Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials

Arthritis and Rheumatology

Volumn 69, Issue 2, 2017, Pages 362-375

  Clowse, Megan E B ^a,n   Wallace, Daniel J ^b   Furie, Richard A ^c   Petri, Michelle A ^d   Pike, Marilyn C ^e   Leszczyński, Piotr ^f   Neuwelt, C Michael ^g   Hobbs, Kathryn ^h   Keiserman, Mauro ⁱ   Duca, Liliana ^j   Kalunian, Kenneth C ^k   Galateanu, Catrinel ^l   Bongardt, Sabine ^l   Stach, Christian ^l   Beaudot, Carolyn ^l   Kilgallen, Brian ^l   Gordon, Caroline ^m   Batalov, A ⁿ   Bojinca, M ⁿ   Djerassi, R ⁿ   Duca, L ⁿ   Horak, P ⁿ   Kolarov, Z ⁿ   Milasiene, R ⁿ   Monova, D ⁿ   Otsa, K ⁿ   Pileckyte, M ⁿ   Popova, T ⁿ   Radulescu, F ⁿ   Rashkov, R ⁿ   Rednic, S ⁿ   Repin, M ⁿ   Stoilov, R ⁿ   Tegzova, D ⁿ   Vezikova, N ⁿ   Vitek, P ⁿ   Zainea, C ⁿ   East, Far ⁿ   Baek, H ⁿ   Chen, Y ⁿ   Chiu, Y ⁿ   Cho, C ⁿ   Chou, C ⁿ   Choe, J ⁿ   Huang, C ⁿ   Kang, Y ⁿ   Kang, S ⁿ   Lai, N ⁿ   Lee, S ^n,n   Park, W ⁿ   Shim, S ⁿ   Suh, C ⁿ   Yoo, W ⁿ   Armengol, H Avila ⁿ   Zapata, F Avila ⁿ   Santiago, M Barreto ⁿ   Cavalcanti, F ⁿ   Chahade, W ⁿ   Costallat, L ⁿ   Keiserman, M ⁿ   Alcala, J Orozco ⁿ   Remus, C Ramos ⁿ   Roimicher, L ⁿ   Abu Shakra, M ⁿ   Agarwal, V ⁿ   Agmon Levin, N ⁿ   Kadel, J ⁿ   Levy, Y ⁿ   Mevorach, D ⁿ   Paran, D ⁿ   Reitblat, T ⁿ   Rosner, I ⁿ   Shobha, V ⁿ   Sthoeger, Z ⁿ   Zisman, D ⁿ   Ayesu, K ⁿ   Berney, S ⁿ   Box, J ⁿ   Busch, H ⁿ   Buyon, J ⁿ   Carter, J ⁿ   Chi, J ⁿ   Collins, R ⁿ   Dao, K ⁿ   Diab, I ⁿ   Dikranian, A ⁿ   El Shahawy, M ⁿ   Gaylis, N ⁿ   Grossman, J ⁿ   Halpert, E ⁿ   Huff, J ⁿ   Jarjour, W ⁿ   Kao, A ⁿ   Katz, R ⁿ   Kennedy, A ⁿ   Khan, M ⁿ   Kivitz, A ⁿ   Kohen, M ⁿ   Lawrence Ford, T ⁿ   Lawson, J ⁿ   Levesque, M ⁿ   Lowenstein, M ⁿ   Majjhoo, A ⁿ   Mcarthur, R ⁿ   McLain, D ⁿ   Merrill, J ⁿ   Murillo, A ⁿ   Neucks, S ⁿ   Niemer, G ⁿ   Noaiseh, G ⁿ   Parker, C ⁿ   Pantojas, C ⁿ   Pattanaik, D ⁿ   Petri, M ⁿ   Pickrell, P ⁿ   Reveille, J ⁿ   Roman Miranda, A ⁿ   Rothfield, N ⁿ   Sankoorikal, A ⁿ   Sayers, M ⁿ   Singhal, A ⁿ   Snyder, A ⁿ   Striebich, C ⁿ   Vo, Q ⁿ   von Feldt, J ⁿ   Wallace, D ⁿ   Wasko, M ⁿ   Young, C ⁿ   Adelstein, S ⁿ   Hall, S ⁿ   Littlejohn, G ⁿ   Nicholls, D ⁿ   Suranyi, M ⁿ   Amoura, Z ⁿ   Bannert, B ⁿ   Behrens, F ⁿ   Perez, L Carreno ⁿ   Chakravarty, K ⁿ   Gonzales, F Diaz ⁿ   Davies, K ⁿ   Doria, A ⁿ   Emery, P ⁿ   Fernandez Nebro A ⁿ   Govoni, M ⁿ   Hachulla, E ⁿ   Hellmich, B ⁿ   Houssiau, F ⁿ   Malaise, M ⁿ   Margaux, J ⁿ   Maugars, Y ⁿ   Munoz Fernandez S ⁿ   Navarro, F ⁿ   Ordi Ros, J ⁿ   Pellerito, R ⁿ   Pena Sagredo, J ⁿ   Roussou, E ⁿ   Schmidt, R E ⁿ   Ucar Angulo, E ⁿ   Viallard, J F ⁿ   Westhovens, R ⁿ   Worm, M ⁿ   Yee, C S ⁿ   Nayiager, S ⁿ   Reuter, H ⁿ   Spargo, C ⁿ   Bazela, B ⁿ   Brzosko, M ⁿ   Chudzik, D ⁿ   Gasztonyi, B ⁿ   Geher, P ⁿ   Ionescu, R ⁿ   Jeka, S ⁿ   Kemeny, L ⁿ   Kiss, E ⁿ   Kotyla, P ⁿ   Kovacs, L ⁿ   Kovalenko, V ⁿ   Kucharz, E ⁿ   Kwiatkowska, B ⁿ   Leszczynski, P ⁿ   Levchenko, E ⁿ   Lysenko, G ⁿ   Majdan, M ⁿ   Mihailov, C ⁿ   Nalotov, S ⁿ   Nedelciu, M ⁿ   Pavel, M ⁿ   Raskina, T ⁿ   Rebrov, B ⁿ   Rezus, E ⁿ   Semen, T ⁿ   Smakotina, S ⁿ   Stanislavchuk, M ⁿ   Stanislav, M ⁿ   Szombati, I ⁿ   Szucs, G ⁿ   Udrea, G ⁿ   Zajdel, J ⁿ   Zon Giebel, A ⁿ   Bonfiglioli, R ⁿ   Bustamante, R ⁿ   Klumb, E ⁿ   Ramirez, G Medrano ⁿ   Neiva, C ⁿ   Olguin, M ⁿ   Gonzaga, J Reyes ⁿ   Scotton, A ⁿ   Ayala, S Sicsik ⁿ   Ximenes, A ⁿ   Sharma, R ⁿ   Srikantiah, C ⁿ   Aelion, J ⁿ   Aranow, C ⁿ   Baker, M ⁿ   Chadha, A ⁿ   Chao, J ⁿ   Chatham, W ⁿ   Chow, A ⁿ   Clay, C ⁿ   Cohen Gadol, S ⁿ   Conaway, D ⁿ   Denburg, J ⁿ   Escalante, A ⁿ   Espinoza, L ⁿ   Fiechtner, J ⁿ   Fortin, I ⁿ   Fraser, A ⁿ   Furie, R ⁿ   Gladman, D ⁿ   Goddard, D ⁿ   Goldberg, M ⁿ   Gonzalez Rivera, R ⁿ   Gorman, J ⁿ   Griffin, R ⁿ   Haaland, D ⁿ   Halter, D ⁿ   Hemaiden, A ⁿ   Hobbs, K ⁿ   Joshi, V ⁿ   Lim, S ⁿ   Kalunian, K ⁿ   Karpouzas, G ⁿ   Khraishi, M ⁿ   Lafyatis, R ⁿ   Lidman, R ⁿ   Lue, C ⁿ   Mohan, M ⁿ   Mease, P ⁿ   Mehta, C ⁿ   Mizutani, W ⁿ   Nami, A ⁿ   Nascimento, J ⁿ   Neuwelt, C ⁿ   Pappas, J ⁿ   Pope, J ⁿ   Porges, A ⁿ   Roane, G ⁿ   Rosenberg, D ⁿ   Ross, S ⁿ   Saadeh, C ⁿ   Scoville, C ⁿ   Sherrer, Y ⁿ   Solomon, M ⁿ   Surbeck, W ⁿ   Valenzuela, G ⁿ   Waller, P ⁿ   Alten, R ⁿ   Baerwald, C ⁿ   Bienvenu, B ⁿ   Bombardieri, S ⁿ   Braun, J ⁿ   Dival, L ⁿ   Espinosa, G ⁿ   Fernandez, I Figueroa ⁿ   Gomez Reino, J ⁿ   Hiepe, F ⁿ   Hopkinson, N ⁿ   Isenberg, D ⁿ   Jacobi, A ⁿ   Jorgensen, C ⁿ   Guern, V Le ⁿ   Paul, C ⁿ   Pego Reigosa, J M ⁿ   Heredia, J Rodriguez ⁿ   Rubbert Roth, A ⁿ   Sabbadini, M ⁿ   Schroeder, J ⁿ   Schwarting, A ⁿ   Spieler, W ⁿ   Valesini, G ⁿ   Wollenhaupt, J ⁿ   Mendoza, A Zea ⁿ   Zouboulis, C ⁿ   more..

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b CEDARS SINAI MEDICAL CENTER   (United States)

^c Northwell Health   (United States)

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

^e MedPharm Consulting   (United States)

^f POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^g Alameda Health System   (United States)

^h Denver Arthritis Clinic PC   (United States)

ⁱ PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^j Clinica Neomed   (Romania)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l UCB PHARMA   (Belgium)

^m UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

ⁿ NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINUCLEAR ANTIBODY; DOUBLE STRANDED DNA ANTIBODY; EPRATUZUMAB; PLACEBO; PREDNISONE; MONOCLONAL ANTIBODY;

ADULT; ARTICLE; BRITISH ISLES LUPUS ASSESSMENT GROUP; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DISEASE ACTIVITY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEADACHE; HERPES ZOSTER; HUMAN; INJURY; INTOXICATION; KIDNEY DISEASE; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; MUSCULOSKELETAL DISEASE ASSESSMENT; NAUSEA; NUTRITIONAL DISORDER; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SKIN DISEASE; SLEDAI; SOFT TISSUE DISEASE; SUBCUTANEOUS TISSUE; SUBCUTANEOUS TISSUE DISORDER; SYSTEMIC LUPUS ERYTHEMATOSUS; THORAX DISEASE; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT DISEASE; URINARY TRACT INFECTION; VASCULAR DISEASE; CLINICAL TRIAL; LUPUS ERYTHEMATOSUS, SYSTEMIC; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85010857654     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/art.39856     Document Type: Article

References (28)

1. Tsokos GC, Gordon C, Smolen JS. Systemic lupus erythematosus: a companion to rheumatology. 1st ed. Philadelphia: Mosby; 2007.
2. Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH. Rheumatology e-dition. 4th ed. St. Louis: Mosby-Elsevier; 2008.
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. 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.
6. Dorner T, Shock A, Goldenberg DM, Lipsky PE. The mechanistic impact of CD22 engagement with epratuzumab on B cell function: implications for the treatment of systemic lupus erythematosus. Autoimmun Rev 2015;14:1079–86.
7. 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.
8. 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.
9. Wallace DJ, Hobbs K, Clowse ME, Petri M, Strand V, Pike M, et al. 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 Res (Hoboken) 2015;68:534–43.
10. Tan EM, Cohen AS, Fries JF, Masi AT, McShane DJ, Rothfield NF, et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1982;25:1271–7.
11. Yee CS, Farewell V, Isenberg DA, Griffiths B, Teh LS, Bruce IN, et al. The BILAG-2004 index is sensitive to change for assessment of SLE disease activity. Rheumatology (Oxford) 2009;48:691–5.
12. Gladman DD, Ibanez D, Urowitz MB. Systemic Lupus Erythematosus Disease Activity Index 2000. J Rheumatol 2002;29:288–91.
13. Wallace D, Strand V, Furie R, Petri M, Kalunian K, Pike M, et al. Evaluation of treatment success in systemic lupus erythematosus clinical trials: development of the British Isles Lupus Assessment Group–based composite lupus assessment endpoint [abstract]. Arthritis Rheum 2011;63 Suppl 10:2265.
14. Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus. Arthritis Rheum 1966;39:363–9.
15. 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.
16. Ware JE Jr, Snow KK, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
17. 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.
18. 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.
19. Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, et al. Novel evidence-based Systemic Lupus Erythematosus Responder Index. Arthritis Care Res (Hoboken) 2009;61:1143–51.
20. Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, et al. Effect of a treatment strategy of Tight Control for Rheumatoid Arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004;364:263–9.
21. European Medicines Agency. Summary of product characteristics: Benlysta 120 mg powder for concentrate for solution for infusion. Glaxo Group Limited (Middlesex, UK). September 8, 2011. URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002015/WC500110150.pdf.
22. 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;63:3918–30.
23. 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;377:721–31.
24. Isenberg DA, Urowitz MB, Merrill JT, Hoffman RW, Linnik MD, Morgan-Cox MA, et al. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus (SLE): results from 2 phase 3, 52-week, multicenter, randomized, double-blind, placebo-controlled trials [abstract]. URL: http://acrabstracts.org/abstract/efficacy-and-safety-of-subcutaneous-tabalumab-in-patients-with-systemic-lupus-erythematosus-sle-results-from-0000-phase-3-0000-week-multicenter-randomized-double-blind-placebo-controlled-trials/.
25. Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, et al. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis 2016;75:196–202.
26. Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum 2012;64:1215–26.
27. Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum 2010;62:222–33.
28. Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis 2015;74:2006–15.