Plasma Exchange for MG

Seeing results as quickly as possible is critical in order to hasten recovery or maintain optimal symptom management.

Plasma exchange rapidly reduces disease mediators, essentially quieting the immune response and relieving symptoms.¹ For MG crisis, this may mean hastening recovery, such as enabling the patient to come off the ventilator faster and achieve quicker functional outcome improvement.^1,2,3

Plasma Exchange Treatment for Myasthenia Gravis (MG)

Hear from Dr. Demeret as she shares her extensive experience in using TPE to treat MG.

What do you know about plasma exchange?

Relatively safe
Outpatient setting
Peripheral venous access
Lasts about 2 hours

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Plasma exchange may be more effective than IVIg in MuSK+ MG.

Review the data.

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Plasma exchange can be performed peripherally.

Myth or reality?

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"Although clinical trials suggest that intravenous immunoglobulin (IVIg) and plasma exchange are equally effective in the treatment of impending or manifest myasthenic crisis, expert consensus suggests that plasma exchange is more effective and works more quickly." ³

Time to Clinical Effect of Therapies for MG¹

Treatment	Time to Clinical Effect
Pyridostigmine	10–15 minutes
Plasma exchange	1–14 days
IVIg	1–4 weeks
Prednisone	2–8 weeks
Mycophenolate mofetil	2–6 months
Cyclosporine	2–6 months
Azathaioprine	3–18 months

Speed to Recovery for MG and MuSK+ MG Patients

Studies show therapeutic plasma exchange (TPE) provides significant clinical benefits when used as a stand-alone therapy for MG patients, including those with moderate-severe generalized, refractory, crisis and muscle-specific tyrosine kinase MG (MuSK+ MG). TPE has been shown to be effective for the majority of patients in these groups—not all patients respond the same to therapy. ^3,4,5,6

MG Results Using Plasma Exchange in Addition to Standard of Care

A REDUCTION IN DISEASE SEVERITY BY 2 GRADES
experienced by 89% of 18 patients ⁷

IMPROVEMENTS IN THE MG DISEASE SCALE
shown in 78.7% of 33 patients ⁸

AN IMPROVEMENT IN FUNCTIONAL GRADING FROM A MEDIAN OF 4 TO 1 ⁹
experienced in 100% of 11 patients

FULL RECOVERY FROM MG CRISIS
in 81% of 16 patients ¹⁰

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MuSK+ MG Results
Multiple studies and expert opinions support that plasma exchange has superior efficacy over IVIg for MuSK+ MG.^1,3,5,11,12

Retrospective chart review of 53 MuSK+ MG patients at nine university-based centers in the U.S. showed that 51 percent of patients improved with plasma exchange versus 20 percent with IVIg.¹²

In a 2011 review of 110 MuSK+ MG patients from two large clinics in Italy and the U.S., plasma exchange produced improvement in 93 percent of patients, compared with 61 percent who improved after IVIg. Clinical improvement was determined by a treating physician.¹¹

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Plasma Exchange as First-Line Therapy for MG

The Spectra Optia^® Apheresis System is the first therapeutic apheresis system indicated to treat MG. Plasma exchange is recommended as first-line therapy by the American Society for Apheresis (ASFA), the European Federation of Neurological Societies (EFNS), the German Neurological Society (GNS) and the Myasthenia Gravis Foundation of America (MGFA) for acute/crisis and refractory myasthenia gravis and pre-thymectomy.

Evidence-Based Guidelines for Plasma Exchange in MG

European Federation of Neurological Societies (EFNS) 2010¹³

Acute exacerbation (Level A)
Pre-thymectomy (Level B)

American Society for Apheresis (ASFA) 2016⁶

Moderate-severe Category I (Grade 1B)
Pre-thymectomy Category I (Grade 1C)

Myasthenia Gravis Foundation of America (MGFA) Consensus 2016³

Short-term treatment in myasthenic crisis
Pre-thymectomy
Refractory MG
Prior to corticosteroids

German Neurological Society (GNS) 2016¹⁴

Myasthenic crisis—Category I

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Guide: How to Order Plasma Exchange

Interested in Plasma Exchange for GBS?

Using plasma exchange on Spectra Optia results in a fast road to recovery for the majority of GBS patients by delivering a rapid clinical response.

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Apheresis-Related Safety Information

Contraindications

Leukocytapheresis is contraindicated in acute myeloid leukemia FAB M3 (acute promyelocytic leukemia) because of the accompanying disseminated intravascular coagulation.^1,2 Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.

Adverse events of apheresis procedures can include

Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable set failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance and inadequate separation of blood components.

Reactions to blood products transfused during procedures can include

Hemolytic transfusion reaction, immune-mediated platelet destruction, fever, allergic reactions, anaphylaxis, transfusion-related acute lung injury (TRALI), alloimmunization, posttransfusion purpura (PTP), transfusion-associated graft-versus-host disease (TA-GVHD), circulatory overload, hypothermia, metabolic complications and transmission of infectious diseases and bacteria.^3,4

Restricted to prescription use only

Operators must be familiar with the system's operating instructions.
Procedures must be performed by qualified medical personnel.

¹Vahdat L, Maslak P, Miller WH Jr, et al. Early mortality and the retinoic acid syndrome in acute promyelocytic leukemia: impact of leukocytosis, low-dose chemotherapy, PMN/RAR-alpha isoform and CD13 expression in patients treated with all-trans retinoic acid. Blood. 1994;84(11):3843-3849.

²Daver N, Kantarjian H, Marcucci G, et al. Clinical characteristics and outcomes in patients with acute promyelotic leukaemia and hyperleucocytosis. Br J Haematol. 2015;168(5):646-653.

³AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2017.

⁴European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the Preparation, Use and Quality Assurance of Blood Components. 19th edition. Strasbourg, France: EDQM Council of Europe; 2017.

¹Saperstein D, Barohn R. Management of myasthenia gravis. Semin Neurology. 2004;24(1):41-48.

²Quereshi A, Choudhry M, Akbar M, et al. Plasma exchange versus intravenous immunoglobulin treatment in myasthenic crisis. Neurology. 1999;52(3):629-632.

³Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425.

⁴Ebadi H, Barth D, Bril V. Safety of plasma exchange therapy in patients with myasthenia gravis. Muscle Nerve. 2013;47(4):510-514.

⁵Guptill JT, Juel VC, Massey JM, et al. Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis. Autoimmunity. 2016;49(7):472-479.

⁶Schwartz J, Padmanabhan A, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice—Evidence-based approach from the writing committee of the American Society for Apheresis: The seventh special issue. J Clin Apher. 2016;31(3):149-162.

⁷Szczeklik W, Wawrycka K, Wludarcyzk A, et al. Complications in patients treated with plasmapheresis in the intensive care unit. Anesthesial Intensive Ther. 2013;45(1):7-13.

⁸Trikha I, Singh S, Goyal V, Shukla G, Bhasin R, Behari M. Therapeutic plasma exchange in the treatment of neuroimmunologic disorders: review of 50 cases. Neurology. 2007;254:989-995.

⁹Kaynar L, Altuptas F, Aydogedu T, et al. Therapeutic plasma exchange in patients with neurologic diseases: retrospective multicenter study. Transfus Apher Sci. 2008;38(2):109-115.

¹⁰Sorgun M, Erdogan S, Bay M, et al. Therapeutic plasma exchange in treatment of neuroimmunologic disorders: Review of 92 cases. Transfus Apher Sci. 2013;49(2):174-180.

¹¹Guptill J, Sanders D, Evoli A. Anti-MuSK antibody myasthenia gravis: clinical findings and response to treatment in two large cohorts. Muscle Nerve. 2011;44(1):36-40.

¹²Pasnoor M, Wolfe G, Nations S, et al. Clinical findings in MuSK-antibody positive myasthenia gravis: A U.S. experience. Muscle Nerve. 2010;41(3):370-374.

¹³Skeie GO, Apostolski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902.

¹⁴Meltzer N, Ruck T, Fuhr P, et al. Clinical features, pathogenesis, and treatment of myasthenia gravis: a supplement to the Guidelines of the German Neurological Society. J Neurol. 2016; 263:1473-1497.

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