/past versus never smokers for TEAEs, but similar for SAEs/discontinuation due to AEs.</p><p><strong>Conclusions: </strong>In both patients with PsA and AS, tofacitinib efficacy was greater versus placebo, and comparable across smoking categories. Adjusted IRs were higher in current/past versus never smokers for TEAEs, SAEs, discontinuation due to AEs in PsA, and for TEAEs in AS, complementing reports of associations between smoking and comorbidities in spondyloarthritis. Findings support increased surveillance/caution for patients with PsA or AS with smoking history.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT01877668/NCT01882439/NCT03486457/NCT01976364/NCT01786668/NCT03502616.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1649-1664"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-14DOI: 10.1007/s40744-024-00721-x
Peter C Taylor, Alejandro Balsa, Anne-Barbara Mongey, Mária Filková, Myriam Chebbah, Solenn Le Clanche, Linda A W Verhagen, Torsten Witte, Daniela Opris-Belinski, Hubert Marotte, Jérôme Avouac
{"title":"Does Concomitant Use of Methotrexate with JAK Inhibition Confer Benefit for Cardiovascular Outcomes? A Commentary.","authors":"Peter C Taylor, Alejandro Balsa, Anne-Barbara Mongey, Mária Filková, Myriam Chebbah, Solenn Le Clanche, Linda A W Verhagen, Torsten Witte, Daniela Opris-Belinski, Hubert Marotte, Jérôme Avouac","doi":"10.1007/s40744-024-00721-x","DOIUrl":"10.1007/s40744-024-00721-x","url":null,"abstract":"<p><p>This commentary explores the potential cardiovascular (CV) benefits of combining methotrexate (MTX) and Janus kinase inhibitors (JAKis) in the treatment of rheumatoid arthritis (RA). While European guidelines recommend MTX as first-line treatment, concerns about the CV risks associated with JAKis have emerged. This article reviews the existing literature to assess the role of concomitant MTX in reducing CV risk when used with JAKis. Clinical trials confirm the efficacy of JAKis in combination with MTX in terms of treatment outcomes in RA. However, the number of major adverse cardiovascular events (MACEs) reported is too low to draw conclusions on adverse CV outcomes. Indirect evidence does, however, suggest potential protective effects of MTX on CV outcomes, as several mechanisms may contribute to MTX's cardioprotective effects, including reduced inflammation, adenosine monophosphate-activated protein kinase (AMPK) activation, increased cholesterol efflux, and adenosine accumulation. These mechanisms and the available data may support the case for CV benefits of concomitant MTX when JAKis are used in the treatment of patients with RA, although further research is needed. In particular, the lipid paradox associated with RA highlights the complex relationship between RA treatments (MTX, JAKis, tumor necrosis factor (TNF) inhibitors, and interleukin (IL)-6 receptor inhibitors), inflammation, different lipid profiles, and CV risk. In the absence of contraindications and when MTX is tolerated, this commentary suggests the concomitant use of MTX and JAKis as a preferred option for optimizing CV protection in patients with RA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1425-1435"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142473628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-09-25DOI: 10.1007/s40744-024-00713-x
Philip Mease, Tatiana Korotaeva, Pavel Shesternya, Muza Kokhan, Anton Rukavitsyn, Dmitry Vasilchenkov, Mohamed Sharaf, Frédéric Lavie, Atul Deodhar
{"title":"Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.","authors":"Philip Mease, Tatiana Korotaeva, Pavel Shesternya, Muza Kokhan, Anton Rukavitsyn, Dmitry Vasilchenkov, Mohamed Sharaf, Frédéric Lavie, Atul Deodhar","doi":"10.1007/s40744-024-00713-x","DOIUrl":"10.1007/s40744-024-00713-x","url":null,"abstract":"<p><strong>Introduction: </strong>There are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase 3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia.</p><p><strong>Methods: </strong>This post hoc analysis of DISCOVER-1 and -2 included 1002 biologic-naïve patients with active PsA from Russia (n = 317) and the rest of the world (RoW; n = 685). Patients received guselkumab 100 mg every 4 weeks (Q4W), or at week 0 and 4 then Q8W, or placebo then guselkumab Q4W at week 24 (Russian: n = 119, 88, and 110, respectively; RoW: n = 216, 246, and 223, respectively). Outcomes through week 52 were pooled (DISCOVER-1 and -2); outcomes from week 52 to 100 represent DISCOVER-2 only.</p><p><strong>Results: </strong>In patients from Russia, ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria response rates were higher with guselkumab vs. placebo at week 24, increased through week 52, and were consistent across all guselkumab-treated groups at week 100. Similar trends were generally observed for ACR50, ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90), achievement of Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity/remission and minimal disease activity, enthesitis and dactylitis resolution, ≥ 0.35 improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score, improvement in patient-reported pain, and measures in patients with axial PsA (including Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS], and patient-reported spinal pain). Efficacy responses were similar between patients from Russia and the RoW across all endpoints and timepoints. The safety profile of guselkumab in patients from Russia was consistent with previous findings.</p><p><strong>Conclusion: </strong>This analysis demonstrated that the safety and efficacy profiles of guselkumab across all PsA domains and patient-reported outcomes in patients from Russia were similar to those in patients from the RoW.</p><p><strong>Trial registration numbers: </strong>NCT03162796 and NCT03158285.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1551-1567"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-10DOI: 10.1007/s40744-024-00718-6
Jessica Marvel, Elizabeth Gargon, Chloe Howse, Aishwarya Chohan, Megan Mayhew, Gayle Kenney, Linda Stone, Benjamin A Fisher, Monia Steenackers, Nicola Williamson, Chiara Perella, Pushpendra Goswami
{"title":"The Development and Content Validation of the Sjögren's Related Quality of Life Instrument (SRQoL).","authors":"Jessica Marvel, Elizabeth Gargon, Chloe Howse, Aishwarya Chohan, Megan Mayhew, Gayle Kenney, Linda Stone, Benjamin A Fisher, Monia Steenackers, Nicola Williamson, Chiara Perella, Pushpendra Goswami","doi":"10.1007/s40744-024-00718-6","DOIUrl":"10.1007/s40744-024-00718-6","url":null,"abstract":"<p><strong>Introduction: </strong>Several clinical outcome assessment (COA) instruments assess Sjögren's disease (Sjögren's) symptoms, but do not provide comprehensive assessment of the health-related quality of life (HRQoL) impact of Sjögren's. This study aimed to develop a patient-reported outcome (PRO) instrument for the assessment of HRQoL, intended for use in clinical trials and clinical practice in the assessment of treatment benefit.</p><p><strong>Methods: </strong>Review of study sponsor proprietary data and qualitative interviews informed the development of a conceptual model, the Sjögren's Related Quality of Life (SRQoL) and patient global impression of severity (PGI-S) and change (PGI-C) items. Combined concept elicitation and cognitive debriefing interviews with patients with Sjögren's explored their HRQoL impact experience and content validity of the SRQoL and PGI items.</p><p><strong>Results: </strong>Twenty participants were interviewed about their Sjögren's experience. Following inductive analysis of interviews, concepts were categorized into eight domains: emotional well-being (e.g., worry and stress; n = 20/20; 100%), sleep (e.g., daytime sleepiness and waking up during the night; n = 20/20; 100%), activities of daily living (e.g., difficulty looking at screens and difficulty driving; n = 20/20; 100%), cognition (e.g., concentration difficulties and word finding difficulties; n = 19/20; 95.0%), physical functioning (e.g., difficulty walking and difficulty exercising; n = 19/20; 95.0%), social and family functioning (e.g., dependent on others and relationship difficulties; n = 17/20; 85.0%), work (n = 15/20; 75.0%), and sexual functioning (n = 12/20; 60.0%). SRQoL and PGI items, instructions, response options, and recall period were well understood and relevant to participants.</p><p><strong>Conclusions: </strong>The SRQoL is a new PRO instrument to assess Sjögren's impact on HRQoL, developed in accordance with regulatory guidance. This study provides considerable insight into the patient experience of Sjögren's and evidence to support the content validity of the SRQoL. Future research should evaluate the psychometric properties of the SRQoL to support its use in clinical trials and clinical practice and further validate its use as an assessment of treatment benefit.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1591-1609"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142401136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-11-01DOI: 10.1007/s40744-024-00719-5
Boulos Haraoui, Majed Khraishi, Denis Choquette, Isabelle Fortin, Cassandra D Kinch, Corina Galos, Patrice Roy, David Gruben, Julie Vaillancourt, John S Sampalis, Edward C Keystone
{"title":"Tofacitinib Safety and Effectiveness in Canadian Patients with Rheumatoid Arthritis by Cardiovascular Risk Enrichment: Subanalysis of the CANTORAL Study.","authors":"Boulos Haraoui, Majed Khraishi, Denis Choquette, Isabelle Fortin, Cassandra D Kinch, Corina Galos, Patrice Roy, David Gruben, Julie Vaillancourt, John S Sampalis, Edward C Keystone","doi":"10.1007/s40744-024-00719-5","DOIUrl":"10.1007/s40744-024-00719-5","url":null,"abstract":"<p><strong>Introduction: </strong>ORAL Surveillance, a post-authorisation safety study of patients with rheumatoid arthritis (RA) enriched for cardiovascular (CV) risk, demonstrated increased risk of major adverse CV events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) for tofacitinib versus tumour necrosis factor inhibitors (TNFi). This analysis of a real-world Canadian observational study evaluated tofacitinib safety/effectiveness in patients meeting or not meeting CV risk criteria.</p><p><strong>Methods: </strong>CANTORAL included patients with moderate-to-severe RA initiating tofacitinib (10/2017-07/2020; N = 504). Interim data (data-cut: 07/2021) were stratified as CV risk-enriched (CV+ ; patients ≥ 50 years with ≥ 1 additional CV risk factor) or not CV risk-enriched (CV-; ≥ 50 years without additional CV risk factors and 18-49 years with/without CV risk factors). Safety and persistence were evaluated to month (M) 36. Effectiveness outcomes to M18 included Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA)/remission (CANTORAL co-primary endpoints) and Disease Activity Score in 28 joints, C-reactive protein (DAS28-4[CRP]) < 3.2/ < 2.6.</p><p><strong>Results: </strong>Overall, 272/232 patients were included in CV+ /CV- cohorts (full analysis set) (435/356 patient-years [safety analysis set]). Incidence rates (events/100 patient-years) in CV+ /CV- cohorts were 138.5/112.5 for treatment-emergent adverse events (AEs); 17.0/5.6 for serious AEs; 1.2/0.3 for deaths; 5.5/1.7 for serious infections; 1.4/1.1 for herpes zoster; 1.6/0.0 for MACE; 2.1/0.3 for malignancies (excluding NMSC); 0.7/0.6 for NMSC; 0.5/0.0 for venous thromboembolic events. Persistence was generally comparable between cohorts. In CV+ /CV- cohorts, at M6, CDAI LDA and remission rates were 51.5%/54.6% and 12.0%/19.6%; DAS28-4(CRP) < 3.2/ < 2.6 rates were 44.0%/39.3% and 31.5%/28.8%, respectively; effectiveness was generally maintained to M18.</p><p><strong>Conclusions: </strong>In concordance with studies of background risk, AEs were more common in patients with CV risk enrichment, particularly those aged ≥ 65 years. Tofacitinib effectiveness/persistence were generally similar regardless of CV risk enrichment. These findings support individualised treatment benefit-risk assessment, including CV assessment/management, to optimise RA outcomes.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1629-1648"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2024-12-01Epub Date: 2024-10-18DOI: 10.1007/s40744-024-00722-w
Xabier Michelena, Clementina López-Medina, Eugenio De Miguel, Manuel José Moreno-Ramos, Rubén Queiro, Helena Marzo-Ortega, Xavier Juanola
{"title":"How Are We Addressing Axial Psoriatic Arthritis in Clinical Practice?","authors":"Xabier Michelena, Clementina López-Medina, Eugenio De Miguel, Manuel José Moreno-Ramos, Rubén Queiro, Helena Marzo-Ortega, Xavier Juanola","doi":"10.1007/s40744-024-00722-w","DOIUrl":"10.1007/s40744-024-00722-w","url":null,"abstract":"<p><p>Psoriatic arthritis (PsA) is a chronic inflammatory disease affecting the musculoskeletal system, skin and nails. In addition to peripheral joints, inflammation of the spine and sacroiliac joints may occur. Yet, research into this axial phenotype has lagged behind partly because of the challenge in its clinical identification with a lack of specific clinical, molecular or imaging biomarkers. In the absence of a validated definition of what constitutes axial PsA (axPsA), guidelines for the management of axial involvement in PsA in clinical practice are scarce. On the basis of a literature review and their clinical expertise, a group of rheumatology experts provide their opinion to aid the diagnosis and management of axial PsA in clinical practice.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1441-1456"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142473629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patient-Reported and Economic Racial and Ethnic Disparities in Patients with Psoriatic Arthritis: Results from the National Health and Wellness Survey.","authors":"Iris Lin, Kathryn Krupsky, Nate Way, Aarti A Patel, Arlene Tieng","doi":"10.1007/s40744-024-00717-7","DOIUrl":"10.1007/s40744-024-00717-7","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriatic arthritis (PsA) is a chronic, autoimmune form of arthritis that is associated with a substantial humanistic and economic burden. Potential differences in patient-reported outcomes (PROs) and economic outcomes among groups of varying PsA severity and different races/ethnicities have not been well studied.</p><p><strong>Methods: </strong>This cross-sectional study assessed sociodemographic data, PROs, and economic outcomes for participants with PsA from the National Health and Wellness Survey (2018-2020). Multivariable analyses were used to assess the association of self-reported PsA severity and race/ethnicity with health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HCRU), and medical costs.</p><p><strong>Results: </strong>This study included 1544 participants with PsA (1073 non-Hispanic white, 114 non-Hispanic Black, 223 Hispanic, and 134 Other). Self-reported moderate/severe PsA was associated with significantly worse HRQoL and WPAI, greater HCRU, and higher costs than self-reported mild PsA. Black participants reported more absenteeism (31.11% vs. 16.69%; P = 0.007) and activity impairment (54.27% vs. 47.96%; P = 0.047) than white participants, and fewer healthcare provider (5.93 vs. 7.42; P = 0.039) and rheumatologist visits (0.29 vs. 0.53; P = 0.028) over the past 6 months. No differences in outcomes were observed between Hispanic and white participants. Race/ethnicity moderated the association of perceived PsA severity and PROs and HCRU, such that white participants with self-reported moderate/severe PsA had a higher likelihood of depression (P < 0.001), lower HRQoL (P < 0.001), and more emergency room visits (P = 0.001) than those with self-reported mild PsA. Race/ethnicity did not moderate the relationship of PROs, HCRU, and economic outcomes among Black or Hispanic participants.</p><p><strong>Conclusion: </strong>Participants with self-reported moderate/severe PsA reported a greater burden than those with self-reported mild PsA. Black participants had a greater humanistic burden than white participants but reported lower HCRU. Moderation results were driven by white participants, suggesting important differences in PROs, HCRU, and perception of PsA severity across race/ethnicity groups. Small sample sizes in Hispanic and non-Hispanic racial/ethnic groups limited ability to discern differences related to disease severity in these groups. Further research is needed to better understand the differential burden of PsA among individuals with varying perceptions of PsA severity across different racial/ethnic groups.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1569-1590"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142352974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert J Morlock, Deepan Dalal, Victoria Divino, Mitchell DeKoven, Stephanie D Taylor, Atsuko Powers, Naina Barretto, Robert J Holt, Brian LaMoreaux
{"title":"Characteristics and Management of Uncontrolled Gout Prior to Pegloticase Therapy: A 2-year Claims Analysis.","authors":"Robert J Morlock, Deepan Dalal, Victoria Divino, Mitchell DeKoven, Stephanie D Taylor, Atsuko Powers, Naina Barretto, Robert J Holt, Brian LaMoreaux","doi":"10.1007/s40744-024-00723-9","DOIUrl":"https://doi.org/10.1007/s40744-024-00723-9","url":null,"abstract":"<p><strong>Objective: </strong>Gout is a progressive form of arthritis that causes significant pain and disability. Patients with treatment-refractory (or uncontrolled) gout experience a higher prevalence and severity of comorbidities than those whose gout is controlled. Pegloticase is a recombinant PEGylated uricase indicated for the treatment of gout in patients refractory to conventional therapy. We evaluated the treatment journey of patients with chronic uncontrolled gout before initiation of pegloticase therapy.</p><p><strong>Methods: </strong>Using IQVIA's PharMetrics<sup>®</sup> Plus database, we conducted a retrospective observational analysis of adults with ≥ 1 pegloticase claim between April 1, 2011, and August 31, 2020. Demographics were assessed at baseline. Clinical outcomes, health care resource utilization (HCRU), and associated costs were compared over two 12-month periods (months 13-24 and 1-12) prior to the first pegloticase claim (index date).</p><p><strong>Results: </strong>The study included 408 patients. Prevalence of all gout-associated conditions increased between months 1-12 and 13-24 (P < 0.05 for all). The percentage of patients with tophi increased from 15.4% to 61.5%, the percentage with ≥ 1 flare increased from 49% to 84%, and mean number of flares per patient increased from 1.0 to 2.1 (P < 0.0001 for all). The frequency of all categories of HCRU except emergency department visits also increased (P < 0.0001 for all), as did gout-related healthcare utilization (P£0.005).</p><p><strong>Conclusions: </strong>Patients with uncontrolled gout experienced an increase in the clinical burden of disease and HCRU in the 2 years before the initiation of pegloticase. Earlier patient identification and initiation of potentially effective therapy may help alleviate these burdens.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142626485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}