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1. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting

Author

Aberer, W., Grumach, A., Bygum, A., Blanchard Delaunay, C., Bouillet, L., Coppere, B., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Arnolds, J., Aygören-Pürsün, E., Baş, M., Bauer, A., Bork, K., Martinez, I., Maurer, M., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Baeza, M.L., Caballero, T., Cabañas, R., Guilarte, M., Hernandez de Rojas, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Sáenz de San Pedro, B., Bjorkander, J., Helbert, M., Longhurst, H.J., Zanichelli, Andrea, Longhurst, Hilary J., Maurer, Marcus, Bouillet, Laurence, Aberer, Werner, Fabien, Vincent, Andresen, Irmgard, and Caballero, Teresa

Published
2016
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2. Clinical Presentation, Diagnosis, and Bacterial Epidemiology of Peritoneal Tuberculosis in Two University Hospitals in France

Author

Cavalli, Zoé, Ader, Florence, Valour, Florent, Saison, Julien, Boussel, Loïc, Dumitrescu, Oana, Perpoint, Thomas, Chidiac, Christian, May, Thierry, Ferry, Tristan, Adelaïde, L., Ader, F., Biron, F., Boibieux, A., Bouaziz, A., Bouledrak, K., Braun, E., Broussolle, C., Carret, G., Catho, G., Charhon, N., Chidiac, C., Chumbi-Flores, W., Coppere, B., Couraud, S., Demontclos, M., Devouassoux, G., Dumitrescu, O., Ernesto, S., Ferry, T., Floret, D., Fredenucci, I., Freymond, N., Gardes, S., Gerbier-Colomban, S., Gillet, Y., Girard-Madoux, M. H., Goutelle, S., Grando, J., Grima, R., Hees, L., Hodille, E., Hot, A., Karsenty, J., Kiakouama-Maleka, L., Lina, G., Maury, J. M., Miailhes, P., Moreau, L., Nesme, P., Ninet, J., Perard, L., Perpoint, T., Perrot, E., Ranc, A. G., Rasigade, J. P., Reix, R., Renaud-Baron, A. S., Saison, J., Senechal, A., Sève, P., Souquet, P. J., van Thai, H., Tronc, F., Valour, F., Vanhems, P., and Lyon TB Study group

Published
2016
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4. Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice

Author

Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., Garcez, T., Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., and Garcez, T.

Subjects
safety, 0301 basic medicine, real-world, medicine.medical_specialty, Immunology, Brief Communication, Off-label use, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Icatibant, Internal medicine, angioedema, icatibant, Immunology and Allergy, Medicine, Reflux esophagitis, Adverse effect, Pregnancy, Angioedema, business.industry, real‐world, medicine.disease, 030104 developmental biology, 030228 respiratory system, chemistry, Anesthesia, Observational study, Long term safety, medicine.symptom, business
Abstract

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real‐world setting. We analyzed safety data from 3025 icatibant‐treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off‐label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on‐label vs off‐label icatibant users.

Published
2017
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5. Elderly versus younger patients with hereditary angioedema type I/II: patient characteristics and safety analysis from the Icatibant Outcome Survey

Author

Bygum A, Caballero T, Grumach A, Longhurst H, Bouillet L, Aberer W, Zanichelli A, Botha J, Andresen I, Maurer M, Delaunay C, Boccon-Gibod I, Coppere B, Du Thanh A, Dzviga C, Fain O, Goichot B, Gompel A, Guez S, Jeandel P, Kanny G, Launay D, Maillard H, Martin L, Masseau A, Ollivier Y, Sobel A, Aygoren-Pursun E, Bas M, Bauer M, Bork K, Greve J, Magerl M, Martinez-Saguer I, Strassen U, Papadopoulou-Alataki E, Psarros F, Graff Y, Kivity S, Reshef A, Toubi E, Arcoleo F, Bova M, Cicardi M, Nconi P, Marone G, Montinaro V, Triggiani M, Baeza M, Cabanas R, Guilarte M, Hernandez D, de Larramendi C, Lleonart R, Lobera T, Marques L, Pedro B, Bjorkander J, Bethune C, Garcez T, and IOS Study Grp

Subjects
Hereditary angioedema, Elderly, Icatibant Outcome Survey, Safety
Abstract

Background: Hereditary angioedema with C1 inhibitor deficiency (C1-INH-HAE) is characterized by recurrent swelling in subcutaneous or submucosal tissues. Symptoms often begin by age 5-11 years and worsen during puberty, but attacks can occur at any age and recur throughout life. Disease course in elderly patients is rarely reported. Methods: The Icatibant Outcome Survey (IOS) is an observational study evaluating the safety, tolerability, and efficacy of icatibant. We conducted descriptive analyses in younger (age < 65 years) versus elderly patients (age >= 65 years). Here, we report patient characteristics and safety-related findings. Results: As of February 2018, 872 patients with C1-INH-HAE type I/II were enrolled, of whom 100 (11.5%) were >= 65 years old. Significant differences between elderly versus younger patients, respectively, were noted for median age at symptom onset (17.0 vs 12.0 years), age at diagnosis (41.0 vs 19.4 years), and delay between symptom onset and diagnosis (23.9 vs 4.8 years) (P

Published
2019

6. Breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis are responsive to icatibant:findings from the Icatibant Outcome Survey

Author

Aberer, Werner, Maurer, Marcus, Bouillet, Laurence, Zanichelli, Andrea, Caballero, Teresa, Longhurst, Hilary J., Perrin, Amandine, Andresen, Irmgard, Wiednig, M., Grumach, A., Bygum, A., Blanchard Delauny, C., Boccon-Gibod, I., Coppere, B., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P. Y., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Arnolds, J., Aygören-Pürsün, E., Bas, M., Bauer, M., Bork, K., Magerl, M., Martinez-Saguer, I., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Montinaro, V., Marone, G., Baeza, M. L., Cabañas, R., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Bjoerkander, J., Bethune, C., Garcez Pereira, T., Helbert, M., Aberer, Werner, Maurer, Marcu, Bouillet, Laurence, Zanichelli, Andrea, Caballero, Teresa, Longhurst, Hilary J., Perrin, Amandine, Andresen, Irmgard, Wiednig, M., Grumach, A., Bygum, A., Blanchard Delauny, C., Boccon-Gibod, I., Coppere, B., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P. Y., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Arnolds, J., Aygören-Pürsün, E., Bas, M., Bauer, M., Bork, K., Magerl, M., Martinez-Saguer, I., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Montinaro, V., Marone, G., Baeza, M. L., Cabañas, R., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Bjoerkander, J., Bethune, C., Garcez Pereira, T., and Helbert, M.

Subjects
lcsh:Immunologic diseases. Allergy, Pulmonary and Respiratory Medicine, Breakthrough attack, Immunology, Attack rate, Time to treatment, Long term prophylaxis, Bradykinin, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Icatibant, Immunology and Allergy, Medicine, In patient, 030212 general & internal medicine, Prophylaxi, Breakthrough attacks, Hereditary angioedema, business.industry, Prophylaxis, Research, musculoskeletal, neural, and ocular physiology, General Medicine, medicine.disease, Rescue medication, Treatment characteristics, 030228 respiratory system, chemistry, nervous system, Anesthesia, lcsh:RC581-607, business
Abstract

BACKGROUND: Patients with hereditary angioedema (HAE) due to C1-inhibitor deficiency (C1-INH-HAE) experience recurrent attacks of cutaneous or submucosal edema that may be frequent and severe; prophylactic treatments can be prescribed to prevent attacks. However, despite the use of long-term prophylaxis (LTP), breakthrough attacks are known to occur. We used data from the Icatibant Outcome Survey (IOS) to evaluate the characteristics of breakthrough attacks and the effectiveness of icatibant as a treatment option.METHODS: Data on LTP use, attacks, and treatments were recorded. Attack characteristics, treatment characteristics, and outcomes (time to treatment, time to resolution, and duration of attack) were compared for attacks that occurred with versus without LTP.RESULTS: Data on 3228 icatibant-treated attacks from 448 patients with C1-INH-HAE were analyzed; 30.1% of attacks occurred while patients were using LTP. Attack rate, attack severity, and the distribution of attack sites were similar across all types of LTP used, and were comparable to the results found in patients who did not receive LTP. Attacks were successfully treated with icatibant; 82.5% of all breakthrough attacks were treated with a single icatibant injection without C1-INH rescue medication. Treatment outcomes were comparable for breakthrough attacks across all LTP types, and for attacks without LTP.CONCLUSIONS: Patients who use LTP should be aware that breakthrough attacks can occur, and such attacks can be severe. Thus, patients with C1-INH-HAE using LTP should have emergency treatment readily available. Data from IOS show that icatibant is effective for the treatment of breakthrough attacks. Trial Registration NCT01034969.

Published
2017
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7. The Icatibant Outcome Survey: experience of hereditary angioedema management from six European countries

Author

Caballero, T., Aberer, W., Longhurst, H.J., Maurer, M., Zanichelli, A., Perrin, A., Bouillet, L., Andresen, I., Arcoleo, F., Bova, M., Cicardi, M., Cillari, E., Montinaro, V., Marone, G., Blanchard Delauny, C., Boccon‐Gibod, I., Coppere, B., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P.Y., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Magerl, M., Baeza, M.L., Cabañas, R., Guilarte, M., Hernández, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marqués, L., Bangs, C., Buckland, M., Grigoriadou, S., Helbert, M., Lorenzo, L., Caballero, T., Aberer, W., Longhurst, H. J., Maurer, M., Zanichelli, A., Perrin, A., Bouillet, L., Andresen, I., Arcoleo, F., Bova, M., Cicardi, M., Cillari, E., Montinaro, V., Marone, G., Blanchard Delauny, C., Boccon-Gibod, I., Coppere, B., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P. Y., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Magerl, M., Baeza, M. L., Cabañas, R., Guilarte, M., Hernández, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marqués, L., Bangs, C., Buckland, M., Grigoriadou, S., Helbert, M., and Lorenzo, L.

Subjects
Male, Pediatrics, medicine.medical_specialty, Treatment outcome, Dermatology, Bradykinin, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Icatibant, Original Articles and Short Reports, Bradykinin B2 Receptor Antagonists, media_common.cataloged_instance, Medicine, Humans, In patient, 030212 general & internal medicine, Registries, European union, media_common, Retrospective Studies, business.industry, Significant difference, Angioedemas, Hereditary, Retrospective cohort study, medicine.disease, Urticaria ‐ Angioderma ‐ Pruritus, Europe, Treatment Outcome, Infectious Diseases, 030228 respiratory system, chemistry, Hereditary angioedema, Observational study, Original Article, Female, business
Abstract

Background Hereditary angioedema (HAE) due to C1-inhibitor deficiency (C1-INH-HAE) is a rare, potentially fatal, bradykinin-mediated disease. Icatibant is a bradykinin B2 receptor antagonist originally approved in 2008 in the European Union and 2011 in the United States as an acute therapy option for HAE attacks in adults. Objective To compare demographics, disease characteristics and treatment outcomes of icatibant-treated HAE attacks in patients with C1-INH-HAE enrolled in the Icatibant Outcome Survey across six European countries: Austria, France, Germany, Italy, Spain and the UK. Methods The Icatibant Outcome Survey [IOS; Shire, Zug, Switzerland (NCT01034969)] is an international observational study monitoring the safety and effectiveness of icatibant. Descriptive, retrospective analyses compared IOS country data derived during July 2009–April 2015. Results Overall, 481 patients with C1-INH-HAE provided demographic data. A significant difference across countries in age at onset (P = 0.003) and baseline attack frequency (P < 0.001) was found although no significant differences were found with respect to gender (majority female; P = 0.109), age at diagnosis (P = 0.182) or delay in diagnosis (P = 0.059). Icatibant was used to treat 1893 attacks in 325 patients with majority self-administration in all countries. Overall, significant differences (all P < 0.001) were found across countries in time to treatment [median 1.8 h; median range: 0.0 (Germany–Austria) to 4.4 (France) h], time to resolution [median 6.5 h; median range: 3 (Germany–Austria) to 12 (France) h] and attack duration [median 10.5 h; median range: 3.1 (Germany–Austria) to 18.5 (France) h]. Conclusion These data form the first European cross-country comparison of disease characteristics and icatibant use in patients with C1-INH-HAE who are enrolled in IOS. International variation in icatibant practice and treatment outcomes across the six European countries assessed highlight the need to further investigate the range of country-specific parameters driving regional variations in icatibant use.

Published
2017

8. Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study

Author

Herrick, A, Peytrignet, S, Lunt, M, Pan, X, Hesselstrand, R, Mouthon, L, Silman, A, Dinsdale, G, Brown, E, Czirják, L, Distler, J, Distler, O, Fligelstone, K, Gregory, W, Ochiel, R, Vonk, M, Ancuţa, C, Ong, V, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jobanputra, P, Jordan, A, Stevens, W, Moinzadeh, P, Hall, F, Agard, C, Anderson, M, Diot, E, Madhok, R, Akil, M, Buch, M, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, Macgregor, A, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P, Fauchais, A, Hachulla, E, Hamilton, J, İnanç, M, McLaren, J, Van Laar, J, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D, Grange, C, Trad, G, and Denton, C

Subjects
Adult, Male, Skin/pathology, systemic sclerosis, autoantibodies, Severity of Illness Index, Scleroderma, Diffuse/diagnosis, outcomes research, Predictive Value of Tests, Skin Tests/statistics & numerical data, Humans, Prospective Studies, Skin, Skin Tests, RNA Polymerase III, Clinical and Epidemiological Research, Early Diagnosis, Logistic Models, ROC Curve, RNA Polymerase III/analysis, Area Under Curve, Scleroderma, Diffuse, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Disease Progression, Female, Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study
Abstract

ObjectivesOur aim was to use the opportunity provided by the European Scleroderma Observational Study to (1) identify and describe those patients with early diffuse cutaneous systemic sclerosis (dcSSc) with progressive skin thickness, and (2) derive prediction models for progression over 12 months, to inform future randomised controlled trials (RCTs). MethodsThe modified Rodnan skin score (mRSS) was recorded every 3 months in 326 patients. ‘Progressors’ were defined as those experiencing a 5-unit and 25% increase in mRSS score over 12 months (±3 months). Logistic models were fitted to predict progression and, using receiver operating characteristic (ROC) curves, were compared on the basis of the area under curve (AUC), accuracy and positive predictive value (PPV). Results66 patients (22.5%) progressed, 227 (77.5%) did not (33 could not have their status assessed due to insufficient data). Progressors had shorter disease duration (median 8.1 vs 12.6 months, P=0.001) and lower mRSS (median 19 vs 21 units, P=0.030) than non-progressors. Skin score was highest, and peaked earliest, in the anti-RNA polymerase III (Pol3+) subgroup (n=50). A first predictive model (including mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.666 and PPV of 33.8%. By adding a variable for Pol3 positivity, the model reached an accuracy of 71%, AUC of 0.711 and PPV of 41%. ConclusionsTwo prediction models for progressive skin thickening were derived, for use both in clinical practice and for cohort enrichment in RCTs. These models will inform recruitment into the many clinical trials of dcSSc projected for the coming years. Trial registration numberNCT02339441.

Published
2018
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9. The Icatibant Outcome Survey: Treatment of laryngeal angioedema attacks

Author

Longhurst, Hilary J, Aberer, Werner, Bouillet, Laurence, Caballero, Teresa, Maurer, Marcus, Fabien, Vincent, Zanichelli, Andrea, Bygum, A., Boccon Gibod, I., Coppere, B., Fain, O., Jeandel, P. Y., Kanny, G., Launay, D., Martin, L., Masseau, A., Ollivier, Y., Graif, Y., Montinaro, V., Guilarte, M., Marques, L., BOVA, MARIA, MARONE, GIANNI, Longhurst, Hilary J, Aberer, Werner, Bouillet, Laurence, Caballero, Teresa, Maurer, Marcu, Fabien, Vincent, Zanichelli, Andrea, Bygum, A., Boccon Gibod, I., Coppere, B., Fain, O., Jeandel, P. Y., Kanny, G., Launay, D., Martin, L., Masseau, A., Ollivier, Y., Graif, Y., Bova, Maria, Montinaro, V., Marone, Gianni, Guilarte, M., and Marques, L.

Subjects
Male, Pediatrics, medicine.medical_specialty, Injections, Subcutaneous, Bradykinin, Laryngeal Diseases, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Short Reports, Icatibant, Surveys and Questionnaires, medicine, Retrospective analysis, Humans, 030212 general & internal medicine, laryngeal edema, skin and connective tissue diseases, Retrospective Studies, therapy, Hereditary Angioedema Types I and II, Angioedema, C1-inhibitor deficiency, business.industry, icatibant, Anti-Inflammatory Agents, Non-Steroidal, Angioedemas, Hereditary, 030208 emergency & critical care medicine, Retrospective cohort study, medicine.disease, hereditary angioedema, Treatment Outcome, chemistry, Anesthesia, Concomitant, Hereditary angioedema, Emergency Medicine, Female, Observational study, observational study, medicine.symptom, acquired angioedema, business
Abstract

Objective To characterize the management and outcomes of life-threatening laryngeal attacks of hereditary angioedema (HAE) treated with icatibant in the observational Icatibant Outcome Survey (NCT01034969) registry. Methods This retrospective analysis was based on data from patients with HAE type I/II who received healthcare professional-administered or self-administered icatibant to treat laryngeal attacks between September 2008 and May 2013. Results Twenty centers in seven countries contributed data. Overall, 42 patients with HAE experienced 67 icatibant-treated laryngeal attacks. Icatibant was self-administered for 62.3% of attacks (healthcare professional-administered, 37.7%). One icatibant injection was used for 87.9% of attacks, with rescue or concomitant medication used for 9.0%. The median time to treatment was 2.0 h (n=31 attacks) and the median time to resolution was 6.0 h (n=35 attacks). Conclusions This analysis describes successful use of icatibant for the treatment of laryngeal HAE attacks in a real-world setting.

Published
2016

10. Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study

Author

Herrick, A.L., Peytrignet, S., Lunt, M., Pan, X., Hesselstrand, R., Mouthon, L., Silman, A.J., Dinsdale, G., Brown, E., Czirjak, L., Distler, J.H., Distler, O., Fligelstone, K., Gregory, W.J., Ochiel, R., Vonk, M.C., Ancuta, C., Ong, V.H., Farge, D., Hudson, M., Matucci-Cerinic, M., Balbir-Gurman, A., Midtvedt, O., Jobanputra, P., Jordan, A.C., Stevens, W.B.C., Moinzadeh, P., Hall, F.C., Agard, C., Anderson, M.E., Diot, E., Madhok, R., Akil, M., Buch, M.H., Chung, L., Damjanov, N.S., Gunawardena, H., Lanyon, P., Ahmad, Y., Chakravarty, K., Jacobsen, S., MacGregor, A.J., McHugh, N., Muller-Ladner, U., Riemekasten, G., Becker, M., Roddy, J., Carreira, P.E., Fauchais, A.L., Hachulla, E., Hamilton, J., Inanc, M., McLaren, J.S., Laar, J.M. van, Pathare, S., Proudman, S.M., Rudin, A., Sahhar, J., Coppere, B., Serratrice, C., Sheeran, T., Veale, D.J., Grange, C., Trad, G.S., Denton, C.P., Herrick, A.L., Peytrignet, S., Lunt, M., Pan, X., Hesselstrand, R., Mouthon, L., Silman, A.J., Dinsdale, G., Brown, E., Czirjak, L., Distler, J.H., Distler, O., Fligelstone, K., Gregory, W.J., Ochiel, R., Vonk, M.C., Ancuta, C., Ong, V.H., Farge, D., Hudson, M., Matucci-Cerinic, M., Balbir-Gurman, A., Midtvedt, O., Jobanputra, P., Jordan, A.C., Stevens, W.B.C., Moinzadeh, P., Hall, F.C., Agard, C., Anderson, M.E., Diot, E., Madhok, R., Akil, M., Buch, M.H., Chung, L., Damjanov, N.S., Gunawardena, H., Lanyon, P., Ahmad, Y., Chakravarty, K., Jacobsen, S., MacGregor, A.J., McHugh, N., Muller-Ladner, U., Riemekasten, G., Becker, M., Roddy, J., Carreira, P.E., Fauchais, A.L., Hachulla, E., Hamilton, J., Inanc, M., McLaren, J.S., Laar, J.M. van, Pathare, S., Proudman, S.M., Rudin, A., Sahhar, J., Coppere, B., Serratrice, C., Sheeran, T., Veale, D.J., Grange, C., Trad, G.S., and Denton, C.P.

Abstract

Contains fulltext : 191335.pdf (publisher's version ) (Open Access), OBJECTIVES: Our aim was to use the opportunity provided by the European Scleroderma Observational Study to (1) identify and describe those patients with early diffuse cutaneous systemic sclerosis (dcSSc) with progressive skin thickness, and (2) derive prediction models for progression over 12 months, to inform future randomised controlled trials (RCTs). METHODS: The modified Rodnan skin score (mRSS) was recorded every 3 months in 326 patients. 'Progressors' were defined as those experiencing a 5-unit and 25% increase in mRSS score over 12 months (+/-3 months). Logistic models were fitted to predict progression and, using receiver operating characteristic (ROC) curves, were compared on the basis of the area under curve (AUC), accuracy and positive predictive value (PPV). RESULTS: 66 patients (22.5%) progressed, 227 (77.5%) did not (33 could not have their status assessed due to insufficient data). Progressors had shorter disease duration (median 8.1 vs 12.6 months, P=0.001) and lower mRSS (median 19 vs 21 units, P=0.030) than non-progressors. Skin score was highest, and peaked earliest, in the anti-RNA polymerase III (Pol3+) subgroup (n=50). A first predictive model (including mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.666 and PPV of 33.8%. By adding a variable for Pol3 positivity, the model reached an accuracy of 71%, AUC of 0.711 and PPV of 41%. CONCLUSIONS: Two prediction models for progressive skin thickening were derived, for use both in clinical practice and for cohort enrichment in RCTs. These models will inform recruitment into the many clinical trials of dcSSc projected for the coming years. TRIAL REGISTRATION NUMBER: NCT02339441.

Published
2018

11. Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study.

Author

Midtvedt O., Veale D.J., Grange C., Trad G.-S., Denton C.P., Herrick A.L., Peytrignet S., Lunt M., Pan X., Hesselstrand R., Mouthon L., Silman A.J., DInsdale G., Brown E., Czirjak L., DIstler J.H.W., DIstler O., Fligelstone K., Gregory W.J., Ochiel R., Vonk M.C., Ancu C., Ong V.H., Farge D., Hudson M., Matucci-Cerinic M., Balbir-Gurman A., Jobanputra P., Jordan A.C., Stevens W., Moinzadeh P., Hall F.C., Agard C., Anderson M.E., DIot E., Madhok R., Akil M., Buch M.H., Chung L., Damjanov N.S., Gunawardena H., Lanyon P., Ahmad Y., Chakravarty K., Jacobsen S., MacGregor A.J., McHugh N., Muller-Ladner U., Riemekasten G., Becker M., Roddy J., Carreira P.E., Fauchais A.L., Hachulla E., Hamilton J., Inanc M., McLaren J.S., Van Laar J.M., Pathare S., Proudman S.M., Rudin A., Sahhar J., Coppere B., Serratrice C., Sheeran T., Midtvedt O., Veale D.J., Grange C., Trad G.-S., Denton C.P., Herrick A.L., Peytrignet S., Lunt M., Pan X., Hesselstrand R., Mouthon L., Silman A.J., DInsdale G., Brown E., Czirjak L., DIstler J.H.W., DIstler O., Fligelstone K., Gregory W.J., Ochiel R., Vonk M.C., Ancu C., Ong V.H., Farge D., Hudson M., Matucci-Cerinic M., Balbir-Gurman A., Jobanputra P., Jordan A.C., Stevens W., Moinzadeh P., Hall F.C., Agard C., Anderson M.E., DIot E., Madhok R., Akil M., Buch M.H., Chung L., Damjanov N.S., Gunawardena H., Lanyon P., Ahmad Y., Chakravarty K., Jacobsen S., MacGregor A.J., McHugh N., Muller-Ladner U., Riemekasten G., Becker M., Roddy J., Carreira P.E., Fauchais A.L., Hachulla E., Hamilton J., Inanc M., McLaren J.S., Van Laar J.M., Pathare S., Proudman S.M., Rudin A., Sahhar J., Coppere B., Serratrice C., and Sheeran T.

Abstract

Objectives Our aim was to use the opportunity provided by the European Scleroderma Observational Study to (1) identify and describe those patients with early diffuse cutaneous systemic sclerosis (dcSSc) with progressive skin thickness, and (2) derive prediction models for progression over 12 months, to inform future randomised controlled trials (RCTs). Methods The modified Rodnan skin score (mRSS) was recorded every 3 months in 326 patients. 'Progressors' were defined as those experiencing a 5-unit and 25% increase in mRSS score over 12 months (+/-3 months). Logistic models were fitted to predict progression and, using receiver operating characteristic (ROC) curves, were compared on the basis of the area under curve (AUC), accuracy and positive predictive value (PPV). Results 66 patients (22.5%) progressed, 227 (77.5%) did not (33 could not have their status assessed due to insufficient data). Progressors had shorter disease duration (median 8.1 vs 12.6 months, P=0.001) and lower mRSS (median 19 vs 21 units, P=0.030) than non-progressors. Skin score was highest, and peaked earliest, in the anti-RNA polymerase III (Pol3+) subgroup (n=50). A first predictive model (including mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.666 and PPV of 33.8%. By adding a variable for Pol3 positivity, the model reached an accuracy of 71%, AUC of 0.711 and PPV of 41%. Conclusions Two prediction models for progressive skin thickening were derived, for use both in clinical practice and for cohort enrichment in RCTs. These models will inform recruitment into the many clinical trials of dcSSc projected for the coming years. Trial registration number NCT02339441.Copyright © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Published
2018

12. Patterns and predictors of skin score change in early diffuse systemic sclerosis from the European Scleroderma Observational Study.

Author

Herrick, AL, Peytrignet, S, Lunt, M, Pan, X, Hesselstrand, R, Mouthon, L, Silman, AJ, Dinsdale, G, Brown, E, Czirják, L, Distler, JHW, Distler, O, Fligelstone, K, Gregory, WJ, Ochiel, R, Vonk, MC, Ancuţa, C, Ong, VH, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jobanputra, P, Jordan, AC, Stevens, W, Moinzadeh, P, Hall, FC, Agard, C, Anderson, ME, Diot, E, Madhok, R, Akil, M, Buch, MH, Chung, L, Damjanov, NS, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, AJ, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, PE, Fauchais, AL, Hachulla, E, Hamilton, J, İnanç, M, McLaren, JS, van Laar, JM, Pathare, S, Proudman, SM, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, DJ, Grange, C, Trad, G-S, Denton, CP, Herrick, AL, Peytrignet, S, Lunt, M, Pan, X, Hesselstrand, R, Mouthon, L, Silman, AJ, Dinsdale, G, Brown, E, Czirják, L, Distler, JHW, Distler, O, Fligelstone, K, Gregory, WJ, Ochiel, R, Vonk, MC, Ancuţa, C, Ong, VH, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jobanputra, P, Jordan, AC, Stevens, W, Moinzadeh, P, Hall, FC, Agard, C, Anderson, ME, Diot, E, Madhok, R, Akil, M, Buch, MH, Chung, L, Damjanov, NS, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, AJ, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, PE, Fauchais, AL, Hachulla, E, Hamilton, J, İnanç, M, McLaren, JS, van Laar, JM, Pathare, S, Proudman, SM, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, DJ, Grange, C, Trad, G-S, and Denton, CP

Abstract

OBJECTIVES: Our aim was to use the opportunity provided by the European Scleroderma Observational Study to (1) identify and describe those patients with early diffuse cutaneous systemic sclerosis (dcSSc) with progressive skin thickness, and (2) derive prediction models for progression over 12 months, to inform future randomised controlled trials (RCTs). METHODS: The modified Rodnan skin score (mRSS) was recorded every 3 months in 326 patients. 'Progressors' were defined as those experiencing a 5-unit and 25% increase in mRSS score over 12 months (±3 months). Logistic models were fitted to predict progression and, using receiver operating characteristic (ROC) curves, were compared on the basis of the area under curve (AUC), accuracy and positive predictive value (PPV). RESULTS: 66 patients (22.5%) progressed, 227 (77.5%) did not (33 could not have their status assessed due to insufficient data). Progressors had shorter disease duration (median 8.1 vs 12.6 months, P=0.001) and lower mRSS (median 19 vs 21 units, P=0.030) than non-progressors. Skin score was highest, and peaked earliest, in the anti-RNA polymerase III (Pol3+) subgroup (n=50). A first predictive model (including mRSS, duration of skin thickening and their interaction) had an accuracy of 60.9%, AUC of 0.666 and PPV of 33.8%. By adding a variable for Pol3 positivity, the model reached an accuracy of 71%, AUC of 0.711 and PPV of 41%. CONCLUSIONS: Two prediction models for progressive skin thickening were derived, for use both in clinical practice and for cohort enrichment in RCTs. These models will inform recruitment into the many clinical trials of dcSSc projected for the coming years. TRIAL REGISTRATION NUMBER: NCT02339441.

Published
2018

13. Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS)

Author

Herrick, A, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, J, Distler, O, Fligelstone, K, Gregory, W, Ochiel, R, Vonk, M, Ancuţa, C, Ong, V, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, A, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, F, Agard, C, Anderson, M, Diot, E, Madhok, R, Akil, M, Buch, M, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, Macgregor, A, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, P, Fauchais, A, Hachulla, E, Hamilton, J, İnanç, M, McLaren, J, Van Laar, J, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, D, Grange, C, Trad, G, and Denton, C

Subjects
Adult, Male, Methotrexate/therapeutic use, RNA Polymerase III/immunology, Antibodies, Antinuclear/immunology, Systemic Sclerosis, Severity of Illness Index, Cohort Studies, Early Medical Intervention, Journal Article, Humans, Prospective Studies, Cyclophosphamide, Autoantibodies, Nuclear Proteins, RNA Polymerase III, Mycophenolic Acid/therapeutic use, Clinical and Epidemiological Research, Middle Aged, Mycophenolic Acid, Scleroderma, Diffuse/drug therapy, Treatment, Europe, Survival Rate, Methotrexate, Treatment Outcome, DNA Topoisomerases, Type I, Cyclophosphamide/therapeutic use, Antibodies, Antinuclear, Scleroderma, Diffuse, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Immunosuppressive Agents/therapeutic use, Nuclear Proteins/immunology, Female, Autoantibodies/immunology, Immunosuppressive Agents
Abstract

Objectives: The rarity of early diffuse cutaneous systemic sclerosis (dcSSc) makes randomised controlled trials very difficult. We aimed to use an observational approach to compare effectiveness of currently used treatment approaches. Methods: This was a prospective, observational cohort study of early dcSSc (within three years of onset of skin thickening). Clinicians selected one of four protocols for each patient: methotrexate, mycophenolate mofetil (MMF), cyclophosphamide or ‘no immunosuppressant’. Patients were assessed three-monthly for up to 24 months. The primary outcome was the change in modified Rodnan skin score (mRSS). Confounding by indication at baseline was accounted for using inverse probability of treatment (IPT) weights. As a secondary outcome, an IPT-weighted Cox model was used to test for differences in survival. Results: Of 326 patients recruited from 50 centres, 65 were prescribed methotrexate, 118 MMF, 87 cyclophosphamide and 56 no immunosuppressant. 276 (84.7%) patients completed 12 and 234 (71.7%) 24 months follow-up (or reached last visit date). There were statistically significant reductions in mRSS at 12 months in all groups: −4.0 (−5.2 to −2.7) units for methotrexate, −4.1 (−5.3 to −2.9) for MMF, −3.3 (−4.9 to −1.7) for cyclophosphamide and −2.2 (−4.0 to −0.3) for no immunosuppressant (p value for between-group differences=0.346). There were no statistically significant differences in survival between protocols before (p=0.389) or after weighting (p=0.440), but survival was poorest in the no immunosuppressant group (84.0%) at 24 months. Conclusions: These findings may support using immunosuppressants for early dcSSc but suggest that overall benefit is modest over 12 months and that better treatments are needed. Trial Registration Number: NCT02339441.

Published
2017
Full Text
View/download PDF

15. Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS)

Author

Herrick, A.L., Pan, X., Peytrignet, S., Lunt, M., Hesselstrand, R., Mouthon, L., Silman, A., Brown, E., Czirjak, L., Distler, J.H., Distler, O., Fligelstone, K., Gregory, W.J., Ochiel, R., Vonk, M.C., Ancuta, C., Ong, V.H., Farge, D., Hudson, M., Matucci-Cerinic, M., Balbir-Gurman, A., Midtvedt, O., Jordan, A.C., Jobanputra, P., Stevens, W.B.C., Moinzadeh, P., Hall, F.C., Agard, C., Anderson, M.E., Diot, E., Madhok, R., Akil, M., Buch, M.H., Chung, L., Damjanov, N., Gunawardena, H., Lanyon, P., Ahmad, Y., Chakravarty, K., Jacobsen, S., MacGregor, A.J., McHugh, N., Muller-Ladner, U., Riemekasten, G., Becker, M, Roddy, J., Carreira, P.E., Fauchais, A.L., Hachulla, E., Hamilton, J., Inanc, M., McLaren, J.S., Laar, J.M. van, Pathare, S., Proudman, S., Rudin, A., Sahhar, J., Coppere, B., Serratrice, C., Sheeran, T., Veale, D.J., Grange, C., Trad, G.S., Denton, C.P., Herrick, A.L., Pan, X., Peytrignet, S., Lunt, M., Hesselstrand, R., Mouthon, L., Silman, A., Brown, E., Czirjak, L., Distler, J.H., Distler, O., Fligelstone, K., Gregory, W.J., Ochiel, R., Vonk, M.C., Ancuta, C., Ong, V.H., Farge, D., Hudson, M., Matucci-Cerinic, M., Balbir-Gurman, A., Midtvedt, O., Jordan, A.C., Jobanputra, P., Stevens, W.B.C., Moinzadeh, P., Hall, F.C., Agard, C., Anderson, M.E., Diot, E., Madhok, R., Akil, M., Buch, M.H., Chung, L., Damjanov, N., Gunawardena, H., Lanyon, P., Ahmad, Y., Chakravarty, K., Jacobsen, S., MacGregor, A.J., McHugh, N., Muller-Ladner, U., Riemekasten, G., Becker, M, Roddy, J., Carreira, P.E., Fauchais, A.L., Hachulla, E., Hamilton, J., Inanc, M., McLaren, J.S., Laar, J.M. van, Pathare, S., Proudman, S., Rudin, A., Sahhar, J., Coppere, B., Serratrice, C., Sheeran, T., Veale, D.J., Grange, C., Trad, G.S., and Denton, C.P.

Abstract

Contains fulltext : 174691.pdf (publisher's version ) (Open Access), OBJECTIVES: The rarity of early diffuse cutaneous systemic sclerosis (dcSSc) makes randomised controlled trials very difficult. We aimed to use an observational approach to compare effectiveness of currently used treatment approaches. METHODS: This was a prospective, observational cohort study of early dcSSc (within three years of onset of skin thickening). Clinicians selected one of four protocols for each patient: methotrexate, mycophenolate mofetil (MMF), cyclophosphamide or 'no immunosuppressant'. Patients were assessed three-monthly for up to 24 months. The primary outcome was the change in modified Rodnan skin score (mRSS). Confounding by indication at baseline was accounted for using inverse probability of treatment (IPT) weights. As a secondary outcome, an IPT-weighted Cox model was used to test for differences in survival. RESULTS: Of 326 patients recruited from 50 centres, 65 were prescribed methotrexate, 118 MMF, 87 cyclophosphamide and 56 no immunosuppressant. 276 (84.7%) patients completed 12 and 234 (71.7%) 24 months follow-up (or reached last visit date). There were statistically significant reductions in mRSS at 12 months in all groups: -4.0 (-5.2 to -2.7) units for methotrexate, -4.1 (-5.3 to -2.9) for MMF, -3.3 (-4.9 to -1.7) for cyclophosphamide and -2.2 (-4.0 to -0.3) for no immunosuppressant (p value for between-group differences=0.346). There were no statistically significant differences in survival between protocols before (p=0.389) or after weighting (p=0.440), but survival was poorest in the no immunosuppressant group (84.0%) at 24 months. CONCLUSIONS: These findings may support using immunosuppressants for early dcSSc but suggest that overall benefit is modest over 12 months and that better treatments are needed. TRIAL REGISTRATION NUMBER: NCT02339441.

Published
2017

16. Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS).

Author

Herrick, AL, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, JHW, Distler, O, Fligelstone, K, Gregory, WJ, Ochiel, R, Vonk, M, Ancuţa, C, Ong, VH, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, AC, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, FC, Agard, C, Anderson, ME, Diot, E, Madhok, R, Akil, M, Buch, MH, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, AJ, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, PE, Fauchais, AL, Hachulla, E, Hamilton, J, İnanç, M, McLaren, JS, van Laar, JM, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, DJ, Grange, C, Trad, G-S, Denton, CP, Herrick, AL, Pan, X, Peytrignet, S, Lunt, M, Hesselstrand, R, Mouthon, L, Silman, A, Brown, E, Czirják, L, Distler, JHW, Distler, O, Fligelstone, K, Gregory, WJ, Ochiel, R, Vonk, M, Ancuţa, C, Ong, VH, Farge, D, Hudson, M, Matucci-Cerinic, M, Balbir-Gurman, A, Midtvedt, Ø, Jordan, AC, Jobanputra, P, Stevens, W, Moinzadeh, P, Hall, FC, Agard, C, Anderson, ME, Diot, E, Madhok, R, Akil, M, Buch, MH, Chung, L, Damjanov, N, Gunawardena, H, Lanyon, P, Ahmad, Y, Chakravarty, K, Jacobsen, S, MacGregor, AJ, McHugh, N, Müller-Ladner, U, Riemekasten, G, Becker, M, Roddy, J, Carreira, PE, Fauchais, AL, Hachulla, E, Hamilton, J, İnanç, M, McLaren, JS, van Laar, JM, Pathare, S, Proudman, S, Rudin, A, Sahhar, J, Coppere, B, Serratrice, C, Sheeran, T, Veale, DJ, Grange, C, Trad, G-S, and Denton, CP

Abstract

OBJECTIVES: The rarity of early diffuse cutaneous systemic sclerosis (dcSSc) makes randomised controlled trials very difficult. We aimed to use an observational approach to compare effectiveness of currently used treatment approaches. METHODS: This was a prospective, observational cohort study of early dcSSc (within three years of onset of skin thickening). Clinicians selected one of four protocols for each patient: methotrexate, mycophenolate mofetil (MMF), cyclophosphamide or 'no immunosuppressant'. Patients were assessed three-monthly for up to 24 months. The primary outcome was the change in modified Rodnan skin score (mRSS). Confounding by indication at baseline was accounted for using inverse probability of treatment (IPT) weights. As a secondary outcome, an IPT-weighted Cox model was used to test for differences in survival. RESULTS: Of 326 patients recruited from 50 centres, 65 were prescribed methotrexate, 118 MMF, 87 cyclophosphamide and 56 no immunosuppressant. 276 (84.7%) patients completed 12 and 234 (71.7%) 24 months follow-up (or reached last visit date). There were statistically significant reductions in mRSS at 12 months in all groups: -4.0 (-5.2 to -2.7) units for methotrexate, -4.1 (-5.3 to -2.9) for MMF, -3.3 (-4.9 to -1.7) for cyclophosphamide and -2.2 (-4.0 to -0.3) for no immunosuppressant (p value for between-group differences=0.346). There were no statistically significant differences in survival between protocols before (p=0.389) or after weighting (p=0.440), but survival was poorest in the no immunosuppressant group (84.0%) at 24 months. CONCLUSIONS: These findings may support using immunosuppressants for early dcSSc but suggest that overall benefit is modest over 12 months and that better treatments are needed. TRIAL REGISTRATION NUMBER: NCT02339441.

Published
2017

19. Detection of hospital outbreaks of influenza-like illness based on excess of incidence rates compared to the community

Author

Vanhems, Philippe, Voirin, N., Benet, T., Roche, S., Escuret, V., Regis, C., Giard, M., Lina, B., Comte, B., Coppere, B., Ecochard, René, Biostatistiques santé, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), and Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)

Subjects
[SDV]Life Sciences [q-bio]
Published
2014

21. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting

Author

Zanichelli, Andrea, primary, Longhurst, Hilary J., additional, Maurer, Marcus, additional, Bouillet, Laurence, additional, Aberer, Werner, additional, Fabien, Vincent, additional, Andresen, Irmgard, additional, Caballero, Teresa, additional, Aberer, W., additional, Grumach, A., additional, Bygum, A., additional, Blanchard Delaunay, C., additional, Bouillet, L., additional, Coppere, B., additional, Fain, O., additional, Goichot, B., additional, Gompel, A., additional, Guez, S., additional, Jeandel, P., additional, Kanny, G., additional, Launay, D., additional, Maillard, H., additional, Martin, L., additional, Masseau, A., additional, Ollivier, Y., additional, Sobel, A., additional, Arnolds, J., additional, Aygören-Pürsün, E., additional, Baş, M., additional, Bauer, A., additional, Bork, K., additional, Martinez, I., additional, Maurer, M., additional, Papadopoulou-Alataki, E., additional, Psarros, F., additional, Graif, Y., additional, Kivity, S., additional, Reshef, A., additional, Toubi, E., additional, Arcoleo, F., additional, Cicardi, M., additional, Manconi, P., additional, Marone, G., additional, Montinaro, V., additional, Baeza, M.L., additional, Caballero, T., additional, Cabañas, R., additional, Guilarte, M., additional, Hernandez de Rojas, D., additional, Hernando de Larramendi, C., additional, Lleonart, R., additional, Lobera, T., additional, Sáenz de San Pedro, B., additional, Bjorkander, J., additional, Helbert, M., additional, and Longhurst, H.J., additional

Published
2016
Full Text
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23. DUO Registry Group. Functional impairment of systemic scleroderma patients with digital ulcerations: results from the DUO Registry

Author

Guillevin, L, Hunsche, E, Denton, Cp, Krieg, T, Schwierin, B, Rosenberg, D, Matucci Cerinic, M, DUO Registry Group Collaborators Raffier, B, Hirschi, M, Trautinger, F, Schmidt, P, Stetter, M, Hundstorfer, M, Reinhart, V, Monshi, B, Pirkhammer, D, Richter, L, Hamberger, N, Metz, S, Feldmann, R, Semmelweis, K, Lackner, K, Tomi, N, Kolle, H, Hafner, F, Brodmann, M, Kuen Spiegel, M, Minmair, G, Heil, Pm, Broil, H, Holzer, G, Illmer, X, Rintelen, B, Sautner, J, Takacs, M, Thun, M, Zemanova, I, Soukup, T, Smrzova, A, Bohmova, J, Prochazkova, L, Nemec, P, Fojtik, Z, Suchy, D, Becvar, R, Olsen, Ab, Sondergaard, Kh, Luosu jarvi, R, Vidqvist, Kl, Madaule, S, Beneton, N, Maillard, H, Charlanne, H, Granelbrocard, F, Hachulla, E, Hatron, Py, Jourdain, N, Lambert, M, Launay, D, Morell, S, Woijtasik, G, Skowron, F, Zenone, T, Dadban, A, Lok, C, Ferrandiz, D, Magybertrand, N, Moiton, Mp, Taieb, A, Balquiere, S, Belin, E, Droitcourt, C, Julien, S, Prey, S, Boulon, C, Constans, J, Doutre, Ms, Kostrzwewa, E, Richez, C, Greco, M, Misery, L, Sassolas, B, Collet, E, Berthier, S, Leguy Seguin, V, Imbert, B, Carpentier, P, Blaise, S, Couraud, A, Doeffel Hantz, V, Spars, A, Bezanahary, H, Boussely, N, Dumonteil, S, Fauchais, Al, Goudran, G, Loustaud Ratti, V, Manea, P, Vidal, E, Coppere, B, Desmursclavel, H, Girard Madoux MH, Hot, A, Ninet, J, Granel, B, Cohen, Jd, Keynote, A, Khau van Kien, A, Le Quellec, A, Riviere, S, Rullier, P, Bessis, D, Farcas, C, Bravetti, V, Moline, T, Wahl, D, Zuily, S, Granel Brocard, F, Agard, C, Durant, C, Fuzibet, Jg, Queyrel, V, Berezne, A, Mouthon, L, Cabane, J, Tiev, K, Toledano, C, Lazareth, I, Michon Pasturel, U, Priollet, P, Reguiai, Z, Cazaletslacoste, C, Jego, P, Letremy, A, Perlat, A, Duval Modeste AB, Chatelus, E, Chiffot, H, Sibillia, J, Sordet, C, Adoue, D, Couret, B, Moulis, G, Pugnet, G, Sailler, L, Diot, E, Gaches, F, Farge, D, Keshtmand, H, Frances, C, von Elling, A, Bora, D, Ebel, J, Ahmadi Simab, K, Klein, E, Hahn, K, Schulze, K, Rasche, C, Riemekasten, G, Lee, Hh, Deuschle, K, Mattat, K, Becker, M, Worm, M, Mensing, C, Klings, D, Mensing, H, Messall, J, Zuper, R, Eilbacher, P, Saar, P, Kaufmann, P, Hallermann, C, Schmidt, K, Wahn, H, Schildt, K, Schuart, T, Kaczmarczyk, A, Kellner, C, von Oelhafen, J, Baron von Bildering, P, Kunze, S, Kleiner, Hj, Alsheimer, B, Schuetz, N, Miirker Hermann, E, Gottl, Kh, Weiss, E, Reischel, N, Kern, S, Goettl, Kh, Goetheuniversitiitsklinikum, Jw, Himsel, A, Henkemeier, U, Schwarting, A, Hazenbiller, A, Nichelmann, V, Rumbaur, C, Boesenberg, I, Schmeiser, T, Mueller Ladner, U, Unholzer, A, Starz, H, Welzel, J, Plaumann, K, Stoeckl, F, Sperling, S, Podda, M, Wagner, N, Rapprich, H, Niedermeier, A, Messer, G, Sardy, M, Bekou, V, Dill MUller, D, Wlodarz, M, Belloni, B, Huettig, B, Ziai, M, Hein, R, Kneitz, C, Federow, I, Schneider, K, Semmler, M, Hapke, S, Metzler, C, Stein, T, Enderlein, M, Kayser, M, Werthmann, M, Guenther, Cu, Neul, S, Hellmich, B, Loeffler, C, Pflugfelder, J, Karaenke, P, Mueglich, C, Tony, Hp, Marina, P, Popp, M, Mittag, M, Baumann, C, Scheib, Eg, Brand, H, Wilhelm, Hu, Bohm, J, Dyballa, J, Boehm, J, Taggeselle, J, Luthke, K, Wuerzburg, I, Niefanger, K, Mayer, L, Drabek, J, Harmuth, W, Dietl, S, Moritz, D, Gause, A, Gaubitz, M, Hallecker, A, Krupp, E, Rumpel, H, Moosig, F, Frey, P, Kahl, S, Linke, M, Merk, B, Bloching, Hh, Ochs, W, Kurthen, R, Eiden, E, Guertler, I, Aries, Pm, Kirchberg, S, Jahnke, K, Mettler, S, Toeller, S, Zwenger, S, Langer, He, Deininger, F, Hartmann, F, Neeck, G, Neek, G, Wernitzsch, H, Meier, L, Herr, U, Meier, U, Aaig, W, Bruckner, L, Sheikh, N, Wollenhaupt, J, Krog, B, Wollersdorfer, E, Hall, R, Diehm, C, Tiggers, C, Peters, J, Kirschke, J, Schroeder, Jo, Zeuner, R, Uhlig, S, Barth, S, Huegel, R, Glaeser, R, Schaefer, C, Monshausen, M, Mengden, T, Funkert, A, Blank, N, Lupaschko, S, Voss, B, Megahed, M, Sadeghlar, F, Seidel, M, Wasmuth, Jc, Kreuter, A, Vosswinkel, J, Pfoehler, C, Gerber, A, Haust, M, Hoff, Np, Mota, R, Akanay Diesel, S, Homey, B, Katzemich, A, Erfurt Berge, C, Sticherling, M, Beyer, C, Distler, J, Mitchell, A, Freundlieb, C, Rushentsova, U, Hermanns, G, Blaschke, S, Fiene, M, Wessel, C, Norgauer, J, Rabe, B, Schuster, J, Scholz, J, Kremer, K, Robakidze Torbahn, M, Moinzadeh, P, Dohse, A, Muhlack, A, Schultz, L, Schult, S, Frambach, Y, Kruse, S, Kettenbach, A, Fell, I, Schweda, K, Steinbrink, K, Podobinska, M, Fieri beck, G, Schanz, S, Pfeiffer, C, Hassel, R, Herrgott, I, Sunderkoetter, C, Guenzel, J, Athanassiou, P, Dimitroulas, T, Settas, L, Kritikos, I, Tsifetaki, N, Garyfallos, A, Vasilopoulos, D, Boura, P, Kamali, S, Aslanidis, S, Vlachoyannopoulos, P, Galanopoulo, V, Sakkas, L, Koutroubas, A, Elezoglou, T, Galanopoulos, N, Grier, A, Murray, M, O'Rourke, M, Del Papa, N, Maglione, W, Zeni, S, Foti, R, Benenati, A, De Vita, S, Ferraccioli, G, Grassi, W, de Angeli, R, Pomponio, G, Mussi, A, Colonna, L, Airo, P, Zingarelli, S, Scorza, R, Serverino, A, Puppo, F, Negrini, S, Roma, I, Salsano, F, Triolo, G, Mazzuca, S, Carignola, R, Gatti, S, Lunardi, G, Riccieri, V, Salvarani, C, Bajocchi, G, Varcasia, G, Marasini, B, Belloll, L, de Luca, R, Stisi, S, Bellissimo, S, Fusaro, E, Pellerito, R, Cozzi, F, Rizzo, M, Bartoluzzi, A, Trotta, F, Cantatore, F, Corrado, A, Ferri, Claudio, Colaci, M, Malavolta, N, Mule, R, Galeazzi, M, Lapadula, G, Mathieu, A, Vacca, A, Giacomelli, Roberto, Cipriani, Paola, Montecucco, Cm, Codullo, V, Bucci, R, Battaglia, E, Valentini, G, Cuomo, G, Terlizzi, N, Serafino, L, Reumatologia, Uo, Bombardieri, S, Della Rossa, A, Doveri, M, Perricone, R, de Mattia, M, Pallotta, S, Groenendael, Jh, Seys, P, Goekoop, Rj, Han, Kh, Wlarvens, M, Bonte Mineur, F, de Bois MH, de Beus WM, van Zeben, D, Vonk, M, Knaapen, Hk, Smit, A, Bootsma, H, Ton, E, Voskuyl, A, Dutmer, Ea, Stalk, Jn, Madland, Tm, Seip, M, Hoffmann Vold AM, Bitter, H, Stocklund Thomsen, R, Resende, C, Ponte, C, Martinho, S, Silva, F, Ferreira, P, Grilo, A, Riso, N, Santos, C, Camara, I, Costa, J, Alves, J, Oliveira, S, Almeida, I, Silva, I, Cordeiro, A, Coelho, P, Lukac, J, Dolnicar, As, Espinosa, G, Mejia, Jc, Ramos, M, Plasin Rodriguez MA, Mera, A, Blanco, Js, Diaz, Jj, Losada, L, Perez, E, Maneiro, Jr, Caamano, M, Fermindez, S, Insua, Sa, Barbado, J, Fonseca, Em, Nufio, Fj, Castellvi, I, Garcia de Ia Pena, P, Bellido, D, Paulino, M, Garcia, Pv, Salas, V, Minguez, Md, Sanchez, Ma, Urrego, C, Martin, I, Rueda, A, Calvo, J, Ripoll, Mm, Torres, Mc, Corteguera, M, Maceiras, F, Cruz, J, Mosquera, Ja, Gomez, R, Area, B, Carrio, I, Rubio, M, Castellvi Barranco, I, Santos, P, Simeon, Cp, Fonollosa, V, Egurbide, Mv, Garcia de Vicuna, R, Vicente, E, Villaverde, V, Fernandez, C, Garcia, E, Uson, J, Miguelez, R, Callejas, Jl, Ortego, N, Roman, J, Alegre Sancho JJ, Robles, A, Rios, Jj, Bonilla, Mg, Sanchez Andrade, A, Vazquez, Tr, Miranda, Ja, Saez, L, Zea, A, De la Puente, C, Martinez, Fg, Aguirre, Ma, Collado, P, Cruz, A, Crespo, M, Sanchez Roman, J, Castillo, Mj, Garcia, Am, Muniz, G, Hedin, Pj, Stahl, C, Bracin, T, Nordin, A, Albertsson, K, Rydvald, Y, Thorsson, C, Hermansson, E, Maurer, B, Verner, D, Schmidt Bosshard, R, Hall, F, Murphy, K, Lamb, J, Anderson, M, Moots, R, Buch, M, Bissell, L, Madhok, R, Hampson, R, D'Cruz, D, Choong, Lm, Gordon, P, Dobson, J, Salerno, R, Nisar, M, Williams, C, Wilcox, L, Denton, C, Ochiel, R, Ngcozana, T, Parker, L, Vincent, R, Mchugh, N, Cole, S, Brown, S, James, J, Herrick, A, Manning, J, Moore, T, Faizal, A, Skyes, H, Smythe, A, and Hamilton, A.

Published
2013

24. Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

Author

Goldhaber, Sz, Leizorovicz, A, Kakkar, A, Haas, Sk, Merli, G, Weitz, Ji, Ceresetto, Jm, Kyrle, P, Gallus, A, Cools, F, Saraiva, J, Faucher, Jp, Chlumsky, J, Husted, S, Emmerich, J, Bauersachs, R, Zeltser, D, Prandoni, Paolo, Ghiraduzzi, A, Leiva, J, Sparby, Ja, Torbiki, A, Kobalava, Z, Jacobson, B, Suarez, C, Fu, M, Savas, I, Parkhomenko, A, Ansell, J, Landis, Jr, Elliott, Cg, Borris, Lc, Samama, Mm, Pinede, L, Becker, F, Coppere, B, Nony, P, Merah, A, Alves, M, Boulet, H, Loppinet, A, Nicol, C, Ohanessian, L, Roncato, C, Knabb, Rm, Liaw, D, Smith, K, Hess, T, Rossi, L, Chen, D, Doan, C, Doran, J, Matheis, E, Ballard, M, Tsarova, O, Levenstein, S, Tvedegaard, M, Akkal, Z, Jure, H, Mercado, Da, Zangroniz, P, Constantino, M, Bello, F, Giumelli, C, de Sagastizabal, D, Risso Patron, F, Ceresetto, J, Dran, R, Vita, N, Baratta, S, Ahuad Guerrero, R, Penchasky, D, Rubinfeld, A, Layden, M, Karrasch, J, Coughlin, P, Peters, M, Gibbs, H, Ward, Ch, Hahn, U, Pilger, E, Minar, E, El Allaf, D, Marechal, P, Motte, S, Verhamme, P, Wollaert, B, Duck, L, Freire, A, Piegas, L, Jorge, Jm, Guimaraes, H, Oliveira, M, Blacher, C, Leães, P, Toniolo, J, Okoshi, M, Rosa, Dd, Cunha, C, Lobo, S, Leader, R, Dhar, A, Tarabain, O, Miron, M, Brossoit, R, Kahn, S, Kassis, J, Douketis, J, Spencer, F, Faucher, J, Alarcon, Ma, Gutierrez Valenzuela, F, Bisbal Malig, C, Vejar, M, Jaramillo, N, Saaibi, D, Londono, D, Kolman, P, Reiterer, P, Ballek, L, Spacek, R, Soucek, M, Patek, F, Vitovec, M, Kovarova, K, Ceska, R, Podpera, I, Faber, J, Oestergaard, L, Vejby Christensen, H, Frost, L, Rasmussen, Sl, Tuxen, C, Ingerslev, J, Knudsen, T, Torp Pedersen, C, Pedersen, C, Nielsen, H, Mottier, D, Simoneau, G, Leduc, J, Lorcerie, B, Paleiron, N, Proust, A, Conri, C, Pernod, G, Mismetti, P, Achkar, A, Maignan, M, Harenberg, J, Beyer, J, Horacek, T, Lawall, H, Hecker, U, Hammerstingl, C, Weil, J, Fischer, D, Brachmann, J, Klepzig, H, Cheng, G, Soltesz, P, Schnabel, R, Futo, L, Jobbagy, L, Singh, P, Talwar, D, Bhadade, R, Bharani, A, Krishnamurthy, S, Goyal, A, Mehta, P, Samiuddin, M, D'Souza, G, Sinha, S, Sathe, P, Sethuraman, S, Jaganmani, S, Sundaram, P, Saxena, A, Mehta, M, Omar, A, Rajkumar, J, Jog, S, Kumar, S, Hayek, T, Hussein, O, Lahav, M, Efrati, S, Elias, M, Grossman, E, Lugassy, G, Porath, A, Porreca, E, Prandoni, P, Tosetto, A, Imberti, D, Pierfranceschi, G, Ghirarduzzi, A, Scannapieco, G, Testa, S, Ling, P, Yusoff, K, Yusof, Z, Lopez Rosas, E, Hernandez, I, Nanez Terreros, H, Flota, L, Campos, E, Alcocer, M, Viergever, P, Sparby, J, Cotrina, R, Salas, M, Pamo, O, Fajardo, L, Horna, M, Ulloa, V, Toce, L, Moncada, Z, Salazar, O, Habaluyas, R, Collado, F, Edmilao, M, Abola, T, Sevilla, R, Torbicki, A, Tracz, W, Kasprzak, J, Jastrzebski, D, Psuja, P, Hiczkiewicz, J, Piepiorka, M, Pulkowski, G, Tyszkiewicz, I, Kuc, K, Gordeev, I, Boyarkin, M, Privalov, D, Abrosimov, V, Reshetko, O, Goloshchekin, B, Vishnevsky, A, Boldueva, S, Kostenko, V, Mkrtchian, V, Chernichka, I, Belenkov, Y, Rodoman, G, Andreev, D, Shvarts, Y, Aleksandrov, O, Zadionchenko, V, Klochkov, O, Tay, J, Jagadesan, R, Basson, M, Siebert, R, Viljoen, J, Gray, T, Abdool Gaffar, M, Suh, G, In, K, Choi, D, Kim, S, Baek, S, Chung, H, Shin, J, Alvarez Sala, L, Cepeda, J, Ferrer, M, Mallibovsky, L, Garcia Morillo, J, Villalta, J, Gomez Cerezo, J, Capitán, F, Gonzalez Garrido, F, Guijarro, C, Jimenez, D, Richart, C, Elf, J, Ueng, K, Huang, T, Karan, A, Erten, N, Abrahamovych, O, Chopey, I, Gavrysiuk, V, Kraiz, I, Karpenko, A, Volkov, V, Denesyuk, V, Kharchenko, N, Tseluyko, V, Batushkin, V, Sushko, V, Yagensky, A, Ignatenko, G, Dziublyk, O, Cohen, A, Bareford, D, Kesteven, P, Mccollum, P, Das, S, Conrad, S, Botnick, W, Nathanson, A, Hamad, A, Fraiz, J, Goytia Leos, D, Fulmer, J, Mclaren, G, Streiff, M, Hahn, B, Ardolic, B, Klausner, H, Welch, M, Pullman, J, Phillips, D, Felt, J, Mitchell, G, Margolis, B, Pendleton, R, Mahesh, A, Barney, J, Shadan, F, Schuller, D, Joslin, S, Feldman, J, Pearl, R, Welker, J, Hazelrigg, M, Stevens, S, Siegel, M, Meade, A, Bates, J, Tahirkheli, N, Rosenberg, D, Dishman, K, Ikerd, T, Feldman, G, O'Connell, C, Vaince, U, Dabbagh, O, Eyster, E, Weinstein, G, Ginsberg, R, Fine, J, Tillinghast, A, Alabi, F, Nathan, R, Haught, H, Oliver, M., Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Thrombosis Research Institute (AKK), University College of London [London] (UCL), Institute for Experimental Oncology and Therapy Research (IEOTR), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Jefferson Medical College (JMC), Thomas Jefferson University Hospitals, Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Pulmonary Embolism, Placebo-controlled study, MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, MESH: Aged, 80 and over, Randomized controlled trial, law, Risk Factors, MESH: Risk Factors, Medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, General Medicine, Orvostudományok, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Hospitalization, Treatment Outcome, Acute Disease, MESH: Acute Disease, Apixaban, Female, Respiratory Insufficiency, MESH: Hemorrhage, medicine.drug, Adult, medicine.medical_specialty, Randomization, MESH: Enoxaparin, Pyridones, Medicina, Hemorrhage, MESH: Anticoagulants, MESH: Drug Administration Schedule, Klinikai orvostudományok, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Pyridones, Humans, Risk factor, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, Heart Failure, MESH: Humans, business.industry, Anticoagulants, MESH: Adult, medicine.disease, MESH: Male, Surgery, chemistry, Relative risk, Betrixaban, MESH: Heart Failure, Pyrazoles, business, Pulmonary Embolism, MESH: Female, MESH: Pyrazoles, MESH: Respiratory Insufficiency, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin. METHODS: In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated. RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome - 2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P = 0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P = 0.04). CONCLUSIONS: In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin, Supported by Bristol-Myers Squibb and Pfizer

Published
2011
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25. Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity - A phase II evaluation

Author

Buller, H R, Cariou, R, Gallus, A, Gent, M, Ginsberg, J, Prins, M H, Lensing, A, Levi, M, Nurmohammed, N, Hirsh, J, Roberts, R, ten Cate, J W, Decousus, H, Mismetti, P, Buchmuller, A, Charlet, [No Value], Viallon, A, van der Meer, J, Meinardi, [No Value], Meijer, K, Piovella, F, Barone, M, Beltrametti, C, Serafini, S, Kraaijenhagen, R A, Koopman, M M W, Jagt, H H T, Muller, M B R, Kooy, M V, Nauta, S, Gallus, A S, Coghlan, D, Rich, C, Prandoni, P, Scudeller, A, Scarano, L, Girolami, A, Baker, R, Tan, E, Cooney, J, Eikelboom, J, Ninet, J, Dolmazon, C, Madoux, M H G, Coppere, B, Nenci, G G, Agnelli, G, Falcinelli, F, Morini, M, and d'Angelo, A

Subjects
anticoagulants, PULMONARY-EMBOLISM, ANTITHROMBIN-III, HEPARIN, imaging, PENTASACCHARIDE, HOME, thrombosis
Abstract

Background-Patients with venous thromboembolism require initial treatment with an immediate-acting anticoagulant, low-molecular-weight heparin. We evaluated a novel synthetic factor Xa inhibitor (SR90107a/ORG31540) as an alternative treatment. Methods and Results-A randomized-parallel-group, phase II trial to assess the efficacy and safety of SR90107a/ORG31540 (5, 7.5, or 10 mg once daily) relative to low-molecular-weight heparin (dalteparin, 100 IU/kg twice daily) in symptomatic proximal deep vein thrombosis. The primary outcome measure was the change in thrombus mass, assessed by ultrasonography of the leg veins and perfusion lung scintigraphy, performed at baseline and day 7+/-1. A positive outcome was defined as improvement of the ultrasound and/or perfusion scan result without deterioration of either test. Other outcome measures included symptomatic, recurrent venous thromboembolism and major bleeding for a period of 3 months. All outcomes were interpreted with the observer unaware of treatment allocation. A positive primary outcome was observed in 46 of 100 (46%), 52 of 108 (48%), 48 of 115 (42%), and 56 of 115 (49%), respectively, of the subjects given 5, 7.5, or 10 mg SR90107a/ORG31540 or dalteparin. There were 8 recurrent thromboembolic complications (2.4%) in the 334 patients treated with SR90107a/ORG31540 and 6 (5.0%) in the 119 dalteparin patients, a difference of 2.6% in favor of SR90107a/ORG31540 (95% CI -2.1% to 10.1%). The incidence of bleeding was low and was similar among the groups. Conclusions-The factor Xa inhibitor SR90107a/ORG31540 appears to be an effective and safe treatment for patients with deep vein thrombosis across a wide range of doses. This synthetic compound merits evaluation in phase III studies.

Published
2000

30. [Vascular and/or cardiac manifestations of type IV Ehlers-Danlos syndrome. 9 cases]

Author

de Wazières B, Coppere B, Durieu I, thierry fest, Ninet J, Levrat R, Da, Vuitton, and Jl, Dupond

Subjects
Adult, Male, Radiography, Mitral Valve Prolapse, Cardiovascular Diseases, Humans, Ehlers-Danlos Syndrome, Female, Intracranial Aneurysm, Raynaud Disease, Middle Aged
Abstract

Type IV Ehlers-Danlos syndrome, a rare disease caused by abnormal synthesis of type III collagen, often leads to vascular fragility. We report 9 cases (6 men and 3 women, mean age 35 years). For 7 of the patients, the inaugural signs were arterial complications including haemoperitoneum in 2 patients with multiple aneurysmal dystrophy of the abdominal arteries, one case of ruptured subclavian artery, two dissections of the renal artery, one case with rupture of a cerebral aneurysm, one rupture of the mesenteric artery and a haematoma after arterial puncture. Other vascular manifestations were acrosyndrome (n = 4), varicose veins (n = 3), and prolapsus of the mitral valve (n = 2). In addition, 8 of the 9 patients presented extravascular signs. There was a history of familial disease in 5 cases. Pregnancy was completed to term in three patients: a cesarean section was required in one case and intra-uterine growth retardation was seen in 2. Morbidity was important with hemiparesia, blindness and paraparesis sequellae. One patient died from haemorrhage. This series of patients with type IV Ehlers-Danlos syndrome illustrates the severity of this disease whose prevalence is often underestimated. The disease is transmitted by autosomal dominant inheritance, underscoring the importance of familial testing for early diagnosis. Clinicians should be aware of the vascular manifestations and avoid invasive punctures or operations except in exceptional indications.

Published
1995

35. PSY6 THE ICATIBANT OUTCOME SURVEY:A PROSPECTIVE STUDY OF SAFETY AND EFFECTIVENESS OF ICATIBANT IN A ‘REAL WORLD' SETTING IN PATIENTS WITH HEREDITARY ANGIOEDEMA

Author

Maurer, M, primary, Aberer, W, additional, Amat, LM, additional, Karon-Klefbom, M, additional, Malmenäs, M, additional, Bouillet, L, additional, Kanny, G, additional, Martin, L, additional, Coppere, B, additional, Longhurst, H, additional, Fain, O, additional, Launay, D, additional, Gompel, A, additional, Bork, K, additional, Greve, J, additional, Yann, O, additional, Rubio-Sotes, M, additional, Sala, A, additional, Lleonart, R, additional, Hernando, de, additional, Larramendi, C, additional, and Hernandez, D, additional

Published
2010
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40. Étude de 131grossesses chez 36patientes présentant un syndrome des anticorps antiphospholipides : évolution, traitement et facteurs prédictifs de gravité obstétricale

Author

Rolin, M.A., primary, Pérard, L., additional, Hot, A., additional, Simon, M., additional, Desmurs, H., additional, Gaucherand, P., additional, Girard-Madoux, M.H., additional, Durieu, I., additional, Seve, P., additional, Coppere, B., additional, and Ninet, J., additional

Published
2008
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