Skip to main content

Advertisement

Log in

A novel means to demonstrate early efficacy of a product in systemic lupus erythematosus

  • Invited Commentary
  • Published:
Current Rheumatology Reports Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. Strand V: Issues in drug development in SLE: clinical trial design, outcome measures and biomarkers. In Dubois’ Lupus Erythematosus, 7th edn. Edited by Wallace DJ, Hahn GH. Baltimore: Williams & Wilkins; 2006:1317–1332.

    Google Scholar 

  2. Strand V, Kimberly R, Isaacs JD: Biologic therapies in rheumatology: lessons learned, future directions. Nat Rev Drug Discov 2007, 6:1–18.

    Article  CAS  Google Scholar 

  3. Strand V: Lessons learned from clinical trials in SLE. Autoimmun Rev 2007, 6:209–214.

    Article  PubMed  CAS  Google Scholar 

  4. Kalunian KC, Davis JC Jr, Merrill JT, et al.: Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD 154: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002, 46:3251–3258.

    Article  PubMed  CAS  Google Scholar 

  5. Gordon C, Sutcliffe N, Skan J, et al.: Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford) 2003, 42:1372–1379.

    Article  CAS  Google Scholar 

  6. Alarcon-Segovia D, Tumlin JA, Furie RA, et al.: LJP 394 for the prevention of renal flare in patients with systemic lupus erythematosus:results from a randomized, double-blind, placebo-controlled study. Arthritis Rheum 2003, 48:442–444.

    Article  PubMed  CAS  Google Scholar 

  7. Linnik MD, Hu JZ, Heilbrunn KR, et al.: Relationship between anti-double-stranded DNA antibodies and exacerbation of renal disease in patients with systemic lupus erythematosus. Arthritis Rheum 2005, 52:1129–1137.

    Article  PubMed  CAS  Google Scholar 

  8. Buyon JP, Petri M, 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, 142:953–962.

    PubMed  CAS  Google Scholar 

  9. 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.

    Article  PubMed  CAS  Google Scholar 

  10. Sanchez-Guerrero J, Uribe AG, Jimenez-Santana L, et al.: A trial of contraceptive methods in women with systemic lupus erythematosus. N Engl J Med 2005, 353:2539–2549.

    Article  PubMed  CAS  Google Scholar 

  11. Furie R, Lisse J, Merrill JT, et al.: Belimumab (fully human monoclonal antibody to B-lymphocyte stimulator [BLyS] improves or stabilizes SLE activity in a multicenter phase 2 trial. Arthritis Rheum 2006, 54:S258.

    Google Scholar 

  12. Swaak AJ, Groenwold J, Bronsveld W, et al.: Predictive value of complement profiles and anti-dsDNA in systemic lupus erythematosus. Ann Rheum Dis 1986, 45:359–366.

    Article  PubMed  CAS  Google Scholar 

  13. TerBorg EJ, Horst G, Hummel EJ, et al.: Measurement of increases in anti-double-stranded DNA antibody levels as a predictor of disease exacerbation in systemic lupus erythematosus: a long-term, prospective study. Arthritis Rheum 1990, 33:634–643.

    Article  CAS  Google Scholar 

  14. Bootsma H, Spronk P, Derksen R, et al.: Prevention of relapses in systemic lupus erythematosus. Lancet 1995, 345:1595–1599.

    Article  PubMed  CAS  Google Scholar 

  15. Bijl M, Horst G, Bootsma H, et al.: Mycophenolate mofetil prevents a clinical relapse in patients with systemic lupus erythematosus at risk. Ann Rheum Dis 2003: 62:534–539.

    Article  PubMed  CAS  Google Scholar 

  16. Gladman DD, Urowitz MB, Keystone EC: Serologically active clinically quiescent systemic lupus erythematosus: a discordance between clinical and serologic features. Am J Med 1979, 66:210–215.

    Article  PubMed  CAS  Google Scholar 

  17. Tseng CE, Buyon JP, Kim M, et al.: The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus: findings of a prospective, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006, 54:3623–3632.

    Article  PubMed  CAS  Google Scholar 

  18. Thumboo J, Strand V: Health-related quality of life in patients with systemic lupus erythematosus: an update. Ann Acad Med Singapore 2007, in press.

  19. Petri MA, Mease PJ, Merrill JT, et al.: Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus. Arthritis Rheum 2004, 50:2858–2868.

    Article  PubMed  CAS  Google Scholar 

  20. Nordmark G, Bengtsson C, Larsson A, et al.: Effects of dehydroepiandrosterone supplement on health-related quality of life in glucocorticoid treated female patients with systemic lupus erythematosus. Autoimmunity 2005, 38:531–540.

    Article  PubMed  CAS  Google Scholar 

  21. Tse KC, Tang CS, Lio WL, et al.: Quality of life comparison between corticosteroid and-mycophenolate mofetil and corticosteroid and-oral cyclophosphamide in the treatment of severe lupus nephritis. Lupus 2006, 15:371–379.

    Article  PubMed  CAS  Google Scholar 

  22. Strand V, Aranow C, Cardiel MH, et al.: Improvement in health-related quality of life in systemic lupus erythematosus patients enrolled in a randomized clinical trial comparing LJP 394 treatment with placebo. Lupus 2003, 12:677–686.

    Article  PubMed  CAS  Google Scholar 

  23. Strand V, Crawford B: Improvement in health-related quality of life in patients with SLE following sustained reductions in anti-dsDNA antibodies. Expert Rev Pharmacoeconomics Outcomes Res 2005, 5:317–326.

    Article  Google Scholar 

  24. Strand V, Crawford B, Petri M, et al.: Patients with active systemic lupus erythematosus (SLE) treated with belimumab improve health-related quality of life (HRQoL) in a randomized controlled trial (RCT). Arthritis Rheum 2006, 54:S277.

    Google Scholar 

  25. Strand V, Crawford B, Petri M, et al.: Therapeutic responses reflecting a reduction in SELENA SLEDAI score are associated with a stabilization or improvement in health-related quality of life (HRQoL). Arthritis Rheum 2006, 54:S278.

    Google Scholar 

  26. Petri M, Buyon J, Sigler L, et al.: Beneficial effects of hormone therapy on health-related quality of life (HRQoL) in systemic lupus erythematosus (SLE): Results of SELENA OCP and HRT randomized controlled trials (RCTs). Arthritis Rheum 2006, 54:S447

    Google Scholar 

  27. Strand V, Petri M, Buyon J, et al.: Baseline data from 5 randomized controlled trials (RCTs) demonstrated that SLE impacts all domains of health-related quality of life (HRQoL). Arthritis Rheum 2006, 54:S277.

    Google Scholar 

  28. Kirou KA, Lee C, George S, et al.: Activation of the interferon-alpha pathway identifies a subgroup of systemic lupus erythematosus patients with distinct serologic features and active disease. Arthritis Rheum 2005, 52:1491–1503.

    Article  PubMed  CAS  Google Scholar 

  29. Petri M, Stohl W, Chatham W, et al.: BLyS plasma concentrations correlate with disease activity and levels of Anti-dsDNA autoantibodies and immunoglobulins (Ig) in a SLE patient observational study. Arthritis Rheum 2003, 48:S655.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Vibeke Strand.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Strand, V. A novel means to demonstrate early efficacy of a product in systemic lupus erythematosus. Curr Rheumatol Rep 9, 427–430 (2007). https://doi.org/10.1007/s11926-007-0069-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11926-007-0069-z

Keywords

Navigation