GBS and MG Brochure
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MAP A TREATMENT PLAN FOR A FAST ROAD TO RESULTS Plasma Exchange for GBS and MG Patients Therapeutic Systems Unlocking the Potential of Blood PLASMA EXCHANGE: A CLEAR ROAD TO RESULTS When Quick Results Can Make a Difference for Your Patients, Consider Plasma Exchange As First-Line Therapy The Spectra Optia system is the first indicated therapeutic apheresis system to treat Guillain-Barré syndrome (GBS) and myasthenia gravis (MG) with plasma exchange. Fast results, such as response to therapy and fast recovery, can make a difference for these patients. Plasma Exchange Rapidly Reduces Disease Mediators Plasma exchange is an immunotherapeutic that rapidly reduces disease mediators and circulating immune complexes to relieve GBS and MG symptoms. Improvement following plasma exchange can occur within a few days. Physicians can quantify and measure known disease mediators before plasma exchange as well as after in order to inform the next phase of treatment providing immediate objective results.1 THE IMMUNOMODULATORY EFFECT OF PLASMA EXCHANGE2 Reduction of pathological Reduction of antibodies cytokines Reduction of immunocomplexes, Replacement of enhancing necessary plasma macrophage/monocyte components function ONE PROCEDURE CAN RAPIDLY LOWER ALL IMMUNOGLOBULINS (IgA, IgM AND IgG 1–4) UP TO % (Guptill JT, Juel VC, Massey JM, et al. Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis. Autoimmunity. 2016;49(7):472-479.) 75 DID YOU KNOW? Plasma Exchange Can Be Performed: Peripherally or by central access On an inpatient or outpatient basis GBS: IMPROVE YOUR PATIENTS’ SPEED TO RESPONSE AND RECOVERY When your GBS patients are progressing quickly, a decisive first response is critical. The longer it takes for a treatment to take effect, the less likely that a patient will receive optimal results. Studies show that GBS patients who receive plasma exchange therapy experience faster response and recovery compared to those receiving only supportive care.3 GBS PATIENTS RECEIVING PLASMA EXCHANGE TREATMENT SHOWED THE FOLLOWING:3 One or more disability-grade improvements after 4 weeks Decreased time on a ventilator Improved functional abilities (for example, faster time to unaided walking and significantly improved grip strength 3 weeks after first plasma exchange) Increased probability of full muscle strength recovery and decreased probability of severe sequelae and relapse at 1 year Plasma Exchange As First-Line Therapy for GBS Spectra Optia is the first therapeutic apheresis system indicated to treat GBS. Plasma exchange is recommended as first-line therapy. EVIDENCE-BASED GUIDANCE FOR PLASMA EXCHANGE IN GBS European Federation of American Academy of American Society for Apheresis Neurological Societies (EFNS) Neurology (AAN)4 (ASFA) 20165 20086 Class I (Level A for severe GBS) Category I (Grade 1A) and Category III Level A (Grade 2C) MG: SEEING FAST RESULTS FOR YOUR PATIENTS IS CRITICAL In choosing a therapy, quick results remain a priority in order to hasten recovery or maintain optimal symptom management. Plasma exchange rapidly reduces disease mediators, essentially quieting the immune response and relieving symptoms.7 TIME TO CLINICAL EFFECT OF THERAPIES1 Speed to Response Treatment Time to Clinical Effect For MG crisis, this means hastening recovery, such as enabling the Pyridostigmine 10–15 minutes patient to come off the ventilator faster and achieve quicker functional outcome improvement.8 Plasma exchange 1–14 days IVIg 1–4 weeks Speed to Recovery Prednisone 2–8 weeks Studies show that plasma exchange treatment provides significant Mycophenolate mofetiI 2–6 months clinical benefits when used as a stand-alone therapy for MG patients.9 Cyclosporine 2–6 months Azathioprine 3–18 months Plasma Exchange As First-Line Therapy for MG Spectra Optia is the first therapeutic apheresis system indicated to treat MG. Plasma exchange is recommended as first-line therapy for refractory, crisis and MuSK+ MG. EVIDENCE-BASED GUIDANCE FOR PLASMA EXCHANGE IN MG European Federation of Myasthenia Gravis Foun- American Society for Neurological Societies Cochrane 201310 dation of America (MGFA) Apheresis (ASFA) 20165 (EFNS) 20106 Consensus 20169 ■ Level A for acute exacerbation ■ Moderate–severe (Grade II) ■ Category I ■ Short-term treatment in ■ Level B prethymectomy ■ Prethymectomy (Grade III) ■ Moderate–severe (Grade 1B) myasthenic crisis ■ Prethymectomy (Grade 1C) ■ Prethymectomy ■ Refractory MG ■ Prior to corticosteroids Multiple Studies and Expert Opinion Support That Plasma Exchange Has Superior Efficacy Over IVIg for MuSK+ MG11,12,13 100% THE INTERNATIONAL CONSENSUS GUIDANCE FOR MANAGEMENT OF MYASTHENIA GRAVIS TPE 80 9 93% STATES, “MuSK-MG RESPONDS WELL TO PLEX, WHILE IVIg SEEMS TO BE LESS EFFECTIVE.” 60 IVIg 40 IN A 2011 REVIEW OF 110 MuSK-MG PATIENTS FROM TWO LARGE CLINICS IN ITALY AND 61% THE U.S., PLASMA EXCHANGE PRODUCED IMPROVEMENT IN 93 PERCENT OF PATIENTS, 20 COMPARED WITH ONLY 61 PERCENT WHO IMPROVED AFTER IVIg.11 0% IMPROVED WITH IMPROVED AFTER IVIg PLASMA EXCHANGE COMPARE HOW YOU TREAT PATIENTS TODAY ... ... WITH HOW PLASMA EXCHANGE CAN PUT YOUR PATIENTS ON A FAST ROAD TO RESULTS TOMORROW. PLASMA EXCHANGE ON THE SPECTRA OPTIA® APHERESIS SYSTEM: ■ Provides automated monitoring and allows for the maintenance of fluid balance ■ Helps efficiently remove targeted components and achieve highly predictable results with the patented Automated Interface Management (AIM) system ■ Has a plasma removal efficiency (PRE)* up to 87 percent14 ■ Can be performed peripherally via dual- or single-needle access or with central venous access ■ Can be provided as an outpatient or inpatient treatment ■ Of more than 40,000 procedures, the median procedure time was 1 hour and 45 minutes ■ Accommodates smaller patients and supports patient comfort and safety *PRE is an established metric to analyze the performance of an apheresis device during a TPE procedure. PATIENT SAFETY Plasma exchange is known to be safe and well tolerated, with the majority of reactions being mild, easily treated and of limited duration.15 Adverse Events (AEs) in Recent Literature The World Apheresis Association registry data update of over 50,000 therapeutic apheresis procedures reported that 94.2 percent of patients did not experience any adverse event. Of the 5.8 percent of patients that did experience adverse events, the below describes the type and severity of the reactions:16 ■ 2.4% Mild (tolerated without medication): access issues, device malfunctions, hypotension, tingling ■ 3.0% Moderate (needed medication due to AE): tingling, urticaria, hypotension, nausea ■ 0.4% Severe (interrupted due to AE): syncope/hypotension, urticaria, chills/fever, arrhythmia/asystole, nausea/vomiting For more information on the cautions and warnings associated with Spectra Optia, please refer to the operator’s manual. PLASMA EXCHANGE ON THE Safety Information SPECTRA OPTIA® APHERESIS SYSTEM: Contraindications ■ No known contraindications for the system’s use, except for those associated with all automated apheresis systems ■ The infusion of certain solutions and replacement fluids may be contraindicated in some patients Possible patient reactions ■ Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions Reactions to transfused blood products can include17 ■ Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection Restricted to prescription use only ■ Operators must be familiar with the system’s operating instructions ■ Procedures must be performed by qualified medical personnel ■ A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available18 References 1Saperstein D, Barohn R. Management of myasthenia gravis. Semin Neurology. 2004;24(1):41-48. 2Reeves H, Winters J. The mechanisms of action of plasma exchange. Br J Haematol. 2014;164(3). 3Chevret S, et al. Plasma exchange for Guillain-Barré syndrome (review). Cochrane Database of Systematic Reviews. 2017(2). 4Cortese I, Chaudhry V, Yuen T, et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders. Neurology. 2011;76(3):294-300. 5Schwartz 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. 6Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases. Eur J Neurol. 2008;15(893-908). Corrigendum 2009;16(4):547. 7Derksen RS. The efficacy of plasma exchange in the removal of plasma components. J Lab Clin Med. 1984;104:346-354. 8Quereshi A, Choudhry M, Akbar M, et al. Plasma exchange versus intravenous immunoglobulin treatment in myasthenic crisis. Neurology. 1999;52(3):629-632. 9Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425. 10Raphaël JC, Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barré syndrome. Cochrane Database Syst Rev. 2012(7). 11Guptill J, Sanders D, Evoli A. Anti-MuSK antibody myasthenia gravis: clinical findings and response to treatment in two large