2,280
Views
10
CrossRef citations to date
0
Altmetric
Original Articles: Connective Tissue Diseases and Related Disorders

Organ system improvements in Japanese patients with systemic lupus erythematosus treated with belimumab: A subgroup analysis from a phase 3 randomized placebo-controlled trial

, , , , &
Pages 313-320 | Received 21 Feb 2019, Accepted 08 Jun 2019, Published online: 04 Jul 2019

References

  • Tunnicliffe DJ, Singh-Grewal D, Kim S, Craig JC, Tong A. Diagnosis, monitoring, and treatment of systemic lupus erythematosus: a systematic review of clinical practice guidelines. Arthritis Care Res (Hoboken). 2015;67(10):1440–52.
  • Yildirim-Toruner C, Diamond B. Current and novel therapeutics in the treatment of systemic lupus erythematosus. J Allergy Clin Immunol. 2011;127(2):303–12. quiz 13-4.
  • Gilboe IM, Kvien TK, Husby G. Disease course in systemic lupus erythematosus: changes in health status, disease activity, and organ damage after 2 years. J Rheumatol. 2001;28(2):266–74.
  • Bertsias GK, Ioannidis JPA, Boletis J, Bombardieri S, Cervera R, Dostal C, et al. EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints. Ann Rheum Dis. 2009;68(4):477–83.
  • Bruce IN, O'Keeffe AG, Farewell V, Hanly JG, Manzi S, Su L, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort. Ann Rheum Dis. 2015;74(9):1706–13.
  • Lateef A, Petri M. Unmet medical needs in systemic lupus erythematosus. Arthritis Res Ther. 2012;14(Suppl 4):S4.
  • Frieri M, Heuser W, Bliss J. Efficacy of novel monoclonal antibody belimumab in the treatment of lupus nephritis. J Pharmacol Pharmacother. 2015;6(2):71.
  • Tanaka Y, Kubo S, Iwata S, Yoshikawa M, Nakayamada S. B cell phenotypes, signaling and their roles in secretion of antibodies in systemic lupus erythematosus. Clin Immunol. 2018;186:21–5.
  • European Medicines Agency (EMA). Summary of product characteristics 2011. Available from: http://www.ema.europa.eu/ema/
  • Food and Drug Administration (FDA). FDA approves Benlysta to treat lupus 2011. Available from: https://wayback.archive-it.org/7993/20170112024037/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm
  • GSK. GSK receives approval for Benlysta in Japan for the treatment of systemic lupus erythematosus 2017. Available from: https://us.gsk.com/en-us/media/press-releases/2017/gsk-receives-approval-for-benlysta-in-japan-for-the-treatment-of-systemic-lupus-erythematosus/
  • Jakes RW, Bae S-C, Louthrenoo W, Mok C-C, Navarra SV, Kwon N, et al. Systematic review of the epidemiology of systemic lupus erythematosus in the Asia-Pacific region: prevalence, incidence, clinical features, and mortality. Arthritis Care Res (Hoboken). 2012;64(2):159–68.
  • Osio-Salido E, Manapat-Reyes H. Epidemiology of systemic lupus erythematosus in Asia. Lupus. 2010;19(12):1365–73.
  • Zhang F, Bae SC, Bass D, et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis 2018;77:355–63.
  • Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová 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.
  • Navarra SV, Guzmán 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.
  • Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, 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;69(5):1016–27.
  • Tanaka Y, Mimori T, Yamanaka H, Nakajima R, Morita K, Kimura J, et al. Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: a subgroup analysis of a phase 3 randomized placebo-controlled trial. Mod Rheumatol. 2018;1–9.
  • Gladman DD, Goldsmith CH, Urowitz MB, Bacon P, Fortin P, Ginzler E, et al. The systemic lupus international collaborating clinics/American college of rheumatology (SLICC/ACR) damage index for systemic lupus erythematosus international comparison. J Rheumatol. 2000;27(2):373–6.
  • Gladman DD, Urowitz MB, Rahman P, Ibañez D, Tam L-S. Accrual of organ damage over time in patients with systemic lupus erythematosus. J Rheumatol. 2003;30(9):1955–9.
  • Stoll T, Seifert B, Isenberg DA. SLICC/ACR damage index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol. 1996;35(3):248–54.
  • Urowitz MB, Gladman DD, Ibañez D, Fortin PR, Bae SC, Gordon C, et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arthritis Care Res (Hoboken). 2012;64(1):132–7.
  • Chambers SA, Allen E, Rahman A, Isenberg D. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford). 2009;48(6):673–5.
  • Alarcon GS, Roseman JM, McGwin G, Jr., et al. Systemic lupus erythematosus in three ethnic groups. XX. Damage as a predictor of further damage. Rheumatology (Oxford). 2003;43(2):202–5.
  • Stoll T, Sutcliffe N, Klaghofer R, Isenberg DA. Do present damage and health perception in patients with systemic lupus erythematosus predict extent of future damage?: a prospective study. Ann Rheum Dis. 2000;59(10):832–5.
  • Rahman P, Gladman DD, Urowitz MB, Hallett D, Tam LS. Early damage as measured by the SLICC/ACR damage index is a predictor of mortality in systemic lupus erythematosus. Lupus. 2001;10(2):93–6.
  • Manger K, Manger B, Repp R, et al. Definition of risk factors for death, end stage renal disease, and thromboembolic events in a monocentric cohort of 338 patients with systemic lupus erythematosus. Ann Rheum Dis. 2002;61(12):1065–70.
  • Furst DE, Clarke A, Fernandes AW, Bancroft T, Gajria K, Greth W, et al. Resource utilization and direct medical costs in adult systemic lupus erythematosus patients from a commercially insured population. Lupus. 2013;22(3):268–78.
  • Furukawa M, Kiyohara C, Horiuchi T, Tsukamoto H, Mitoma H, Kimoto Y, et al. Quality of life in Japanese female patients with systemic lupus erythematosus: evaluation using the short form 36 health survey. Mod Rheumatol. 2016;26(2):240–7.
  • Manzi S, Sánchez-Guerrero J, Merrill JT, Furie R, Gladman D, Navarra SV, 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(11):1833–8.
  • Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016;25(7):699–709.
  • Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med. 2008;358(9):929–39.
  • Wada Y, Hasegawa H, Saeki T, Ito S, Kuroda T, Nakano M, et al. Long-term prognosis and factors associated with damage accrual in Japanese patients with systemic lupus erythematosus. Clin Exp Nephrol. 2018;22(3):597–602.
  • 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.
  • van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012;71(8):1343–9.