Christopher J Swearingen, Jeyanesh R S Tambiah, Ismail Simsek, Heli Ghandehari, Sarah Kennedy, Yusuf Yazici
{"title":"Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial.","authors":"Christopher J Swearingen, Jeyanesh R S Tambiah, Ismail Simsek, Heli Ghandehari, Sarah Kennedy, Yusuf Yazici","doi":"10.1007/s40744-024-00731-9","DOIUrl":"https://doi.org/10.1007/s40744-024-00731-9","url":null,"abstract":"<p><strong>Introduction: </strong>Lorecivivint (LOR), a CDC-like kinase/dual-specificity tyrosine kinase (CLK/DYRK) inhibitor thought to modulate inflammatory and Wnt pathways, is being developed as a potential intra-articular knee osteoarthritis (OA) treatment. The objective of this trial was to evaluate long-term safety of LOR within an observational extension of two phase 2 trials.</p><p><strong>Methods: </strong>This 60-month, observational extension study (NCT02951026) of a 12-month phase 2a trial (NCT02536833) and 6-month phase 2b trial (NCT03122860) was administratively closed after 36 months as data inferences became limited. Participants received a single intra-articular LOR or placebo (PBO) injection at their parent-trial baseline. The primary outcome was the comparative incidence of serious adverse events (SAEs), with AEs and similar safety measures comprising secondary outcomes. A post hoc baseline-adjusted analysis of covariance (ANCOVA) compared changes from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function subscores and medial joint space width (JSW) between LOR 0.07 mg and PBO groups in a subpopulation of participants with unilateral knee pain and widespread pain low enough to allow participants to differentiate their target knee pain.</p><p><strong>Results: </strong>The safety analysis set for the extension study included 495 LOR-treated and 208 control participants, with 409 (82.6%) and 175 (84.1%) remaining at study close, respectively. There were 68 SAEs reported in 38 (5.4%) patients; none were considered treatment-related by investigators. The incidence of AEs was similar between groups. In the post hoc subgroup efficacy analyses, LOR 0.07 mg demonstrated greater mean improvements from baseline compared with PBO in WOMAC pain and function scores out to 12 months post-injection. No between-group differences in medial JSW were observed out to 18 months.</p><p><strong>Conclusions: </strong>LOR appeared generally safe and well tolerated. Efficacy analyses on the subset of completer patients demonstrated durable symptom improvements in WOMAC pain and function for at least 12 months compared to PBO after a single injection of LOR.</p><p><strong>Clinical trial registration number: </strong>NCT02951026.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927975","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}
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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ennio Giulio Favalli, Francesco Grossi, Alberto Batticciotto, Matteo Filippini, Simone Parisi, Ombretta Viapiana, Paolo Gisondi, Paolo Dapavo, Lorenzo Dagna, Filippo De Braud
{"title":"Spondyloarthritis and Risk of Malignancy: A Narrative Review on a Still Controversial Issue.","authors":"Ennio Giulio Favalli, Francesco Grossi, Alberto Batticciotto, Matteo Filippini, Simone Parisi, Ombretta Viapiana, Paolo Gisondi, Paolo Dapavo, Lorenzo Dagna, Filippo De Braud","doi":"10.1007/s40744-024-00734-6","DOIUrl":"https://doi.org/10.1007/s40744-024-00734-6","url":null,"abstract":"<p><p>Current literature regarding cancer risk in rheumatic and musculoskeletal diseases (RMDs) is particularly poor and controversial, even though the incidence of malignancy in some patients with RMDs is considered to be increased compared with the general population. Malignancy may be a major comorbidity in subjects with spondyloarthritis (SpA) as the result of multifactorial mechanisms, from disease pathogenesis to the iatrogenic effect of immunomodulating drugs. Several recommendations for screening and management of cancer risk have been developed in recent years with the aim of improving the different outcomes in these patients. The goal of this narrative review is to provide an overview of the currently available evidence on the risk of malignancy connected with RMDs and examine the association of SpA with cancer and the potential impact of its treatment with biologic and targeted synthetic disease-modifying anti-rheumatic drugs on development of malignancy.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882858","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}
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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Peter C Taylor, Walid Fakhouri, Samuel Ogwu, Ewa Haladyj, Inmaculada de la Torre, Bruno Fautrel, Rieke Alten, Peter Nash, Eugen Feist
{"title":"Association Between Patient-Reported Pain and Remission or Low Disease Activity in Patients with Rheumatoid Arthritis: Data from RA-BE-REAL Prospective Observational Study.","authors":"Peter C Taylor, Walid Fakhouri, Samuel Ogwu, Ewa Haladyj, Inmaculada de la Torre, Bruno Fautrel, Rieke Alten, Peter Nash, Eugen Feist","doi":"10.1007/s40744-024-00732-8","DOIUrl":"https://doi.org/10.1007/s40744-024-00732-8","url":null,"abstract":"<p><strong>Introduction: </strong>We aim to assess the association of patient-reported pain and remission or low disease activity (LDA) at 3 months (M) in patients receiving baricitinib or other treatments in RA-BE-REAL.</p><p><strong>Methods: </strong>RA-BE-REAL reports on patients with rheumatoid arthritis (RA) who were prescribed, for the first time, baricitinib (cohort A) or a tumour necrosis factor inhibitor (TNFi) (cohort B-TNFi) or any other mode of action (OMA) (cohort B-OMA). Pain was measured using the visual analogue scale (VAS) (0-100 mm) and clinically meaningful pain improvement thresholds of ≥ 30%, ≥ 50% and ≥ 70% from baseline to 3, 6, 12 and 24 M.</p><p><strong>Results: </strong>At 3 M, the mean change from baseline (CFB) pain VAS of patients in remission/LDA was - 32.6 mm (cohort A), - 27.3 mm (cohort B-TNFi) and - 28.0 mm (cohort B-OMA). Almost half the patients who were in remission/LDA receiving baricitinib achieved ≥ 70% pain relief. At 3 M, the proportion of patients in remission/LDA with pain VAS ≤ 20 mm was 62.1% (cohort A), 55.0% (cohort B-TNFi) and 55.6% (cohort B-OMA), while for those not in remission/LDA, it was 8.5% and 8.7% (cohort A and B-TNFi, respectively) and 5.3% (B-OMA). More patients on baricitinib achieved pain improvement in all analyzed thresholds than patients in cohort B-TNFi and B-OMA at 3 M. At 24 M, - 26.2 mm (cohort A), - 20.8 mm (cohort B-TNFi) and - 16.0 mm (cohort B-OMA) mean CFBs in pain measurement were observed. For baricitinib and the other treatments, residual pain decreased with achievement of remission/LDA and was sustained up to 24 M.</p><p><strong>Conclusions: </strong>Patients in remission/LDA receiving baricitinib are more likely to achieve pain control than patients receiving TNFi/OMA.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839369","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}
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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/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":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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}