Rheumatology and Therapy最新文献

{"title":"Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance.","authors":"Bogdan Batko, Slawomir Jeka, Piotr Wiland, Agnieszka Zielińska, Maria Stopińska-Polaszewska, Marcin Stajszczyk, Magdalena Kosydar-Piechna, Mary Jane Cadatal, Jose L Rivas","doi":"10.1007/s40744-024-00693-y","DOIUrl":"10.1007/s40744-024-00693-y","url":null,"abstract":"<p><strong>Introduction: </strong>In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions.</p><p><strong>Methods: </strong>Patients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50 years with ≥ 1 additional CV risk factor, received tofacitinib 5 or 10 mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported.</p><p><strong>Results: </strong>Of 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30 kg/m² and history of diabetes/hypertension; however, more patients from Poland versus other regions were ever smokers and more patients from Poland/North America versus Other countries had history of coronary artery disease. MACE IRs were similar in North America and Poland, and numerically higher versus Other countries. IRs for malignancies (excluding NMSC) were numerically higher in North America versus Poland/Other countries with tofacitinib. Serious infections IRs were numerically higher in North America versus Poland across treatments. Venous thromboembolism/all-cause mortality IRs were generally comparable across regions. DAS28-4(CRP)/HAQ-DI improvements were generally lowest in North America.</p><p><strong>Conclusions: </strong>Differences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries.</p><p><strong>Trial registration: </strong>NCT02092467 (ClinicalTrials.gov).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1217-1235"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11422304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141767212","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":"A Canadian Retrospective Chart Review Evaluating Concomitant Methotrexate De-escalation Patterns in Patients with Rheumatoid Arthritis Treated with Biologic or Targeted Synthetic DMARDs.","authors":"Louis Bessette, Brandusa Florica, Latha Naik, Dalton Sholter, Pierre-André Fournier, Tanya Girard, Dalinda Liazoghli, Philip A Baer","doi":"10.1007/s40744-024-00696-9","DOIUrl":"10.1007/s40744-024-00696-9","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) guidelines recommend methotrexate (MTX)-anchored therapy with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs); however, tolerability issues often lead to non-adherence. Canadian data on MTX tapering and/or withdrawal following b/tsDMARD initiation are minimal. This chart review assessed frequency of MTX tapering or withdrawal following b/tsDMARD initiation and the impact on disease status in Canadian adults with RA.</p><p><strong>Methods: </strong>Eligible patients had received MTX for ≥ 3 months before b/tsDMARD initiation. The b/tsDMARD was prescribed continuously for ≥ 18 months. Patients taking > 10 mg/day oral prednisone or equivalent were excluded.</p><p><strong>Results: </strong>Eight hundred eighty-nine patients (mean baseline MTX dose 19.0 mg/week) prescribed b/tsDMARDs (tumor necrosis factor inhibitor 52.1%, Janus kinase inhibitor 18.3%, interleukin-6 inhibitor [IL-6i] 11.9%, other 17.7%) were evaluated at 22 Canadian centers. Within 2 years of b/tsDMARD initiation, MTX was tapered in 123 (13.8%) patients and discontinued in 147 (16.5%), most commonly due to planned tapering (36.6%) and patient decision (27.2%), respectively, and most commonly with IL-6i use (34.9%). The MTX dose was unchanged for 582 (65.5%) patients and increased for 37 (4.2%). Missing data limit interpretations of MTX dose effects on some secondary endpoints and challenge the assertion that a disease activity measure-based treat-to-target approach is routinely used in Canadian rheumatology practice.</p><p><strong>Conclusions: </strong>Methotrexate tapering or withdrawal occurred in 30.4% of Canadians with RA within 2 years following b/tsDMARD initiation. Baseline disease activity measures were missing from many medical records. However, for patients with baseline assessments, MTX tapering or discontinuation did not worsen disease activity.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1165-1180"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11422300/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555402","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":"Treatment with Targeted Therapy in Patients with Psoriatic Arthritis and Inadequate Response to Methotrexate: Proposal for a Rational Strategy.","authors":"Philippe Goupille, Guillermo Carvajal Alegria, Frank Verhoeven, Daniel Wendling","doi":"10.1007/s40744-024-00704-y","DOIUrl":"10.1007/s40744-024-00704-y","url":null,"abstract":"<p><strong>Introduction: </strong>The therapeutic arsenal for psoriatic arthritis (PsA) is gradually being expanded, but the use of these targeted treatments must be optimal. Our objective was to guide the choice of targeted therapy to use as first-line treatment in a patient with PsA in whom methotrexate (MTX) has failed.</p><p><strong>Methods: </strong>We searched for literature data in PubMed with the appropriate keywords for the six points of our argument: (1) the tolerance of MTX; (2) the efficacy of targeted therapies combined with MTX vs monotherapy; (3) immunogenicity of anti-tumor necrosis alpha (TNFα) monoclonal antibodies (mAbs); (4) immunogenicity of anti-interleukin (IL)-17, anti-IL-12/23, and anti-IL-23 mAbs; (5) the therapeutic maintenance of anti-TNFα mAbs when combined or not with MTX; (6) the therapeutic maintenance of anti-IL-17 vs anti-TNFα mAbs as first-line targeted therapy.</p><p><strong>Results: </strong>The proposed rational strategy is as follows: in case of initiation of an anti-TNFα agent, maintaining treatment with MTX seems preferable, even in the absence of evidence of the superior efficacy of the combination, to avoid immunization and reduced therapeutic maintenance; in case of initiation of anti-IL-17, anti-IL-12/23, anti-IL-23 agents, or Janus kinase (JAK) inhibitors, again in the absence of evidence of the superior efficacy of the combination, discontinuing MTX therapy may be possible, at least in two steps, after verifying the efficacy of the targeted therapy initiated on the joints and skin.</p><p><strong>Conclusion: </strong>We have data from the literature to guide the choice of targeted therapy to use as first-line treatment in a patient with PsA in whom MTX has failed.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1065-1079"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11422401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141971752","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 Effectiveness of Sarilumab in RA: Results from the Open-label, Prospective, Single-arm Observational PROFILE Study","authors":"Alan Kivitz, Jacques Eric Gottenberg, Martin Bergman, Chunfu Qiu, Hubert van Hoogstraten, Ron de Nijs, Louis Bessette","doi":"10.1007/s40744-024-00715-9","DOIUrl":"https://doi.org/10.1007/s40744-024-00715-9","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>The 1-year PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational (PROFILE) study evaluated the real-world effectiveness and safety of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Safety endpoints included adverse events (AEs) and lab abnormalities. Effectiveness endpoints included the ACR core set. The primary endpoint was the change from baseline in Clinical Disease Activity Index (CDAI). All statistics are descriptive and <i>p</i> values were nominal.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>In total, 595 patients were treated, of whom 223 (37.5%) received sarilumab monotherapy and 372 (62.5%) received combination therapy. Upon initiation of sarilumab, an improvement in the mean (SD) CDAI score was observed at week 24 [11.4 (10.3)] and was maintained through week 52 [10.0 (10.5)], resulting in a mean [SD] reduction of −14.9 (12.7) and −14.4 (12.9), respectively. There were consistent improvements in disease activity that were similar for patients on monotherapy vs. combination therapy. An increase in the proportion of patients achieving remission and low disease activity was reported. By week 52, both groups had improved physical function and quality of life. There were no new safety signals. The proportions of any patients reporting a treatment-emergent adverse event (TEAE) or serious treatment-emergent AE (SAE) was 66.2% and 5.9%, respectively, and were similar between both treatment groups. Overall, 15.6% of patients discontinued sarilumab treatment due to TEAEs. The most commonly reported TEAE of interest was neutropenia (14.1%).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>In this 1-year, observational real-world study, sarilumab therapy resulted in improved clinical outcomes. The safety profile was consistent with that observed in sarilumab randomized clinical trials.</p><p>This study was entered on the German website (Paul Ehrlich Institute) on January 11, 2018, with NIS No.: 423.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"72 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142256707","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":"Summary of Research: Ten-Year Safety and Clinical Benefit from Open-Label Etanercept Treatment in Children and Young Adults with Juvenile Idiopathic Arthritis","authors":"Jelena Vojinović, Ivan Foeldvari, Joke Dehoorne, Violeta Panaviene, Gordana Susic, Gerd Horneff, Valda Stanevica, Katarzyna Kobusinska, Zbigniew Zuber, Bogna Dobrzyniecka, Tadej Avcin, Cecilia Borlenghi, Edmund Arthur, Chuanbo Zang, Vassilis Tsekouras, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto","doi":"10.1007/s40744-024-00703-z","DOIUrl":"https://doi.org/10.1007/s40744-024-00703-z","url":null,"abstract":"<p>This is a summary of the original article ‘Ten-year safety and clinical benefit from open label etanercept treatment in children and young adults with juvenile idiopathic arthritis’. Juvenile idiopathic arthritis (JIA) usually appears before the age of 16. JIA causes pain, swelling, and stiffness in the joints. People with JIA receive treatment for several years until the disease goes into prolonged remission. Therefore, the long-term safety of these treatments is an important topic. Etanercept is a treatment for JIA, which acts on the body’s immune system to reduce arthritis. This summary of research article describes safety and how well etanercept works in children with JIA taking it for up to 10 years.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"17 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142208529","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":"Fibro-adhesive Bursitis: A Novel Sonographic Finding in Adhesive Capsulitis Patients and a Proposal of Management","authors":"Fabio Vita, Roberta Gualtierotti, Marco Miceli, Roberto Tedeschi, Flavio Origlio, Marco Cavallo, Stefano Galletti, Salvatore Massimo Stella, Enrico Guerra, Danilo Donati, Cesare Faldini","doi":"10.1007/s40744-024-00716-8","DOIUrl":"https://doi.org/10.1007/s40744-024-00716-8","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Adhesive capsulitis, also known as “frozen shoulder,” is a debilitating shoulder condition increasingly linked to fibroadhesive bursitis, particularly after COVID-19 and related vaccinations. There is no definitive gold standard for its treatment, the primary therapeutic objectives of which are the reduction of pain and the restoration of shoulder range of motion. The aim of our study was to analyze treatment outcomes based on quantitative measures of shoulder function and symptom relief.</p><h3 data-test=\"abstract-sub-heading\">Method</h3><p>Conducted between January 2022 and April 2023, the research involved 45 patients initially diagnosed with adhesive capsulitis and associated fibroadhesive bursitis. After excluding nine patients for other concomitant pathologies (five for calcific tendinopathy and four for rotator cuff injury), 36 patients were randomized into two groups: one group was treated with glenohumeral hydrodistension, the other with glenohumeral hydrodistension combined with bursal injection. Assessments were conducted at baseline and then 2, 4, and 6 months after treatment, focusing on changes in pain levels, functional scores, and range of motion in all planes. Each group followed a home-based rehabilitation protocol.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Significant improvements were observed in both treatment groups, with the combined hydrodistension and bursal injection group showing notably superior outcomes. Specifically, the range of motion in flexion improved from an initial median of 80° to 155° in the combined treatment group, compared to an increase from 75.5° to 129° in the group treated with hydrodistension alone. This enhancement was statistically significant (<i>p</i> &lt; 0.001).</p><p>Regarding pain reduction, the combined treatment group demonstrated a dramatic decrease in visual analogue scale (VAS) scores, from a baseline median of 7 to 1 at the 6-month follow-up. In contrast, the hydrodistension-only group showed a reduction from 7 to 3, with these differences also proving statistically significant (<i>p</i> &lt; 0.001).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Ultrasound-guided hydrodistension of the glenohumeral joint, if combined with bursal injection and specific exercises, effectively reduces pain, decreases disability, and improves range of motion in patients with second-stage adhesive capsulitis. This study highlights the importance of a combined approach in the management of this complex condition, especially after the histological changes that occurred after COVID-19 and related vaccinations.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>ClinicalTrials.gov identifier NCT06062654.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"18 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142208714","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":"Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials","authors":"Jeffrey R. Curtis, Atul Deodhar, Enrique R. Soriano, Emmanouil Rampakakis, May Shawi, Natalie J. Shiff, Chenglong Han, William Tillett, Dafna D. Gladman","doi":"10.1007/s40744-024-00702-0","DOIUrl":"https://doi.org/10.1007/s40744-024-00702-0","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Post hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Among patients with highly active PsA (baseline cDAPSA = 44.1–45.0, PASDAS = 6.4–6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3–2.5; <i>P</i> &lt; 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28–68%/29–65%) vs. placebo (19–47%; both <i>P</i> &lt; 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4–17.2/1.4–5.4).</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>In a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with a higher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52.</p><h3 data-test=\"abstract-sub-heading\">Trial registration</h3><p>DISCOVER-1 (NCT03162796).</p><p>DISCOVER-2 (NCT03158285).</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"7 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142208713","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":"Ear Complaints in Fibromyalgia: A Narrative Review","authors":"Thelma Larocca Skare, Jozélio Freire de Carvalho","doi":"10.1007/s40744-024-00701-1","DOIUrl":"https://doi.org/10.1007/s40744-024-00701-1","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Patients with fibromyalgia (FM) have innumerable complaints due to the central amplification of somatic stimuli. The aim of this paper was to review the ear complaints in patients with FM.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A review of articles published in PubMed/MEDLINE, Embase, Web of Science, and Scopus from 1966 to June 2023 was performed.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Seventeen papers were included in the review. They showed that patients with FM have a higher hearing loss rate, mostly at high frequencies, and hyperacusis. The prevalence of vestibular symptoms (tinnitus, dizziness) and hyperacusis was higher than in the general population, reaching 87.0% of the sample. Subjective findings did not always correspond to objective results. In some studies, the degree of FM severity was associated with ear symptoms; in others, it was not.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Ear complaints in patients with FM are linked to subjacent disease and may be related to stimuli central amplification.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":"34 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141881792","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":"Regional Differences in Diagnosis Journey and Healthcare Utilization: Results from the International Map of Axial Spondyloarthritis (IMAS).","authors":"Marco Garrido-Cumbrera, Denis Poddubnyy, Fernando Sommerfleck, Christine Bundy, Souzi Makri, José Correa-Fernández, Shashank Akerkar, Jo Lowe, Elie Karam, Victoria Navarro-Compán","doi":"10.1007/s40744-024-00672-3","DOIUrl":"10.1007/s40744-024-00672-3","url":null,"abstract":"<p><strong>Introduction: </strong>To assess differences in the diagnosis journey and access to care in a large sample of patients with axial spondyloarthritis (axSpA) from around the world, included in the International Map of Axial Spondyloarthritis (IMAS).</p><p><strong>Methods: </strong>IMAS was a cross-sectional online survey (2017-2022) of 5557 unselected patients with axSpA from 27 countries. Across five worldwide geographic regions, the patient journey until diagnosis and healthcare utilization in the last 12 months prior to survey were evaluated. Univariable and multivariable linear regression was used to analyze factors associated with higher healthcare utilization.</p><p><strong>Results: </strong>Of 5557 participants in IMAS, the diagnosis took an average of 7.4 years, requiring more than two visits to HCPs (77.7% general practitioner and 51.3% rheumatologist), and more than two diagnostic tests [67.5% performed human leukocyte antigen B27 (HLA-B27), 64.2% x-ray, and 59.1% magnetic resonance imaging (MRI) scans]. North America and Europe were the regions with the highest number of healthcare professional (HCP) visits for diagnosis, while the lowest number of visits was in the Asian region. In the previous 12 months, 94.9% (n = 5272) used at least one healthcare resource, with an average of 29 uses per year. The regions with the highest healthcare utilization were Latin America, Europe, and North America. In the multiple linear regression, factors associated with higher number of healthcare utilization were younger age (b =  - 0.311), female gender (b = 7.736), higher disease activity (b = 1.461), poorer mental health (b = 0.624), greater functional limitation (b = 0.300), greater spinal stiffness (b = 1.527), and longer diagnostic delay (b = 0.104).</p><p><strong>Conclusion: </strong>The diagnosis of axSpA usually takes more than two visits to HCPs and at least 7 years. After diagnosis, axSpA is associated with frequent healthcare resource use. Younger age, female gender, higher disease activity, poorer mental health, greater functional limitation, greater spinal stiffness, and longer diagnostic delay are associated with higher healthcare utilization. Europe and North America use more HCP visits and diagnostic tests before and after diagnosis than the other regions.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"927-945"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284644","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":"Matching-Adjusted Indirect Comparison of the 52-Week Efficacy of Bimekizumab Versus Secukinumab and Ixekizumab for the Treatment of Radiographic Axial Spondyloarthritis.","authors":"Walter P Maksymowych, Howard Thom, Michael F Mørup, Vanessa Taieb, Damon Willems, Nikos Lyris, Karl Gaffney","doi":"10.1007/s40744-024-00684-z","DOIUrl":"10.1007/s40744-024-00684-z","url":null,"abstract":"<p><strong>Introduction: </strong>A previous network meta-analysis established 16-week relative efficacy with bimekizumab, an inhibitor of interleukin (IL)-17F in addition to IL-17A, versus other treatments for patients with radiographic axial spondyloarthritis (r-axSpA; i.e., ankylosing spondylitis), including the IL-17A inhibitors secukinumab and ixekizumab. This matching-adjusted indirect comparison (MAIC) assessed 52-week relative efficacy of bimekizumab versus secukinumab and ixekizumab.</p><p><strong>Methods: </strong>Individual patient data from BE MOBILE 2 (bimekizumab 160 mg; N = 220) were matched to pooled summary data from MEASURE 1/2/3/4 (secukinumab 150 mg), MEASURE 3 (secukinumab 300 mg; escalated dose for inadequate responders), COAST-V (ixekizumab) and COAST-V/-W (ixekizumab). BE MOBILE 2 patients were reweighted using propensity score weights based on age, sex, ethnicity, tumor necrosis factor inhibitor (TNFi) exposure, weight, baseline ASDAS and BASFI (secukinumab) and baseline BASDAI (ixekizumab), and 52-week efficacy outcomes from the trial recalculated. Odds ratios (OR) or mean difference for unanchored comparisons are reported with 95% confidence intervals (CI).</p><p><strong>Results: </strong>At week 52, MAIC demonstrated that patients may have higher likelihood of improvement in key efficacy outcomes with bimekizumab versus secukinumab 150 mg (e.g., ASAS40: [OR (95% CI): 1.48 (1.05, 2.10); p = 0.026]; effective sample size [ESS] = 177). Differences in 52-week efficacy outcomes between bimekizumab and secukinumab 300 mg dose escalation were non-significant (ESS = 120). Bimekizumab versus ixekizumab 80 mg comparisons (COAST-V only; ESS = 84) also suggested that differences were non-significant for most key efficacy outcomes. Other ixekizumab comparisons (COAST-V/-W; ESS = 45) suggested bimekizumab may have higher comparative efficacy for many of the same efficacy outcomes, however ixekizumab analyses were limited by poor population overlap, likely due to the greater proportion of patients with previous TNFi exposure.</p><p><strong>Conclusions: </strong>Patients treated with bimekizumab may have a higher likelihood of achieving improved longer-term efficacy versus secukinumab 150 mg, suggesting bimekizumab may be a favorable therapeutic option for r-axSpA. Differences in efficacy outcomes with bimekizumab versus ixekizumab 80 mg were mostly non-significant, depending on the populations considered.</p>","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"1023-1041"},"PeriodicalIF":2.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11265043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446962","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}