Multicenter longitudinal study of B-lymphocyte depletion in refractory systemic lupus erythematosus: The LESIMAB study

Lupus

Volumn 21, Issue 10, 2012, Pages 1063-1076

  Fernandez Nebro A ^a   De La Fuente, J L Marenco ^b   Carreno L ^c   Izquierdo, M Galindo ^d   Tomero, E ^e   Rua Figueroa I ^f   Hernandez Cruz B E ^g   Narvaez J ^h   Ucar, E ⁱ   Olive A ^j   Zea, A ^k   Fernandez Castro M ^l   Raya Alvarez E ^m   Pego Reigosa, J M ⁿ   Freire, M ^o   Martinez Taboada V M ^p   Perez Venegas J ^q   Sanchez Atrio A I ^r   Villa Blanco, I ^s   Manrique Arija, S ^a   Lopez Longo F J ^c   Carreira, P E ^d   Martinez Perez R ^b   Garcia Vicuna R ^e   more..

^a HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA   (Spain)

^b HOSPITAL UNIVERSITARIO DE VALME   (Spain)

^c HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^d HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^e HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^f HOSPITAL UNIVERSITARIO DE GRAN CANARIA DR NEGRÍN   (Spain)

^g HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^h HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

ⁱ HOSPITAL DE BASURTO   (Spain)

^j HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^k HOSPITAL RAMÓN Y CAJAL   (Spain)

^l HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^m HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

ⁿ HOSPITAL DO MEIXOEIRO   (Spain)

^o HOSPITAL JUAN CANALEJO   (Spain)

^p HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^q HOSPITAL DE JEREZ   (Spain)

^r HOSPITAL UNIVERSITARIO PRÍNCIPE DE ASTURIAS   (Spain)

^s HOSPITAL SIERRALLANA   (Spain)

more..

Author keywords

biological therapy; effectiveness treatment; infection; rituximab; safety; Systematic lupus erythematosus

Indexed keywords

ANTIBIOTIC AGENT; AZATHIOPRINE; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; DANAZOL; EPRATUZUMAB; GLUCOCORTICOID; HISTAMINE H1 RECEPTOR ANTAGONIST; HYDROXYCHLOROQUINE; IMMUNOGLOBULIN; LEFLUNOMIDE; MERCAPTOPURINE; METHOTREXATE; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE; RITUXIMAB; TACROLIMUS; TUMOR NECROSIS FACTOR INHIBITOR;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ANXIETY; ARTHRALGIA; ARTICLE; B LYMPHOCYTE; BLOOD DISEASE; BREAST CANCER; DEMYELINATION; DIARRHEA; DISEASE EXACERBATION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG INDICATION; DRUG INDUCED DISEASE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TREATMENT FAILURE; EDEMA; FEMALE; FEVER; FOLLOW UP; HEART FAILURE; HEMORRHAGIC CYSTITIS; HERPES VIRUS INFECTION; HUMAN; LABORATORY TEST; LONGITUDINAL STUDY; LUNG HEMORRHAGE; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; PERIPHERAL ISCHEMIA; PNEUMONIA; PRIORITY JOURNAL; PULMONARY HYPERTENSION; PYELONEPHRITIS; RELAPSE; RETCHES; SEIZURE; SIDE EFFECT; SKIN LUPUS ERYTHEMATOSUS; SYSTEMIC LUPUS ERYTHEMATOSUS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; URINARY TRACT INFECTION; UTERINE CERVIX DYSPLASIA; VOMITING;

ADULT; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; B-LYMPHOCYTES; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LONGITUDINAL STUDIES; LUPUS ERYTHEMATOSUS, SYSTEMIC; LYMPHOCYTE DEPLETION; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84865078041     PISSN: 09612033     EISSN: 14770962     Source Type: Journal    
DOI: 10.1177/0961203312446627     Document Type: Article

References (47)

1. Cervera R, Khamashta MA, Font J, et al. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine (Baltimore). 2003 ; 82: 299-308
2. Doria A, Iaccarino L, Ghirardello A, et al. Long-term prognosis and causes of death in systemic lupus erythematosus. Am J Med. 2006 ; 119: 700-706
3. Bruce IN. Re-evaluation of biologic therapies in systemic lupus erythematosus. Curr Opin Rheumatol. 2010 ; 22: 273-277
4. Sabahi R, Anolik JH. B-cell-targeted therapy for systemic lupus erythematosus. Drugs. 2006 ; 66: 1933-1948
5. Merrill J, Neuwelt C, Wallace D, Shanahan J, Latinins K, Oates J. Design and baseline characteristics of patients in randomized double blind placebo controlled phase I/II study (EXPLORER) to evaluate the efficacy and safety of rituximab in patients with moderate to severely active systemic lupus erythematosus [abstract]. Ann Rheum Dis. 2008 ; 67 (Suppl 2). s347 - s347
6. 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: 222-233
7. Furie R, Looney R, Rovin B, et al. Efficacy and safety of rituximab in subjects with active proliferative lupus nephritis (LN): results from the randomized, double-blind phase III LUNAR study [abstract]. Arthritis Rheum. 2009 ; 60: 1149-1149
8. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1997 ; 40
9. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987 ; 40: 373-383
10. Buyon JP, Petri MA, Kim MY, et al. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann Intern Med. 2005 ; 142 (Suppl 1). 953-962
11. Petri M, Kim MY, Kalunian KC, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med. 2005 ; 353: 2550-2558
12. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996 ; 39: 363-369
13. Esteve-Vives J, Batlle-Gualda E, Reig A. Spanish version of the Health Assessment Questionnaire: reliability, validity and transcultural equivalency. Grupo para la Adaptacion del HAQ a la Poblacion Espanola. J Rheumatol. 1993 ; 20: 2116-2122
14. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006 ; 4: 295-306
15. Fernández-Nebro A, Palacios-Muñoz R, Gordillo J, et al. Chronic or recurrent headache in patients with systemic lupus erythematosus: a case control study. Lupus. 1999 ; 8: 151-156
16. Weening JJ, D'Agati VD, Schwartz MM, et al. The classification of glomerulonephritis in systemic lupus erythematosus revisited. J Am Soc Nephrol. 2004 ; 15: 241-250
17. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999 ; 20: 109-117
18. Merrill J, Neuwelt C, Wallace D, 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.
19. Leandro MJ, Edwards JC, Cambridge G, Ehrenstein MR, Isenberg DA. An open study of B lymphocyte depletion in systemic lupus erythematosus. Arthritis Rheum. 2002 ; 46: 2673-2677
20. Leandro MJ, Edwards JC, Cambridge G. Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion. Ann Rheum Dis. 2002 ; 61: 883-888
21. Leandro MJ, Cambridge G, Edwards JC, Ehrenstein MR, Isenberg DA. B-cell depletion in the treatment of patients with systemic lupus erythematosus: a longitudinal analysis of 24 patients. Rheumatology (Oxford). 2005 ; 44: 1542-1545
22. Lu TY, Ng KP, Cambridge G, et al. A retrospective seven-year analysis of the use of B cell depletion therapy in systemic lupus erythematosus at University College London Hospital: the first fifty patients. Arthritis Rheum. 2009 ; 61: 482-487
23. Ng KP, Cambridge G, Leandro MJ, Edwards JC, Ehrenstein M, Isenberg DA. B cell depletion therapy in systemic lupus erythematosus: long-term follow-up and predictors of response. Ann Rheum Dis. 2007 ; 66: 1259-1262
24. 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: 2580-2589
25. 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: 913-920
26. Terrier B, Amoura Z, Ravaud P, et al. Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry. Arthritis Rheum. 2010 ; 62: 2458-2466
27. Sfikakis PP, Boletis JN, Tsokos GC. Rituximab anti-B-cell therapy in systemic lupus erythematosus: pointing to the future. Curr Opin Rheumatol. 2005 ; 17: 550-557
28. Vigna-Perez M, Hernandez-Castro B, Paredes-Saharopulos O, et al. Clinical and immunological effects of rituximab in patients with lupus nephritis refractory to conventional therapy: a pilot study. Arthritis Res Ther. 2006 ; 8
29. Cambridge G, Isenberg DA, Edwards JC, et al. B cell depletion therapy in systemic lupus erythematosus: relationships among serum B lymphocyte stimulator levels, autoantibody profile and clinical response. Ann Rheum Dis. 2008 ; 67: 1011-1016
30. Catapano F, Chaudhry AN, Jones RB, Smith KG, Jayne DW. Long-term efficacy and safety of rituximab in refractory and relapsing systemic lupus erythematosus. Nephrol Dial Transplant. 2010 ; 25: 3586-3592
31. Tokunaga M, Fujii K, Saito K, et al. Down-regulation of CD40 and CD80 on B cells in patients with life-threatening systemic lupus erythematosus after successful treatment with rituximab. Rheumatology (Oxford). 2005 ; 44: 176-182
32. Tokunaga M, Saito K, Kawabata D, et al. Efficacy of rituximab (anti-CD20) for refractory systemic lupus erythematosus involving the central nervous system. Ann Rheum Dis. 2007 ; 66: 470-475
33. Sutter JA, Kwan-Morley J, Dunham J, et al. A longitudinal analysis of SLE patients treated with rituximab (anti-CD20): factors associated with B lymphocyte recovery. Clin Immunol. 2008 ; 126: 282-290
34. Albert D, Dunham J, Khan S, et al. Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus. Ann Rheum Dis. 2008 ; 67: 1724-1731
35. Favas C, Isenberg DA. B-cell-depletion therapy in SLE-what are the current prospects for its acceptance?. Nat Rev Rheumatol. 2009 ; 5: 711-716
36. Smith KG, Jones RB, Burns SM, Jayne DR. Long-term comparison of rituximab treatment for refractory systemic lupus erythematosus and vasculitis: remission, relapse, and re-treatment. Arthritis Rheum. 2006 ; 54: 2970-2982
37. Sfikakis PP, Boletis JN, Lionaki S, et al. Remission of proliferative lupus nephritis following B cell depletion therapy is preceded by down-regulation of the T cell costimulatory molecule CD40 ligand: an open-label trial. Arthritis Rheum. 2005 ; 52: 501-513
38. Ng KP, Leandro MJ, Edwards JC, Ehrenstein MR, Cambridge G, Isenberg DA. Repeated B cell depletion in treatment of refractory systemic lupus erythematosus. Ann Rheum Dis. 2006 ; 65: 942-945
39. Jonsdottir T, Gunnarsson I, Risselada A, Henriksson EW, Klareskog L, van , Vollenhoven RF. Treatment of refractory SLE with rituximab plus cyclophosphamide: clinical effects, serological changes, and predictors of response. Ann Rheum Dis. 2008 ; 67: 330-334
40. Li EK, Tam L-S, Zhu TY, et al. Is combination rituximab with cyclophosphamide better than rituximab alone in the treatment of lupus nephritis?. Rheumatology (Oxford). 2009 ; 48: 892-898
41. Ramos-Casals M, Brito-Zeron P, Munoz S, Soto MJ. A systematic review of the off-label use of biological therapies in systemic autoimmune diseases. Medicine (Baltimore). 2008 ; 87: 345-364
42. Lateef A, Lahiri M, Teng GG, Vasoo S. Use of rituximab in the treatment of refractory systemic lupus erythematosus: Singapore experience. Lupus. 2010 ; 19: 765-770
43. Turner-Stokes T, Lu TY, Ehrenstein MR, Giles I, Rahman A, Isenberg DA. The efficacy of repeated treatment with B-cell depletion therapy in systemic lupus erythematosus: an evaluation. Rheumatology (Oxford). 2011 ; 50: 1401-1408
44. Sanz I, Lee FE. B cells as therapeutic targets in SLE. Nat Rev Rheumatol. 2010 ; 6: 326-337
45. Dixon WG, Watson K, Lunt M, Hyrich KL, Silman AJ, Symmons DP. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2006 ; 54: 2368-2376
46. Listing J, Strangfeld A, Kary S, et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum. 2005 ; 52: 3403-3412
47. Micheloud D, Nuño L, Rodríguez-Mahou M, et al. Efficacy and safety of Etanercept, high-dose intravenous gammaglobulin and plasmapheresis combined therapy for lupus diffuse proliferative nephritis complicating pregnancy. Lupus. 2006 ; 15: 881-885