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Drug Evaluation

Belimumab in the management of systemic lupus erythematosus – an update

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Pages 901-908 | Received 11 Feb 2017, Accepted 26 Apr 2017, Published online: 16 May 2017

References

  • Muangchan C, Van Vollenhoven RF, Bernatsky SR, et al. Treatment algorithms in systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2015;67:1237–1245.
  • Bertsias G, Ioannidis JP, Boletis J, et al. EULAR recommendations for the management of systemic lupus erythematosus. Report of a task force of the EULAR Standing Committee for International Clinical Studies including therapeutics. Ann Rheum Dis. 2008;67:195–205.
  • 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;73:958–967.
  • Gatto M, Kiss E, Naparstek Y, et al. In/off-label use of biologic therapy in systemic lupus erythematosus. BMC Med. 2014;12:30. DOI:10.1186/1741-7015-12-30
  • Blüml S, McKeever K, Ettinger R, et al. B-cell targeted therapeutics in clinical development. Arthritis Res Ther. 2013;15(Suppl 1):S4.
  • Kamal A, Khamashta M. The efficacy of novel B cell biologics as the future of SLE treatment: a review. Autoimmun Rev. 2014;13:1094–1101.
  • Vincent FB, Saulep-Easton D, Figgett WA, et al. The BAFF/APRIL system: emerging functions beyond B cell biology and autoimmunity. Cytokine Growth Factor Rev. 2013;24:203–215.
  • Frieri M, Heuser W, Bliss J. Efficacy of novel monoclonal antibody belimumab in the treatment of lupus nephritis. J Pharmacol Pharmacother. 2015;6:71–76.
  • Struemper H, Chen C, Cai W. Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus. J Clin Pharmacol. 2013;53:711–720.
  • Navarra SV, Guzmán RM, Gallcher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:721–731.
  • 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;63:3918–3930.
  • Chiche L, Jourde N, Thomas G, et al. New treatment options for lupus – a focus on belimumab. Ther Clin Risk Manag. 2012;8:33–43.
  • Luijten KM, Tekstra J, Bijlsma JW, et al. The systemic lupus erythematosus responder index (SRI): a new SLE disease activity assessment. Autoimmune Rev. 2012;11:326–329.
  • Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014;41:300–309.
  • Lutalo PM, D´Cruz DP. Belimumab for the management of systemic lupus erythematosus. Expert Opin Biol Ther. 2012;12:957–963.
  • Lutalo PM, D´Cruz DP. Update on belimumab for the management of systemic lupus erythematosus. Expert Opin Biol Ther. 2014;14:1701–1708.
  • Stohl W, Hiepe F, Latinis KM, et al. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with lupus erythematosus. Arthritis Rheum. 2012;64:2328–2337.
  • Manzi S, Sánchez-Guerrero J, Merrill JT, et al. Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Ann Rheum Dis. 2012;71:1833–1838.
  • Tesar V, Hruskova Z. Treatment of proliferative lupus nephritis: a slowly changing landscape. Nat Rev Nephrol. 2011;7:96–109.
  • Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22:63–72.
  • Sciascia S, Radin M, Yazdany J, et al. Efficacy of belimumab on renal outcomes in patients with systemic lupus erythematosus: a systematic review. Autoimmun Rev. 2017;16:287–293.
  • Carter LM, Isenberg DA, Ehrenstein MR. Elevated serum BAFF levels are associated with rising anti-double-stranded DNA antibody levels and disease flare following B cell depletion therapy in systemic lupus erythematosus. Arthritis Rheum. 2013;65:2672–2679.
  • Simonetta F, Allali D, Roux-Lombard P, et al. Successful treatment of refractory lupus nephritis by the sequential use of rituximab and belimumab. Joint Bone Spine. 2017;84:235–236.
  • Gonzalez-Echavarri C, Ugarte A, Ruiz-Irastorza G. Rituximab-refractory lupus nephritis successfully treated with belimumab. Clin Exp Rheumatol. 2016;34:355–356.
  • Kraaij T, Huizinga TW, Rabelink TJ, et al. Belimumab after rituximab as maintenance therapy in lupus nephritis. Rheumatology (Oxford). 2014;53:2122–2124.
  • Strand V, Levy RA, Cervera R, et al. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014;73:838–844.
  • Schwarting A, Dooley MA, Roth DA, et al. Impact of concomitant medication use on belimumab efficacy and safety in patients with systemic lupus erythematosus. Lupus. 2016;25:1587–1596.
  • Bruce IN, Urowitz M, Van Vollenhoven R, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016;25:699–709.
  • Van Vollenhoven RF, Petri M, Wallace DJ, et al. Cumulative corticosteroid dose over fifty-two weeks in patients with systemic lupus erythematosus: pooled analyses from the phase III belimumab trials. Arthritis Rheumatol. 2016;68:2184–2192.
  • Petri MA, Van Vollenhoven RF, Buyon J, et al. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013;65:2143–2153.
  • Roth DA, Thompson A, Tang Y, et al. Elevated BLyS levels in patients with systemic lupus erythematosus: associated factors and reponses to belimumab. Lupus. 2016;25:346–354.
  • Gordon C, Wofsy D, Wax S, et al. Post hoc analysis of the phase II/III APRIL-SLE Study: association between response to atacicept and serum biomarkers including BlyS and APRIL. Arthritis Rheumatol. 2017;69:122–130.
  • Collins CE, Dall´Era M, Kan H, et al. Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA. Lupus Sci Med. 2016;3:e000118.
  • Schwarting A, Schroeder JO, Alexander T, et al. First real-world insights into belimumab use and outcomes in routine clinical care of systemic lupus erythematosus in Germany: results from the OBSErve Germany Study. Rheumatol Ther. 2016;3:271–290.
  • Iaccarino L, Bettio S, Reggia R, et al. Belimumab decreases flare rate and hinders the expected damage progression in patients with active systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2017;69:115–123.
  • Scheinberg M, De Melo FF, Bueno AN, et al. Belimumab for the treatment of corticosteroid-dependent systemic lupus erythematosus: from clinical trials to real-life experience after 1 year of use in 48 Brazilian patients. Clin Rheumatol. 2016;35:1719–1723.
  • Hui-Yuen JS, Reddy A, Taylor J, et al. Safety and efficacy of belimumab to treat systemic lupus erythematosus in academic clinical practices. J Rheumatol. 2015;42:2288–2295.
  • Koutsokeras T, Healy T. Systemic lupus erythematosus and lupus nephritis. Nat Rev Drug Discov. 2014;13:173–174.
  • Wallace DJ, Navarra S, Petri MA, et al. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013;22:144–154.
  • Chatham WW, Wallace DJ, Stohl W, et al. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococall, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012;39:1632–1640.
  • Fredericks CA, Kvam KA, Bear J, et al. A case of progressive multifocal leukoencephalopathy in lupus patient treated with belimumab. Lupus. 2014;23:711–713.
  • Benvenuti F, Gatto M, Doria A. A case of progressive multifocal leukoencephalopathy in lupus patient treated with belimumab – comments on article by Fredericks et al. Lupus. 2016;25:1445–1446.
  • Leblanc-Trudeau C, Masetto A, Bocti C. Progressive multifocal leukoencephalopathy associated with belimumab in a patient with systemic lupus erythematosus. J Rheumatol. 2015;42:551–552.
  • Raisch DW, Rafi JA, Chen C, et al. Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA´s averse event reporting system. Expert Opin Drug Saf. 2016;15:1003–1011.
  • Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795–810.
  • Peart E, Clowse ME. Systemic lupus erythematosus and pregnancy outcomes: an update and review of the literature. Curr Opin Rheumatol. 2014;26:118–123.
  • Sandhu VK, Wallace DJ, Weisman MH. Monoclonal antibodies, systemic lupus erythematosus, and pregnancy: insights from an open-label study. J Rheumatol. 2015;42:728–730.
  • Cai WW, Fiscella M, Chen C, et al. Bioavailability, pharmacokinetics, and safety of belimumab administered subcutaneously in healthy subjects. Clin Pharmacol Drug Dev. 2013;2:349–357.
  • Yapa SW, Roth D, Gordon D, et al. Comparison of intravenous and subcutaneous exposure supporting dose selection of subcutaneous belimumab systemic lupus erythematosus phase 3 program. Lupus. 2016;25:1448–1455.
  • Sheikh SZ, Hammer AE, Fox NL, et al. Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupus erythematosus. Int J Clinic Pharmacol Ther. 2016;54:914–922.
  • Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017 Jan 24. Epub ahead of print. DOI:10.1002/art.40049
  • Isenberg DA, Petri M, Kalunian K, et al. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:323–331.
  • Merrill JT, Van Vollenhoven FR, Buyon JP, et al. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016;75:332–340.
  • Clowse ME, Wallace DJ, Furie RA, et al. Efficacy and safety of epratuzumab in moderately to severely active systemic lupus erythematosus: results from the phase 3, randomized, double-blind, placebo-controlled trials, EMBODYTM1 and EMBODYTM2. Arthritis Rheumatol. 2017;69:362–375.
  • Isenberg DA, Merrill JT. Why, why, why de-lupus (does so badly in clinical trials). Expert Rev Clin Immunol. 2016;12:95–98.

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