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2,968 results on '"Busch, H."'

9. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double‐Blind, Placebo‐Controlled Trials

Author

Clowse, Megan EB, Wallace, Daniel J, Furie, Richard A, Petri, Michelle A, Pike, Marilyn C, Leszczyński, Piotr, Neuwelt, C Michael, Hobbs, Kathryn, Keiserman, Mauro, Duca, Liliana, Kalunian, Kenneth C, Galateanu, Catrinel, Bongardt, Sabine, Stach, Christian, Beaudot, Carolyn, Kilgallen, Brian, Gordon, Caroline, Batalov, A, Bojinca, M, Djerassi, R, Duca, L, Horak, P, Kolarov, Z, Milasiene, R, Monova, D, Otsa, K, Pileckyte, M, Popova, T, Radulescu, F, Rashkov, R, Rednic, S, Repin, M, Stoilov, R, Tegzova, D, Vezikova, N, Vitek, P, Zainea, C, East, Far, Baek, H, Chen, Y, Chiu, Y, Cho, C, Chou, C, Choe, J, Huang, C, Kang, Y, Kang, S, Lai, N, Lee, S, Park, W, Shim, S, Suh, C, Yoo, W, Armengol, H Avila, Zapata, F Avila, Santiago, M Barreto, Cavalcanti, F, Chahade, W, Costallat, L, Keiserman, M, Alcala, J Orozco, Remus, C Ramos, Roimicher, L, Abu‐Shakra, M, Agarwal, V, Agmon‐Levin, N, Kadel, J, Levy, Y, Mevorach, D, Paran, D, Reitblat, T, Rosner, I, Shobha, V, Sthoeger, Z, Zisman, D, Ayesu, K, Berney, S, Box, J, Busch, H, Buyon, J, Carter, J, Chi, J, Clowse, M, Collins, R, Dao, K, Diab, I, Dikranian, A, El‐Shahawy, M, Gaylis, N, Grossman, J, Halpert, E, Huff, J, Jarjour, W, Kao, A, Katz, R, Kennedy, A, Khan, M, Kivitz, A, Kohen, M, and Lawrence‐Ford, T

Subjects
Autoimmune Disease, Clinical Trials and Supportive Activities, Clinical Research, Lupus, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Inflammatory and immune system, Adult, Antibodies, Monoclonal, Humanized, Double-Blind Method, Female, Humans, Lupus Erythematosus, Systemic, Male, Severity of Illness Index, Treatment Outcome, EMBODY Investigator Group, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract

ObjectiveEpratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double-blind, placebo-controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE).MethodsPatients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti-double-stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG-2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5-60 mg/day). BILAG-2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12-week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG-based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG-2004 score, no worsening in the BILAG-2004 score, SLEDAI-2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders.ResultsIn the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified.ConclusionIn patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

Published
2017

10. Curriculum Internistische Intensivmedizin

Author

John, S., Riessen, R., Karagiannidis, C., Janssens, U., Busch, H.‑J., Kochanek, M., Michels, G., Hermes, C., Buerke, M., Kluge, S., Baumgärtel, M., Braune, S., Erbguth, F., Fuhrmann, V., Lebiedz, P., Mayer, K., Müller-Werdan, U., Oppert, M., Sayk, F., Sedding, D., Willam, C., and Werdan, K.

Published
2021
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19. Empfehlungen zur extrakorporalen kardiopulmonalen Reanimation (eCPR): Konsensuspapier der DGIIN, DGK, DGTHG, DGfK, DGNI, DGAI, DIVI und GRC

Author

Michels, G., Wengenmayer, T., Hagl, C., Dohmen, C., Böttiger, B. W., Bauersachs, J., Markewitz, A., Bauer, A., Gräsner, J.-T., Pfister, R., Ghanem, A., Busch, H.-J., Kreimeier, U., Beckmann, A., Fischer, M., Kill, C., Janssens, U., Kluge, S., Born, F., Hoffmeister, H. M., Preusch, M., Boeken, U., Riessen, R., and Thiele, H.

Published
2019
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29. Empfehlungen zur extrakorporalen kardiopulmonalen Reanimation (eCPR): Konsensuspapier der DGIIN, DGK, DGTHG, DGfK, DGNI, DGAI, DIVI und GRC

Author

Michels, G., Wengenmayer, T., Hagl, C., Dohmen, C., Böttiger, B. W., Bauersachs, J., Markewitz, A., Bauer, A., Gräsner, J.-T., Pfister, R., Ghanem, A., Busch, H.-J., Kreimeier, U., Beckmann, A., Fischer, M., Kill, C., Janssens, U., Kluge, S., Born, F., Hoffmeister, H. M., Preusch, M., Boeken, U., Riessen, R., and Thiele, H.

Published
2018
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34. A concurrent, deep learning-based computer-aided detection system for prostate multiparametric MRI: a performance study involving experienced and less-experienced radiologists

Author

Labus, S., Altmann, M.M., Huisman, H.J., Tong, A., Penzkofer, T., Choi, M.H., Shabunin, I., Winkel, D.J., Xing, P., Szolar, D.H., Shea, S.M., Grimm, R., Busch, H., Kamen, A., Herold, T., Baumann, C., Labus, S., Altmann, M.M., Huisman, H.J., Tong, A., Penzkofer, T., Choi, M.H., Shabunin, I., Winkel, D.J., Xing, P., Szolar, D.H., Shea, S.M., Grimm, R., Busch, H., Kamen, A., Herold, T., and Baumann, C.

Abstract

Item does not contain fulltext, OBJECTIVES: To evaluate the effect of a deep learning-based computer-aided diagnosis (DL-CAD) system on experienced and less-experienced radiologists in reading prostate mpMRI. METHODS: In this retrospective, multi-reader multi-case study, a consecutive set of 184 patients examined between 01/2018 and 08/2019 were enrolled. Ground truth was combined targeted and 12-core systematic transrectal ultrasound-guided biopsy. Four radiologists, two experienced and two less-experienced, evaluated each case twice, once without (DL-CAD-) and once assisted by DL-CAD (DL-CAD+). ROC analysis, sensitivities, specificities, PPV and NPV were calculated to compare the diagnostic accuracy for the diagnosis of prostate cancer (PCa) between the two groups (DL-CAD- vs. DL-CAD+). Spearman's correlation coefficients were evaluated to assess the relationship between PI-RADS category and Gleason score (GS). Also, the median reading times were compared for the two reading groups. RESULTS: In total, 172 patients were included in the final analysis. With DL-CAD assistance, the overall AUC of the less-experienced radiologists increased significantly from 0.66 to 0.80 (p = 0.001; cutoff ISUP GG >/= 1) and from 0.68 to 0.80 (p = 0.002; cutoff ISUP GG >/= 2). Experienced radiologists showed an AUC increase from 0.81 to 0.86 (p = 0.146; cutoff ISUP GG >/= 1) and from 0.81 to 0.84 (p = 0.433; cutoff ISUP GG >/= 2). Furthermore, the correlation between PI-RADS category and GS improved significantly in the DL-CAD + group (0.45 vs. 0.57; p = 0.03), while the median reading time was reduced from 157 to 150 s (p = 0.023). CONCLUSIONS: DL-CAD assistance increased the mean detection performance, with the most significant benefit for the less-experienced radiologist; with the help of DL-CAD less-experienced radiologists reached performances comparable to that of experienced radiologists. KEY POINTS: * DL-CAD used as a concurrent reading aid helps radiologists to distinguish between benign and cancerous lesio

Published
2023

36. POS0150 AUTOANTIBODIES AGAINST FIBROBLAST GROWTH FACTOR (FGF-2), PLACENTAL GROWTH FACTOR (PLGF) AND BETA-ADRENERGIC RECEPTOR 1 (ADRB1) IN AN ALTERED NETWORK OF AUTOANTIBODIES IN SYSTEMIC SCLEROSIS

Author

Schinke, S., primary, Sterner, K., additional, Heidecke, H., additional, Busch, H., additional, Kuenstner, A., additional, König, I., additional, Fouodo, C. J. K., additional, Müller, A., additional, Comduehr, S., additional, Lange, T., additional, Lübber, F., additional, Paulus, F., additional, Grasshoff, H., additional, and Riemekasten, G., additional

Published
2023
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38. 370 Role of proliferation and mechanostructural signaling in pemphigus vulgaris

Author

Rahimi, S., primary, Hariton, W.V., additional, Guo, S., additional, Sauta, P., additional, Borradori, L., additional, Hartmann, V., additional, Zare-Eelanjegh, E., additional, Paccagnan, G., additional, Zambelli, T., additional, Hundt, J.E., additional, Hammers, C.M., additional, Ludwig, R.J., additional, Busch, H., additional, and Mueller, E.J., additional

Published
2023
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