Sifalimumab, a human anti-interferon-α monoclonal antibody, in systemic lupus erythematosus: A phase i randomized, controlled, dose-escalation study

Arthritis and Rheumatism

Volumn 65, Issue 4, 2013, Pages 1011-1021

  Petri, Michelle ^a   Wallace, Daniel J ^b   Spindler, Alberto ^c   Chindalore, Vishala ^d   Kalunian, Kenneth ^e   Mysler, Eduardo ^f   Neuwelt, C Michael ^g   Robbie, Gabriel ^h   White, Wendy I ^h   Higgs, Brandon W ^h   Yao, Yihong ^h   Wang, Liangwei ^h   Greth, Warren ^h  

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

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Centro Medico Privado de Reumatologia   (Argentina)

^d Pinnacle Research Group   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f OMI Organizacion Medica de Investigacion   (Argentina)

^g East Bay Rheumatology Medical Group   (United States)

^h MEDIMMUNE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INTERFERON; METHYLPREDNISOLONE; PLACEBO; PREDNISONE; SIFALIMUMAB;

ADULT; ADVERSE OUTCOME; ARTHRALGIA; ARTICLE; BACKACHE; COMPETITIVE INHIBITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIARRHEA; DISEASE ACTIVITY; DISEASE EXACERBATION; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOKALEMIA; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RHINOPHARYNGITIS; SCORING SYSTEM; SIDE EFFECT; SINUSITIS; SYSTEMIC LUPUS ERYTHEMATOSUS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING;

ADULT; ANTIBODIES, MONOCLONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-ALPHA; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84875697484     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.37824     Document Type: Article

References (36)

1. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum 1999; 42: 1785-96.
2. Rahman A, Isenberg DA,. Systemic lupus erythematosus. N Engl J Med 2008; 358: 929-39.
3. Bertsias G, Ioannidis JP, Boletis J, Bombardieri S, Cervera R, Dostal C, et al. EULAR recommendations for the management of systemic lupus erythematosus: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics. Ann Rheum Dis 2008; 67: 195-205.
4. 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 1996; 39: 363-9.
5. To CH, Petri M,. Is antibody clustering predictive of clinical subsets and damage in systemic lupus erythematosus? Arthritis Rheum 2005; 52: 4003-10.
6. 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.
7. Lau CS, Mak A,. The socioeconomic burden of SLE. Nat Rev Rheumatol 2009; 5: 400-4.
8. Clarke AE, Petri M, Manzi S, Isenberg DA, Gordon C, Senecal JL, et al, for the Tri-nation Study Group. The systemic lupus erythematosus Tri-nation Study: absence of a link between health resource use and health outcome. Rheumatology (Oxford) 2004; 43: 1016-24.
9. Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al, the BLISS-52 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.
10. US Food and Drug Administration. FDA approves Benlysta to treat lupus. March 2011. URL: http://www.fda.gov/newsevents/newsroom/pressAnnouncements/ ucm246489.htm.
11. Kalunian K, Joan TM,. New directions in the treatment of systemic lupus erythematosus. Curr Med Res Opin 2009; 25: 1501-14.
12. La Cava A,. Anticytokine therapies in systemic lupus erythematosus. Immunotherapy 2010; 2: 575-82.
13. Obermoser G, Pascual V,. The interferon-α signature of systemic lupus erythematosus. Lupus 2010; 19: 1012-9.
14. Ronnblom L, Alm GV, Eloranta ML,. The type I interferon system in the development of lupus. Semin Immunol 2011; 23: 113-21.
15. Schilling PJ, Kurzrock R, Kantarjian H, Gutterman JU, Talpaz M,. Development of systemic lupus erythematosus after interferon therapy for chronic myelogenous leukemia. Cancer 1991; 68: 1536-7.
16. Ioannou Y, Isenberg DA,. Current evidence for the induction of autoimmune rheumatic manifestations by cytokine therapy [review]. Arthritis Rheum 2000; 43: 1431-42.
17. Bengtsson AA, Sturfelt G, Truedsson L, Blomberg J, Alm G, Vallin H, et al. Activation of type I interferon system in systemic lupus erythematosus correlates with disease activity but not with antiretroviral antibodies. Lupus 2000; 9: 664-71.
18. Dall'Era MC, Cardarelli PM, Preston BT, Witte A, Davis JC Jr,. Type I interferon correlates with serological and clinical manifestations of SLE. Ann Rheum Dis 2005; 64: 1692-7.
19. Bauer JW, Petri M, Batliwalla FM, Koeuth T, Wilson J, Slattery C, et al. Interferon-regulated chemokines as biomarkers of systemic lupus erythematosus disease activity: a validation study. Arthritis Rheum 2009; 60: 3098-107.
20. Higgs BW, Liu Z, White B, Zhu W, White WI, Morehouse C, et al. Patients with systemic lupus erythematosus, myositis, rheumatoid arthritis and scleroderma share activation of a common type I interferon pathway. Ann Rheum Dis 2011; 70: 2029-36.
21. Criswell LA,. The genetic contribution to systemic lupus erythematosus. Bull NYU Hosp Jt Dis 2008; 66: 176-83.
22. Sigurdsson S, Goring HH, Kristjansdottir G, Milani L, Nordmark G, Sandling JK, et al. Comprehensive evaluation of the genetic variants of interferon regulatory factor 5 (IRF5) reveals a novel 5 bp length polymorphism as strong risk factor for systemic lupus erythematosus. Hum Mol Genet 2008; 17: 872-81.
23. Santiago-Raber ML, Baccala R, Haraldsson KM, Choubey D, Stewart TA, Theofilopoulos AN,. Type-I interferon receptor deficiency reduces lupus-like disease in NZB mice. J Exp Med 2003; 197: 777-88.
24. Zagury D, Le Buanec H, Mathian A, Larcier P, Burnett R, Amoura Z, et al. IFNα kinoid vaccine-induced neutralizing antibodies prevent clinical manifestations in a lupus flare murine model. Proc Natl Acad Sci U S A 2009; 106: 5294-9.
25. Yao Y, Richman L, Higgs BW, Morehouse CA, de Los Reyes M, Brohawn P, et al. Neutralization of interferon-α/β-inducible genes and downstream effect in a phase I trial of an anti-interferon-α monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum 2009; 60: 1785-96.
26. Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, et al, for the Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis 2011; 70: 1905-13.
27. 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.
28. Hochberg MC, for the Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus [letter]. Arthritis Rheum 1997; 40: 1725.
29. Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR, et al, for the OC-SELENA Trial. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005; 353: 2550-8.
30. Hay EM, Bacon PA, Gordon C, Isenberg DA, Maddison P, Snaith ML, 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.
31. Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, et al. BILAG 2004: development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford) 2005; 44: 902-6.
32. Yao Y, Higgs BW, Morehouse C, de los Reyes M, Trigona W, Brohawn P, et al. Development of potential pharmacodynamic and diagnostic markers for anti-IFN-α monoclonal antibody trials in systemic lupus erythematosus. Hum Genomics Proteomics 2009; 2009: 374312.
33. Yao Y, Higgs BW, Richman L, White B, Jallal B,. Use of type I interferon-inducible mRNAs as pharmacodynamic markers and potential diagnostic markers in trials with sifalimumab, an anti-IFNα antibody, in systemic lupus erythematosus. Arthritis Res Ther 2010; 12: S6.
34. 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.
35. Strand V,. Lessons learned from clinical trials in SLE. Autoimmun Rev 2007; 6: 209-14.
36. Eisenberg R,. Why can't we find a new treatment for SLE? J Autoimmun 2009; 32: 223-30.