{"title":"Secukinumab Persistence in Patients with Psoriatic Arthritis: An Adalimumab-Matched Retrospective Cohort Database Study (FLYWAY).","authors":"Hideto Kameda, Kentaro Ishii, Junna Kiriyama, Toshiaki Mikami, Hideya Uratsuji, Akimichi Morita","doi":"10.1007/s40744-025-00749-7","DOIUrl":"https://doi.org/10.1007/s40744-025-00749-7","url":null,"abstract":"<p><strong>Introduction: </strong>Long-term treatment of psoriatic arthritis (PsA) is required to prevent progression. However, persistence with current treatments is challenging due to tolerability and acceptability issues. The objective of this study was to estimate 1-year persistence with secukinumab in patients with PsA treated with secukinumab, to compare persistence rates between secukinumab and adalimumab, to estimate usefulness rates, and to document adverse events.</p><p><strong>Methods: </strong>This retrospective study used data from the Japanese Medical Data Vision database. A total of 182 patients with PsA initiating secukinumab were identified between February 1, 2015 and September 30, 2020. Of these, 171 could be matched to 171 patients initiating adalimumab over the same period using a propensity score. Patients were followed until death, treatment discontinuation, or until the end of the study period. Persistence rates were analyzed using Kaplan-Meier survival analysis. Usefulness was evaluated using a published algorithm. Selected adverse events were documented.</p><p><strong>Results: </strong>Twelve-month persistence with secukinumab was 68.3%. The median persistence duration was significantly higher (p = 0.002) for secukinumab (27.8 months) than for adalimumab (12.5 months). After 12 months, the treatment was found to be useful in 47.0% of the secukinumab cohort and 22.2% of the adalimumab cohort (p < 0.001). Fourteen patients (7.7%) in the unmatched secukinumab cohort and 32 (9.1%) in the unmatched adalimumab cohort presented an adverse event of interest.</p><p><strong>Conclusions: </strong>Patients with PsA showed higher persistence with secukinumab than with adalimumab. Since PsA is a chronic disease that requires long-term treatment, long-term persistence and usefulness should be considered for the treatment choice. Infographic available for this article. INFOGRAPHIC.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617083","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}
Ran Jin, James M Haughton, Emily J Goddard, Delphine Courmier, Waldemar Radziszewski, Rachael H Meadows, James Piercy, Stanley Cohen
{"title":"Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme.","authors":"Ran Jin, James M Haughton, Emily J Goddard, Delphine Courmier, Waldemar Radziszewski, Rachael H Meadows, James Piercy, Stanley Cohen","doi":"10.1007/s40744-025-00755-9","DOIUrl":"https://doi.org/10.1007/s40744-025-00755-9","url":null,"abstract":"<p><strong>Introduction: </strong>Biosimilars have provided additional treatment options for patients with immune-mediated inflammatory diseases. This study evaluated the real-world use of adalimumab biosimilar ABP 501 in European patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or psoriasis (PsO).</p><p><strong>Methods: </strong>Data were drawn from the RA, spondyloarthritis, and PsO Adelphi Disease Specific Programmes (DSP)™, cross-sectional surveys conducted in France, Germany, Italy, Spain, and the UK between January 2020 and February 2022. Physicians completed patient record forms which collected data on demographics, treatment history, and clinical outcomes. Patients voluntarily completed questionnaires self-reporting health-related quality of life. Outcome measures were assessed for patients who initiated ABP 501 as the first advanced therapy (AT, \"ABP 501 initiators\") and patients who switched to ABP 501 from the first-line AT with reference product (RP) (\"RP-ABP 501 switchers\") in each indication.</p><p><strong>Results: </strong>Across disease cohorts, 868 initiators and 428 switchers were analyzed. At time of consultation, physicians reported that 77.1%, 63.2%, 67.8%, and 83.0% of initiators with RA, AS, PsA, and PsO, respectively, presented with mild disease after receiving ABP 501 for a median of 10.4-12.3 months. Among switchers, the most common reasons for switching were related to formulary or financial reasons and insurance restrictions. Most switching patients were assessed by physicians to have mild disease (75.0-87.5% across indications) at time of consultation having received ABP 501 for a median of 11.2-15.3 months. Patients' self-assessment, including EQ-5D and work productivity scores, indicated an overall good state of health while using ABP 501, regardless of indication and prior RP exposure. Overall, more than 89% of physicians and more than 86% patients reported being satisfied with the disease control provided by ABP 501.</p><p><strong>Conclusion: </strong>Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143597515","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}
Rheumatology and TherapyPub Date : 2025-02-01Epub Date: 2024-12-13DOI: 10.1007/s40744-024-00727-5
Laure Gossec, Jessica A Walsh, Raj Sengupta, Andrew G Bushmakin, Joseph C Cappelleri, Arne Yndestad, Oluwaseyi Dina, David Cella
{"title":"Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial.","authors":"Laure Gossec, Jessica A Walsh, Raj Sengupta, Andrew G Bushmakin, Joseph C Cappelleri, Arne Yndestad, Oluwaseyi Dina, David Cella","doi":"10.1007/s40744-024-00727-5","DOIUrl":"10.1007/s40744-024-00727-5","url":null,"abstract":"<p><strong>Introduction: </strong>Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib.</p><p><strong>Methods: </strong>This post hoc analysis used data from a phase 3 trial (NCT03502616) in patients with active AS receiving tofacitinib 5 mg twice daily or placebo. Time to improvement in fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score, experience domain score, and impact domain score. The rapidity of improvement was assessed by time-to-event analyses (nonparametric Kaplan-Meier models); initial improvement events (i.e., time to first week of FACIT-F improvement) and stable improvement events (i.e., time to first week of FACIT-F improvement, sustained to 16 weeks) were examined.</p><p><strong>Results: </strong>Overall, 269 patients were assessed (mean disease duration: 14.2 [standard deviation (SD): 9.8] years; mean baseline FACIT-F total score: 27.2 [SD: 9.3]). Median times to initial and stable improvement events in FACIT-F total and domain scores were significantly shorter and occurred in more patients receiving tofacitinib than placebo. Median time to initial and stable improvement events of 6 points in FACIT-F total score were 8 and 12 weeks with tofacitinib, respectively (placebo: not reached); 70.0% versus 48.5% of patients receiving tofacitinib versus placebo, respectively, experienced initial improvements of 6 points in FACIT-F total score within 16 weeks.</p><p><strong>Conclusions: </strong>Improvements in fatigue occurred more rapidly with tofacitinib than with placebo. These results may be useful for healthcare providers when discussing tofacitinib treatment expectations with patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT03502616 (June 7, 2018).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"85-98"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142819030","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":"Evaluation of the \"Multivariable Psoriatic Arthritis Risk Estimation Tool\" in a Cohort of Patients with Psoriasis: Preliminary Results of a Prospective Observational Study.","authors":"Ennio Lubrano, Filomena Mandato, Marcella Antenucci, Fabio Massimo Perrotta","doi":"10.1007/s40744-024-00729-3","DOIUrl":"10.1007/s40744-024-00729-3","url":null,"abstract":"<p><strong>Introduction: </strong>An intriguing aspect that emerged in recent years is the transition phase from psoriasis (PsO) to psoriatic arthritis (PsA). The PRESTO instrument allows estimating a patient's risk of developing PsA based on a few clinical items. The aim of this study was to apply and evaluate the performance of the PRESTO tool in a cohort of patients with PsO.</p><p><strong>Methods: </strong>Consecutive patients with PsO were enrolled. Dermatological and rheumatological assessment was carried out in order to evaluate clinical features of PsO, to exclude the diagnosis of PsA, and to administer the PRESTO tool.</p><p><strong>Results: </strong>Between January 1, 2024 and April 1, 2024, 100 patients were assessed. Eight-four patients found the questionnaire to be very useful and easy. The estimated risk (median/IQR) of 1-year progression to PsA found in our group was 2.45% at 1 year (1.1-4).</p><p><strong>Conclusions: </strong>The PRESTO instrument was feasible and well accepted by patients. The 1-year risk assessed by PRESTO tools is consistent with other reports in the literature.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"203-209"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785732","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 : 2025-02-01Epub Date: 2024-12-05DOI: 10.1007/s40744-024-00726-6
Hillary Norton, Paula Sliwinska-Stanczyk, Tomas Hala, Bassel El-Zorkany, Lori Stockert, Rajiv Mundayat, Lisy Wang, Christopher T Ritchlin
{"title":"Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials.","authors":"Hillary Norton, Paula Sliwinska-Stanczyk, Tomas Hala, Bassel El-Zorkany, Lori Stockert, Rajiv Mundayat, Lisy Wang, Christopher T Ritchlin","doi":"10.1007/s40744-024-00726-6","DOIUrl":"10.1007/s40744-024-00726-6","url":null,"abstract":"<p><strong>Introduction: </strong>We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category.</p><p><strong>Methods: </strong>Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratified by baseline BMI into < 25, ≥ 25 to < 30, and ≥ 30 kg/m<sup>2</sup> categories. Efficacy was assessed at week 12 and safety to week 16.</p><p><strong>Results: </strong>Of 370 patients, 153, 131, and 86 had a baseline BMI of < 25, ≥ 25 to < 30, and ≥ 30 kg/m<sup>2</sup>, respectively. At baseline, patients with BMI < 25 kg/m<sup>2</sup> were younger and more likely to be current smokers/Asian, and patients with BMI ≥ 30 kg/m<sup>2</sup> had higher mean waist circumference/swollen joint count (SJC) and were more likely to have enthesitis, high-sensitivity C-reactive protein (hsCRP) > 5 mg/L, an inadequate response to tumor necrosis factor inhibitors (TNFi), and prior biologic disease-modifying anti-rheumatic drug (bDMARD) use versus other categories. Across categories, tofacitinib responses/improvements were greater than with placebo, except for ≥ 40% Assessment of SpondyloArthritis international Society improvement (ASAS40), ASAS partial remission, 50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI50), and Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) inactive disease rates, which were similar for tofacitinib and placebo in the BMI ≥ 30 kg/m<sup>2</sup> category. Treatment effects were similar across categories, except for BASDAI50, which was smaller in the BMI ≥ 30 category versus the < 25 kg/m<sup>2</sup> category. More adverse events (AEs) and serious adverse events (SAEs) with tofacitinib were reported in the BMI < 25 kg/m<sup>2</sup> category, which had a higher proportion of current smokers versus other categories.</p><p><strong>Conclusions: </strong>Regardless of baseline BMI category, efficacy was greater with tofacitinib versus placebo in patients with AS, and no treatment effect differences between categories were observed, with exceptions for BMI ≥ 30 kg/m<sup>2</sup> (more active/treatment-refractory disease and a smaller sample size). Overall, tofacitinib safety was generally comparable across categories; however, AE/SAE rates with tofacitinib were higher in the BMI < 25 kg/m<sup>2</sup> category (which had more current smokers). This post hoc analysis demonstrates that tofacitinib can be considered as a treatment option for AS, regardless of baseline BMI category; however, interpretation was limited by small sample sizes and differences in sample sizes and baseline characteristics across categories.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifiers, NCT01786668 and NCT03502616.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"67-84"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786119","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 : 2025-02-01Epub Date: 2024-12-19DOI: 10.1007/s40744-024-00730-w
Victor Davi R S Oliveira, Ana Paula M G Reis, Claiton V Brenol, Ivânio A Pereira, Karina R Bonfiglioli, Letícia R Pereira, Manoel B Bértolo, Maria de Fátima L C Sauma, Maria Fernanda B R Guimarães, Paulo Louzada-Júnior, Rina D N Giorgi, Sebastião C Radominski, Licia Maria H Mota, Cleandro P Albuquerque, Geraldo R Castelar-Pinheiro
{"title":"High-Titer Rheumatoid Factor is Associated with Worse Clinical Outcomes and Higher Needs for Advanced Therapies in Rheumatoid Arthritis Under Real-Life Conditions.","authors":"Victor Davi R S Oliveira, Ana Paula M G Reis, Claiton V Brenol, Ivânio A Pereira, Karina R Bonfiglioli, Letícia R Pereira, Manoel B Bértolo, Maria de Fátima L C Sauma, Maria Fernanda B R Guimarães, Paulo Louzada-Júnior, Rina D N Giorgi, Sebastião C Radominski, Licia Maria H Mota, Cleandro P Albuquerque, Geraldo R Castelar-Pinheiro","doi":"10.1007/s40744-024-00730-w","DOIUrl":"10.1007/s40744-024-00730-w","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid factor (RF) plays an important role in rheumatoid arthritis (RA) pathophysiology, yet the differential effects of varying RF titers remain understudied. We evaluated associations between different RF titers and clinical outcomes in long-standing RA.</p><p><strong>Methods: </strong>This multicenter, cross-sectional study included adults meeting ACR/EULAR (2010) criteria for RA. Circulating RF titers and clinical-epidemiological characteristics were evaluated. Bivariate (Student's t and chi-squared tests) tests and multiple logistic and linear regression analyses were conducted.</p><p><strong>Results: </strong>We included 1097 participants; 78.7% had positive RF, with high titers (≥ 3 × the upper limit of normality) in 56.2%. Negative vs. low-positive RF groups performed similarly concerning all clinical outcomes, being subsequently aggregated as \"non-high\" RF group. High RF titers (compared to \"non-high\") were associated with tobacco use (odds ratio, OR [95% confidence interval, CI]: 2.04 [1.35, 3.08]; p < 0.001), multiraciality (OR [95% CI] 1.31 [1.03, 1.67]; p = 0.028, compared to White race), and higher body mass index (mean difference [95% CI] 0.69 [0.05, 1.33] kg/m<sup>2</sup>; p = 0.033). In multivariate analyses, high-titer RF was independently associated with higher disease activity (Clinical Disease Activity Index, CDAI: β = 2.44 [0.89, 3.99], p = 0.002), worse functional capacity (Health Assessment Questionnaire Disability Index, HAQ-DI: β = 0.112 [0.018, 0.205], p = 0.020); extra-articular manifestations (OR 1.48 [1.09, 2.00], p = 0.011); increased corticosteroid (OR 1.53 [1.19, 1.96], p = 0.001) and biological disease-modifying antirheumatic drugs (bDMARD) use (OR 1.41 [1.08, 1.84], p = 0.011).</p><p><strong>Conclusions: </strong>High RF titers in long-standing RA were associated with worse disease activity, lower physical functionality, increased extra-articular manifestations, and higher usage of corticosteroids and bDMARDs. Comparing high vs. non-high RF titers (rather than positive vs. negative RF) seems more useful for evaluating the clinical effects of RF in RA. This approach should be considered in future studies of RF.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"123-136"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855515","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 : 2025-02-01Epub Date: 2024-12-26DOI: 10.1007/s40744-024-00733-7
Prasad T Oommen, Tilmann Kallinich, Juergen Rech, Norbert Blank, Julia Weber-Arden, Jasmin B Kuemmerle-Deschner
{"title":"Long-Term Safety and Effectiveness of Canakinumab in Patients with MKD/HIDS: Interim Analysis of the RELIANCE Registry.","authors":"Prasad T Oommen, Tilmann Kallinich, Juergen Rech, Norbert Blank, Julia Weber-Arden, Jasmin B Kuemmerle-Deschner","doi":"10.1007/s40744-024-00733-7","DOIUrl":"10.1007/s40744-024-00733-7","url":null,"abstract":"<p><strong>Introduction: </strong>Interim analysis of the long-term safety and effectiveness of canakinumab, at a patient level, in the mevalonate kinase deficiency/hyperimmunoglobulin-D syndrome (MKD/HIDS) cohort of the RELIANCE registry.</p><p><strong>Methods: </strong>From June 2018, the RELIANCE registry enrolled paediatric (aged ≥ 2 years) and adult patients (aged ≥ 18 years) with MKD/HIDS who were receiving canakinumab as part of their routine medical care. Safety, physician- and patient-reported measures of disease activity and dosing patterns were evaluated at baseline and every 6 months until end-of-study visit.</p><p><strong>Results: </strong>At the analysis cut-off date of December 2022, eight patients with MKD/HIDS were enrolled. Five (62.5%) were children (< 18 years) and five (62.5%) were female. The median patient age was 8.0 (range 2.0-39.0) years, and all patients were pre-treated with canakinumab prior to enrolment (median duration of canakinumab treatment: 3.8 years). Canakinumab was well tolerated, with seven (87.5%) patients reporting 48 adverse events (incidence rate/100 patient years: 218.1). No serious adverse drug reactions were reported. Patients continued to receive vaccinations during long-term treatment with canakinumab. Disease activity, evaluated by physician-reported (physician's global assessment, disease remission, C-reactive protein, serum amyloid A, erythrocyte sedimentation rate) and patient-reported (autoinflammatory disease activity index diary, disease activity, fatigue, impact on social life) measures, was generally well controlled throughout the study. Over 50.0% of patients maintained disease remission from baseline to month 24, and medians of all inflammatory markers remained within normal limits throughout the study. Most patients received higher than the recommended starting dose of canakinumab throughout the study.</p><p><strong>Conclusion: </strong>Data from this interim analysis of a unique registry of patients with a rare disease support the long-term safety and effectiveness of the IL-1-blocking agent canakinumab for the treatment of MKD/HIDS.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"137-155"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142897058","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":"Real-World Persistence and Effectiveness of Upadacitinib versus Other Janus Kinase Inhibitors and Tumor Necrosis Factor Inhibitors in Australian Patients with Rheumatoid Arthritis.","authors":"Peter Youssef, Sabina Ciciriello, Talib Tahir, Joanna Leadbetter, Belinda Butcher, Miriam Calao, Nicole Walsh, Catherine O'Sullivan, Tegan Smith, Geoffrey Littlejohn","doi":"10.1007/s40744-024-00736-4","DOIUrl":"10.1007/s40744-024-00736-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study sought to describe treatment patterns, persistence, and effectiveness of upadacitinib (UPA) alone and compared to other Janus kinase inhibitors (JAKis) or tumor necrosis factor inhibitors (TNFis) in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>This retrospective, non-interventional study used the OPAL dataset, derived from electronic medical records. Patients initiated UPA (N = 2624), other JAKis (baricitinib and tofacitinib [N = 925]), or TNFis (adalimumab, etanercept, certolizumab, golimumab, infliximab [N = 3540]) between May 2020 and March 2023. Median persistence (Kaplan-Meier) and effectiveness (Disease Activity Score 28-joint C-reactive protein, three variables [DAS28CRP{3}]) were evaluated for UPA-treated patients and in three propensity score-matched cohorts: UPA monotherapy versus combination therapy, UPA versus other JAKis, and UPA versus TNFis.</p><p><strong>Results: </strong>In patients prescribed UPA, 41.3% were ≥ 65 years old, 33.8% were prescribed as first-line advanced therapy, and 27.2% were prescribed monotherapy. Persistence on UPA was 26.6 months (95% confidence intervals: 24.4, 29.9) and longest in earlier lines of therapy. The DAS28CRP(3) remission rate was 73% at 3 months, with improvements observed across lines of therapy. UPA monotherapy and combination therapy had similar persistence (27.8 [23.5, 33.4] versus 30.4 months [22.1, 35.3], p = 0.84) and effectiveness. UPA showed longer persistence than other JAKis (28.8 [25.6, 32.4] versus 17.2 months [14.9, 19.8], p < 0.001) and TNFis (26.6 [24.9, 30.8] versus 13.3 months [11.5, 14.5], p < 0.001). DAS28CRP(3) remission rates were greater at 3 months for UPA than other JAKis (75.0% versus 61.5%) and TNFis (72.7% versus 59.5%). In unmatched subgroups, compared to cycling between TNFis, switching to UPA from other JAKis or TNFis resulted in longer persistence (JAKi-to-UPA: 25.3 [16.1, not reached]; TNFi-to-UPA: 27.8 [23.2, 35.4]; TNFi-to-TNFi: 9.6 [8.4, 10.7]) and greater DAS28CRP(3) remission rates over 9 months.</p><p><strong>Conclusions: </strong>Overall, the breadth and depth of data from this large real-world dataset continue to support a favorable clinical profile of UPA for the treatment of RA and may inform treatment choices in everyday clinical practice.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"173-202"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932618","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 : 2025-02-01Epub Date: 2024-11-14DOI: 10.1007/s40744-024-00723-9
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":"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":"37-51"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751263/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatology and TherapyPub Date : 2025-02-01Epub Date: 2024-12-14DOI: 10.1007/s40744-024-00728-4
Ivan Giovannini, Nicola Cabas, Marco Marino, Annarita Tullio, Ilaria Tinazzi, Angela Variola, Carmelo Cicciò, Fabro Cinzia, Berretti Debora, Chiara Zuiani, Rossano Girometti, Luca Quartuccio, Alen Zabotti, Lorenzo Cereser
{"title":"Arthralgia and Extraintestinal Manifestations in Crohn's Disease Elevate the Risk of IBD-Related Arthritis over Sacroiliitis.","authors":"Ivan Giovannini, Nicola Cabas, Marco Marino, Annarita Tullio, Ilaria Tinazzi, Angela Variola, Carmelo Cicciò, Fabro Cinzia, Berretti Debora, Chiara Zuiani, Rossano Girometti, Luca Quartuccio, Alen Zabotti, Lorenzo Cereser","doi":"10.1007/s40744-024-00728-4","DOIUrl":"10.1007/s40744-024-00728-4","url":null,"abstract":"<p><strong>Introduction: </strong>Inflammatory bowel disease (IBD) related arthritis is the most prevalent extraintestinal manifestation (EIM) of IBD, ranging between 10 and 39%. Magnetic resonance enterography (MRE) is used to assess small bowel disease involvement in Crohn's disease (CD) and can detect signs of sacroiliitis in up to 23.5% of patients. The predicting role of sacroiliitis detected on MRE is still unknown. The aim of this study is to evaluate the predictive role of sacroiliitis at MRE and other clinical features for IBD-related arthritis development in a cohort of adult patients with CD.</p><p><strong>Methods: </strong>Between December 2012 and May 2020, consecutive patients with CD who performed MRE were enrolled in the study. Patients with a previous diagnosis of IBD-related arthritis were excluded. A baseline demographics and clinical characteristics of the patients were retrospectively collected. The identification of new-onset IBD-related arthritis events during the follow-up was based on rheumatological clinical diagnosis and fulfillment of the ASAS classification criteria.</p><p><strong>Results: </strong>Ninety-five patients, mean age 43.9 years (standard deviation [SD] ± 16.6), 52.6% female were enrolled in the study with a median follow-up of 83 months (Q25:75 25:143). Six out 95 (6.3%) developed IBD-related arthritis with a mean time of 11 months (SD ± 16.8). Sacroiliitis detected on MRE was not associated with an increased risk of IBD-related arthritis (odds ratio [OR] = 2.12 [95% confidence interval (CI) 0.36, 12.53, p = 0.408]). In contrast, the presence of arthralgia and EIMs were found to be a predictor for IBD-related arthritis development (OR = 84.0 [95% CI 8.18, 862.39, p < 0.0001] and OR = 7.37 [95% CI 1.25, 43.32, p = 0.027], respectively).</p><p><strong>Conclusions: </strong>This study highlights that sacroiliitis, as assessed by MRE, was not associated with the development of IBD-related arthritis, whereas extraintestinal manifestations and arthralgia were significantly associated with later IBD-related arthritis development in patients with CD.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"99-108"},"PeriodicalIF":2.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824477","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}