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Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus

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Connock, M., Cummins, E. (Ewen), Sutcliffe, Paul A., Court, Rachel A., Johnson, Rhona, Grove, Amy L., Ngianga-Bakwin, Kandala, Mohiuddin, Syed and Clarke, Aileen, 1955- (2011) Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus. [Report]

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Official URL: http://guidance.nice.org.uk/TA/Wave25/12/Consultat...

Abstract

The manufacturer’s scope encompasses the clinical effectiveness and cost effectiveness of belimumab plus Standard of Care (SoC) relative to SoC alone, for the treatment of adults with active auto-antibody positive Systemic Lupus Erythematosus (SLE) and also for a subgroup of these patients who exhibit signs of high disease activity. According to the manufacturer’s scope and submission the population of greatest interest is the sub-group with high disease activity called the Target population. No subgroup is specified in the National Institute for Health and Clinical Excellence (NICE) scope. The Target population is a subgroup of the proposed licensed population; a decision on the manufacturer’s license application is awaited.

Item Type: Report
Alternative Title: Evidence review group report commissioned by the National Health Service Research & Development Programme on behalf of the National Institute for Health and Clinical Evidence
Subjects: Q Science > QR Microbiology > QR180 Immunology
R Medicine > RC Internal medicine
Divisions: Faculty of Medicine > Warwick Medical School > Warwick Evidence
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Systemic lupus erythematosus -- Treatment, Monoclonal antibodies
Publisher: National Institute for Health and Clinical Excellence (NICE)
Place of Publication: London
Date: 30 September 2011
Number of Pages: 166
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: NIHR Health Technology Assessment Programme (Great Britain)
Grant number: 10/73/01 (NIHR HTA)
References: 1. ACR Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria. The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: Measures of overall disease activity. Arthritis and Rheumatism 2004;50:3418-26. 2. Isenberg DA, Gordon C. From BILAG to BLIPS--disease activity assessment in lupus past, present and future. Lupus 2000;9:651-4. 3. U.S.Food and Drugs Administration. FDA briefing package. 2010. URL: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisdrugsadvisorycommittee/ucm233579.pdf (accessed 23 June 2011). 4. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005;32:811-9. 5. U.S.Food and Drugs Administration. Arthritis Advisory Committee Meeting Briefing Document for the 16 November 2010 Meeting: Belimumab: BENLYSTA® (belimumab): Treatment of Systemic Lupus Erythematosus: BLA 125370. 13/10/2010. URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/UCM233581.pdf (accessed 23 June 2011). 6. 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 & Rheumatism 2009;61:1168-78. 7. 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;377:721-31. 8. van Dis I, Kromhout D, Geleijnse JM, Boer JM, Verschuren WM. Evaluation of cardiovascular risk predicted by different SCORE equations: the Netherlands as an example. Eur J Cardiovasc Prev Rehabil 2010;17:244-9. 9. Swaak AJ, van den Brink HG, Smeenk RJ, Manger K, Kalden JR, Tosi S et al. Systemic lupus erythematosus: clinical features in patients with a disease duration of over 10 years, first evaluation. Rheumatology (Oxford) 1999;38:953-8. 10. Merrill, J. T., Neuwelt, C. M., Wallace, D. J., Shanahan, J. C., Latinis, K. M., Oates, J. C., Utset, T. O., Gordon, C., Isenberg, D. A., Hsieh, H. J., Zhang, D, and Brunetta, P. G. Efficacy and safety of rituximab in patients with moderately to severely active systemic lupus erythematosus: results from the randomized, double-blind phase II/III study EXPLORER. Conference: 72nd Annual Scientific Meeting of the American College of Rheumatology. Abstract L12. 2008. 2008 Oct 24; 11. Gordon C, Merrill JT, Wallace DJ, Hsieh H, Brunetta P. BILAG versus SELENA-SLEDAI scoring in systemic lupus erythematosus (SLE) patients in EXPLORER. Arthritis and Rheumatism 2009;60:281. 12. Scottish Intercollegiate Guideline Network. Search Filters. 21/04/2011. URL: http://www.sign.ac.uk/methodology/filters.html (accessed 23 June 2011). 13. 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 & Rheumatism 2009;61:1168-78. 14. 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;377:721-31. 15. Gladman DD, Urowitz MB, Kagal A, Hallett D. Accurately describing changes in disease activity in Systemic Lupus Erythematosus. J Rheumatol 2000;27:377-9. 16. Centre for Reviews and Dissemination. NHS Economics Evaluation Database Handbook. 2007. URL: www.york.ac.uk/inst/crd/pdf/nhseed-handb07.pdf (accessed 27 June 2011). 17. Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095-108. 18. Department of Health. NHS reference costs 2005-06. 07/12/2006. URL: http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_062884 (accessed 9 April 2011). 19. Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD et al. Mortality in systemic lupus erythematosus. Arthritis and Rheumatism 2006;54:2550-7. 20. Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH 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;142:953-62. 21. Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus 1999;8:685-91. 22. Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005;353:2550-8.
URI: http://wrap.warwick.ac.uk/id/eprint/44419

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