Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results from an Open-Label Extension Study

Arthritis Care and Research

Volumn 68, Issue 4, 2016, Pages 534-543

  Wallace, D J ^a   Hobbs, K ^b   Clowse, M E B ^c   Petri, M ^d   Strand, V ^e   Pike, M ^f   Merrill, J T ^g   Leszczynski P ^h   Neuwelt, C M ⁱ   Jeka, S ^j   Houssiau, F ^k   Keiserman, M ^l   Ordi Ros, J ^m   Bongardt, S ⁿ   Kilgallen, B ⁿ   Galateanu, C ⁿ   Kalunian, K ^o   Furie, R ^p   Gordon, C ^q  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b Denver Arthritis Clinic PC   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

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

^e Biopharmaceutical Consultant ^*  (United States)

^f MedPharm Consulting Inc (For Stryker Biotech)   (United States)

^g UNIVERSITY OF OKLAHOMA   (United States)

^h POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

ⁱ Alameda County Health System   (United States)

^j NICOLAUS COPERNICUS UNIVERSITY   (Poland)

^k CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^l PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^m HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

ⁿ UCB PHARMA   (Belgium)

^o UNIVERSITY OF CALIFORNIA   (United States)

^p Northwell Health   (United States)

^q UNIVERSITY OF BIRMINGHAM   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMALARIAL AGENT; ANTINUCLEAR ANTIBODY; CORTICOSTEROID; EPRATUZUMAB; IMMUNOSUPPRESSIVE AGENT; PLACEBO; MONOCLONAL ANTIBODY;

ADULT; ANXIETY DISORDER; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BASAL CELL CARCINOMA; BILAG B INDEX; BILAG-2004 INDEX; BREAST CANCER; BRITISH ISLES LUPUS ASSESSMENT GROUP SCORE; BRONCHITIS; CAUSE OF DEATH; CHOLELITHIASIS; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DISEASE ACTIVITY; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EAR DISEASE; EDEMA; FATIGUE; FEMALE; FEVER; GASTROENTERITIS; GASTROINTESTINAL DISEASE; GLOBAL ASSESSMENT OF FUNCTIONING; HEADACHE; HEALTH CARE QUALITY; HEART DISEASE; HEMATOLOGIC DISEASE; HOSPITALIZATION; HUMAN; HYPERTENSION; INFECTION; INFESTATION; INNER EAR DISEASE; IRON DEFICIENCY ANEMIA; LIP CANCER; LONG TERM CARE; LUNG HEMORRHAGE; LUPUS ERYTHEMATOSUS NEPHRITIS; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; OPEN STUDY; OROPHARYNX PAIN; PATIENT ASSESSMENT; PHASE 2 CLINICAL TRIAL; PHYSICIAN; PREGNANCY; PREMATURITY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; RATING SCALE; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SEPSIS; SHORT FORM 36; SINUSITIS; SKIN DISEASE; SLEDAI; SOFT TISSUE DISEASE; SPONTANEOUS ABORTION; SUBCUTANEOUS TISSUE DISEASE; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY INDEX SCORE; TACHYCARDIA; THORAX DISEASE; THYROID NODULE; THYROID TUMOR; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UROSEPSIS; VASCULAR DISEASE; VERTIGO; VIRUS INFECTION; VOMITING; BRAZIL; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DISABILITY; EUROPE; LUPUS ERYTHEMATOSUS, SYSTEMIC; MIDDLE AGED; MULTICENTER STUDY; QUESTIONNAIRE; SEVERITY OF ILLNESS INDEX; TIME FACTOR; UNITED STATES;

ADRENAL CORTEX HORMONES; ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; BRAZIL; DISABILITY EVALUATION; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 84961895919     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22694     Document Type: Article

References (31)

1. Flower C, Hennis AJ, Hambleton IR, Nicholson GD, Liang MH, and the Barbados National Lupus Registry Group. Systemic lupus erythematosus in an African Caribbean population: incidence, clinical manifestations, and survival in the Barbados National Lupus Registry. Arthritis Care Res (Hoboken) 2012; 64: 1151-8.
2. Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, editors. Rheumatology. 3rd ed. New York: Mosby; 2003.
3. Shah M, Chaudhari S, McLaughlin TP, Kan HJ, Bechtel B, Dennis GJ, et al., Cumulative burden of oral corticosteroid adverse effects and the economic implications of corticosteroid use in patients with systemic lupus erythematosus. Clin Ther 2013; 35: 486-97.
4. Thamer M, Hernan MA, Zhang Y, Cotter D, Petri M., Prednisone, lupus activity, and permanent organ damage. J Rheumatol 2009; 36: 560-4.
5. Sanz I, Lee FE., B cells as therapeutic targets in SLE. Nat Rev Rheumatol 2010; 6: 326-37.
6. Dorner T, Giesecke C, Lipsky PE., Mechanisms of B cell autoimmunity in SLE. Arthritis Res Ther 2011; 13: 243.
7. Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, and the BLISS-76 Study Group. 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: 3918-30.
8. Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al, and the BLISS-76 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011; 377: 721-31.
9. Dorner T, Shock A, Smith KG., CD22 and autoimmune disease. Int Rev Immunol 2012; 31: 363-78.
10. Carnahan J, Wang P, Kendall R, Chen C, Hu S, Boone T, et al., Epratuzumab, a humanized monoclonal antibody targeting CD22: characterization of in vitro properties. Clin Cancer Res 2003; 9: 3982S-90S.
11. 2+ flux upon activation. Arthritis Rheum 2013; 65: 770-9.
12. Traczewski P, Rudnicka L., Treatment of systemic lupus erythematosus with epratuzumab. Br J Clin Pharmacol 2011; 71: 175-82.
13. Rossi EA, Goldenberg DM, Michel R, Rossi DL, Wallace DJ, Chang CH., Trogocytosis of multiple B-cell surface markers by CD22 targeting with epratuzumab. Blood 2013; 122: 3020-9.
14. Wallace DJ, Kalunian K, Petri MA, Strand V, Houssiau FA, Pike M, et al., Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis 2014; 73: 183-90.
15. Fleischer V, Sieber J, Fleischer SJ, et al., Targeting CD22 with epratuzumab impacts cytokine production by B cells [abstract]. Arthritis Rheumatol 2014; 66: S856.
16. Giltiay NV, Shu GL, Shock A, et al., Regulation of the responses of human B cell subsets to innate immune signals by epratuzumab, a humanized monoclonal antibody targeting CD22 [abstract]. Arthritis Rheumatol 2014; 66: S855.
17. Dean GS, Tyrrell-Price J, Crawley E, Isenberg DA., Cytokines and systemic lupus erythematosus. Ann Rheum Dis 2000; 59: 243-51.
18. Wallace DJ, Gordon C, Strand V, Hobbs K, Petri M, Kalunian K, et al., Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Rheumatology (Oxford) 2013; 52: 1313-22.
19. Strand V, Petri M, Kalunian K, Gordon C, Wallace DJ, Hobbs K, et al., 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 (Oxford) 2014; 53: 502-11.
20. Gladman DD, Ibanez D, Urowitz MB., Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002; 29: 288-91.
21. Yee CS, Cresswell L, Farewell V, Rahman A, Teh LS, Griffiths B, et al., Numerical scoring for the BILAG-2004 index. Rheumatology (Oxford) 2010; 49: 1665-9.
22. Wallace DJ, Strand V, Furie R, et al., Evaluation of treatment success in systemic lupus erythematosus clinical trials: development of the British Isles Lupus Assessment Group-Based Composite Lupus Assessment end point [abstract]. Arthritis Rheum 2011; 63: 2265.
23. Strand V, Singh JA., Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2008; 14: 234-54.
24. Strand V, Crawford B, Singh J, Choy E, Smolen JS, Khanna D., 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.
25. Strand V, Mease P, Burmester GR, Nikai E, Coteur G, van Vollenhoven R, et al., Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial. Arthritis Res Ther 2009; 11: R170.
26. Strand V, Singh JA., Newer biological agents in rheumatoid arthritis: impact on health-related quality of life and productivity. Drugs 2010; 70: 121-45.
27. Strand V, Merrill JT, Nikai E, et al., Sustained improvements in health-related quality of life in patients with systemic lupus erythematosus following epratuzumab treatment: results from a phase IIb trial and its open-label extension [abstract]. Arthritis Rheum 2013; 65: S1080.
28. Neville C, Clarke AE, Joseph L, Belisle P, Ferland D, Fortin PR., Learning from discordance in patient and physician global assessments of systemic lupus erythematosus disease activity. J Rheumatol 2000; 27: 675-9.
29. Jolly M, Garris CP, Mikolaitis RA, Jhingran PM, Dennis G, Wallace DJ, et al., Development and validation of the Lupus Impact Tracker: a patient-completed tool for clinical practice to assess and monitor the impact of systemic lupus erythematosus. Arthritis Care Res (Hoboken) 2014; 66: 1542-50.
30. Jolly M, Pickard AS, Block JA, Kumar RB, Mikolaitis RA, Wilke CT, et al., Disease-specific patient reported outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum 2012; 42: 56-65.
31. McElhone K, Abbott J, Shelmerdine J, Bruce IN, Ahmad Y, Gordon C, et al., Development and validation of a disease-specific health-related quality of life measure, the LupusQol, for adults with systemic lupus erythematosus. Arthritis Rheum 2007; 57: 972-9.