Lucasson F, Kiltz U, Kalyoncu U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ryussen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Richette P, Husni E, Coates LC, de Wit M, Smolen JS, Orbai AM, Gossec L. RMD Open. Patients already on treatment with the study drug (169/1114 [15.2%]) were included only if baseline data were available and could be collected retrospectively. -, Pharmacoeconomics. 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The https:// ensures that you are connecting to the Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Since 1998 President of the Society of Psychosomatics in Rheumatology. In cases of primary treatment failure, timely switching is needed. By clicking "I agree" you consent to the use of cookies for non-essential functions and the related processing of personal data. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Good Clinical Practice: Consolidated Guideline; Notice of Availability, 62 Federal Register 90. FOIA Therefore, the objective of the ACTION study was to translate the validity of RCT results into a real-life setting. MLB made a substantial contribution to the conception and design of the study, to the acquisition of data, and to the analysis and interpretation of data. Differential drug retention between anti-TNF agents and alternative biological agents after inadequate response to an anti-TNF agent in rheumatoid arthritis patients. Biologics licensed by the FDA and/or EMA for the treatment of RA and/or…, MeSH Explor Res Clin Soc Pharm. This cookie is set by GDPR Cookie Consent WordPress Plugin. When you press play, Vimeo will drop third party cookies to enable the video to play and to see how long a viewer has watched the video. Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). This 18 country, real-world study assessed use and switching of immunomodulatory therapy (biologic/apremilast), the extent of treatment failure and its association with reduced physical functioning, health-related quality of life (HRQoL), and work productivity and activity impairment (WPAI). Rieke H. E. Alten has been practising for more than 48 years. PMC The treatment of rheumatoid arthritis (RA) in routine clinical practice comprises both biologic and non-biologic disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX) and tumor necrosis factor (TNF) blocking agents. 2023 Mar;40(3):1047-1061. doi: 10.1007/s12325-022-02404-x. Federal government websites often end in .gov or .mil. Psoriasis (Auckl). TNF inhibitors are shown in black; biologics with other targets are shown in gray. Among second-line patients, mean changes from baseline in DAS28 (ESR), DAS28 (CRP), and CDAI were numerically greater among those who failed one prior anti-TNF and those who failed ≥2, but with overlapping 95% CI (Table 2). Epub 2023 Jan 10. 2014 Jul;13(7):751-5. doi: 10.1016/j.autrev.2014.02.004. A good or moderate EULAR response was achieved by similar proportions of patients regardless of the reasons for which the last biologic therapy was discontinued (67.2, 66.2, and 67.3% for those patients who discontinued due to primary inefficacy, secondary inefficacy, or intolerance, respectively). There are 4 professionals named "Rieke Alten", who use LinkedIn to exchange information, ideas, and opportunities. In addition, higher retention rates and effectiveness outcomes were observed when abatacept treatment was initiated earlier in the course of the disease. Of note was the high retention rate for biologic-naïve patients in the current study (93.0%), which is consistent with evidence from abatacept RCTs showing that patient retention is higher when abatacept is initiated earlier in the treatment regimen [11,14]. D. Boumpas has nothing to disclose. Comorbidity in Adult Psoriasis: Considerations for the Clinician. Nurses are Critical in Aiding Patients Transitioning to Biosimilars in Inflammatory Bowel Disease: Education and Communication Strategies. Bethesda, MD 20894, Web Policies If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Set My Store . The patient population was stratified by prior line of treatment into two subgroups: patients who were either biologic-naïve prior to initiating abatacept (‘first-line’), or patients who had previously received and failed at least one biologic agent (‘second-line’); this second group included patients initiating abatacept as a second- or further-line of treatment. It stores information anonymously and assign a randomly generated number to identify unique visitors. F: +44 (0)1959 563123, European Pharmaceutical Review is published by: Russell Publishing Ltd.Court LodgeHogtrough HillBrasted, Kent, TN16 1NUUnited Kingdom. Efficacy and safety of abatacept therapy for rheumatoid arthritis in routine clinical practice. This large, observational, real-world study demonstrated high patient retention rates with abatacept treatment, regardless of line of treatment (first or second), the number of previously failed anti-TNF agents, or the reason for treatment failure. Among the 974 patients for whom reasons for discontinuation of the prior biologic before study enrollment were available, the reasons were: primary inefficacy (26.6%, n = 259), loss of efficacy (secondary inefficacy) (46.5%, n = 453), safety and tolerability (22.0%, n = 214), other unspecified reasons (5.6%, n = 55), and achieving remission or experiencing a major improvement (0.5%, n = 5). The site is secure. Find a specialized clinic and treatment abroad, Diagnostics and treatment of rheumatoid arthritis (one of the most common inflammatory rheumatic diseases), Diagnostics and treatment of spondylitis (group of inflammatory rheumatic diseases affecting the spine, peripheral joints, ligaments), Ankylosing spondylitis (Bechterev's disease), Reactive forms of arthritis and arthritis caused by the inflammatory bowel disease, Diagnostics and treatment of collagenoses and vasculitides, Diagnostics and treatment of fibromyalgia and other rheumatic lesions of the soft tissues, Diagnostics and treatment of osteoporosis, Diagnostics and treatment of other rheumatic pathologies. The .gov means it’s official. C. Rauch is an employee of Bristol-Myers Squibb. Federal government websites often end in .gov or .mil. Although retention rates for RCTs are expected to be higher than for real-world studies [7], the retention rates in the current study were consistent with an 82–90% retention rate reported from two abatacept RCTs, the ATTAIN and ARRIVE studies [13,32]. 2002 Feb;59(2):119-32 View our Cookie Policy page. M. Le Bars is an employee of Bristol-Myers Squibb and holds stock options. Functional impairment measurement in psoriatic arthritis: Importance and challenges. Safety was presented for the entire enrolled population, regardless of prior or concomitant treatment. F. Rainer has nothing to disclose. CDAI, Clinical Disease Activity Index; DAS, Disease Activity Score; LDAS, Low Disease Activity Score (≤3.2 for DAS and ≤10 for CDAI). As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work. It has been reported that treatment response rates are often lower in routine clinical practice compared with RCT evidence [7], as a result of the patient populations in observational studies not being subject to the strict inclusion and exclusion criteria of RCTs. Bethesda, MD 20894, Web Policies MeSH The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. She received her medical degrees from the Free University Berlin. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. The cookie is a session cookies and is deleted when all the browser windows are closed. For each country, local ethics committee approvals were also obtained, as required by local regulations. Curriculum vitae of Prof. Dr. med. Ascef BO, Almeida MO, Medeiros-Ribeiro AC, Oliveira de Andrade DC, Oliveira Junior HA, de Soárez PC. View the profiles of professionals named "Rieke Alten" on LinkedIn. This site needs JavaScript to work properly. van Vollenhoven RF. Patients who experience lack of efficacy with one anti-TNF agent often have a poorer response to a second or third anti-TNF agent, reflecting loss of efficacy and increased resistance towards TNF-α blockade, which, in some cases is due to the development of anti-therapeutic antibodies [2-5]. HHP made a substantial contribution to the acquisition of data, and to the analysis and interpretation of data. sharing sensitive information, make sure you’re on a federal We do not capture any email address. Accessibility Gill Litalien (Executive Director, Global Health Economics and Outcomes Research) and Nathalie Schmidely (Associate Director Real World Research) from Bristol-Myers Squibb provided input into the design and interpretation of this study. Since 1990 Senior Physician of the Department of Rheumatology and Physiotherapy at the Academic Hospital Schlosspark Berlin. Bethesda, MD 20894, Web Policies The .gov means it’s official. This observational study did not interfere with a physician’s routine clinical practice. Here we present a 6-month interim analysis of a 2-year prospective observational trial in Europe and Canada aiming to assess the real-world effectiveness, safety, and tolerability of intravenous abatacept for the treatment of moderate-to-severe RA. Careers. This cookie is set by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. A SAE was defined as an AE that was fatal or life-threatening, required or extended patient hospitalization (except pregnancy), resulted in persistent or significant disability or incapacity, induced a congenital anomaly or birth defect, or was considered an important medical event. This cookie is native to PHP applications. This cookie is set by OneSignal push notifications and is used for storing user preferences in connection with their notification permission status. Mean change from baseline in DAS28 (ESR), DAS28 (CRP), and CDAI was similar in patients who discontinued their prior biologic due to primary inefficacy, secondary inefficacy, or safety and tolerability issues (Table 4). The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. and transmitted securely. HMC is the principal public healthcare provider in the State of Qatar, delivering the safest, most effective and most compassionate care to each and every one of our patients. Rieke H. E. Alten? Retention rates were calculated using Kaplan–Meier curve estimates. Determinants of work and social participation in patients with psoriatic arthritis in the Netherlands: an observational study. In 1984 she received board certification in internal medicine, 1985 in rheumatology, 1998 in physical therapy und rehabilitation medicine, 2001 in sports medicine. Clipboard, Search History, and several other advanced features are temporarily unavailable. Gender and previous treatment influence outcomes from abatacept in a 5-year rheumatoid arthritis cohort [Abstract]. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Rates of retention, LDAS, remission, HAQ-DI response, and safety outcomes were consistent with data from both abatacept RCTs and local national registries. Unauthorized use of these marks is strictly prohibited. Future analyses of the ACTION study will evaluate the long-term effectiveness, retention rates, and safety of abatacept in the real-world setting. Current Medication Practices and Preferences Among Patients With Psoriatic Arthritis. She has been the lead investigator in clinical trials of novel therapies in rheumatic diseases and has contributed to several investigator-initiated trials. Epub 2014 May 4. These cookies do not store any personal information. More than 67% of patients achieved a good or moderate EULAR response, as defined by DAS28 (ESR) or DAS28 (CRP) independently of whether abatacept was initiated as first- or second-line therapy (Figure 4). Indeed, anti-TNF therapy discontinuation rates in real-world practice are about 30%, based on cohort studies with median follow-up of 15–37 months [2,3]. This cookie is set by Youtube and is used to track the views of embedded videos. Prof. Dr. Rieke Alten is a member of the OMERACT Steering Committee of the Flare in Rheumatoid Arthritis Group. By Bernard Combe, Yannick Allanore, Rieke Alten, Roberto Caporali | Arthritis Research & Therapy Verified. When comparing abatacept as monotherapy versus in combination with a DMARD in patients treated with abatacept as second-line or higher, 63.1% (n = 65/103) versus 68.3% (n = 254/372) of patients achieved a good or moderate EULAR response, 27.5% (n = 38/138) versus 33.6% (n = 151/449) achieved CDAI LDAS, and 5.1% (n = 7/138) versus 4.9% (n = 22/449) achieved CDAI remission. Registered on 14 July 2014. Overall, no new safety signals were identified in the ACTION patient population compared with the safety profile previously reported for abatacept from real-world studies [16,18]. RA, KG, JHJ, JL, and SM have no conflicts of interest that are directly relevant to the content of this article. 2023 May 1;6(5):e2315872. M. Galeazzi has nothing to disclose. Westhovens R, Kremer J, Emery P, Russell A, Li T, Aranda R, Becker JC, Zhao C, Dougados M. Consistent safety and sustained improvement in disease activity and treatment response over 7 years of abatacept treatment in biologic-naïve patients with RA [abstract]. FG has received financial support from AbbVie, Janssen, MSD, and Takeda for lectures and travel to scientific meetings. The Kaplan–Meier estimated retention rates based on reasons for discontinuing prior biologic therapy before initiating abatacept were 84.4% (95% CI: 79.0, 88.6) for patients who discontinued due to primary inefficacy, 90.3% (95% CI: 86.9, 92.8) for those who discontinued due to secondary inefficacy, and 85.1% (95% CI: 79.1, 89.5) for those with safety and tolerability issues with anti-TNF agents (Figure 2B). Furthermore, the subgroup analyses in ACTION showed consistent numerically superior outcomes for patients treated with abatacept earlier in their disease course. Of the 996 patients who had previously failed at least one biologic agent, 22.8% (n = 227) received abatacept as monotherapy and 77.2% (n = 769) received abatacept in combination with another DMARD, of whom 61.0% (n = 469) received abatacept in combination with MTX. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Diverticular perforation resulting in sepsis was reported in one patient, for which surgery was performed. Related treatment-emergent adverse events (AEs) were assessed by the treating physician and reported to the pharmacovigilance department. By using a process of random selection from a comprehensive list of rheumatologists, the investigators in each country were geographically balanced and representative of rheumatologists who treat patients with biologics. Prof. Dr. med. Moreover, evidence from local registries in France [15], Denmark [16], and Sweden [17], as well as evidence from a small, single-site study of abatacept in routine clinical practice [18], support the findings from RCTs. Patients were enrolled prospectively between May 2008 and January 2011, either on, or within 3 months of, initiating treatment with abatacept according to the Summary of Product Characteristics (SmPC) in Europe and the Product Monograph in Canada. Received 2013 Sep 3; Accepted 2014 Jan 2. KP made a substantial contribution to the acquisition of data. BP has received honoraria and speaker fees from AbbVie, AstraZeneca, Celltrion, GSK, Lilly, Pfizer, Roche, and UCB. Patients could report more than one reason for discontinuation of prior treatment before study enrollment. Good Epidemiological Practice (GEP): IEA Guidelines For Proper Conduct In Epidemiologic Research. Rieke.Alten@schlosspark-klinik.de. Keywords: Would you like email updates of new search results? The results of the double-blind study phase comparing the modified-release and the immediate-release tablets and the subsequent 9-month open-label treatment phase with the modified-release tablet are reported in the 2 previous publications on the CAPRA-1 study3,4. As the study was not powered for subgroups analysis, definitive conclusions cannot be drawn. This cookie is set by GDPR Cookie Consent plugin. The authors would like to thank all physicians who participated in the ACTION study. Measurement of patient outcome in arthritis. Please view our. D'Agostino M, Wakefield R, Berner Hammer H, Vittecoq O, Galeazzi M, Balint P, Fillipucci E, Moller I, Iagnocco A, Naredo E, Ostergaard M, Gaillez C, Kerselaers W, Van Holder K, Le Bars M. Early response to abatacept plus MTX in MTX-IR RA patients using power doppler ultrasonography: an open-label study - poster tours. Previous studies have demonstrated that abatacept may have an impact on efficacy measures as early as 7 days from the first infusion [22]. Remission was defined as a DAS28 score <2.6 or a CDAI score ≤2.8. -, Sarzi-Puttini P, Ceribelli A, Marotto D, et al. Joseph’s Hospital/McMaster University, Hamilton, Ontario, Canada, 8Charité-Universitätsmedizin Berlin, Berlin, Germany, 9University Medical Center Freiburg, Freiburg, Germany, 10Hospital Barmherzige Brueder, Graz, Austria, 11Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic, 12Chiltern International, Neuilly, France, 15Bristol-Myers Squibb, Rueil-Malmaison, France. In 1984 she received board certification in internal medicine, 1985 in rheumatology, 1998 in physical therapy und rehabilitation medicine, 2001 in sports medicine. Relationship of pain and fatigue with health-related quality of life and work in patients with psoriatic arthritis on TNFi: results of a multi-national real-world study. CI, confidence interval. official website and that any information you provide is encrypted There are limited data on therapy selection and switching in psoriatic arthritis (PsA). doi: 10.1136/rmdopen-2021-002031. Patients were enrolled from nine countries (Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Italy, The Netherlands) with the largest patient numbers enrolled in Germany (n = 399), Italy (n = 236), Canada (n = 229), and Greece (n = 149). Rieke H. E. Alten works at Academic Hospital Schlosspark Charlottenburg Berlin. In addition, response and remission rates with abatacept in the ACTION study were similar to those reported in the two previously mentioned abatacept RCTs in patients with a prior inadequate response to anti-TNF agents, the ATTAIN [13] and ARRIVE studies [32]. Although these treatments are beneficial for many patients, some may not respond to treatment or may lose their initial response over time [1]. 2019 Feb 1;13(2):259-266. doi: 10.1093/ecco-jcc/jjy150. This cookie is set by LinkedIn and is used for tracking. 1974 - 1975 Postdoctoral Fellow, Department of Immunobiology, University of Zurich. LDAS was defined as a DAS28 score ≤3.2 or a CDAI score ≤10. Corresponding author: Dr. Rieke Alten, Internal Medicine II, Rheumatology bei Schlosspark Klinik, University Medicine Berlin. The estimate is given for each patient group with 95% CIs. Physical function was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [28]. Clinical research organizations involved in the ACTION study were Inventiv Health Clinical, Winicker Norimed, TFS Trial Form Support S.r.l., and Archemin BVBA, and statistical analyses support was provided by Stat Process. Patients who had their clinical assessment more than 8 days after their first abatacept infusion were not included in the effectiveness analysis. Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials, Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Advertising & Targeting". The biosimilar road in inflammatory bowel disease: the right way? Set My Store . 2019;18:583–592. These data support previously reported favorable outcomes from the ARRIVE [32] trial in patients with similar characteristics. LP-B has received consulting fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Enterome, Ferring, Genentech, Gilead, Index Pharmaceuticals, Janssen, Lilly, MSD, Nestle, Oppilan Pharma, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Tillotts, and Vifor; payment for lectures, including service on speakers bureaus, from AbbVie, Biogen, Celltrion, Ferring, Hikma, Janssen, MSD, Pfizer, Roche, Samsung Bioepis, Takeda, and Tillotts; grant/research support from AbbVie, MSD, and Takeda; and stock options from CT-SCOUT.