Characterization of efficacy and safety of pathogen inactivated and quarantine plasma in routine use for treatment of acquired immune thrombotic thrombocytopenic purpura

Herbrecht, Raoul; Ojeda‐Uribe, Mario; Kientz, Daniel; Fohrer, Cécile; Bohbot, Alain; Hinschberger, O.; Liu, K.‐L.; Remy, Emilie; Ernst, Christine; Lin, Jin‐Sying; Corash, Laurence; Cazenave, J.‐P.

doi:10.1111/vox.12663

Cited by 11 publications

(6 citation statements)

References 30 publications

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“…In our small cohort OctaplasLG® provided remission rates consistent with those reported recently in terms of number of TPE and plasma volume [19,21]. The systematic use of early adjuvant immune therapy like corticosteroids and rituximab dramatically decreased the number of TPE to achieve remission.…”

Section: Discussionsupporting

confidence: 87%

“…In 2015, a retrospective French trial in iTTP patients has reported equivalence in terms of clinical efficacy and tolerance of blood bank SD-FFP and quarantine FFP, with a light superiority for SD-FFP in younger patients [18]. Some other retrospective studies comparing amotosaleninactivated plasma to quarantine of plasma showed no difference in term of efficacy [19,20]. Up to now, no study compared OctaplasLG® to another plasma product.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

Poullin

Delmotte

Sanderson

et al. 2020

Transfusion and Apheresis Science

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Background: Octaplas LG® is the first plasma with marketing authorisation, available in France only since February 2016. This is a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma. Clinical data on Octaplas LG® use in thrombotic microangiopathy (TMA) remains very limited. In May 2017, we were the first hospital in France to benefit of this new plasma product now dispensed by hospital pharmacies. We present a prospective review of all therapeutic plasma exchange (TPE) procedures for TMA patients in our hospital to evaluate the new delivery circuit, the efficacy and the adverse events (AE) related to this plasma. Study design and methods: We prospectively reviewed 166 TPE procedures where Octaplas LG® was used as replacement fluid in 15 consecutive TMA patients required TPE in our hospital from May 2017 until December 2018. Results: The total replacement plasma volume administered was 763 L (3818 units) with a median on 32 L (range 6-157) per episode. Remission was achieved in all cases after a median of 7 TPE per patient's episode. No exacerbation nor relapse were noted. One patient presented a grade 1 citrate reaction, and another patient an allergic reaction. We deplored pulmonary embolism in 2 patients. Conclusion: In our experience OctaplasLG® was well-tolerated and was effective at inducing a full clinical remission. Although two PE were noted, the relationship to OctaplasLG® in unclear. The new dispensing circuit through the hospital pharmacy has proven to be safe and efficient.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

Poullin

Delmotte

Sanderson

et al. 2020

Transfusion and Apheresis Science

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“…This study was part of the Phase III clinical development program for AI-FFP registration [44]. Another recent study carried out by our group reported comparable efficacy between AI-FFP and Q-FFP in iTTP [45].…”

Section: Discussionmentioning

confidence: 93%

Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura

Garraud

Malot

Herbrecht

et al. 2019

Transfusion and Apheresis Science

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Background: Therapeutic Plasma Exchange (TPE) is the primary therapy of immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP). Efficacy and safety data for TPE of iTTP have been assessed with Quarantine and Solvent-Detergent inactivated (SD) plasma. Here, amotosalen-UVA pathogen inactivated (AI) plasma, also in routine use, was evaluated in iTTP. Methods: We conducted a retrospective review of iTTP cases prospectively reported to the French national registry (2010)(2011)(2012)(2013). Cases reviewed underwent TPE with ≥70% of either AI or SD plasma. The primary endpoint was time to platelet count recovery; secondary endpoints were related to follow-up (sustained remission, relapses, flare-ups and refractoriness). Results: 30 Test patients were identified in the AI group which could be timely matched to 40 Control patients in the SD group. The groups were fairly comparable for clinical presentation. Major findings were: (i) iTTP patients were exposed to lower plasma volumes in the AI group than in the SD group; (ii) Recovery rates were comparable between the groups. Median time to platelet count recovery (> 150 × 10 9 /L) trended to be shorter in the AI group though non significantly. Tolerance of AI vs SD plasma was of comparable frequency and severity in either group. Conclusion: TPE with Amotosalen-inactivated plasma demonstrated therapeutic efficacy and tolerability for iTTP patients. In view of the retrospective design, confirmation of these results is required in larger prospective studies.

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“…One RCT (liver disease) and two observational studies (liver transplant and TTP) reported on thromboembolism as part of AE (none included prospective monitoring). No study reported significant differences in incidence rates of thromboembolism for PR versus conventional plasma …”

Section: Product Efficacymentioning

confidence: 99%

“…Synopsis: Nine observational trials and six RCTs were used to evaluate the safety of PR plasma. No study reported an increase in AE in PR plasma compared to conventional plasma and most reported similar or decreased AE.…”

Section: Product Efficacymentioning

confidence: 99%

Pathogen reduced plasma products: a clinical practice scientific review from the AABB

et al. 2019

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BACKGROUND A small body of literature assessing the efficacy and safety of pathogen reduced (PR) plasma has been published. STUDY DESIGN AND METHODS An AABB committee systematically reviewed the literature and graded the clinical trial evidence with the assistance of a GRADE expert. RESULTS Most studies identified were low quality and had a small sample size; in addition, efficacy and safety were monitored in many different ways making it difficult to quantify therapeutic benefit and risk. The data analyzed in this systematic review showed that pathogen inactivation did not adversely affect the efficacy of S/D or amotosalen plasma transfusions in any patient population studied. In addition, there were no significant safety issues for these patient populations, other than the specific contraindications noted in their respective package inserts. CONCLUSION Larger, well‐designed trials are needed to further evaluate the efficacy and safety of all of the PR plasma products.

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Characterization of efficacy and safety of pathogen inactivated and quarantine plasma in routine use for treatment of acquired immune thrombotic thrombocytopenic purpura

Abstract: Cardiac and a spectrum of ECG findings are common in TTP. In this study, IBSP and QP had similar therapeutic profiles for TPE.

Cited by 11 publications

References 30 publications

Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura

Pathogen reduced plasma products: a clinical practice scientific review from the AABB

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