Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: Systematic review and meta-analysis

BioDrugs

Volumn 28, Issue 2, 2014, Pages 211-228

  Borba, Helena Hiemisch Lobo ^a   Wiens, Astrid ^a   De Souza, Thais Teles ^a   Correr, Cassyano Januário ^a   Pontarolo, Roberto ^a  

^a FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ABETIMUS; ATACICEPT; BELIMUMAB; DOUBLE STRANDED DNA ANTIBODY; EPRATUZUMAB; RITUXIMAB; SIFALIMUMAB; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

BIOLOGICAL THERAPY; BRITISH ISLES LUPUS ASSESSMENT GROUP INDEX; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; META ANALYSIS; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SLEDAI; SYSTEMATIC REVIEW; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC LUPUS ERYTHEMATOSUS RESPONDER INDEX; UNSPECIFIED SIDE EFFECT; ADULT; LUPUS ERYTHEMATOSUS, SYSTEMIC; PATHOPHYSIOLOGY;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; HUMANS; IMMUNOLOGIC FACTORS; LUPUS ERYTHEMATOSUS, SYSTEMIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84897061025     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-013-0074-x     Document Type: Review

References (40)

1. Achour A, Mankai A, Thabet Y, Sakly W, Braham F, Kechrid C, et al. Systemic lupus erythematosus in the elderly. Rheumatol Int. 2012;32(5):1225-9.
2. Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med. 2008;358(9):929-39. (Pubitemid 351397092)
3. Postal M, Costallat LT, Appenzeller S. Biological therapy in systemic lupus erythematosus. Int J Rheumatol. 2012;2012:578641.
4. Ezra N, Jorizzo J. Hydroxychloroquine and smoking in patients with cutaneous lupus erythematosus. Clin Exp Dermatol. 2012;37(4):327-34.
5. Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006;1:6.
6. Sweetman S. Martindale: the complete drug reference. 37th ed. London: Pharmaceutical Press; 2011. http://www.thomsonhc.com. Accessed 1 Aug 2013.
7. Tullus K. New developments in the treatment of systemic lupus erythematosus. Pediatr Nephrol. 2012;27(5):727-32.
8. Thompson CA. First new lupus drug approved in half-century. Am J Health Syst Pharm. 2011;68(8):646.
9. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration; 2011. http://www.cochrane-handbook.org. Accessed 1 Aug 2013.
10. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1-12. (Pubitemid 26120810)
11. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
12. Huedo-Medina TB, Sanchez-Meca J, Marin-Martinez F, Botella J. Assessing heterogeneity in meta-analysis: Q statistic or I2 index? Psychol Methods. 2006;11(2):193-206.
13. Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008;58(8):2470-80.
14. Dall'Era M, Chakravarty E, Wallace D, Genovese M, Weisman M, Kavanaugh A, et al. Reduced B lymphocyte and immunoglobulin levels after atacicept treatment in patients with systemic lupus erythematosus: results of a multicenter, phase Ib, double-blind, placebo-controlled, dose-escalating trial. Arthritis Rheum. 2007;56(12):4142-50. (Pubitemid 350262342)
15. Furie RA, Cash JM, Cronin ME, Katz RS, Weisman MH, Aranow C, et al. Treatment of systemic lupus erythematosus with LJP 394. J Rheumatol. 2001;28(2):257-65. (Pubitemid 32165130)
16. Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther. 2008;10(5):R109.
17. Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, 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(12):3918-30.
18. Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, 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. 2010a;62(1):222-33.
19. Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010b;62(10):3077-87.
20. Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, et al. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011;70(11):1905-13.
21. Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-31.
22. Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009;61(9):1168-78.
23. Petri M, Wallace DJ, Spindler A, Chindalore V, Kalunian K, Mysler E, et al. Sifalimumab, a human anti-interferon-α monoclonal antibody, in systemic lupus erythematosus: a phase I randomized, controlled, dose-escalation study. Arthritis Rheum. 2013;65(4):1011-21.
24. Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. Epub 2013 Jan 12.
25. Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, 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(4):1215-26.
26. Wallace DJ, Gordon C, Strand V, Hobbs K, Petri M, Kalunian K, et al. Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Rheumatology (Oxford). 2013;52(7):1313-22.
27. Borba EF. Consenso de Lúpus Eritematoso Sistêmico. Rev Bras Reumatol. 2008;48(4):196-207.
28. Luijten KM, Tekstra J, Bijlsma JW, Bijl M. The Systemic Lupus Erythematosus Responder Index (SRI); a new SLE disease activity assessment. Autoimmun Rev. 2012;11(5):326-9.
29. Lam GK, Petri M. Assessment of systemic lupus erythematosus. Clin Exp Rheumatol. 2005;23(5 Suppl 39):S120-32. (Pubitemid 46657518)
30. Nowling TK, Gilkeson GS. Mechanisms of tissue injury in lupus nephritis. Arthritis Res Ther. 2011;13(6):250.
31. Andrejevic S, Jeremic I, Sefik-Bukilica M, Nikolic M, Stojimirovic B, Bonaci-Nikolic B. Immunoserological parameters in SLE: high-avidity anti-dsDNA detected by ELISA are the most closely associated with the disease activity. Clin Rheumatol. Epub 2013 Jul 16.
32. Dooley MA, Houssiau F, Aranow C, D'Cruz DP, Askanase A, Roth DA, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22(1):63-72.
33. Chugh PK. Lupus: novel therapies in clinical development. Eur J Int Med. 2012;23(3):212-8.
34. Ding HJ, Gordon C. New biologic therapy for systemic lupus erythematosus. Curr Opin Pharmacol. 2013;13(3):405-12.
35. Murphy G, Lisnevskaia L, Isenberg D. Systemic lupus erythematosus and other autoimmune rheumatic diseases: challenges to treatment. Lancet. 2013;382(9894):809-18.
36. Rozenfeld S, Valente J. Estudos de utilização de medicamentos - considerações técnicas sobre coleta e análise de dados. Epidemiologia e Serviços de Saúde. 2004;13(2):115-23.
37. Abud-Mendoza C, Moreno-Valdes R, Cuevas-Orta E, Borjas A, Aranda F, Irazoque F, et al. Treating severe systemic lupus erythematosus with rituximab. An open study. Reumatol Clin. 2009;5(4):147-52.
38. 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(10):2673-7. (Pubitemid 36118931)
39. 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(6):345-64.
40. Linnik MD, Hu JZ, et al. Relationship between anti-double-stranded DNA antibodies and exacerbation of renal disease in patients with systemic lupus erythematosus. Arthritis Rheum. 2005;52(4):1129-1137. (Pubitemid 40530120)