Safety and Clinical Outcomes of Rituximab Treatment in Patients with Multiple Sclerosis and Neuromyelitis Optica: Experience from a National Online Registry (GRAID)

Journal of Neuroimmune Pharmacology

Volumn 11, Issue 1, 2016, Pages 1-8

  Rommer, P S ^a,b   Dorner T ^c   Freivogel, K ^d   Haas, J ^e   Kieseier, B C ^f   Kumpfel T ^g   Paul, F ^c   Proft, F ^g   Schulze Koops, H ^g   Schmidt, E ^d   Wiendl, H ^h   Ziemann, U ^i,j   Zettl, U K ^a  

^a UNIVERSITY OF ROSTOCK   (Germany)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d Analytica International GmbH   (Germany)

^e Jewish Hospital of Berlin   (Germany)

^f HEINRICH HEINE UNIVERSITY   (Germany)

^g UNIVERSITY OF MUNICH   (Germany)

^h UNIVERSITY OF MÜNSTER   (Germany)

ⁱ UNIVERSITY OF TÜBINGEN   (Germany)

^j GOETHE UNIVERSITY   (Germany)

more..

Author keywords

Multiple sclerosis; Neuromyelitis optica; Rituximab; Treatment

Indexed keywords

RITUXIMAB; IMMUNOLOGIC FACTOR;

ABDOMINAL PAIN; ADULT; ANEMIA; ARTICLE; CLINICAL TRIAL; DISEASE DURATION; DOSE CALCULATION; DRUG SAFETY; ERYTHEMA; EYE DISEASE; FEMALE; HUMAN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE SCLEROSIS; MYELOOPTIC NEUROPATHY; NUCLEAR MAGNETIC RESONANCE IMAGING; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SHIVERING; TREATMENT OUTCOME; URINARY TRACT INFECTION; UROSEPSIS; GERMANY; NEUROMYELITIS OPTICA; REGISTER;

ADULT; FEMALE; GERMANY; HUMANS; IMMUNOLOGIC FACTORS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; NEUROMYELITIS OPTICA; REGISTRIES; RETROSPECTIVE STUDIES; RITUXIMAB; TREATMENT OUTCOME;

EID: 84957433827     PISSN: 15571890     EISSN: 15571904     Source Type: Journal    
DOI: 10.1007/s11481-015-9646-5     Document Type: Article

References (38)

1. Beres SJ, Graves J, Waubant E (2014) Rituximab use in pediatric central demyelinating disease. Pediatr Neurol 51(1):114–118
2. Boster A, Ankeny DP, Racke MK (2010) The potential role of B cell-targeted therapies in multiple sclerosis. Drugs 70:2343–2356
3. Carmona L, de la Vega M, Ranza R, Casado G, Titton DC, Descalzo MÁ, Gómez-Reino J (2014) BIOBADASER, BIOBADAMERICA, and BIOBADADERM: safety registers sharing commonalities across diseases and countries. Clin Exp Rheumatol 32(5 Suppl 85):S-163–S-167
4. Compston A, Coles A (2008) Multiple sclerosis. Lancet 372(9648):1502–1517
5. Cree BA, Lamb S, Morgan K, Chen A, Waubant E, Genain C (2005) An open label study of the effects of rituximab in neuromyelitis optica. Neurology 64(7):1270–1272
6. Cross AH, Waubant E (2011) MS and the B cell controversy. Biochim Biophys Acta 1812:231–238
7. Eberst L, Cropet C, Le Cesne A, Pautier P, Penel N, Adenis A, Chevreau C, Bay JO, Collard O, Cupissol D, Duffaud F, Gentet JC, Piperno-Neumann S, Marec-Berard P, Bompas E, Thyss A, Chaigneau L, Cassier P, Bertucci F, Blay JY, Ray-Coquard I (2014) The off-label use of targeted therapies in sarcomas: the OUTC’S program. BMC Cancer 14:870. doi:10.1186/1471-2407-14-870
8. Ehler J, Koball S, Sauer M, Hickstein H, Mitzner S, Benecke R, Zettl UK (2014) Therapeutic plasma exchange in glucocorticosteroid-unresponsive patients with Clinically Isolated Syndrome. Ther Apher Dial 18(5):489–496
9. Emery P, Gallo G, Boyd H, Morgan CL, Currie CJ, Poole CD, Nab HW (2014) Association between disease activity and risk of serious infections in subjects with rheumatoid arthritis treated with etanercept or disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol 32(5):653–660
10. Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, Bar-Or A, Panzara M, Sarkar N, Agarwal S, Langer-Gould A, Smith CH, HERMES Trial Group (2008) B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med 358(7):676–688
11. Hawker K, O’Connor P, Freedman MS, Calabresi PA, Antel J, Simon J, Hauser S, Waubant E, Vollmer T, Panitch H, Zhang J, Chin P, Smith CH, OLYMPUS trial group (2009) Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol 66(4):460–471
12. He D, Guo R, Zhang F, Zhang C, Dong S, Zhou H (2013) Rituximab for relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev 12, CD009130
13. Jacob A, Weinshenker BG, Violich I, McLinskey N, Krupp L, Fox RJ, Wingerchuk DM, Boggild M, Constantinescu CS, Miller A, De Angelis T, Matiello M, Cree BA (2008) Treatment of neuromyelitis optica with rituximab: retrospective analysis of 25 patients. Arch Neurol 65(11):1443–1448
14. Jarius S, Ruprecht K, Wildemann B, Kuempfel T, Ringelstein M, Geis C, Kleiter I, Kleinschnitz C, Berthele A, Brettschneider J, Hellwig K, Hemmer B, Linker RA, Lauda F, Mayer CA, Tumani H, Melms A, Trebst C, Stangel M, Marziniak M, Hoffmann F, Schippling S, Faiss JH, Neuhaus O, Ettrich B, Zentner C, Guthke K, Hofstadt-van Oy U, Reuss R, Pellkofer H, Ziemann U, Kern P, Wandinger KP, Bergh FT, Boettcher T, Langel S, Liebetrau M, Rommer PS, Niehaus S, Münch C, Winkelmann A, Zettl UUK, Metz I, Veauthier C, Sieb JP, Wilke C, Hartung HP, Aktas O, Paul F (2012) Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. J Neuroinflammation 9:14. doi:10.1186/1742-2094-9-14
15. Jarius S, Wildemann B, Paul F (2014) Neuromyelitis optica: clinical features, immunopathogenesis and treatment. Clin Exp Immunol 176(2):149–164
16. Kim SH, Huh SY, Lee SJ, Joung A, Kim HJ (2013) A 5-year follow-up of rituximab treatment in patients with neuromyelitis optica spectrum disorder. JAMA Neurol 70(9):1110–1117
17. Koch-Henriksen N, Magyari M, Laursen B (2015) Registers of multiple sclerosis in Denmark. Acta Neurol Scand 132(199):4–10. doi:10.1111/ane.12424
18. Krumbholz M, Meinl E (2014) B cells in MS and NMO: pathogenesis and therapy. Semin Immunopathol 36(3):339–350
19. Kutzelnigg A, Lassmann H (2014) Pathology of multiple sclerosis and related inflammatory demyelinating diseases. Handb Clin Neurol 122:15–58
20. Lennon VA, Wingerchuk DM, Kryzer TJ, Pittock SJ, Lucchinetti CF, Fujihara K, Nakashima I, Weinshenker BG (2004) A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 364:2106–2112
21. Lublin FD, Reingold SC (1996) Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology 46(4):907–911
22. McFarland HF, Martin R (2007) Multiple sclerosis: a complicated picture of autoimmunity. Nat Immunol 8(9):913–919
23. Monson NL, Cravens PD, Frohman EM, Hawker K, Racke MK (2005) Effect of rituximab on the peripheral blood and cerebrospinal fluid B cells in patients with primary progressive multiple sclerosis. Arch Neurol 62(2):258–264
24. Naismith RT, Piccio L, Lyons JA, Lauber J, Tutlam NT, Parks BJ, Trinkaus K, Song SK, Cross AH (2010) Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: a 52-week phase II trial. Neurology 74(23):1860–1867
25. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG (2000) Multiple sclerosis. N Engl J Med 343(13):938–952
26. Pellkofer HL, Krumbholz M, Berthele A, Hemmer B, Gerdes LA, Havla J, Bittner R, Canis M, Meinl E, Hohlfeld R, Kuempfel T (2011) Long-term follow-up of patients with neuromyelitis optica after repeated therapy with rituximab. Neurology 76(15):1310–1315
27. Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O’Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 58(6):840–846
28. Rommer PS, Stüve O (2013) Management of secondary progressive multiple sclerosis: prophylactic treatment-past, present, and future aspects. Curr Treat Options Neurol 15(3):241–258
29. Rommer PS, Patejdl R, Winkelman A, Benecke R, Zettl UK (2011) Rituximab for secondary progressive multiple sclerosis: a case series. CNS Drugs 25:607–613
30. Rommer PS, Patejdl R, Zettl UK (2012) Monoclonal antibodies in the treatment of neuroimmunological diseases. Curr Pharm Des 18(29):4498–4507
31. Rommer PS, Zettl UK, Kieseier B, Hartung HP, Menge T, Frohman E, Greenberg BM, Hemmer B, Stüve O (2014) Requirement for safety monitoring for approved multiple sclerosis therapies: an overview. Clin Exp Immunol 175(3):397–407
32. Tony HP, Burmester G, Schulze-Koops H, Grunke M, Henes J, Kötter I, Haas J, Unger L, Lovric S, Haubitz M, Fischer-Betz R, Chehab G, Rubbert-Roth A, Specker C, Weinerth J, Holle J, Müller-Ladner U, König R, Fiehn C, Burgwinkel P, Budde K, Sörensen H, Meurer M, Aringer M, Kieseier B, Erfurt-Berge C, Sticherling M, Veelken R, Ziemann U, Strutz F, von Wussow P, Meier FM, Hunzelmann N, Schmidt E, Bergner R, Schwarting A, Eming R, Hertl M, Stadler R, Schwarz-Eywill M, Wassenberg S, Fleck M, Metzler C, Zettl U, Westphal J, Heitmann S, Herzog AL, Wiendl H, Jakob W, Schmidt E, Freivogel K, Dörner T, GRAID investigators (2011) Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID). Arthritis Res Ther 13(3):R75
33. Trebst C, Jarius S, Berthele A, Paul F, Schippling S, Wildemann B, Borisow N, Kleiter I, Aktas O, Kümpfel T, Neuromyelitis Optica Study Group (NEMOS) (2014) Update on the diagnosis and treatment of neuromyelitis optica: recommendations of the Neuromyelitis Optica Study Group (NEMOS). J Neurol 261(1):1–16
34. Wahren-Herlenius M, Dörner T (2013) Immunopathogenic mechanisms of systemic autoimmune disease. Lancet 382(9894):819–831
35. Waubant E (2008) Spotlight on anti-CD20. Int MS J 15:19–25
36. Wingerchuk DM, Hogancamp WF, O’Brien PC, Weinshenker BG (1999) The clinical course of neuromyelitis optica (Devic’s syndrome). Neurology 53(5):1107–1114
37. Wingerchuk DM, Lennon VA, Pittock SJ, Lucchinetti CF, Weinshenker BG (2006) Revised diagnostic criteria for neuromyelitis optica. Neurology 66(10):1485–1489
38. Zettl UK, Stüve O, Patejdl R (2012) Immune-mediated CNS diseases: a review on nosological classification and clinical features. Autoimmun Rev 11(3):167–173