Removal Characteristics of Immunoadsorption with the Tryptophan‐Immobilized Column Using Conventional and Selective Plasma Separators in the Treatment of Myasthenia Gravis

Ohkubo, Atsushi; Okado, Tomokazu; Sakurasawa, Takatoshi; Maeda, Takuma; Itagaki, Ayako; Yamamoto, Hiroko; Miyamoto, Satoko; Seshima, Hiroshi; Kurashima, Naoki; Mori, Takayasu; Iimori, Soichiro; Sohara, Eisei; Rai, Tatemitsu; Uchida, Shinichi; Naito, Seiji

doi:10.1111/1744-9987.12820

Cited by 11 publications

(13 citation statements)

References 22 publications

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“…However, this huge loss of fibrinogen could be prevented by placing before the IA column a selective membrane plasma separator with a relatively small pore size of 0.03 μm, which is approximately one-tenth that of conventional plasma separators, thereby retaining fibrinogen while removing approximately 50% of IgG. 27 Biesenbach et al previously reported that IA + MF was associated with impairment of some coagulation tests (fibrinogen, aPTT, and to lesser extent AT level). 26 They reported a~30% reduction in fibrinogen level after a single IA session and a~60% decrease after IA + MF, which is consistent with our results.…”

Section: Discussionmentioning

confidence: 99%

Effect of immunoadsorption alone or combined with membrane filtration on hemostasis parameters

Marlu

Bennani

Seyve

et al. 2020

J of Clinical Apheresis

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Introduction ABO‐ or HLA‐incompatible kidney transplantation is possible thanks to pretransplant antibody‐depletion achieved by extracorporeal‐treatment modalities. These methods induce depletion of some plasma proteins and may also impact on proteins involved in hemostasis. Methods To determine the impact of one session of immunoadsorption (IA) alone or combined with membrane filtration (MF) on clotting factors and natural anticoagulants, we performed a prospective, observational study on 13 patients waiting for HLA‐/ABO‐incompatible kidney transplants. Plasma hemostasis parameters were measured before and immediately after a first session of IA alone in six patients and of IA + MF in seven patients. Results IA alone induced depletion of fibrinogen and factor XIII (FXIII) whereas IA + MF caused greater depletion of all high‐molecular‐weight hemostatic proteins (fibrinogen, FV, FVIII, FXI, FXIII, von‐Willebrand factor [VWF]). After an IA session, median reductions were 30% for fibrinogen and 43% for FXIII compared to baseline values. After a session of IA + MF, median decreases were 70% for fibrinogen, 54% for FV, 56% for FVIII, 37% for FXI, 78% for FXIII, and 62% for VWF. Noticeably, levels of low‐molecular‐weight factors (<100 kDa) were far less decreased than high‐molecular‐weight proteins with IA + MF, except for protein S and the tissue factor pathway inhibitor, which are known to be partially physiologically bound to high‐molecular‐weight molecules. Conclusions IA and IA + MF induced significant depletion of some proteins implicated in the hemostatic process; however, IA + MF resulted in stronger modifications to hemostasis parameters than IA alone. This may have potential clinical implications regarding bleeding risk, and particularly depletion of fibrinogen and FXIII.

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Section: Discussionmentioning

confidence: 99%

Effect of immunoadsorption alone or combined with membrane filtration on hemostasis parameters

Marlu

Bennani

Seyve

et al. 2020

J of Clinical Apheresis

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“…Single-pass devices are used for only one session, while their capacity is limited to approximately 2.0 to 2.5 L (L) of plasma volume. A treatment with tryptophan adsorber and conventional plasma separator results in an elimination of 30% of immunoglobulin IgG and IgM, 15% of IgA, 10% of the patient’s total protein and approximately 60%–70% of the fibrinogen during a single treatment, with a PPV of 2 L [51,52].…”

Section: Resultsmentioning

confidence: 99%

Therapeutic Apheresis in Acute Relapsing Multiple Sclerosis: Current Evidence and Unmet Needs—A Systematic Review

Rolfes

Pfeuffer

Ruck

et al. 2019

JCM

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Multiple sclerosis (MS) is the most abundant inflammatory demyelinating disorder of the central nervous system. Despite recent advances in its long-term immunomodulatory treatment, MS patients still suffer from relapses, significantly contributing to disability accrual. In recent years, apheresis procedures such as therapeutic plasma exchange (TPE) and immunoadsorption (IA) have been recognized as two options for treating MS relapses, that do not respond to standard treatment with corticosteroids. TPE is already incorporated in most international guidelines, although evidence for its use resulted mostly from either case series or small unblinded and/or non-randomized trials. Data on IA are still sparse, but several studies indicate comparable efficacy between both apheresis procedures. This article gives an overview of the published evidence on TPE and IA in the treatment of acute relapses in MS. Further, we outline current evidence regarding individual outcome predictors, describe technical details of apheresis procedures, and discuss apheresis treatment in children and during pregnancy.

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“…The total serum IgG level after rozanolixizumab treatment was reduced by 68% of the highest level in a phase II study [ 9 ]. As extracorporeal removal procedures, PLEX could maximally reduce 73.4% of total serum IgG [ 24 ] and immunoadsorption (IA) could reduce 26.5% after one session with 2.0 L processing plasma volume (PPV) [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study

et al. 2022

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Introduction We investigated the safety and explore potential efficacy of batoclimab administered subcutaneously in Chinese patients with generalized myasthenia gravis (gMG). Methods A randomized, double-blinded, placebo-controlled, parallel phase II study was conducted. First, in the double-blinded treatment period, eligible patients received batoclimab (680 mg), batoclimab (340 mg), or placebo on days 1, 8, 15, 22, 29, and 36. In the open-label treatment period, patients received batoclimab (340 mg) on days 50, 64, and 78. In the follow-up period, patients were examined on days 92, 106, and 120. The primary endpoint was Myasthenia Gravis Activities of Daily Living (MG-ADL) score change on day 43 from baseline. Results In total, 30 eligible patients were enrolled, with 11, 10, and 9 patients in the batoclimab 680 mg, batoclimab 340 mg, and placebo groups, respectively. MG-ADL score changes from baseline to day 43 were −2.2 ± 0.9, −4.7 ± 0.6, and −4.4 ± 1.0 in the placebo, batoclimab 340 mg, and 680 mg groups, respectively. Similar changes were observed in Quantitative Myasthenia Gravis, Myasthenia Gravis Composite, and 15-item Myasthenia Gravis Quality of Life scores in the placebo, batoclimab 340 mg, and 680 mg groups, respectively. The proportion of patients with clinically significant improvement on day 43 was higher in the batoclimab groups. On day 120, all four scales in the placebo group had more significant improvement compared with the batoclimab groups, with total serum IgG levels reaching a plateau. No death or treatment-emergent adverse events (TEAEs) led to study discontinuation. Conclusion Batoclimab is effective and safe in Chinese patients with gMG. Trial Registration This study was registered at ClinicalTrials.gov (NCT04346888) on 15 April 2020, with the first patient enrolled on 23 July 2020. Supplementary Information The online version contains supplementary material available at 10.1007/s40120-022-00345-9.

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Removal Characteristics of Immunoadsorption with the Tryptophan‐Immobilized Column Using Conventional and Selective Plasma Separators in the Treatment of Myasthenia Gravis

Cited by 11 publications

References 22 publications

Effect of immunoadsorption alone or combined with membrane filtration on hemostasis parameters

Effect of immunoadsorption alone or combined with membrane filtration on hemostasis parameters

Therapeutic Apheresis in Acute Relapsing Multiple Sclerosis: Current Evidence and Unmet Needs—A Systematic Review

Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study

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