Epratuzumab for patients with moderate to severe flaring SLE: Health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006

Rheumatology (United Kingdom)

Volumn 53, Issue 3, 2014, Pages 502-511

  Strand, Vibeke ^a   Petri, Michelle ^b   Kalunian, Kenneth ^c   Gordon, Caroline ^d   Wallace, Daniel J ^e   Hobbs, Kathryn ^f   Kelley, Lexy ^g   Kilgallen, Brian ^g   Wegener, William A ^h   Goldenberg, David M ^h,i  

^a STANFORD UNIVERSITY   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f Denver Arthritis Clinic PC   (United States)

^g UCB PHARMA   (Belgium)

^h IMMUNOMEDICS INC   (United States)

ⁱ CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY   (United States)

Author keywords

ALLEVIATE; CD22; Clinical trial; Corticosteroids; Epratuzumab; HRQOL; Lupus; Monoclonal antibody; SF 36; SLE

Indexed keywords

ALLEVIATE; CD22; CLINICAL TRIAL; CORTICOSTEROIDS; EPRATUZUMAB; HRQOL; LUPUS; MONOCLONAL ANTIBODY; SF-36; SLE;

ADOLESCENT; ADRENAL CORTEX HORMONES; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRALGIA; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INTERNATIONALITY; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; PAIN MEASUREMENT; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84894291466     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ket378     Document Type: Article

References (39)

1. Ben-Menachem E. Review article: systemic lupus erythematosus: a review for anesthesiologists. Anesth Analg 2010;111:665-76.
2. Eisenberg R. Why can't we find a new treatment for SLE? J Autoimmun 2009;32:223-30.
3. Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med 2008;358:929-39.
4. Kiani AN, Petri M. Quality-of-life measurements versus disease activity in systemic lupus erythematosus. Curr Rheumatol Rep 2010;12:250-8.
5. Strand V, Chu A. Measuring outcomes in SLE clinical trials. Expert Rev Pharmacoecon Outcomes Res 2011;11:455-68.
6. Strand V. Lessons learned from clinical trials in SLE. Autoimmun Rev 2007;6:209-14.
7. Strand V, Gladman D, Isenberg D et al. Outcome measures to be used in clinical trials in systemic lupus erythematosus. J Rheumatol 1999;26:490-7.
8. Smolen JS, Strand V, Cardiel M et al. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains. J Rheumatol 1999;26:504-7.
9. Strand V, Chu AD. Generic versus disease-specific measures of health-related quality of life in systemic lupus erythematosus. J Rheumatol 2011;38:1821-3.
10. Abu-Shakra M, Mader R, Langevitz P et al. Quality of life in systemic lupus erythematosus: a controlled study. J Rheumatol 1999;26:306-9.
11. Stoll T, Gordon C, Seifert B et al. Consistency and validity of patient administered assessment of quality of life by the MOS SF-36; its association with disease activity and damage in patients with systemic lupus erythematosus. J Rheumatol 1997;24:1608-14.
12. Fortin PR, Abrahamowicz M, Neville C et al. Impact of disease activity and cumulative damage on the health of lupus patients. Lupus 1998;7:101-7.
13. Elbirt D, Sthoeger D, Asher I et al. The management of systemic lupus erythematosus: facts and controversies. Clin Dermatol 2010;28:330-6.
14. Schneider M, Gordon C, Lerstrom K et al. Impact of lupus on fatigue, health-related quality of life and work productivity: results from the Lupus European Online (LEO) survey. Ann Rheum Dis 2011;70(Suppl 3):425.
15. Lerstrom K, Crimmings M, Govoni M et al. Disease symptoms and coping strategies in patient with lupus. Portugal: European Lupus Meeting, Porto, 2011:145.
16. Strand V, Petri M, Buyon J et al. Systemic lupus erythematosus (SLE) impacts all domains of health-related quality of life (HRQOL): baseline results from five randomized controlled trials (RCTs). Ann Rheum Dis 2007;66:482.
17. Thumboo J, Strand V. Health-related quality of life in patients with systemic lupus erythematosus: an update. Ann Acad Med Singapore 2007;36:115-22.
18. Gayed M, Gordon C. Novel treatments for systemic lupus erythematosus. Curr Opin Investig Drugs 2010;11:1256-64.
19. Dorner T, Goldenberg DM. Targeting CD22 as a strategy for treating systemic autoimmune diseases. Ther Clin Risk Manag 2007;3:953-9.
20. Walker JA, Smith KG. CD22: an inhibitory enigma. Immunology 2008;123:314-25.
21. Dorner T, Kaufmann J, Wegener WA et al. Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus. Arthritis Res Ther 2006;8:R74.
22. Jacobi AM, Goldenberg DM, Hiepe F et al. Differential effects of epratuzumab on peripheral blood B cells of patients with systemic lupus erythematosus versus normal controls. Ann Rheum Dis 2008;67:450-7.
23. Wallace DJ, Gordon C, Strand V et al. Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicenter studies (ALLEVIATE) and follow-up. Rheumatology 2013;52:1313-22.
24. ACR. 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus. http://www.rheumatology. org/practice/clinical/classification/SLE/1997_update_of_ the_1982_acr_revised_criteria_for_classification_of_sle. pdf (30 October 2013, date last accessed).
25. Hay EM, Bacon PA, Gordon C et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med 1993;86:447-58.
26. Isenberg DA, Gordon C. From BILAG to BLIPS-disease activity assessment in lupus past, present and future. Lupus 2000;9:651-4.
27. Likert R. A technique for the measurement of attitudes. Arch Psychol 1932;140:1-55.
28. Strand V, Smolen JS, van Vollenhoven RF et al. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis 2011;70:996-1002.
29. Strand V, Crawford B. Improvement in health-related quality of life in patients with SLE following sustained reductions in anti-dsDNA antibodies. Expert Rev Pharmacoecon Outcomes Res 2005;5:317-26.
30. Strand V, Crawford B, Singh J et al. Use of 'spydergrams' to present and interpret SF-36 health-related quality of life data across rheumatic diseases. Ann Rheum Dis 2009;68:1800-4.
31. Ware JE, Kosinski M. SF-36 Physical and Mental Health Summary scales: a manual for users of version 1. 2nd edn. Lincoln, RI: QualityMetric, 2001.
32. Petri M, Hobbs K, Gordon C et al. Clinically meaningful improvements with epratuzumab (anti-CD22 mAb targeting B-cells) in patients (pts) with moderate/severe systemic lupus erythematosus (SLE) flares: results from 2 randomized controlled trials. Arthritis Rheum 2008;57(Suppl):1087.
33. Jolly M. Pitfalls and opportunities in measuring patient outcomes in lupus. Curr Rheumatol Rep 2010;12:229-36.
34. Crimmings M, Lerstrom K, Govoni M et al. Impact of lupus on patients' employment, family relationships and overall well-being. 2010. Presented at: ACR 2010:Poster PO1 F.9.
35. Lerstrom K, Crimmings M, Govoni M et al. Impact of systemic lupus erythematosus on patients' employment, family relationships and overall well-being. Ann Rheum Dis 2010;69(Suppl. 3):753.
36. McElhone K, Abbott J, Gray J et al. Patient perspective of systemic lupus erythematosus in relation to health-related quality of life concepts: a qualitative study. Lupus 2010;19:1640-7.
37. Jolly M, Utset TO. Can disease specific measures for systemic lupus erythematosus predict patients health related quality of life? Lupus 2004;13:924-6.
38. Bernatsky S, Peschken C, Fortin PR et al. Medication use in systemic lupus erythematosus. J Rheumatol 2011;38:271-4.
39. Cresswell L, Yee CS, Farewell V et al. Numerical scoring for the classic BILAG index. Rheumatology 2009;48:1548-52.