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5. Adsorptive cytapheresis for ulcerative colitis with focus on removing platelets and platelet‐aggregates.

Author

Schneider, Matthias, Waitz, Grit, Prophet, Heinrich, Schober, Hans‐Christof, and Ramlow, Wolfgang

Subjects
ULCERATIVE colitis, BLOOD platelets, DISEASE progression, LEUCOCYTES
Abstract

Introduction: Platelet abnormalities and secondary thrombocytosis are clinical features of ulcerative colitis (UC) and seem to play a relevant role in pathogenesis. This work analyzed the adsorption characteristics of the adsorber Immunopure. Methods: A prospective study was performed to investigate the module in vitro with blood from healthy donors in a down‐scaled recirculation model and in vivo in six patients suffering from UC. Furthermore, adsorber beads were investigated by immunofluorescence analyses. Apheresis was performed over 5 weeks at weekly intervals. Results: In vitro as well as in vivo, the module showed a strong adsorption of platelets, monocytes, CD14+CD16+ monocytes, neutrophils, and platelet leukocyte aggregates (PLAs). Five of the six patients benefited from the treatment (83%), and four (67%) went into remission. On average, the CAI was reduced by 6.4 points. Conclusion: Immunopure treatments improved the course of the disease and were well tolerated. The module strongly adsorbs platelets and platelet‐aggregates. [ABSTRACT FROM AUTHOR]

Published
2023
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6. The German Lipoprotein Apheresis Registry—Summary of the ninth annual report.

Author

Schettler, Volker J. J., Peter, Christian, Zimmermann, Thomas, Julius, Ulrich, Roeseler, Eberhard, Schlieper, Georg, Heigl, Franz, Grützmacher, Peter, Löhlein, Iris, Klingel, Reinhard, Hohenstein, Bernd, Ramlow, Wolfgang, and Vogt, Anja

Subjects
CORPORATION reports, LDL cholesterol, MAJOR adverse cardiovascular events, DATA analysis
Abstract

During 2012–2020, 89 German apheresis centers collected retrospective and prospective observational data of 2028 patients undergoing regular lipoprotein apheresis (LA) for the German Lipoprotein Apheresis Registry (GLAR). More than 47 500 LA sessions are documented in GLAR. In 2020, all patients treated with LA showed a high immediate median reduction rate of LDL‐C (68.2%, n = 1055) and Lp(a) (72.4%, n = 994). Patient data were analyzed for the incidence rate of major coronary events (MACE) 1 and 2 years before the beginning of LA treatment (y‐2 and y‐1) and prospectively up to 7 years on LA (y + 1 to y + 7). During the first 2 years of LA (y + 1 and y + 2), a MACE reduction of 78% was observed. Current analysis of GLAR data shows very low incidence rates of cardiovascular events in patients with high LDL‐C and/or high Lp(a) levels, progressive ASCVD, and maximally tolerated lipid lowering medication regular by LA results. [ABSTRACT FROM AUTHOR]

Published
2022
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7. Report of WAA apheresis register data during the latest 3 years

Author

Wallquist, Carin, Hellberg, Matthias, Strineholm, Virginia, Toss, Fredrik, Nilsson, Thomas, Berlin, Gösta, Dykes, Josefina, Eich, Torstein, Welander, Gunilla, Stegmayr, Bernd, Newman, Elizabeth, Derfler, Kurt, Witt, Volker, Deeren, Dries, Bojanic, Ines, Blaha, Milan, Gasova, Zdenka, Kielstein, Jan T, Prophet, Heinrich, Ramlow, Wolfgang, Audzijoniene, Judita, Griskevicius, Antanas, Aandahl, Astrid, Vrielink, Hans, Reuser Kaasenbrood, Ilhan, Osman, Guldane Cengiz Seval, and Poole, Colwyn

Published
2021
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8. Using the World Apheresis Association Registry Helps to Improve the Treatment Quality of Therapeutic Apheresis

Author

Stegmayr, Bernd, Newman, Elizabeth, Witt, Volker, Derfler, Kurt, Leitner, Gerda, Eloot, Sunny, Dhondt, Annemieke, Deeren, Dries, Ptak, Jan, Blaha, Milan, Lanska, Mirka, Gasova, Zdenka, Bhuiyan-Ludvikova, Zdenka, Hrdlickova, Radomira, Ramlow, Wolfgang, Prophet, Heinrich, Kielstein, Jan T., Liumbruno, Giancarlo, Mori, Elena, Griskevicius, Antanas, Audzijoniene, Judita, Vrielink, Hans, Rombout-Sestrienkova, Eva, Aandahl, Astrid, Sikole, Aleksandar, Tomaz, Jorge, Lalic, Katarina, Bojanic, Ines, Strineholm, Virginia, Brink, Bo, Berlin, Gosta, Dykes, Josefina, Nilsson, Thomas, Eich, Torsten, Hadimeri, Henrik, Welander, Gunilla, Ortega Sanchez, Sandra, Ilhan, Osman, Poole, Colwyn, Stegmayr, Bernd, Newman, Elizabeth, Witt, Volker, Derfler, Kurt, Leitner, Gerda, Eloot, Sunny, Dhondt, Annemieke, Deeren, Dries, Ptak, Jan, Blaha, Milan, Lanska, Mirka, Gasova, Zdenka, Bhuiyan-Ludvikova, Zdenka, Hrdlickova, Radomira, Ramlow, Wolfgang, Prophet, Heinrich, Kielstein, Jan T., Liumbruno, Giancarlo, Mori, Elena, Griskevicius, Antanas, Audzijoniene, Judita, Vrielink, Hans, Rombout-Sestrienkova, Eva, Aandahl, Astrid, Sikole, Aleksandar, Tomaz, Jorge, Lalic, Katarina, Bojanic, Ines, Strineholm, Virginia, Brink, Bo, Berlin, Gosta, Dykes, Josefina, Nilsson, Thomas, Eich, Torsten, Hadimeri, Henrik, Welander, Gunilla, Ortega Sanchez, Sandra, Ilhan, Osman, and Poole, Colwyn

Abstract

Therapeutic apheresis (TA) is prescribed to patients that suffer from a severe progressive disease that is not sufficiently treated by conventional medications. A way to gain more knowledge about this treatment is usually by the local analysis of data. However, the use of large quality assessment registries enables analyses of even rare findings. Here, we report some of the recent data from the World Apheresis Association (WAA) registry. Data from >104,000 procedures were documented, and TA was performed on >15,000 patients. The main indication for TA was the collection of autologous stem cells (45% of patients) as part of therapy for therapy. Collection of stem cells from donors for allogeneic transplantation was performed in 11% of patients. Patients with indications such as neurological diseases underwent plasma exchange (28%). Extracorporeal photochemotherapy, lipid apheresis, and antibody removal were other indications. Side effects recorded in the registry have decreased significantly over the years, with approximately only 10/10,000 procedures being interrupted for medical reasons. Conclusion: Collection of data from TA procedures within a multinational and multicenter concept facilitates the improvement of treatment by enabling the analysis of and feedback on indications, procedures, effects, and side effects. (c) 2021 S. Karger AG, Basel

Published
2021
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12. Using the World Apheresis Association Registry Helps to Improve the Treatment Quality of Therapeutic Apheresis

Author

Stegmayr, Bernd, primary, Newman, Elizabeth, additional, Witt, Volker, additional, Derfler, Kurt, additional, Leitner, Gerda, additional, Eloot, Sunny, additional, Dhondt, Annemieke, additional, Deeren, Dries, additional, Ptak, Jan, additional, Blaha, Milan, additional, Lanska, Mirka, additional, Gasova, Zdenka, additional, Bhuiyan-Ludvikova, Zdenka, additional, Hrdlickova, Radomira, additional, Ramlow, Wolfgang, additional, Prophet, Heinrich, additional, Kielstein, Jan T., additional, Liumbruno, Giancarlo, additional, Mori, Elena, additional, Griskevicius, Antanas, additional, Audzijoniene, Judita, additional, Vrielink, Hans, additional, Rombout-Sestrienkova, Eva, additional, Aandahl, Astrid, additional, Sikole, Aleksandar, additional, Tomaz, Jorge, additional, Lalic, Katarina, additional, Bojanic, Ines, additional, Strineholm, Virginia, additional, Brink, Bo, additional, Berlin, Gösta, additional, Dykes, Josefina, additional, Nilsson, Thomas, additional, Eich, Torsten, additional, Hadimeri, Henrik, additional, Welander, Gunilla, additional, Ortega Sanchez, Sandra, additional, Ilhan, Osman, additional, and Poole, Colwyn, additional

Published
2021
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17. Novel Leucocyte/Thrombocyte Apheresis for Induction of Steroid-Free Remission in Ulcerative Colitis: A Controlled Randomized Pilot Study

Author

Kruis, Wolfgang, Morgenstern, Julia, Ramlow, Wolfgang, Dignass, Axel, Stallmach, Andreas, Drebber, Uta, Kruis, Wolfgang, Morgenstern, Julia, Ramlow, Wolfgang, Dignass, Axel, Stallmach, Andreas, and Drebber, Uta

Abstract

Background and Aims: In active ulcerative colitis [UC] refractory to mesalazine, escalation to either steroids or immunosuppression is common practice. The efficacy and safety of alternative escalation therapy with a novel leukocyte apheresis device were studied. Methods: This was a prospective, randomized, controlled multicentre pilot study comparing leukocyte apheresis with prednisolone in refractory UC (disease activity index [DAI] >= 4 and <= 8). Group A received weekly apheresis over five consecutive weeks. Group P received oral prednisolone 40 mg/day tapered to 0 mg at week 6. The primary end point was steroid-free clinical remission [DAI <= 2] at week 12. Clinical response was also analysed. Results: Twenty-four patients were enrolled, 13 of whom were randomized into group A and 11 into group P. Clinical remission off steroids at week 12 was achieved in 3/12 patients [25.0%] with apheresis and 2/10 [20.0%] with prednisolone [p = 1.0]. The response rate after 12 weeks was 75.0% in group A and 50.0% in group P. Mean DAI scores improved in both treatment groups [p = 0.008]. C-reactive protein decreased from 6.0 +/- 5.3 to 3.8 +/- 3.7 mg/L at 12 weeks in group A and increased from 5.2 +/- 6.0 to 6.3 +/- 7.9 mg/mL in group P. Both treatments were well tolerated. No unexpected serious adverse events were seen in group A. In group P one symptomatic infection with Clostridium difficile occurred. Conclusions: In patients with active UC refractory to mesalazine a novel leukocyte apheresis showed promising results. A comparison with prednisolone revealed similar therapeutic effectivity and excellent safety, providing the chance to escalate without systemic steroids.

Published
2019

31. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis

Author

Dignass, Axel, primary, Akbar, Ayesha, additional, Baumgart, Daniel C., additional, Bommelaer, Gilles, additional, Bouguen, Guillaume, additional, Cadiot, Guillaume, additional, Gillessen, Anton, additional, Grimaud, Jean-Charles, additional, Hart, Ailsa, additional, Hoque, Syed, additional, Makins, Richard, additional, Michiels, Christophe, additional, Moreau, Jacques, additional, Premchand, Purushothaman, additional, Ramlow, Wolfgang, additional, Schanz, Stefan, additional, Subramanian, Sreedhar, additional, von Tirpitz, Christian, additional, and Bonaz, Bruno, additional

Published
2018
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32. Safety aspects of lipidapheresis using DALI and MONET – Multicenter observational study

Author

Kozik-Jaromin, Justyna, primary, Röseler, Eberhard, additional, Heigl, Franz, additional, Spitthöver, Ralf, additional, Ringel, Jens, additional, Schmitz, Gerd, additional, Heinzler, Rainer, additional, Abdul-Rahman, Nadim, additional, Leistikow, Frank, additional, Himmelsbach, Frido, additional, Schettler, Volker, additional, Uhlenbusch-Körwer, Ingrid, additional, and Ramlow, Wolfgang, additional

Published
2017
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33. Efficacy of lipid reduction with DALI and MONET

Author

Ramlow, Wolfgang, primary, Röseler, Eberhard, additional, Heigl, Franz, additional, Spitthöver, Ralf, additional, Ringel, Jens, additional, Schmitz, Gerd, additional, Heinzler, Rainer, additional, Abdul-Rahman, Nadim, additional, Leistikow, Frank, additional, Himmelsbach, Frido, additional, Schettler, Volker, additional, Pham, Jenny, additional, and Kozik-Jaromin, Justyna, additional

Published
2017
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36. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial

Author

Moriarty, Patrick M., primary, Parhofer, Klaus G., additional, Babirak, Stephan P., additional, Cornier, Marc-Andre, additional, Duell, P. Barton, additional, Hohenstein, Bernd, additional, Leebmann, Josef, additional, Ramlow, Wolfgang, additional, Schettler, Volker, additional, Simha, Vinaya, additional, Steinhagen-Thiessen, Elisabeth, additional, Thompson, Paul D., additional, Vogt, Anja, additional, von Stritzky, Berndt, additional, Du, Yunling, additional, and Manvelian, Garen, additional

Published
2016
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49. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis

Author

Dignass, Axel, Akbar, Ayesha, Baumgart, Daniel C., Bommelaer, Gilles, Bouguen, Guillaume, Cadiot, Guillaume, Gillessen, Anton, Jean-Charles Grimaud, Hart, Ailsa, Hoque, Syed, Makins, Richard, Michiels, Christophe, Moreau, Jacques, Purushothaman Premchand, Ramlow, Wolfgang, Schanz, Stefan, Sreedhar Subramanian, Tirpitz, Christian Von, and Bonaz, Bruno

Subjects
3. Good health
Abstract

Objectives: Current options for patients with steroid-dependent, chronic-active ulcerative colitis (UC) with insufficient response/intolerance to immunosuppressants (ISs) and/or biologics are limited. The aim of this study was to assess the long-term outcome of granulocyte/monocyte adsorptive (GMA) apheresis (Adacolumn®) in this population. Materials and methods: Ninety five adults with steroid-dependent active UC and insufficient response/intolerance to IS and/or TNF inhibitors received 5–8 aphereses in a single induction series of ≤10 weeks. Endpoints included rates of remission (clinical activity index [CAI] ≤ 4) at weeks 24 and 48. Results: Of 94 patients (ITT population), remission and response rates were 34.0% and 44.7% at week 24, and 33.0% and 39.4% at week 48. Among 30 patients with prior failure of IS and biologics, 33.3% and 20.0% were in remission at weeks 24 and 48. At both weeks, 19.2% of patients achieved steroid-free remission. Sustained remission or response occurred in 27.7% of patients at 48 weeks. The cumulative colectomy rate at week 96 was 23.4%. Safety was consistent with previous findings. Conclusions: This study confirms findings of the 12-week interim analysis and demonstrates that GMA apheresis provides a safe and beneficial long-term outcome for patients with chronic active UC resistant/intolerant to IS and/or TNF inhibitors.

50. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis

Author

Dignass, Axel, Akbar, Ayesha, Baumgart, Daniel C., Bommelaer, Gilles, Bouguen, Guillaume, Cadiot, Guillaume, Gillessen, Anton, Jean-Charles Grimaud, Hart, Ailsa, Hoque, Syed, Makins, Richard, Michiels, Christophe, Moreau, Jacques, Purushothaman Premchand, Ramlow, Wolfgang, Schanz, Stefan, Sreedhar Subramanian, Tirpitz, Christian Von, and Bonaz, Bruno

Subjects
3. Good health
Abstract

Objectives: Current options for patients with steroid-dependent, chronic-active ulcerative colitis (UC) with insufficient response/intolerance to immunosuppressants (ISs) and/or biologics are limited. The aim of this study was to assess the long-term outcome of granulocyte/monocyte adsorptive (GMA) apheresis (Adacolumn®) in this population. Materials and methods: Ninety five adults with steroid-dependent active UC and insufficient response/intolerance to IS and/or TNF inhibitors received 5–8 aphereses in a single induction series of ≤10 weeks. Endpoints included rates of remission (clinical activity index [CAI] ≤ 4) at weeks 24 and 48. Results: Of 94 patients (ITT population), remission and response rates were 34.0% and 44.7% at week 24, and 33.0% and 39.4% at week 48. Among 30 patients with prior failure of IS and biologics, 33.3% and 20.0% were in remission at weeks 24 and 48. At both weeks, 19.2% of patients achieved steroid-free remission. Sustained remission or response occurred in 27.7% of patients at 48 weeks. The cumulative colectomy rate at week 96 was 23.4%. Safety was consistent with previous findings. Conclusions: This study confirms findings of the 12-week interim analysis and demonstrates that GMA apheresis provides a safe and beneficial long-term outcome for patients with chronic active UC resistant/intolerant to IS and/or TNF inhibitors.

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