The Experts below are selected from a list of 78 Experts worldwide ranked by ideXlab platform
Syed Hoque - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of granulocyte monocyte Apheresis in steroid dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and or biologics art trial 12 week interim results
Journal of Crohns & Colitis, 2016Co-Authors: Axel Dignass, Gilles Bommelaer, Richard Makins, Jean-charles Grimaud, Ayesha Akbar, Daniel C. Baumgart, Sreedhar Subramanian, Ailsa Hart, Guillaume Cadiot, Syed HoqueAbstract:BACKGROUND AND AIMS: Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive Apheresis Device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup. METHODS: This single arm, open-label, multicentre trial (ART) was conducted at 18 centres across the UK, France and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥5 weekly Apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate (clinical activity index ≤4) at Week 12. RESULTS: Eighty-six patients were enrolled. At Week 12, 33/84 (39.3%) of patients in the intention-to-treat population achieved clinical remission, with 47/84 (56.0%) achieving a clinical response (clinical activity index reduction of ≥3). Clinical remission was achieved in 30.0% of patients with prior immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life (Short Health Scale) significantly improved at Week 12 (p\textless0.0001). The majority of adverse events were of mild/moderate intensity. CONCLUSIONS: At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup
Uta Drebber - One of the best experts on this subject based on the ideXlab platform.
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novel leucocyte thrombocyte Apheresis for induction of steroid free remission in ulcerative colitis a controlled randomized pilot study
Journal of Crohns & Colitis, 2019Co-Authors: Wolfgang Kruis, Phuong Nguyen, Julia Morgenstern, Wolfgang Ramlow, Axel Dignas, A Stallmach, Uta DrebberAbstract: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.
Axel Dignass - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of granulocyte monocyte Apheresis in steroid dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and or biologics art trial 12 week interim results
Journal of Crohns & Colitis, 2016Co-Authors: Axel Dignass, Gilles Bommelaer, Richard Makins, Jean-charles Grimaud, Ayesha Akbar, Daniel C. Baumgart, Sreedhar Subramanian, Ailsa Hart, Guillaume Cadiot, Syed HoqueAbstract:BACKGROUND AND AIMS: Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive Apheresis Device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup. METHODS: This single arm, open-label, multicentre trial (ART) was conducted at 18 centres across the UK, France and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥5 weekly Apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate (clinical activity index ≤4) at Week 12. RESULTS: Eighty-six patients were enrolled. At Week 12, 33/84 (39.3%) of patients in the intention-to-treat population achieved clinical remission, with 47/84 (56.0%) achieving a clinical response (clinical activity index reduction of ≥3). Clinical remission was achieved in 30.0% of patients with prior immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life (Short Health Scale) significantly improved at Week 12 (p\textless0.0001). The majority of adverse events were of mild/moderate intensity. CONCLUSIONS: At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup
Wolfgang Kruis - One of the best experts on this subject based on the ideXlab platform.
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novel leucocyte thrombocyte Apheresis for induction of steroid free remission in ulcerative colitis a controlled randomized pilot study
Journal of Crohns & Colitis, 2019Co-Authors: Wolfgang Kruis, Phuong Nguyen, Julia Morgenstern, Wolfgang Ramlow, Axel Dignas, A Stallmach, Uta DrebberAbstract: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.
Halvard Bonig - One of the best experts on this subject based on the ideXlab platform.
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automatic interface controlled Apheresis collection of stem progenitor cells results from an autologous donor validation trial of a novel stem cell Apheresis Device
Transfusion, 2011Co-Authors: Peter Reinhardt, Susanne Brauninger, Heike Bialleck, Kristin Thorausch, Richard Smith, Hubert Schrezenmeier, Erhard Seifried, Markus Wiesneth, Halvard BonigAbstract:BACKGROUND: Cryopreserved hematopoietic progenitor cells collected by Apheresis from granulocyte–colony-stimulating factor with or without chemotherapy–mobilized patients have become the preferred type of autograft to support treatment of diseases amenable to high-dose chemotherapy. A novel Apheresis system, the Spectra Optia v.5.0 (CaridianBCT), was constructed to meet certain shortcomings of manual Apheresis systems such as the COBE Spectra MNC (CaridianBCT), including the need for continuous optical or manual monitoring and readjustment of buffy coat position and sensitivity to inconsistent blood flow. By use of optical sensors, which provide real-time automatic interface (buffy coat) and collection line control, the Spectra Optia promises to automatically guide Apheresis procedures, potentially freeing up operator time and reducing variability in collection efficiency (CE2). STUDY DESIGN AND METHODS: In a two-center clinical trial, 35 autologous stem cell donors were subjected to Apheresis with the Spectra Optia to validate feasibility and effectiveness of Apheresis procedures. Results were compared to data from 80 autologous Apheresis procedures with the COBE Spectra MNC. RESULTS: Usability and function of the automatic interface management were excellent. CD34+ cell quality, assessed by viability staining, colony-forming unit–culture frequency, and engraftment kinetics, was equally good with both systems. CE2 of the Spectra Optia, calculated as CD34+ contents in the product divided by the number of CD34+ cells presented to the collection port, exceeded that of the COBE Spectra MNC. Spectra Optia product volumes were significantly smaller. Very high white blood cell and platelet counts modestly reduced CE2 with the Spectra Optia. CONCLUSION: The Spectra Optia is a novel automatic Apheresis system supporting autologous stem cell collection with at least equal efficiency and superior user-friendliness compared to the COBE Spectra MNC.