32 results on '"Meissner, Y"'
Search Results
2. Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs
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Strangfeld, A, Richter, A, Siegmund, B, Herzer, P, Rockwitz, K, Demary, W, Aringer, M, Meißner, Y, Zink, A, and Listing, J
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- 2017
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3. 2022 EULAR Points to consider for remote care in rheumatic and musculoskeletal diseases
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de Thurah, A., Bosch, P., Marques, A., Meissner, Y., Mukhtyar, C.B., Zabotti, A., Knitza, J., Najm, A., Østerås, N., Pelle, T., Knudsen, L.R., Šmucrová, H., Berenbaum, F., Jani, M., Geenen, R., Krusche, M., Pchelnikova, P., de Souza, S., Badreh, S., Wiek, D., Piantoni, S., Gwinnutt, J.M., Duftner, C., Canhão, H., Quartuccio, L., Stoilov, N., Prior, Y., Bijlsma, J.W.J., Stamm, T.A., Dejaco, C., Clinical Psychology (onderzoeksprogramma), Leerstoel Geenen, Clinical Psychology (onderzoeksprogramma), and Leerstoel Geenen
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Patient Care Team ,Epidemiology ,Biochemistry, Genetics and Molecular Biology(all) ,education ,Immunology ,COVID-19 ,Biochemistry ,Health Services Accessibility ,Telemedicine ,General Biochemistry, Genetics and Molecular Biology ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,Rheumatology ,Humans ,Health services research ,Immunology and Allergy ,Musculoskeletal Diseases ,Pandemics ,health care economics and organizations ,Genetics and Molecular Biology(all) - Abstract
BackgroundRemote care and telehealth have the potential to expand healthcare access, and the COVID-19 pandemic has called for alternative solutions to conventional face-to-face follow-up and monitoring. However, guidance is needed on the integration of telehealth into clinical care of people with rheumatic and musculoskeletal diseases (RMD).ObjectiveTo develop EULAR points to consider (PtC) for the development, prioritisation and implementation of telehealth for people with RMD.MethodsA multidisciplinary EULAR task force (TF) of 30 members from 14 European countries was established, and the EULAR standardised operating procedures for development of PtC were followed. A systematic literature review was conducted to support the TF in formulating the PtC. The level of agreement among the TF was established by anonymous online voting.ResultsFour overarching principles and nine PtC were formulated. The use of telehealth should be tailored to patient’s needs and preferences. The healthcare team should have adequate equipment and training and have telecommunication skills. Telehealth can be used in screening for RMD as preassessment in the referral process, for disease monitoring and regulation of medication dosages and in some non-pharmacological interventions. People with RMD should be offered training in using telehealth, and barriers should be resolved whenever possible.The level of agreement to each statement ranged from 8.5 to 9.8/10.ConclusionThe PtC have identified areas where telehealth could improve quality of care and increase healthcare access. Knowing about drivers and barriers of telehealth is a prerequisite to successfully establish remote care approaches in rheumatologic clinical practice.
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- 2022
4. Malignancy and hospitalised infections in patients with RA treated with abatacept and other DMARDs: results from a 10-year international post-approval study
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Simon, TA, Suissa, S, Skovron, ML, Frisell, T, Askling, J, Michaud, K, Pedro, S, Strangfeld, A, Meissner, Y, Boers, M, Lacaille, D, Hochberg, M, Hoffman, V, and Gomez, A
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musculoskeletal diseases ,ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Background: The global post-marketing epidemiology programme for abatacept consists of observational studies based on registries and healthcare claims databases to assess malignancy and infection risks associated with abatacept treatment vs conventional synthetic (cs)DMARDs and other biologic (b) or[for full text, please go to the a.m. URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)
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- 2019
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5. FACTORS ASSOCIATED WITH PREGNANCY-RELATED CONCERNS IN WOMEN WITH INFLAMMATORY RHEUMATIC DISEASES - AN ANALYSIS OF A NATIONWIDE PREGNANCY COHORT.
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Meissner, Y., Eickhoff, B., Glaser, C., Henes, J., Richter, J., Spaethling-Mestekemper, S., Specker, C., Fischer-Betz, R., and Strangfeld, A.
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- 2023
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6. SEX-RELATED DIFFERENCES IN CHARACTERISTICS AND MORTALITY OF PATIENTS WITH RHEUMATOID ARTHRITIS AND CONCOMITANT HEART FAILURE.
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Rudi, T., Zietemann, V., Meissner, Y., Schneider, M., Worsch, M., and Strangfeld, A.
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- 2023
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7. THE IMPACT OF DIFFERENT DMARDS ON MORTALITY IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PREVALENT INTERSTITIAL LUNG DISEASE.
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Rudi, T., Zietemann, V., Schaefer, M., Meissner, Y., Zink, A., Krause, A., and Strangfeld, A.
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- 2023
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8. INCIDENT MALIGNANCIES IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY RHEUMATOLOGICAL CARE.
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Schaefer, M., Meissner, Y., Manger, B., Berger, S., Rockwitz, K., Regierer, A., and Strangfeld, A.
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- 2023
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9. Role of rheumatoid arthritis registries worldwide: What have they taught us?
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Studenic P, Meissner Y, Kearsley-Fleet L, and De Cock D
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Rheumatoid arthritis (RA) is one of the most common rheumatic conditions, impacting quality of life on several domains. Major breakthroughs have been achieved over the past three decades in the management benefitting the patients' lives. With increasing as well as novel treatment options, clinical registries have been established and continuously evolve to portray patient characteristics, monitor disease activity of RA, effectiveness and safety of the novel compounds. The greatest insights derived from registries is our current knowledge on the risks for malignancies and infections but also extending our knowledge collected in clinical trials on comparative effectiveness, long-term drug utilisation and under-represented populations. Moreover, the possible evolution of registries involving Big Data and AI, and the increased focus on patient centredness is discussed., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Paul Studenic reports a relationship with AbbVie Ltd. that includes: consulting or advisory. Paul Studenic reports a relationship with AstraZeneca that includes: speaking and lecture fees. Yvette Meissner reports a relationship with Eli Lilly and Company that includes: speaking and lecture fees. Yvette Meissner reports a relationship with Pfizer Inc that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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10. Rhekiss-The German Register for Child Wish and Pregnancies in Inflammatory Rheumatic Diseases.
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Strangfeld A, Meissner Y, Weiß A, Rudi T, Zink A, Ellmann T, Filla T, Aries P, Baraliakos X, Bungartz C, Glaser C, Henes J, Lorenz HM, Schneider M, Späthling-Mestekemper S, Specker C, Richter JG, and Fischer-Betz R
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- Humans, Pregnancy, Female, Germany epidemiology, Longitudinal Studies, Adult, Pharmacoepidemiology methods, Adolescent, Young Adult, Registries, Rheumatic Diseases drug therapy, Rheumatic Diseases epidemiology, Pregnancy Complications epidemiology, Pregnancy Complications drug therapy, Pregnancy Outcome epidemiology, Antirheumatic Agents therapeutic use, Antirheumatic Agents adverse effects
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In pharmacoepidemiology, robust data are needed to judge the impact of drug treatment on pregnancy, pregnancy outcomes and breast-fed infants. As pregnant and breastfeeding women are usually excluded from randomised clinical trials, observational studies are required. One of those data sources are pregnancy registers specifically developed to focus on certain diseases or disease groups. The German Rhekiss register investigates pregnancies in women with chronic inflammatory rheumatic diseases (IRD). Rhekiss is a nationwide, multicentre, longitudinal study, in which women aged 18 years or older with an underlying IRD can be enrolled by a rheumatologist either when planning a pregnancy or in the first half of pregnancy. Data are collected prospectively at regular follow-up visits. Rheumatologists and patients provide information in a web-based system before conception (if enrolment was at the time of pregnancy planning), during and after pregnancy. A smartphone app is available for patients. Maternal and clinical information, general laboratory markers, treatment with antirheumatic and other drugs, adverse events, items related to course and outcome of pregnancy and the health of the child are uniformly assessed for all diseases. Individual information on the IRD includes classification criteria, diagnosis-specific laboratory parameters, clinical parameters and validated instruments to measure disease activity or damage. Furthermore, patient-reported outcome measures are captured. A total of 2013 individual patients have been enrolled in the register, and data on 1801 completed pregnancies are available. In summary, Rhekiss is a comprehensive and complex register that can answer various research questions about pregnancy in women with chronic IRDs., (© 2024 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)
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- 2024
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11. Impact of DMARD treatment and systemic inflammation on all-cause mortality in patients with rheumatoid arthritis and interstitial lung disease: a cohort study from the German RABBIT register.
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Rudi T, Zietemann V, Meissner Y, Zink A, Krause A, Lorenz HM, Kneitz C, Schaefer M, and Strangfeld A
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- Humans, Cohort Studies, Tumor Necrosis Factor-alpha, Inflammation drug therapy, Biological Factors therapeutic use, Biomarkers, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid complications, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid chemically induced, Lung Diseases, Interstitial complications, Lung Diseases, Interstitial drug therapy, Biological Products therapeutic use
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Objectives: To investigate the impact of disease activity and treatment with disease-modifying antirheumatic drugs (DMARDs) on all-cause mortality in patients with rheumatoid arthritis and prevalent interstitial lung disease (RA-ILD)., Methods: Patients with RA-ILD were selected from the biologics register Rheumatoid Arthritis: Observation of Biologic Therapy (RABBIT). Using time-varying Cox regression, the association between clinical measures and mortality was investigated. The impact of DMARDs was analysed by (1) Cox regression considering cumulative exposure (ie, treatment months divided by total months) and (2) time-varying Cox regression as main approach (treatment exposures at monthly level)., Results: Out of 15 566 participants, 381 were identified as RA-ILD cases with 1258 person-years of observation and 2.6 years median length of follow-up. Ninety-seven patients (25.5%) died and 34 (35.1%) of these were not receiving DMARD therapy at the time of death. Higher inflammatory biomarkers but not swollen and tender joint count were significantly associated with mortality. Compared with tumour necrosis factor inhibitors (TNFi), non-TNFi biologic DMARDs (bDMARDs) exhibited adjusted HRs (aHRs) for mortality below 1, lacking statistical significance. This finding was stable in various sensitivity analyses. Joint aHR for non-TNFi biologics and JAKi versus TNFi was 0.56 (95% CI 0.33 to 0.97). Receiving no DMARD treatment was associated with a twofold higher mortality risk compared with receiving any DMARD treatment, aHR 2.03 (95% CI 1.23 to 3.35)., Conclusions: Inflammatory biomarkers and absence of DMARD treatment were associated with increased risk of mortality in patients with RA-ILD. Non-TNFi bDMARDs may confer enhanced therapeutic benefits in patients with RA-ILD., Competing Interests: Competing interests: AK: consulting fees: AbbVie, Gilead, Boehringer Ingelheim, Novartis, Janssen, UCB, Lilly and payment for lectures, presentations: AbbVie, Gilead, Boehringer Ingelheim, Roche, Novartis, Janssen, UCB, Lilly and support for attending meetings and/or travel: AbbVie, Boehringer Ingelheim and participation on a Data Safety Monitoring Board or Advisory Board: Pfizer and leadership or fiduciary role in other board, society, commitee or advocacy group, paid or unpaid: German Society for Rheumatology. CK: payment for lectures, presentations: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, Galapagos, GSK, Hexal, Janssen, Lilly, Medical School Hamburg, MSD, Novartis, Pfizer, Roche, Sanofi, UCB and participation on a Data Safety Monitoring Board or Advisory Board: Boehringer Ingelheim, Novartis. H-ML: grants or contracts from any entity: Pfizer, Novartis and consulting fees: AbbVie, AstraZeneca, Actelion, Amgen, Bayer Vital, Boehringer Ingelheim, BMS, Celgene, GSK, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche/Chugai, Sanofi, UCB and payment for lectures, presentations: AbbVie, AstraZeneca, Actelion, Amgen, Bayer Vital, Boehringer Ingelheim, BMS, Celgene, GSK, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche/Chugai, Sanofi, UCB and support for attending meetings and/or travel: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, GSK, Gilead/Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche/Chugai, Sanofi, USB and participation on a Data Safety Monitoring Board or Advisory Board: AbbVie, AstraZeneca, Amgen, Boehringer Ingelheim, BMS, Celgene, GSK, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche/Chugai, Sanofi, UCB. AS: lecture honoraria from AbbVie, Amgen, BMS, Celltrion, MSD, Lilly, Pfizer, Roche, UCB., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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12. Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study.
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Simon TA, Suissa S, Skovron ML, Frisell T, Askling J, Michaud K, Pedro S, Strangfeld A, Meissner Y, Boers M, Hoffman V, Dominique A, Gomez A, and Hochberg MC
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- Humans, Abatacept adverse effects, Marketing, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid epidemiology, Opportunistic Infections chemically induced, Opportunistic Infections epidemiology, Biological Products adverse effects, Tuberculosis chemically induced, Tuberculosis epidemiology
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Objective: To evaluate risk of infections requiring hospitalization and opportunistic infections, including tuberculosis, in patients with rheumatoid arthritis (RA) treated with abatacept versus conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biologic/targeted synthetic (b/ts) DMARDs., Methods: Five international observational data sources were used: two biologic registries (Sweden, Germany), a disease registry (USA) and two healthcare claims databases (Canada, USA). Crude incidence rates (IRs) per 1000 patient-years, with 95 % CIs, were used to estimate rate ratios (RRs) comparing abatacept versus csDMARDs or other b/tsDMARDs. RRs were adjusted for demographic factors, comorbidities, and other potential confounders and then pooled across data sources using a random effects model (REM)., Results: The data sources included 6450 abatacept users, 136,636 csDMARD users and 54,378 other b/tsDMARD users, with a mean follow-up range of 2.2-6.2 years. Across data sources, the IRs for infections requiring hospitalization ranged from 16 to 56 for abatacept, 19-46 for csDMARDs, and 18-40 for other b/tsDMARDs. IRs for opportunistic infections were 0.4-7.8, 0.3-4.3, and 0.5-3.8; IRs for tuberculosis were 0.0-8.4, 0.0-6.0, and 0.0-6.3, respectively. The pooled adjusted RR (95 % CI), only reported for infections requiring hospitalization, was 1.2 (0.6-2.2) for abatacept versus csDMARDs and 0.9 (0.6-1.3) versus other b/tsDMARDs., Conclusions: Data from this international, observational study showed similar hospitalized infection risk for abatacept versus csDMARDs or other b/tsDMARDs. IRs for opportunistic infections, including tuberculosis, were low. These data are consistent with the known safety profile of abatacept., Competing Interests: Declaration of Competing Interest TAS and AG were employees of (at the time of the analysis) Bristol Myers Squibb. SS has attended scientific advisory committee meetings for Atara, Boehringer Ingelheim, Merck, Pfizer, and Seqirus; received speaking fees from AstraZeneca, Boehringer Ingelheim, and Novartis; and received grant/research support from Boehringer Ingelheim. MLS is an employee of, shareholder in, and consultant for Bristol Myers Squibb. JA has received grant/research support from and has served as a PI for AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB. AS has received grant/research support from a consortium of 14 companies (AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Gilead/Galapagos, Hexal, Lilly, Mylan/Viatris, Merck Sharp & Dohme, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB); and has received honoraria from AbbVie, Bristol Myers Squibb, Celltrion, Merck Sharp & Dohme, Pfizer, and Roche. YM (for the German RABBIT register) is supported by a joint, unconditional grant from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Hexal, Lilly, Merck Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, UCB, and Viatris; and has received honoraria from Pfizer. MB has received speaker fees from Novartis and Pfizer and provides expert testimony for Celltrion. VH was an employee of and shareholder in Optum at the time of the analysis; and has received grant/research support from Bristol Myers Squibb (to institution). AD is an employee of Bristol Myers Squibb. MCH has received personal fees from Bristol Myers Squibb (advisory board member) and is Editor-in-Chief of Seminars in Arthritis and Rheumatism. No other disclosures relevant to this article were reported., (Copyright © 2023. Published by Elsevier Inc.)
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- 2024
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13. Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study.
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Simon TA, Suissa S, Boers M, Hochberg MC, Skovron ML, Askling J, Michaud K, Strangfeld A, Pedro S, Frisell T, Meissner Y, Dominique A, and Gomez A
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- Humans, Abatacept adverse effects, Marketing, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Arthritis, Rheumatoid chemically induced, Lung Neoplasms drug therapy, Lymphoma chemically induced, Lymphoma drug therapy, Biological Products therapeutic use
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Objective: To evaluate the risk of malignancy (overall, breast, lung, and lymphoma) in patients with rheumatoid arthritis treated with abatacept, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs), and other biologic/targeted synthetic (b/ts)DMARDs in clinical practice., Methods: Four international observational data sources were included: ARTIS (Sweden), RABBIT (Germany), FORWARD (USA), and BC (Canada). Crude incidence rates (IRs) per 1000 patient-years of exposure with 95% confidence intervals (CIs) for a malignancy event were calculated; rate ratios (RRs) were estimated and adjusted for demographics, comorbidities, and other potential confounders. RRs were then pooled in a random-effects model., Results: Across data sources, mean follow-up for patients treated with abatacept (n = 5182), csDMARDs (n = 73,755), and other b/tsDMARDs (n = 37,195) was 3.0-3.7, 2.9-6.2, and 3.1-4.7 years, respectively. IRs per 1000 patient-years for overall malignancy ranged from 7.6-11.4 (abatacept), 8.6-13.2 (csDMARDs), and 5.0-11.8 (other b/tsDMARDs). IRs ranged from: 0-4.4, 0-3.3, and 0-2.5 (breast cancer); 0.1-2.8, 0-3.7, and 0.2-2.9 (lung cancer); and 0-1.1, 0-0.9, and 0-0.6 (lymphoma), respectively, for the three treatment groups. The numbers of individual cancers (breast, lung, and lymphoma) in some registries were low; RRs were not available. There were a few cases of lymphoma in some of the registries; ARTIS observed an RR of 2.8 (95% CI 1.1-6.8) with abatacept versus csDMARDs. The pooled RRs (95% CIs) for overall malignancy with abatacept were 1.1 (0.8-1.5) versus csDMARDs and 1.0 (0.8-1.3) versus b/tsDMARDs., Conclusions: This international, post-marketing observational safety study did not find any statistically significant increase in the risk of overall malignancies in pooled data in patients treated with abatacept compared with csDMARDs or with other b/tsDMARDs. Assessment of larger populations is needed to further evaluate the risks for individual cancers, especially lymphoma., Competing Interests: Declaration of Competing Interest TAS and AG were employees of (at the time of the analysis), and are shareholders in, Bristol Myers Squibb. SS has attended scientific advisory committee meetings for Atara, Boehringer Ingelheim, Merck, Pfizer, and Seqirus; received speaking fees from AstraZeneca, Boehringer Ingelheim, and Novartis; and received grant/research support from Boehringer Ingelheim. MB has received speaker fees from Novartis and Pfizer and provides expert testimony for Celltrion. MCH has received personal fees from Bristol Myers Squibb (advisory board member) and is Editor-in-Chief of Seminars in Arthritis and Rheumatism. MLS is an employee of, shareholder in, and consultant for Bristol Myers Squibb. JA has received grant/research support from and has served as a PI for AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB. AS has received grant/research support from a consortium of 14 companies (AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Gilead/Galapagos, Hexal, Lilly, Mylan/Viatris, Merck Sharp & Dohme, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB); and has received honoraria from AbbVie, Bristol Myers Squibb, Celltrion, Merck Sharp & Dohme, Pfizer, and Roche. YM (for the German RABBIT register) is supported by a joint, unconditional grant from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Hexal, Lilly, Merck Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, UCB, and Viatris; and has received honoraria from Pfizer. AD is an employee of, and shareholder in, Bristol Myers Squibb. No other disclosures relevant to this article were reported., (Copyright © 2023. Published by Elsevier Inc.)
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- 2024
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14. Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies.
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Simon TA, Dong L, Suissa S, Michaud K, Pedro S, Hochberg M, Boers M, Askling J, Frisell T, Strangfeld A, Meissner Y, Khaychuk V, Dominique A, and Maldonado MA
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- Humans, Abatacept adverse effects, Incidence, Randomized Controlled Trials as Topic, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Arthritis, Rheumatoid complications, Biological Products therapeutic use, Skin Neoplasms chemically induced, Skin Neoplasms epidemiology
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Objectives: This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA)., Methods: This evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs)., Results: ~49 000 patients receiving abatacept were analysed from clinical trials (~7000) and observational studies (~42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs., Conclusions: Consistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity., Competing Interests: Competing interests: TS was an employee of and shareholder in Bristol Myers Squibb (at the time of the analysis; former employee at present). LD, VK, AD and MAM are employees of and shareholders in Bristol Myers Squibb. SS reports advisory board involvement, speaker fees and grant/research support from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, and Novartis. KM reports grant/research support from Rheumatology Research Foundation. MH is an employee of the University of Maryland School of Medicine (full time) and US Department of Veterans Affairs (part time); reports consultancy fees and advisory board involvement from Bristol Myers Squibb, Eli Lilly, Kolon TissueGene, Inc, Novartis, Pfizer, Samumed and Theralogix; is a member of the Data Safety Monitoring Committee for Galapagos, Roche, and IQVIA; reports royalties from Elsevier and UpToDate; reports stock ownership in BriOri Biotech and Theralogix; and is president of Rheumcon. MB reports consultancy fees from Novartis. JA reports grant/research support from AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Merck, Pfizer, Roche, Samsung Bioepis, Sanofi and UCB for ARTIS. AS reports speaker fees from AbbVie, Bristol Myers Squibb, Celltrion, Lilly, Merck, Pfizer and Roche., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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15. Risk of major adverse cardiovascular events in patients with rheumatoid arthritis treated with conventional synthetic, biologic and targeted synthetic disease-modifying antirheumatic drugs: observational data from the German RABBIT register.
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Meissner Y, Schäfer M, Albrecht K, Kekow J, Zinke S, Tony HP, and Strangfeld A
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- Humans, Middle Aged, Cohort Studies, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid complications, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Biological Products adverse effects, Cardiovascular Diseases epidemiology, Cardiovascular Diseases etiology, Janus Kinase Inhibitors adverse effects
- Abstract
Objective: To estimate the effects of Janus kinase inhibitors (JAKi), tumour necrosis factor inhibitors (TNFi), other biologic(b) or conventional synthetic(cs) disease-modifying antirheumatic drugs (DMARDs) on the risk of major adverse cardiovascular events (MACE) in patients with rheumatoid arthritis (RA)., Methods: Cohort study analysing episodes of DMARD-treatment initiated between January 2017 and April 2022 in the biologics register Rheumatoid Arthritis: Observation of Biologic Therapy. Incidence rates (IRs) per 100 patient-years with 95% CIs were calculated for overall patients and those with cardiovascular risk (age ≥50 years and ≥1 cardiovascular risk factor). MACE risk was estimated as HRs by inverse probability of treatment weight-adjusted Andersen-Gill models., Results: A total of 154 MACE occurred among 14 203 treatment episodes (21 218 patient-years). IRs were 0.68 (0.47; 0.95), 0.62 (0.45; 0.83), 0.76 (0.53; 1.06) and 0.95 (0.68; 1.29) for JAKi, TNFi, bDMARDs and csDMARDs, respectively. IRs were higher in cardiovascular risk patients. Adjusted HRs (95% CI) comparing JAKi, bDMARDs and csDMARDs with TNFi were 0.89 (0.52 to 1.52), 0.76 (0.45; to1.27) and 1.36 (0.85 to 2.19) in overall, and 0.74 (0.41 to 1.31), 0.75 (0.45 to 1.27) and 1.21 (0.74 to 1.98) in cardiovascular risk patients. HRs were not increased in patients ≥65 years, with cardiovascular history or smokers, and also not when using csDMARD as reference instead of TNFi. IRs for baricitinib, tofacitinib and upadacitinib were 0.49 (0.25 to 0.85), 0.98 (0.58 to 1.55) and 0.53 (0.15 to 1.36), respectively., Conclusion: In this German observational cohort study, MACE did not occur more frequently with JAKi compared with other DMARDs. However, individual JAKis showed different unadjusted IRs., Competing Interests: Competing interests: YM: Lecture honoraria from Lilly, Pfizer. MS: None. KA: None. JK: None. SZ: Consulting fees from UCB, Astra-Zeneca, Galapagos, Lecture honoraria from Lilly, Jannsen, Abbvie, Biogen, Support for meeting attendance/Travel: Amgen, Leadership/ fiduciary role in other board, society, committee or advocacy group: BDRH e.V. HPT: Consulting fees from Abbvie, Chugai, Janssen, Lilly, Novartis, Galapagos, BMS, Sanofi. AS: Lecture honoraria from AbbVie, Amgen, BMS, Celltrion, MSD, Lilly, Pfizer, Roche, UCB., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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16. Global comment on the use of hydroxychloroquine during the periconception period and pregnancy in women with autoimmune diseases.
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Schreiber K, Giles I, Costedoat-Chalumeau N, Nelson-Piercy C, Dolhain RJ, Mosca M, Förger F, Fischer-Betz R, Molto A, Tincani A, Pasquier E, Marin B, Elefant E, Salmon J, Bermas BL, Sammaritano L, Clowse MEB, Chambers C, Buyon J, Inoue SA, Agmon-Levin N, Aguilera S, Emadi SA, Andersen J, Andrade D, Antovic A, Arnaud L, Christiansen AA, Avcin T, Badreh-Wirström S, Bertsias G, Bini I, Bobirca A, Branch W, Brucato A, Bultink I, Capela S, Cecchi I, Cervera R, Chighizola C, Cobilinschi C, Cuadrado MJ, Dey D, Etomi O, Espinosa G, Flint J, Fonseca JE, Fritsch-Stork R, Gerosa M, Glintborg B, Skorpen CG, Goulden B, Graversgaard C, Gunnarsson I, Gupta L, Hetland M, Hodson K, Hunt BJ, Isenberg D, Jacobsen S, Khamashta M, Levy R, Linde L, Lykke J, Meissner Y, Moore L, Morand E, Navarra S, Opris-Belinski D, Østensen M, Ozawa H, Perez-Garcia LF, Petri M, Pons-Estel GJ, Radin M, Raio L, Rottenstreich A, Ruiz-Irastorza G, Tunjić SR, Rygg M, Sciascia S, Strangfeld A, Svenungsson E, Tektonidou M, Troldborg A, Vinet E, Vojinovic J, Voss A, Wallenius M, and Andreoli L
- Subjects
- Pregnancy, Humans, Female, Hydroxychloroquine adverse effects, Autoimmune Diseases drug therapy
- Abstract
Competing Interests: The idea for this collaborative global response was born at the inaugural meeting of the EULAR study group for Reproductive Health and Family Planning in Milan in June, 2023. We would like to thank Kirsten Frøhlich (Danish Centre for Expertise in Rheumatology (CeViG), Danish Hospital for Rheumatic Diseases, Sonderborg, Denmark) for her immense logistic support throughout the process of this work. CN-P reports consultancy fees from Sanofi Aventis and UCB; speakers fees from UCB, Sanofi and Otsuka; is a medical advisor (medical advisory board) for the pregnancy sickness support charity; and a patron of the Lauren Page Trust. RJEMD reports grants from Galapagos and UCB; speakers fees from Galapagos, Eli Lilly, Novartis, and UCB; support for attending meetings from UCB; and participation on advisory boards for Galapagos and UCB. MM reports consulting fees from GSK, Eli Lilly, and AstraZeneca; speaker fees from UCB, Eli Lilly, AstraZeneca, GSK, Janssen, and AbbVie; participation on an advisory board for Idorsia; and has received Anifrolumab from AstraZeneca for compassionate use. RF-B reports consulting fees from AbbVie, Otsuka, and UCB; and speakers fees from Biogen, Bristol Myers Squibb, GSK, MSD, Novartis, Sanofi, and UCB. AM reports consulting fees from AbbVie, Biogen, Bristol Myers Squibb, MSD, Novartis, Janssen, Eli Lilly, Pfizer, Amgen, UCB, Gilead, Galapagos; speakers fees from AbbVie, Biogen, Bristol Myers Squibb, MSD, Novartis, Janssen, Eli Lilly, Pfizer, Amgen, UCB, Gilead, Galapagos; and support for attending meetings from AbbVie, Novartis, Galapagos, UCB, Janssen. AT reports speakers fees from GSK and UCB, and participation on advisory boards for Galapagos and UCB. BLB reports royalties from Up To Date and is a member of the data safety monitoring committee for the Stop Bloq study. MEBC reports grants from GSK and UCB and consulting fees from UCB. CC reports research support form Amgen, AstraZeneca, GSK, Janssen, Pfizer, Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company, Sanofi, UCB, Leo Pharma, Sun Pharma Global FZE, Gilead, Novartis, and the Gerber Foundation; and Speaker honorarium from the American Academy of Allergy, Asthma & Immunology aunual meeting. JB reports consultancy fees from Related Sciences, GSK, and Bristol Myers Squibb. DA reports speakers fees from Bristol Myers Squibb. LA reports consulting fees from Sanofi. GB reports grants from AstraZeneca and Pfizer; consulting fees from AstraZeneca and Eli Lilly; and speakers fees from Aenorasis, AstraZeneca, GSK, Eli Lilly, Novartis, and SOBI. WB reports grants from UCB; is an advisory board member for UCB; payment for expert testimony; and is a member of data safety monitoring boards for the Lutein and Zeaxanthin in Pregnancy study and the Stop Bloq study. AB reports research grants from SOBI and participation on an advisory board for SOBI. IB reports consulting fees from AstraZeneca; speakers fees from Amgen, AstraZeneca, GSK, Eli Lilly, MSD, Roche, Sanofi Genzyme, and UCB; support for attending meetings from UCB; and is an advisory group member for AstraZeneca. RC reports speakers fees from GSK, AstraZeneca, Celgene, Janssen, Eli Lilly, Pfizer, UCB, Rubió, and Werfen. SAE reports support for attending meetings from Pfizer. GE reports consulting fees from GSK and Otsuka; and speakers fees from GSK, Otsuka, and Boehringer Ingelheim. JF reports speakers fees and support for attending meetings from UCB. RF-S reports consultancy fees, speakers fees, and support for attending meetings from AstraZeneca. BG reports grants from Bristol Myers Squibb, Pfizer, and Sandoz. IG reports speakers’ fees from Otsuka and participation on an advisory board for Novartis. MH reports research grants from AbbVie, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Janssen Biologics BV, Lundbeck Foundation, MSD, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis, and Nordforsk; speakers fees from Pfizer, Medac, and Sandoz; and participation on an advisory board for AbbVie. MH has chaired the steering committee of the Danish Rheumatology Quality Registry, which receives public funding from the hospital owners and funding from pharmaceutical companies. MH cochairs EuroSpA, which generates real-world evidence of treatment of psoriatic arthritis and axial spondylorthritis on the basis of secondary data and is partly funded by Novartis. MK is an employee of GSK. RL is an employee of GSK. LFP-G reports consulting fees from Galapagos. MR is a member of the data safety monitoring committee for the Comparison of Step-up and step-down therapeutic strategies in childhood ArthritiS, which is partly supported by Pfizer. AS reports speakers fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, MSD, Eli Lilly, Pfizer, Roche, and UCB; and is principle investigator of the German Biologics Register RABBIT, which is supported by grants from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Galapagos, Hexal, Eli Lilly, MSD, Pfizer, Samsung Bioepis, Sanofi Aventis, Viatris Sante, UCB, and previously Roche. JV reports speakers’ fees from Eli Lilly, Novartis, Sandoz, and AbbVie. All other authors declare no competing interests.
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- 2023
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17. Response to: 'Correspondence on 'EULAR recommendations for a core data set for pregnancy registries in rheumatology" by De Cock et al .
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Meissner Y, Fischer-Betz R, Zink A, and Strangfeld A
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- Humans, Pregnancy, Female, Societies, Medical, Rheumatology
- Abstract
Competing Interests: Competing interests: AS: speaker fees from AbbVie, BMS, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB; AZ: speaker fees from AbbVie, Janssen, Pfizer, Roche and Sanofi-Aventis; RFB: speaker/consultant fees from AbbVie, Biogen, BMS, Celgene, Chugai, GSK, Janssen, Lilly, Medac, MSD, Novartis, Roche, UCB; YM: lecture honoraria from Pfizer.
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- 2023
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18. Pregnancy and neonatal outcomes in women with axial spondyloarthritis: pooled data analysis from the European Network of Pregnancy Registries in Rheumatology (EuNeP).
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Meissner Y, Strangfeld A, Molto A, Forger F, Wallenius M, Costedoat-Chalumeau N, Bjørngaard H, Couderc M, Flipo RM, Guettrot-Imbert G, Haase I, Jakobsen B, Koksvik HSS, Richez C, Sellam J, Weiß A, Zbinden A, and Fischer-Betz R
- Subjects
- Adult, Cesarean Section, Data Analysis, Female, Humans, Infant, Newborn, Pregnancy, Registries, Severity of Illness Index, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Tumor Necrosis Factor-alpha, Axial Spondyloarthritis, Premature Birth epidemiology, Rheumatology, Spondylarthritis drug therapy, Spondylitis, Ankylosing
- Abstract
Objective: To investigate outcome and course of pregnancies in women with axial spondyloarthritis (axSpA) in a pooled data analysis of pregnancy registries in rheumatology., Methods: Prospectively followed women with axSpA, fulfilling ASAS classification criteria and for whom a pregnancy outcome was reported, were eligible for the analysis. Anonymised data of four registries was pooled. Rates of adverse pregnancy outcomes were calculated. Systemic inflammation, disease activity and treatment patterns with tumour necrosis factor inhibitor (TNFi) before, during and after pregnancy were analysed., Results: In a total of 332 pregnancies from 304 axSpA women, 98.8% of the pregnancies resulted in live birth. Mean maternal age was 31 years and disease duration 5 years. Most of these patients received pre-conception counselling (78.4%). Before pregnancy, 53% received TNFi treatment, 27.5% in first and 21.4% in third trimester. Pregnancy and neonatal outcomes were favourable with rates of 2.2% for pre-eclampsia, 4.9% for preterm birth, 3.1% for low birth weight and 9.5% for small for gestational age. Neonates were delivered by caesarean section in 27.7% of pregnancies, of which 47.4% were emergencies. Pooled mean CRP was 4 mg/L before conception peaking in the second trimester at 9.4 mg/L. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was below 4 at all time-points., Conclusions: Pooled rates of most outcomes were better than what had been reported in the literature and within expected rates of those reported for the general population. Pre-conception counselling, planned pregnancies and a tight management in expert centres applying a tailored treatment approach may have contributed to the favourable pregnancy outcomes., Competing Interests: Competing interests: YM: lecture honoraria from Pfizer outside the scope of the submitted work. AS: speaker fees from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, Pfizer, Roche, Sanofi, UCB. AM: consulting fees and symposia: AbbVie, BMS, Janssen, MSD, Pfizer, Biogen, Galapagos, Lilly; research grants: UCB France and Pfizer. FF: Grant/research support from UCB Pharma and GSK; speakers bureau for Mepha, Roche and UCB Pharma. The GR2 study has received grants from patient associations (Lupus France; association des Sclérodermiques de France, association Gougerot Sjögren, AFPCA - Association Francophone contre la Polychondrite chronique atrophiante), from the AFM-Telethon, the French Society of Internal Medicine (SNFMI), the French Society of Rheumatology (SFR), the CMEL commission for Research and Innovation of Cochin Hospital, the Ministère de la Santé (the Clinical REsearch Contract – Database CRCBDD17003), FOREUM (Foundation for Research in Rheumatology), ORRICK society (Price Véronique ROUALET) and an unrestricted grant from UCB (the company had no role in the initiation, planning, conduct, data assembly, analysis or interpretation of the study). IH: consulting fees and symposia: Boehringer Ingelheim, Lilly. CR: consulting fees and symposia: AbbVie, Amgen, Astra Zeneca, BMS, Celltrion, GSK, MSD, Novartis, Pfizer, Biogen, Galapagos, Lilly; research grants: Biogen and Lilly. JS: consulting fees and symposia: AbbVie, BMS, Janssen, MSD, Pfizer, Roche, Sandoz, Fresenius Kabi, Galapagos, Lilly; research grants: Roche France, MSD and Pfizer. The remaining authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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19. 2022 EULAR points to consider for remote care in rheumatic and musculoskeletal diseases.
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de Thurah A, Bosch P, Marques A, Meissner Y, Mukhtyar CB, Knitza J, Najm A, Østerås N, Pelle T, Knudsen LR, Šmucrová H, Berenbaum F, Jani M, Geenen R, Krusche M, Pchelnikova P, de Souza S, Badreh S, Wiek D, Piantoni S, Gwinnutt JM, Duftner C, Canhão HM, Quartuccio L, Stoilov N, Prior Y, Bijlsma JW, Zabotti A, Stamm TA, and Dejaco C
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- Health Services Accessibility, Humans, Pandemics, COVID-19, Musculoskeletal Diseases therapy, Telemedicine
- Abstract
Background: Remote care and telehealth have the potential to expand healthcare access, and the COVID-19 pandemic has called for alternative solutions to conventional face-to-face follow-up and monitoring. However, guidance is needed on the integration of telehealth into clinical care of people with rheumatic and musculoskeletal diseases (RMD)., Objective: To develop EULAR points to consider (PtC) for the development, prioritisation and implementation of telehealth for people with RMD., Methods: A multidisciplinary EULAR task force (TF) of 30 members from 14 European countries was established, and the EULAR standardised operating procedures for development of PtC were followed. A systematic literature review was conducted to support the TF in formulating the PtC. The level of agreement among the TF was established by anonymous online voting., Results: Four overarching principles and nine PtC were formulated. The use of telehealth should be tailored to patient's needs and preferences. The healthcare team should have adequate equipment and training and have telecommunication skills. Telehealth can be used in screening for RMD as preassessment in the referral process, for disease monitoring and regulation of medication dosages and in some non-pharmacological interventions. People with RMD should be offered training in using telehealth, and barriers should be resolved whenever possible.The level of agreement to each statement ranged from 8.5 to 9.8/10., Conclusion: The PtC have identified areas where telehealth could improve quality of care and increase healthcare access. Knowing about drivers and barriers of telehealth is a prerequisite to successfully establish remote care approaches in rheumatologic clinical practice., Competing Interests: Competing interests: AN has received consulting and/or speaker’s fees from UCB, CHUGAI, BMS all unrelated to this manuscript. YM has received speakers fees from Pfizer unrelated to this manuscript. AdT has received an unrestricted grant from Novartis, and speakers fee from Pfizer and Eli Lily unrelated to this manuscript. CD has received consulting/speaker’s fees from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Galapagos and Sanofi, all unrelated to this manuscript., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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20. Effectiveness of remote care interventions: a systematic review informing the 2022 EULAR Points to Consider for remote care in rheumatic and musculoskeletal diseases.
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Marques A, Bosch P, de Thurah A, Meissner Y, Falzon L, Mukhtyar C, Bijlsma JW, Dejaco C, and Stamm TA
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- Humans, Musculoskeletal Diseases therapy
- Abstract
Objective: To perform a systematic literature review (SLR) on different outcomes of remote care compared with face-to-face (F2F) care, its implementation into clinical practice and to identify drivers and barriers in order to inform a task force formulating the EULAR Points to Consider for remote care in rheumatic and musculoskeletal diseases (RMDs)., Methods: A search strategy was developed and run in Medline (PubMed), Embase and Cochrane Library. Two reviewers independently performed standardised data extraction, synthesis and risk of bias (RoB) assessment., Results: A total of 2240 references were identified. Forty-seven of them fulfilled the inclusion criteria. Remote monitoring (n=35) was most frequently studied, with telephone/video calls being the most common mode of delivery (n=30). Of the 34 studies investigating outcomes of remote care, the majority addressed efficacy and user perception; 34% and 21% of them, respectively, reported a superiority of remote care as compared with F2F care. Time and cost savings were reported as major benefits, technical aspects as major drawback in the 13 studies that investigated drivers and barriers of remote care. No study addressed remote care implementation. The main limitation of the studies identified was the heterogeneity of outcomes and methods, as well as a substantial RoB (50% of studies with high RoB)., Conclusions: Remote care leads to similar or better results compared with F2F treatment concerning efficacy, safety, adherence and user perception outcomes, with the limitation of heterogeneity and considerable RoB of the available studies., Competing Interests: Competing interests: CD has received consulting/speaker’s fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Galapagos and Sanofi, all unrelated to this manuscript, (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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21. Pregnancy in women with psoriatic arthritis: A systematic literature review of disease activity and adverse pregnancy outcomes.
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Meissner Y, Rudi T, Fischer-Betz R, and Strangfeld A
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- Cesarean Section, Female, Humans, Infant, Newborn, Postpartum Period, Pregnancy, Pregnancy Outcome, Arthritis, Psoriatic, Premature Birth epidemiology
- Abstract
Background: There is limited robust evidence on the course of pregnancy and its outcomes in women with psoriatic arthritis (PsA) on which to base recommendations for the management of these patients., Objective: The primary objective was to review available data on (I) disease activity during pregnancy and on (II) adverse pregnancy outcomes (APO) in women with PsA. Secondly, neonatal outcomes and treatment of the rheumatic disease were investigated., Methods: Systematic literature search within the databases Pubmed and Embase until 30 Nov 2020 was performed. Additionally, reference lists of included studies and of review articles revealed by the search were screened. All full text articles identified and published in English language were systematically evaluated by two reviewers. All studies that reported on one of the primary outcomes and included at least five pregnancies in women with PsA were considered., Results: The review of 734 search results revealed 13 eligible publications reporting on a total of 2,332 pregnancies in women with PsA. Nine studies reported on PsA activity and showed an increase or worsening of disease activity after delivery compared to the pregnancy period. APOs were reported by nine studies. Adjusted analyses of APOs did not show an increased risk for gestational diabetes, small for gestational age and low birth weight in PsA patients in relation to the respective comparator groups. However, there were signals for a higher pre-eclampsia, elective caesarean section and preterm birth risk in PsA pregnancies. Meta-analysis was not performed due to study heterogeneity., Discussion: This review showed a postpartum deterioration of disease activity in women with PsA and no risk elevation for gestational diabetes, small for gestational age and low birth weight. A higher risk for pre-eclampsia, elective caesarean section and preterm birth in PsA pregnancies cannot be ruled out. Differences in the studies investigated limit overall summary statements on disease activity and APOs in women with PsA. Harmonization of study approaches, instruments and outcome reporting is crucial to ensure informed counselling of patients with PsA before, during and after pregnancy that is based on robust data., Prospero Registration Number: CRD42020162242., Competing Interests: Declaration of Competing Interest YM, TR and AS report grants from FOREUM Foundation for Research in Rheumatology during the conduct of the study. RFB has nothing to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2021
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22. EULAR recommendations for a core data set for pregnancy registries in rheumatology.
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Meissner Y, Fischer-Betz R, Andreoli L, Costedoat-Chalumeau N, De Cock D, Dolhain RJEM, Forger F, Goll D, Molto A, Nelson-Piercy C, Özdemir R, Raio L, Rodríguez-García SC, Sciascia S, Wallenius M, Zbinden A, Zink A, and Strangfeld A
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- Advisory Committees, Arthritis, Juvenile physiopathology, Arthritis, Juvenile therapy, Arthritis, Rheumatoid physiopathology, Arthritis, Rheumatoid therapy, Connective Tissue Diseases physiopathology, Connective Tissue Diseases therapy, Delphi Technique, Europe, Female, Humans, Lupus Erythematosus, Systemic physiopathology, Lupus Erythematosus, Systemic therapy, Postnatal Care, Preconception Care, Pregnancy, Pregnancy Complications physiopathology, Rheumatic Diseases physiopathology, Rheumatology, Severity of Illness Index, Spondylarthropathies physiopathology, Spondylarthropathies therapy, Antirheumatic Agents therapeutic use, Data Collection, Pregnancy Complications therapy, Pregnancy Outcome, Registries, Rheumatic Diseases therapy
- Abstract
Background and Objective: There is an urgent need for robust data on the trajectories and outcomes of pregnancies in women with inflammatory rheumatic diseases (IRD). In particular when rare outcomes or rare diseases are to be investigated, collaborative approaches are required. However, joint data analyses are often limited by the heterogeneity of the different data sources.To facilitate future research collaboration, a European League Against Rheumatism (EULAR) Task Force defined a core data set with a minimum of items to be collected by pregnancy registries in rheumatology covering the period of pregnancy and the 28-day neonatal phase in women with any underlying IRD., Methods: A stepwise process included a two-round Delphi survey and a face-to-face meeting to achieve consensus about relevant items., Results: A total of 64 multidisciplinary stakeholders from 14 different countries participated in the two rounds of the Delphi process. During the following face-to-face meeting of the EULAR Task Force, consensus was reached on 51 main items covering 'maternal information', 'pregnancy' and 'treatment'. Generic instruments for assessment are recommended for every item. Furthermore, for the five most frequent IRDs rheumatoid arthritis, spondyloarthritis, juvenile idiopathic arthritis, systemic lupus erythematosus and other connective tissue diseases, disease-specific laboratory markers and disease activity measurements are proposed., Conclusion: This is the first consensus-based core data set for prospective pregnancy registries in rheumatology. Its purpose is to stimulate and facilitate multinational collaborations that aim to increase the knowledge about pregnancy course and safety of treatment in women with IRDs during pregnancy., Competing Interests: Competing interests: AM: speaker/consultant fees: Abbvie, BMS, MSD, Novartis, Pfizer, UCB; unrestricted grants: Pfizer and UCBAS: speaker fees: AbbVie, BMS, MSD, Novartis, Pfizer, Roche, Sanofi Aventis, UCBA Zbinden: none. AZink: speaker fees from AbbVie, Janssen, Pfizer, Roche and Sanofi-Aventis. CN-P: consultancy fees from UCB and Alliance Pharma. Speaker fees from UCB, Alliance Pharma, Alexion, Sanofi, Falk, Janssen. DDC: none. DG: none. FF: consultant for UCB, GSK, Roche. Speakers bureau: UCB, GSK. Research grants from UCBLA: speaker/consultant fees: GSK, Novartis, UCB, Eli Lilly, INOVA Diagnostics/Werfen Group. LR: none. MW: none. NC-C: no personal fees. Research grants from UCBRD: received an unrestricted research grant form UCB Pharma BV and from the Dutch Arthritis Association a non-commercial fund raising organisation. RFB: speaker/consultant fees: Abbvie, Biogen, BMS, Celgene, Chugai, GSK, Janssen, Lilly, Medac, MSD, Novartis, Roche, UCBRÖ: None. SCR-G: speaker fees from Sanofi, MSD, UCB, Novartis and Janssen. SS: none. YM: lecture honoraria from Pfizer., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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23. Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register.
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Meissner Y, Schäfer M, Schneider M, Wilden E, Zinke S, Zink A, and Strangfeld A
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- Facial Nerve, Humans, Incidence, Paralysis drug therapy, Antirheumatic Agents adverse effects, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology
- Abstract
Competing Interests: Competing interests: YM: lecture honoraria from Pfizer. MSchäfer: none declared. MSchneider: grant/research support from GSK, UCB, Abbvie; consultant of Abbvie, Alexion, Astra Zeneca, BMS, Boehringer Ingelheim, Gilead, Lilly, Sanofi, UCB; speakers bureau: Abbvie, Astra Zeneca, BMS, Chugai, GSK, Lilly, Pfizer, Sanofi. EW: none declared. SZ: none declared. AZ: speakers bureau: AbbVie, Amgen, BMS, Gilead, Hexal, Janssen, Lilly, MSD, Pfizer, Roche, Sanofi Aventis, UCB. AS: speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis.
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- 2020
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24. Corrigendum to: Obesity reduces the real-world effectiveness of cytokine-targeted but not cell-targeted disease-modifying agents in rheumatoid arthritis.
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Schäfer M, Meißner Y, Kekow J, Berger S, Remstedt S, Manger B, Listing J, Strangfeld A, and Zink A
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- 2020
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25. Obesity reduces the real-world effectiveness of cytokine-targeted but not cell-targeted disease-modifying agents in rheumatoid arthritis.
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Schäfer M, Meißner Y, Kekow J, Berger S, Remstedt S, Manger B, Listing J, Strangfeld A, and Zink A
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- Abatacept administration & dosage, Abatacept therapeutic use, Adult, Aged, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized therapeutic use, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid complications, Biological Products administration & dosage, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Rituximab administration & dosage, Rituximab therapeutic use, Treatment Outcome, Tumor Necrosis Factor Inhibitors administration & dosage, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Biological Products therapeutic use, Obesity complications, Tumor Necrosis Factor Inhibitors therapeutic use
- Abstract
Objectives: The effectiveness of TNF inhibitors in RA has been shown to be affected by obesity. No such effect has been found for abatacept and rituximab, while for tocilizumab results are ambiguous. Additionally, it remains unresolved whether sex is an effect modifier for obesity. We investigated the impact of obesity on the drug effectiveness of conventional synthetic or biologic DMARDs, taking into account potential sex-specific differences., Methods: Data from 10 593 RA patients included in the German observational cohort study Rheumatoid Arthritis: oBservation of BIologic Therapy (RABBIT) since 2009 were analysed. Patients had to have a BMI ≥18.5 kg/m2, at least one follow-up and 6 months of observation time. The influence of obesity on drug effectiveness was investigated by regression analysis, adjusting for potential confounders., Results: Obesity had a negative impact on improvement in the DAS with 28 joints using ESR as an inflammation marker of -0.15 (95% CI: -0.26; -0.04) units for women receiving conventional synthetic DMARDs, -0.22 (95% CI: -0.31; -0.12) units for women receiving TNF inhibitors, -0.22 (95% CI: -0.42; -0.03) units for women receiving tocilizumab and -0.41 (95% CI: -0.74; -0.07) units for men receiving tocilizumab. Overall, no negative obesity effects on the effectiveness of rituximab and abatacept were found., Conclusion: Obesity has a negative impact on the effectiveness of cytokine-targeted but not cell-targeted therapies in daily practice, affecting more outcomes and therapies in women than in men. Overall, no effects of obesity on treatment effectiveness were found for rituximab and abatacept., (© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
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- 2020
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26. European Network of Pregnancy Registers in Rheumatology (EuNeP)-an overview of procedures and data collection.
- Author
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Meissner Y, Strangfeld A, Costedoat-Chalumeau N, Förger F, Goll D, Molto A, Özdemir R, Wallenius M, and Fischer-Betz R
- Subjects
- Adult, Arthritis, Psoriatic diagnosis, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic epidemiology, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Comorbidity, Data Collection methods, Female, France epidemiology, Germany epidemiology, Humans, Infant, Newborn, Lactation Disorders diagnosis, Lactation Disorders drug therapy, Lactation Disorders epidemiology, Norway epidemiology, Outcome Assessment, Health Care methods, Pregnancy, Pregnancy Complications diagnosis, Pregnancy Complications epidemiology, Rheumatic Diseases diagnosis, Rheumatic Diseases epidemiology, Rheumatology organization & administration, Spondylitis, Ankylosing diagnosis, Spondylitis, Ankylosing drug therapy, Spondylitis, Ankylosing epidemiology, Switzerland epidemiology, Data Collection statistics & numerical data, Outcome Assessment, Health Care statistics & numerical data, Pregnancy Complications drug therapy, Registries statistics & numerical data, Rheumatic Diseases drug therapy, Rheumatology statistics & numerical data
- Abstract
Background: The collaborative initiative of the European Network of Pregnancy Registers in Rheumatology (EuNeP) aims to combine data available in nationwide pregnancy registers to increase knowledge on pregnancy outcomes in women with inflammatory rheumatic diseases (IRD) and on drug safety during pregnancy and lactation. The objective of this study was to describe the similarities and differences of the member registers., Methods: From all registers, information about their structure and design was collected, as well as which parameters regarding demographics, maternal outcomes, treatment, course and outcome of pregnancy, and development of the child were available in the respective datasets. Furthermore, the current recruitment status was reported., Results: The four registers (EGR2 (France), RePreg (Switzerland), RevNatus (Norway), and Rhekiss (Germany)) collect information prospectively and nationwide. Patients can be enrolled before conception or during pregnancy. To date, more than 3500 patients in total have been included, and data on 2200 pregnancies with an outcome are available. The distribution of diagnoses in the respective registers varies considerably, and only three entities (rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis) are captured by all the registers. Broad consistency was found in non-disease-specific data items, but differences regarding instruments and categories as well as frequency of data collection were revealed. Disease-specific data items are less homogeneously collected., Conclusion: Although the registers in this collaboration have similar designs, we found numerous differences in the variables collected. This survey of the status quo of current pregnancy registers is the first step towards identifying data collected uniformly across registers in order to facilitate joint analyses., Trial Registration: Not applicable.
- Published
- 2019
- Full Text
- View/download PDF
27. Primary and secondary patient data in contrast: the use of observational studies like RABBIT.
- Author
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Richter A, Meißner Y, Strangfeld A, and Zink A
- Subjects
- Antirheumatic Agents adverse effects, Arthritis, Rheumatoid diagnosis, Arthritis, Rheumatoid physiopathology, Biological Products adverse effects, Data Mining, Germany, Health Services Research standards, Humans, Observational Studies as Topic, Process Assessment, Health Care, Research Design, Treatment Outcome, Administrative Claims, Healthcare, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Biological Products therapeutic use, Databases, Factual standards, Health Services Research methods, Registries standards
- Abstract
The study of secondary patient data, particularly represented by claims data, has increased in recent years. The strength of this approach involves easy access to data that have been generated for administrative purposes. By contrast, collection of primary data for research is time-consuming and may therefore appear outdated. Both administrative data and data collected prospectively in clinical care can address similar research questions concerning effectiveness and safety of treatments. Therefore, why should we invest the precious time of rheumatologists to generate primary patient data? This article will outline some features of primary patient data collection illustrated by the German biologics register RABBIT (Rheumatoid arthritis: observation of biologic therapy). RABBIT is a long-term observational cohort study that was initiated more than 15 years ago. We will discuss as quality indicators: (i) study design, (ii) type of documentation, standardisation of (iii) clinical and (iv) safety data, (v) monitoring of the longitudinal follow-up, (vi) losses to follow-up as well as (vii) the possibilities to link the data base. The impact of these features on interpretation and validity of results is illustrated using recent publications. We conclude that high quality and completeness of data prospectively-collected offers many advantages over large quantities of non-standardised data collected in an unsupervised manner. We expect the enthusiasm about the use of secondary patient data to decline with more awareness of their methodological limitations while studies with primary patient data like RABBIT will maintain and broaden their impact on daily clinical practice.
- Published
- 2016
28. Impact of disease activity and treatment of comorbidities on the risk of myocardial infarction in rheumatoid arthritis.
- Author
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Meissner Y, Zink A, Kekow J, Rockwitz K, Liebhaber A, Zinke S, Gerhold K, Richter A, Listing J, and Strangfeld A
- Subjects
- Adult, Aged, C-Reactive Protein analysis, C-Reactive Protein metabolism, Case-Control Studies, Cohort Studies, Comorbidity, Female, Humans, Incidence, Inflammation complications, Male, Middle Aged, Myocardial Infarction complications, Prospective Studies, Risk Factors, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid complications, Arthritis, Rheumatoid drug therapy, Myocardial Infarction epidemiology
- Abstract
Background: The aim was to estimate the impact of individual risk factors and treatment with various disease-modifying antirheumatic drugs (DMARDs) on the incidence of myocardial infarction (MI) in patients with rheumatoid arthritis (RA)., Methods: We analysed data from 11,285 patients with RA, enrolled in the prospective cohort study RABBIT, at the start of biologic (b) or conventional synthetic (cs) DMARDs. A nested case-control study was conducted, defining patients with MI during follow-up as cases. Cases were matched 1:1 to control patients based on age, sex, year of enrolment and five cardiovascular (CV) comorbidities. Generalized linear models were applied (Poisson regression with a random component, conditional logistic regression)., Results: In total, 112 patients developed an MI during follow-up. At baseline, during the first 6 months of follow-up and prior to the MI, inflammation markers (erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)) but not 28-joint-count disease activity score (DAS28) were significantly higher in MI cases compared to matched controls and the remaining cohort. Baseline treatment with DMARDs was similar across all groups. During follow-up bDMARD treatment was significantly more often discontinued or switched in MI cases. CV comorbidities were significantly less often treated in MI cases vs. matched controls (36 % vs. 17 %, p < 0.01). In the adjusted regression model, we found a strong association between higher CRP and MI (OR for log-transformed CRP at follow-up: 1.47, 95 % CI 1.00; 2.16). Furthermore, treatment with prednisone ≥10 mg/day (OR 1.93, 95 % CI 0.57; 5.85), TNF inhibitors (OR 0.91, 95 % CI 0.40; 2.10) or other bDMARDs (OR 0.85, 95 % CI 0.27; 2.72) was not associated with higher MI risk., Conclusions: CRP was associated with risk of MI. Our results underline the importance of tight disease control taking not only global disease activity, but also CRP as an individual marker into account. It seems irrelevant with which class of (biologic or conventional) DMARD effective control of disease activity is achieved. However, in some patients the available treatment options were insufficient or insufficiently used - regarding DMARDs to treat RA as well as regarding the treatment of CV comorbidities.
- Published
- 2016
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- View/download PDF
29. Alternative drug delivery approaches for the therapy of inflammatory bowel disease.
- Author
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Meissner Y and Lamprecht A
- Subjects
- Drug Administration Routes, Humans, Drug Delivery Systems, Inflammatory Bowel Diseases drug therapy
- Abstract
This article shall give an overview on drug delivery systems for new therapeutic strategies in the treatment of inflammatory bowel disease. The various features of the different approaches allowing locally restricted drug delivery to the inflamed colon are discussed including the main physiological and pathophysiological limitations for the different systems. Conventional drug delivery systems are tightly adapted from developments for colonic delivery by oral administration triggered by release mechanisms owing to the physiological environment that these systems encounter in the colonic region. The newer developments in this context aim for an increased selectivity of drug delivery by targeting mechanisms which have a closer relation to pathophysiological particularities of the disease. Therefore, we were focused especially on new strategies for such treatment including liposomal formulations, cyclodextrins, micro- or nanoparticles, viral gene therapy approaches, and others. Effective and selective delivery even of an otherwise nonspecifically acting drug could provide new therapeutic pathways in the treatment of inflammatory bowel disease.
- Published
- 2008
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- View/download PDF
30. Epithelial heparin delivery via microspheres mitigates experimental colitis in mice.
- Author
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Pellequer Y, Meissner Y, Ubrich N, and Lamprecht A
- Subjects
- Animals, Biological Availability, Drug Delivery Systems, Epithelium metabolism, Inflammatory Bowel Diseases drug therapy, Male, Mice, Mice, Inbred BALB C, Colitis drug therapy, Heparin, Low-Molecular-Weight administration & dosage, Microspheres
- Abstract
Low-molecular-weight heparins (LMWH) have been shown to be efficient in the treatment of inflammatory bowel disease (IBD). Parenteral heparin therapy, however, may cause hemorrhagic adverse effects. To reduce this risk, epithelial LMWH delivery in combination with a system ensuring selective drug release to the inflamed tissue was tested here. Enoxaparin loaded microspheres (MS) were administered orally to male BALB mice suffering from a pre-existing experimental colitis, whereas control groups received subcutaneous or rectal LMWH solution. Colon weight/length index and alkaline phosphatase and myeloperoxidase activities were assessed to determine the inflammation. Tissue penetration experiments elucidated the processes involved in the proposed new therapeutic approach. Oral LMWH-MS proved to be equally efficient in mitigating experimental colitis as rectally administered LMWH solution when quantified by myeloperoxidase activity (MS, 10.2+/-1.5 U/mg tissue; rectal, 9.2+/-1.6 U/mg) and to be superior to subcutaneous LMWH (s.c., 21.6+/-5.6 U/mg; untreated colitis control, 30.0+/-3.8 U/mg). Pharmacokinetic studies found a notably low systemic availability of oral LMWH delivered from MS (<5%) indicating a low potential for adverse effects. The tissue permeability was selectively enhanced in the inflamed regions where a 9-fold higher LMWH penetration was found compared with healthy tissue. Epithelial LMWH delivery has been found a promising anti-inflammatory therapeutic approach. The use of LMWH-MS in this context offers a promising tool for IBD therapy by enhancing specifically drug availability at inflamed tissue sites while reducing the risk for systemic adverse effects to a negligibly low level.
- Published
- 2007
- Full Text
- View/download PDF
31. Low molecular weight heparin loaded pH-sensitive microparticles.
- Author
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Meissner Y, Ubrich N, Ghazouani FE, Maincent P, and Lamprecht A
- Subjects
- Administration, Oral, Anti-Inflammatory Agents administration & dosage, Cetrimonium, Cetrimonium Compounds chemistry, Chemistry, Pharmaceutical, Delayed-Action Preparations, Drug Compounding, Emulsions, Enoxaparin administration & dosage, Gastrointestinal Agents administration & dosage, Heparin, Low-Molecular-Weight chemistry, Hexoses chemistry, Hydrogen-Ion Concentration, Kinetics, Oils chemistry, Particle Size, Solubility, Surface Properties, Surface-Active Agents chemistry, Technology, Pharmaceutical, Water chemistry, Anti-Inflammatory Agents chemistry, Drug Carriers, Enoxaparin chemistry, Gastrointestinal Agents chemistry, Methacrylates chemistry, Microspheres, Polymers chemistry
- Abstract
Low molecular weight heparins (LMWH) have shown efficacy in the treatment of inflammatory bowel disease after parenteral administration however risking severe hemorrhagic adverse effects. Therefore, an oral colonic targeted heparin dosage form allowing the release of LMWH directly in the inflamed tissue would be of major interest. Enoxaparin was entrapped into pH-sensitive microspheres using Eudragit P4135F that dissolves at pH>7.2. Particle preparation was based on a double emulsion technique with either solvent extraction or evaporation. In order to increase the entrapment efficacy several preparation parameters were optimized, such as inner phase volume, polymer concentration, stabilization of the internal interface by surfactants. Solvent evaporation led to higher entrapment rates (evaporation: 70.1+/-9.9%; extraction: 46.5+/-6.4%). When increasing the volume of the inner aqueous heparin phase, lower encapsulation rates and larger microspheres ( approximately 100-400 microm) were obtained. Sorbitan monostearate (1.75-28% of the total particle mass) had a stabilizing effect on the primary water/oil emulsion. Indeed, higher encapsulation rates (7%: 78.2+/-3.5%; 14%: 76.4+/-10.1%) and smaller particles ( approximately 120-160 microm) were obtained whereas hexadecyltrimethylammonium bromide destabilized the primary emulsion. Interfacial tension studies at a simulated internal water/oil interface confirmed these results. As expected, in vitro drug release was found to be strongly pH-dependent; LMWH was retained in microspheres at pH<6 (<20% release within 4h) whereas a fast drug release was obtained at pH 7.4. The developed microspheres exhibited a particle size adapted to the needs of inflammatory bowel disease therapy, an efficient LMWH encapsulation, and a pH-controlled drug release. These microspheres represent a promising tool for the selective oral delivery of heparin to the colon, especially interesting in the treatment of inflammatory bowel disease.
- Published
- 2007
- Full Text
- View/download PDF
32. Nanoparticles in inflammatory bowel disease: particle targeting versus pH-sensitive delivery.
- Author
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Meissner Y, Pellequer Y, and Lamprecht A
- Subjects
- Administration, Oral, Animals, Biocompatible Materials chemistry, Blood Urea Nitrogen, Colon enzymology, Colon pathology, Creatinine blood, Disease Models, Animal, Hydrogen-Ion Concentration, Injections, Subcutaneous, Irritable Bowel Syndrome enzymology, Irritable Bowel Syndrome pathology, Male, Mice, Organ Size, Peroxidase metabolism, Tacrolimus administration & dosage, Colon drug effects, Drug Delivery Systems, Irritable Bowel Syndrome drug therapy, Nanostructures, Tacrolimus therapeutic use
- Abstract
Tacrolimus proved its distinct mitigating potential in the treatment of inflammatory bowel disease (IBD). Due to the risk for severe adverse effects and to achieve increased efficiency and tolerability, a selective delivery to the site of inflammation is of interest. Tacrolimus nanoparticles (NP) were tested for their efficiency in local treatment of inflamed bowel tissue in IBD. Drug loaded NP were prepared from either biodegradable poly(lactide-co-glycolide) (PLGA) or pH-sensitive Eudragit P-4135F by using a simple oil/water emulsification method. Tests on the therapeutic effect were conducted using dextran sulfate model colitis in mice receiving tacrolimus formulations daily for 12 days. Clinical activity score and myeloperoxidase activity decreased while colon length increased significantly after administration of all tacrolimus containing formulations. Oral NP formulations were less efficient in mitigating the experimental colitis compared to subcutaneous drug solution (PLGA: 7.88 +/- 0.83; P-4135F: 7.48 +/- 0.42; subcutaneous: 5.27 +/- 0.68 U/mg) but superior to drug solution given by oral route (oral: 8.75 +/- 1.34; untreated colitis control: 9.95 +/- 0.92, all U/mg tissue). Tacrolimus solution groups (oral/subcutaneous) exhibited increased levels of adverse effects, whereas both NP groups demonstrated their potential to reduce nephrotoxicity. Both strategies showed similar mitigating effects while nephrotoxic adverse effects were slightly less expressed with pH-sensitive NP.
- Published
- 2006
- Full Text
- View/download PDF
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