Off-label use of rituximab for systemic lupus erythematosus in Europe

Lupus Science and Medicine

Volumn 3, Issue 1, 2016, Pages

  Ryden Aulin, Monica ^a   Boumpas, Dimitrios ^b   Bultink, Irene ^c   Rubio, Jose Luis Callejas ^d   Caminal Montero, Luis ^e   Castro, Antoni ^f   Ruiz, Agustín Colodro ^g   Doria, Andrea ^h   Dorner, Thomas ⁱ   Gonzalez Echavarri, Cristina ^j   Gremese, Elisa ^k   Houssiau, Frederic A ^l   Huizinga, Tom ^m   Inanc, Murat ⁿ   Isenberg, David ^o   Iuliano, Annamaria ^p   Jacobsen, Soren ^q   Jimenez Alonso, Juan ^r   Kovacs, Laszlo ^s   Mariette, Xavier ^t   Mosca, Marta ^u   Nived, Ola ^v   Oristrell, Joaquim ^w   Ramos Casals, Manuel ^x   Rascon, Javier ^y   Ruiz Irastorza, Guillermo ^j   Sáez Comet, Luis ^z   Cervello, Gonzalo Salvador ^aa   Sebastiani, Gian Domenico ^p   Squatrito, Danilo ^ab   Szucs, Gabriella ^ac   Voskuyl, Alexandre ^ad   Van Vollenhoven, Ronald ^a,ae   more..

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^c Amsterdam Rheumatology and Immunology Center ^*  (Netherlands)

^d HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

^e HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^f HOSPITAL UNIVERSITARI SANT JOAN DE REUS   (Spain)

^g Pasaje Nueva Victoria   (Spain)

^h UNIVERSITY OF PADOVA   (Italy)

ⁱ CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^j BIOCRUCES BIZKAIA HEALTH RESEARCH INSTITUTE   (Spain)

^k CATHOLIC UNIVERSITY   (Italy)

^l CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^m LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

ⁿ ISTANBUL UNIVERSITY   (Turkey)

^o UNIVERSITY COLLEGE LONDON   (United Kingdom)

^p SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^q UNIVERSITY OF COPENHAGEN   (Denmark)

^r HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

^s UNIVERSITY OF SZEGED   (Hungary)

^t UNIVERSITÉ PARIS SACLAY   (France)

^u Rheumatology Unit   (Italy)

^v LUND UNIVERSITY HOSPITAL   (Sweden)

^w UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^x INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^y Carrer de les Sabateres   (Spain)

^z HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^aa HOSPITAL UNIVERSITARIO LA FE   (Spain)

^ab UNIVERSITY OF FLORENCE   (Italy)

^ac UNIVERSITY OF DEBRECEN   (Hungary)

^ad VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^ae ACADEMIC MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; METHOTREXATE; MYCOPHENOLATE MOFETIL; RITUXIMAB;

ADULT; CONTROLLED STUDY; DISEASE ACTIVITY; DISEASE CONTROL; DISEASE DURATION; EUROPE; EUROPEAN; FEMALE; HUMAN; INTERPERSONAL COMMUNICATION; LUPUS ERYTHEMATOSUS NEPHRITIS; MAJOR CLINICAL STUDY; MALE; OFF LABEL DRUG USE; PATIENT REFERRAL; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT OUTCOME;

EID: 84987678542     PISSN: None     EISSN: 20538790     Source Type: Journal    
DOI: 10.1136/lupus-2016-000163     Document Type: Review

References (45)

1. Györi N, Tani C, Mosca M. Advances in therapies for systemic lupus erythematosus. In: RF van Vollenhoven, ed. Clinical therapy research in the inflammatory diseases. World Scientific Press, 2015.
2. Zen M, Iaccarino L, Gatto M, et al. Prolonged remission in Caucasian patients with SLE: prevalence and outcomes. Ann Rheum Dis 2015;74:2117-22.
3. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011;63:3918-30.
4. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011;377:721-31.
5. Leandro MJ, Cooper N, Cambridge G, et al. Bone marrow B-lineage cells in patients with rheumatoid arthritis following rituximab therapy. Rheumatology (Oxford) 2007;46:29-36.
6. Jones RB, Tervaert JW, Hauser T, et al. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med 2010;363:211-20.
7. Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010;363:221-32.
8. Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum 2010;62:222-33.
9. Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum 2012;64:1215-26.
10. Leandro MJ, Edwards JC, Cambridge G, et al. An open study of B lymphocyte depletion in systemic lupus erythematosus. Arthritis Rheum 2002;46:2673-7.
11. Looney RJ, Anolik JH, Campbell D, et al. B cell depletion as a novel treatment for systemic lupus erythematosus: a phase I/II dose-escalation trial of rituximab. Arthritis Rheum 2004;50: 2580-9.
12. Gottenberg JE, Guillevin L, Lambotte O, et al. Tolerance and short term efficacy of rituximab in 43 patients with systemic autoimmune diseases. Ann Rheum Dis 2005;64:913-20.
13. Gunnarsson I, Sundelin B, Jónsdóttir T, et al. Histopathologic and clinical outcome of rituximab treatment in patients with cyclophosphamide-resistant proliferative lupus nephritis. Arthritis Rheum 2007;56:1263-72.
14. Jónsdóttir T, Gunnarsson I, Risselada A, et al. Treatment of refractory SLE with rituximab plus cyclophosphamide: clinical effects, serological changes, and predictors of response. Ann Rheum Dis 2008;67:330-4.
15. Boletis JN, Marinaki S, Skalioti C, et al. Rituximab and mycophenolate mofetil for relapsing proliferative lupus nephritis: a long-term prospective study. Nephrol Dial Transplant 2009;24:2157-60.
16. Li EK, Tam LS, Zhu TY, et al. Is combination rituximab with cyclophosphamide better than rituximab alone in the treatment of lupus nephritis? Rheumatology (Oxford) 2009;48:892-8.
17. Melander C, Sallée M, Trolliet P, et al. Rituximab in severe lupus nephritis: early B-cell depletion affects long-term renal outcome. Clin J Am Soc Nephrol 2009;4:579-87.
18. Roccatello D, Sciascia S, Rossi D, et al. Intensive short-term treatment with rituximab, cyclophosphamide and methylprednisolone pulses induces remission in severe cases of SLE with nephritis and avoids further immunosuppressive maintenance therapy. Nephrol Dial Transplant 2011;26:3987-92.
19. Iaccarino L, Bartoloni E, Carli L, et al. Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry. Clin Exp Rheumatol 2015;33:449-56.
20. Tanaka Y, Takeuchi T, Miyasaka N, et al. Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy. Mod Rheumatol 2016;26:80-6.
21. van Vollenhoven RF, Askling J. Rheumatoid arthritis registries in Sweden. Clin Exp Rheumatol 2005;23(Suppl 39): S195-200.
22. Silman A, Symmons D, Scott DG, et al. British Society for Rheumatology Biologics Register. Ann Rheum Dis 2003;62(Suppl 2):ii28-9.
23. Hetland ML. DANBIO: a nationwide registry of biological therapies in Denmark. Clin Exp Rheumatol 2005;23(Suppl 39):S205-7.
24. Witt M, Grunke M, Proft F, et al. Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE)-results from a nationwide cohort in Germany (GRAID). Lupus 2013;22:1142-9.
25. Fessel WJ. Systemic lupus erythematosus in the community. Incidence, prevalence, outcome, and first symptoms; the high prevalence in black women. Arch Intern Med 1974;134:1027-35.
26. Samanta A, Roy S, Feehally J, et al. The prevalence of diagnosed systemic lupus erythematosus in whites and Indian Asian immigrants in Leicester city, UK. Br J Rheumatol 1992;31:679-82.
27. Hopkinson ND, Doherty M, Powell RJ. Clinical features and race-specific incidence/prevalence rates of systemic lupus erythematosus in a geographically complete cohort of patients. Ann Rheum Dis 1994;53:675-80.
28. Lu TY, Jonsdottir T, van Vollenhoven RF, et al. Prolonged B-cell depletion following rituximab therapy in systemic lupus erythematosus: a report of two cases. Ann Rheum Dis 2008;67:1493-4.
29. Wang C, Mayo NE, Fortin PR. The relationship between health related quality of life and disease activity and damage in systemic lupus erythematosus. The Journal of rheumatology 2001;28:525-32.
30. Jönsen A, Bengtsson AA, Nived O, et al. Outcome of neuropsychiatric systemic lupus erythematosus within a defined Swedish population: increased morbidity but low mortality. Rheumatology (Oxford) 2002;41:1308-12.
31. Pettersson S, Lövgren M, Eriksson LE, et al. An exploration of patient-reported symptoms in systemic lupus erythematosus and the relationship to health-related quality of life. Scand J Rheumatol 2012;41:383-90.
32. Condon MB, Ashby D, Pepper RJ, et al. Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis 2013;72:1280-6.
33. Merrill J, Buyon J, Furie R, et al. Assessment of flares in lupus patients enrolled in a phase II/III study of rituximab (EXPLORER). Lupus 2011;20:709-16.
34. van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis 2014;73:958-67.
35. Voss A, Green A, Junker P. Systemic lupus erythematosus in Denmark: clinical and epidemiological characterization of a county-based cohort. Scand J Rheumatol 1998;27:98-105.
36. Fischer-Betz R, Wessel E, Richter J, et al. [Lupus in Germany: analysis within the German lupus self-help organization (LULA)]. Z Rheumatol 2005;64:111-22.
37. Alamanos Y, Voulgari PV, Siozos C, et al. Epidemiology of systemic lupus erythematosus in northwest Greece 1982-2001. J Rheumatol 2003;30:731-5.
38. Anagnostopoulos I, Zinzaras E, Alexiou I, et al. The prevalence of rheumatic diseases in central Greece: a population survey. BMC Musculoskelet Disord 2010;11:98.
39. López P, Mozo L, Gutiérrez C, et al. Epidemiology of systemic lupus erythematosus in a northern Spanish population: gender and age influence on immunological features. Lupus 2003;12:860-5.
40. EPISER. Prevalencia de enfermedades reumáticas en la población espanola. http://www.ser.es/investigacion/Proyectos/Episer/Episer. php
41. Ståhl-Hallengren C, Jönsen A, Nived O, et al. Incidence studies of systemic lupus erythematosus in Southern Sweden: increasing age, decreasing frequency of renal manifestations and good prognosis. J Rheumatol 2000;27:685-91.
42. Cakir N, Pamuk ÖN, Derviş E, et al. The prevalences of some rheumatic diseases in western Turkey: Havsa study. Rheumatol Int 2012;32:895-908.
43. Hopkinson ND, Doherty M, Powell RJ. The prevalence and incidence of systemic lupus erythematosus in Nottingham, UK, 1989-1990. Br J Rheumatol 1993;32:110-15.
44. Johnson AE, Gordon C, Palmer RG, et al. The prevalence and incidence of systemic lupus erythematosus in Birmingham, England. Relationship to ethnicity and country of birth. Arthritis Rheum 1995;38:551-8.
45. Gourley IS, Patterson CC, Bell AL. The prevalence of systemic lupus erythematosus in Northern Ireland. Lupus 1997;6:399-403.