Biological therapies in primary Sjögren's syndrome

Expert Opinion on Biological Therapy

Volumn 11, Issue 7, 2011, Pages 921-936

  Ng, Wan Fai ^a   Bowman, Simon J ^b  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

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

Author keywords

B cell growth factors; B cells; biological therapies; interleukin 6; primary Sj gren's syndrome; type I interferons

Indexed keywords

ABATACEPT; ALEMTUZUMAB; ALPHA INTERFERON; ALPHA2 INTERFERON; ATACICEPT; AUTOANTIBODY; B CELL ACTIVATING FACTOR; BELIMUMAB; CYCLOPHOSPHAMIDE; DOXORUBICIN; EFALIZUMAB; EPRATUZUMAB; ERLIZUMAB; ETANERCEPT; HYDROXYCHLOROQUINE; INFLIXIMAB; METHYLPREDNISOLONE; OCRELIZUMAB; OTELIXIZUMAB; PLACEBO; PREDNISOLONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; RONTALIZUMAB; SIFALIMUMAB; SUCRALFATE; TOCILIZUMAB; TUMOR NECROSIS FACTOR ALPHA; UNINDEXED DRUG; VINCRISTINE;

ANGIONEUROTIC EDEMA; B LYMPHOCYTE; BIOLOGICAL THERAPY; COMORBIDITY; CORTICOSTEROID THERAPY; CYTOKINE RELEASE SYNDROME; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG TARGETING; DYSPNEA; FEVER; HEALTH CARE COST; HUMAN; LYMPHOMA; MOLECULARLY TARGETED THERAPY; MUCOSA ASSOCIATED LYMPHOID TISSUE LYMPHOMA; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NONHODGKIN LYMPHOMA; PATHOGENESIS; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; QUALITY OF LIFE; REVIEW; RIGOR; RISK BENEFIT ANALYSIS; SJOEGREN SYNDROME; T LYMPHOCYTE; URTICARIA;

ANIMALS; BIOLOGICAL THERAPY; HUMANS; IMMUNOTHERAPY; SJOGREN'S SYNDROME; TREATMENT OUTCOME;

EID: 79958027988     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2011.574120     Document Type: Review

References (165)

1. Bowman SJ, Ibrahim GH, Holmes G, et al. Estimating the prevalence among Caucasian women of primary Sjogren's syndrome in two general practices in Birmingham, UK. Scand J Rheumatol 2004;33:39-43 (Pubitemid 38328081)
2. Callaghan R, Prabu A, Allan RB, et al. Direct healthcare costs and predictors of costs in patients with primary Sjogren's syndrome. Rheumatology (Oxford) 2007;46:105-111 (Pubitemid 44932796)
3. Bowman SJ, St Pierre Y, Sutcliffe N, et al. Estimating indirect costs in primary Sjogren's syndrome. J Rheumatol 2010;11:1010-15
4. Segal B, Bowman SJ, Fox PC, et al. Primary Sjogren's syndrome: health experiences and predictors of health quality among patients in the United States. Health Qual Life Outcomes 2009;7:46
5. Christensen LB, Petersen PE, Thorn JJ, Schiodt M. Dental caries and dental health behavior of patients with primary Sjogren syndrome. Acta Odontol Scand 2001;59:116-20 (Pubitemid 33644359)
6. Meijer JM, Meiners PM, Huddleston Slater JJ, et al. Health-related quality of life, employment and disability in patients with Sjogren's syndrome. Rheumatology (Oxford) 2009;48:1077-82
7. Assistance Publique-Hopitaux de Paris. Hydroxychloroquine Versus Placebo in Primary Sjogren's Syndrome. ClinicalTrials.gov NCT00632866. Available from: http:// clinicaltrials.gov/ct2/show/ NCT00632866? term=NCT00632866&rank=1
8. Fox PC, Datiles M, Atkinson JC, et al. Prednisone and piroxicam for treatment of primary Sjogren's syndrome. Clin Exp Rheumatol 1993;11:149-56 (Pubitemid 23155983)
9. Price EJ, Rigby SP, Clancy U, Venables PJ. A double blind placebo controlled trial of azathioprine in the treatment of primary Sjogren's syndrome. J Rheumatol 1998;25:896-9 (Pubitemid 28210551)
10. Skopouli FN, Jagiello P, Tsifetaki N, Moutsopoulos HM. Methotrexate in primary Sjogren's syndrome. Clin Exp Rheumatol 1996;14:555-8 (Pubitemid 26335480)
11. Drosos AA, Skopouli FN, Galanopoulou VK, et al. Cyclosporin a therapy in patients with primary Sjogren's syndrome: results at one year. Scand J Rheumatol 1986;61:246-9 (Pubitemid 17120370)
12. van Woerkom JM, Kruize AA, Geenen R, et al. Safety and efficacy of leflunomide in primary Sjogren's syndrome: a phase II pilot study. Ann Rheum Dis 2007;66:1026-32 (Pubitemid 47122314)
13. Ng WF, Bowman SJ. Primary Sjogren's syndrome: too dry and too tired. Rheumatology (Oxford) 2010;49:844-53
14. Ramos-Casals M, Tzioufas AG, Stone JH, et al. Treatment of primary Sjogren syndrome: a systematic review. JAMA 2010;304:452-60
15. Voulgarelis M, Tzioufas AG. Pathogenetic mechanisms in the initiation and perpetuation of Sjogren's syndrome. Nat Rev Rheumatol 2010;6:529-37
16. Mariette X, Gottenberg JE. Pathogenesis of Sjogren's syndrome and therapeutic consequences. Curr Opin Rheumatol 2010;22:471-7
17. Mackay F, Woodcock SA, Lawton P, et al. Mice transgenic for BAFF develop lymphocytic disorders along with autoimmune manifestations. J Exp Med 1999;190:1697-710 (Pubitemid 30002351)
18. Qian Y, Giltiay N, Xiao J, et al. Deficiency of Act1, a critical modulator of B cell function, leads to development of Sjogren's syndrome. Eur J Immunol 2008;38:2219-28
19. Mariette X, Roux S, Zhang J, et al. The level of BLyS (BAFF) correlates with the titre of autoantibodies in human Sjogren's syndrome. Ann Rheum Dis 2003;62:168-71 (Pubitemid 36135394)
20. Pers JO, Daridon C, Devauchelle V, et al. BAFF overexpression is associated with autoantibody production in autoimmune diseases. Ann NY Acad Sci 2005;1050:34-9 (Pubitemid 41129420)
21. Jonsson MV, Szodoray P, Jellestad S, et al. Association between circulating levels of the novel TNF family members APRIL and BAFF and lymphoid organization in primary Sjogren's syndrome. J Clin Immunol 2005;25:189-201 (Pubitemid 40884044)
22. Nossent JC, Lester S, Zahra D, et al. Polymorphism in the 5¢ regulatory region of the B-lymphocyte activating factor gene is associated with the Ro/La autoantibody response and serum BAFF levels in primary Sjogren's syndrome. Rheumatology (Oxford) 2008;47:1311-16
23. Lavie F, Miceli-Richard C, Ittah M, et al. B-cell activating factor of the tumour necrosis factor family expression in blood monocytes and T cells from patients with primary Sjogren's syndrome. Scand J Immunol 2008;67:185-92
24. Szodoray P, Alex P, Jonsson MV, et al. Distinct profiles of Sjogren's syndrome patients with ectopic salivary gland germinal centers revealed by serum cytokines and BAFF. Clin Immunol 2005;117:168-76 (Pubitemid 41407727)
25. Ittah M, Miceli-Richard C, Eric Gottenberg J, et al. B cell-activating factor of the tumor necrosis factor family (BAFF) is expressed under stimulation by interferon in salivary gland epithelial cells in primary Sjogren's syndrome. Arthritis Res Ther 2006;8(2):R51
26. Daridon C, Pers JO, Devauchelle V, et al. Identification of transitional type II B cells in the salivary glands of patients with Sjogren's syndrome. Arthritis Rheum 2006;54:2280-8 (Pubitemid 44051085)
27. Katsifis GE, Rekka S, Moutsopoulos NM, et al. Systemic and local interleukin-17 and linked cytokines associated with Sjogren's syndrome immunopathogenesis. Am J Pathol 2009;175:1167-77
28. Nguyen CQ, Hu MH, Li Y, et al. Salivary gland tissue expression of interleukin-23 and interleukin-17 in Sjogren's syndrome: findings in humans and mice. Arthritis Rheum 2008;58:734-43 (Pubitemid 351364871)
29. van Woerkom JM, Kruize AA, Wenting-van Wijk MJ, et al. Salivary gland and peripheral blood T helper 1 and 2 cell activity in Sjogren's syndrome compared with non-Sjogren's sicca syndrome. Ann Rheum Dis 2005;64:1474-9 (Pubitemid 41623860)
30. Fox RI, Kang HI, Ando D, et al. Cytokine mRNA expression in salivary gland biopsies of Sjogren's syndrome. J Immunol 1994;152:5532-9 (Pubitemid 24153003)
31. Koarada S, Haruta Y, Mitamura M, et al. Ex vivo CD+ T-cell cytokine expression from patients with Sjogren's syndrome following in vitro stimulation to induce proliferation. Rheumatology (Oxford) 2006;45:392-9
32. Kolkowski EC, Reth P, Pelusa F, et al. Th1 predominance and perforin expression in minor salivary glands from patients with primary Sjogren's syndrome. J Autoimmun 1999;13:155-62 (Pubitemid 29367020)
33. Prochorec-Sobieszek M, Wagner T, Loukas M, et al. Histopathological and immunohistochemical analysis of lymphoid follicles in labial salivary glands in primary and secondary Sjogren's syndrome. Med Sci Monit 2004;10:BR115-21 (Pubitemid 38525078)
34. Adamson TC III, Fox RI, Frisman DM, Howell FV. Immunohistologic analysis of lymphoid infiltrates in primary Sjogren's syndrome using monoclonal antibodies. J Immunol 1983;130:203-8 (Pubitemid 13172654)
35. Moutsopoulos HM, Hooks JJ, Chan CC, et al. HLA-DR expression by labial minor salivary gland tissues in Sjogren's syndrome. Ann Rheum Dis 1986;45:677-83 (Pubitemid 16038571)
36. Matthews JB, Deacon EM, Kitas GD, et al. Primed and naive helper T cells in labial glands from patients with Sjogren's syndrome. Virchows Arch A Pathol Anat Histopathol 1991;419:191-7
37. Matsumoto I, Okada S, Kuroda K, et al. Single cell analysis of T cells infiltrating labial salivary glands from patients with Sjogren's syndrome. Int J Mol Med 1999;4:519-27
38. Ajjan RA, McIntosh RS, Waterman EA, et al. Analysis of the T-cell receptor Valpha repertoire and cytokine gene expression in Sjogren's syndrome. Br J Rheumatol 1998;37:179-85
39. Yonaha F, Sumida T, Maeda T, et al. Restricted junctional usage of T cell receptor V beta 2 and V beta 13 genes, which are overrepresented on infiltrating T cells in the lips of patients with Sjogren's syndrome. Arthritis Rheum 1992;35:1362-7
40. Ohyama Y, Nakamura S, Matsuzaki G, et al. T-cell receptor Valpha and Vbeta gene use by infiltrating T cells in labial glands of patients with Sjogren's syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1995;79:730-7
41. Smith MD, Lamour A, Boylston A, et al. Selective expression of V beta families by T cells in the blood and salivary gland infiltrate of patients with primary Sjogren's syndrome. J Rheumatol 1994;21:1832-7
42. Kay RA, Hay EM, Dyer PA, et al. An abnormal T cell repertoire in hypergammaglobulinaemic primary Sjogren's syndrome. Clin Exp Immunol 1991;85:262-4
43. Wildenberg ME, van Helden-Meeuwsen CG, van de Merwe JP, et al. Systemic increase in type I interferon activity in Sjogren's syndrome: a putative role for plasmacytoid dendritic cells. Eur J Immunol 2008;38:2024-33
44. Emamian ES, Leon JM, Lessard CJ, et al. Peripheral blood gene expression profiling in Sjogren's syndrome. Genes Immun 2009;10:285-96
45. Gottenberg JE, Cagnard N, Lucchesi C, et al. Activation of IFN pathways and plasmacytoid dendritic cell recruitment in target organs of primary Sjogren's syndrome. Proc Natl Acad Sci USA 2006;103:2770-5
46. Hjelmervik TO, Petersen K, Jonassen I, et al. Gene expression profiling of minor salivary glands clearly distinguishes primary Sjogren's syndrome patients from healthy control subjects. Arthritis Rheum 2005;52:1534-44 (Pubitemid 40663945)
47. Korman BD, Alba MI, Le JM, et al. Variant form of STAT4 is associated with primary Sjogren's syndrome. Genes Immun 2008;9:267-70 (Pubitemid 351584194)
48. Miceli-Richard C, Comets E, Loiseau P, et al. Association of an IRF5 gene functional polymorphism with Sjogren's syndrome. Arthritis Rheum 2007;56:3989-94 (Pubitemid 350262326)
49. Nordmark G, Kristjansdottir G, Theander E, et al. Additive effects of the major risk alleles of IRF5 and STAT4 in primary Sjogren's syndrome. Genes Immun 2009;10:68-76
50. Bave U, Nordmark G, Lovgren T, et al. Activation of the type I interferon system in primary Sjogren's syndrome: a possible etiopathogenic mechanism. Arthritis Rheum 2005;52:1185-95 (Pubitemid 40530126)
51. Zheng L, Zhang Z, Yu C, et al. Association between IFN-alpha and primary Sjogren's syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107:e12-18
52. Rowe D, Griffiths M, Stewart J, et al. HLA class I and II, interferon, interleukin 2, and the interleukin 2 receptor expression on labial biopsy specimens from patients with Sjogren's syndrome. Ann Rheum Dis 1987;46:580-6 (Pubitemid 17137186)
53. Mavragani CP, Niewold TB, Moutsopoulos NM, et al. Augmented interferon-alpha pathway activation in patients with Sjogren's syndrome treated with etanercept. Arthritis Rheum 2007;56:3995-4004 (Pubitemid 350262327)
54. Lovgren T, Eloranta ML, Kastner B, et al. Induction of interferon-alpha by immune complexes or liposomes containing systemic lupus erythematosus autoantigen-and Sjogren's syndrome autoantigen-associated RNA. Arthritis Rheum 2006;54:1917-27 (Pubitemid 43877941)
55. Lavie F, Miceli-Richard C, Quillard J, et al. Expression of BAFF (BLyS) in T cells infiltrating labial salivary glands from patients with Sjogren's syndrome. J Pathol 2004;202:496-502 (Pubitemid 38456168)
56. Ohlsson M, Szodoray P, Loro LL, et al. CD40, CD154, Bax and Bcl-2 expression in Sjogren's syndrome salivary glands: a putative anti-apoptotic role during its effector phases. Scand J Immunol 2002;56:561-71 (Pubitemid 35454338)
57. Kong L, Ogawa N, Nakabayashi T, et al. Fas and Fas ligand expression in the salivary glands of patients with primary Sjogren's syndrome. Arthritis Rheum 1997;40:87-97 (Pubitemid 27044040)
58. Roescher N, Tak PP, Illei GG. Cytokines in Sjogren's syndrome: potential therapeutic targets. Ann Rheum Dis 2010;69:945-8
59. Wen CL, Wang CR, Chuang CY, Chen CY. Increased production of interleukin-6 and autoantibodies in patients with Sjogren's syndrome. Zhonghua Min Guo Wei Sheng Wu Ji Mian Yi Xue Za Zhi 1992;25:189-95
60. Boumba D, Skopouli FN, Moutsopoulos HM. Cytokine mRNA expression in the labial salivary gland tissues from patients with primary Sjogren's syndrome. Br J Rheumatol 1995;34:326-33
61. De Vita S, Dolcetti R, Ferraccioli G, et al. Local cytokine expression in the progression toward B cell malignancy in Sjogren's syndrome. J Rheumatol 1995;22:1674-80
62. Grisius MM, Bermudez DK, Fox PC. Salivary and serum interleukin 6 in primary Sjogren's syndrome. J Rheumatol 1997;24:1089-91 (Pubitemid 27250114)
63. Garcic-Carrasco M, Font J, Filella X, et al. Circulating levels of Th1/Th2 cytokines in patients with primary Sjogren's syndrome: correlation with clinical and immunological features. Clin Exp Rheumatol 2001;19:411-15 (Pubitemid 32685367)
64. Szodoray P, Alex P, Brun JG, et al. Circulating cytokines in primary Sjogren's syndrome determined by a multiplex cytokine array system. Scand J Immunol 2004;59:592-9 (Pubitemid 38789229)
65. Giron-Gonzalez JA, Baturone R, Soto MJ, et al. Implications of immunomodulatory interleukins for the hyperimmunoglobulinemia of Sjogren's syndrome. Cell Immunol 2009;259:56-60
66. Halse A, Tengner P, Wahren-Herlenius M, et al. Increased frequency of cells secreting interleukin-6 and interleukin-10 in peripheral blood of patients with primary Sjogren's syndrome. Scand J Immunol 1999;49:533-8 (Pubitemid 29243126)
67. Reksten TR, Jonsson MV, Szyszko EA, et al. Cytokine and autoantibody profiling related to histopathological features in primary Sjogren's syndrome. Rheumatology (Oxford) 2009;48:1102-6
68. Bombardieri M, Barone F, Pittoni V, et al. Increased circulating levels and salivary gland expression of interleukin-18 in patients with Sjogren's syndrome: relationship with autoantibody production and lymphoid organization of the periductal inflammatory infiltrate. Arthritis Res Ther 2004;6:R447-56
69. Sakai A, Sugawara Y, Kuroishi T, et al. Identification of IL-18 and Th17 cells in salivary glands of patients with Sjogren's syndrome, and amplification of IL-17-mediated secretion of inflammatory cytokines from salivary gland cells by IL-18. J Immunol 2008;181:2898-906
70. Manoussakis MN, Boiu S, Korkolopoulou P, et al. Rates of infiltration by macrophages and dendritic cells and expression of interleukin-18 and interleukin-12 in the chronic inflammatory lesions of Sjogren's syndrome: correlation with certain features of immune hyperactivity and factors associated with high risk of lymphoma development. Arthritis Rheum 2007;56:3977-88 (Pubitemid 350262325)
71. Youinou P, Jamin C. The weight of interleukin-6 in B cell-related autoimmune disorders. J Autoimmun 2009;32:206-10
72. Vosters JL, Landek-Salgado MA, Yin H, et al. Interleukin-12 induces salivary gland dysfunction in transgenic mice, providing a new model of Sjogren's syndrome. Arthritis Rheum 2009;60:3633-41
73. McCartney-Francis NL, Mizel DE, Redman RS, et al. Autoimmune Sjogren's-like lesions in salivary glands of TGF-beta1-deficient mice are inhibited by adhesion-blocking peptides. J Immunol 1996;157:1306-112
74. McCartney-Francis NL, Mizel DE, Frazier-Jessen M, et al. Lacrimal gland inflammation is responsible for ocular pathology in TGF-beta1 null mice. Am J Pathol 1997;151:1281-8 (Pubitemid 27479758)
75. Stott DI, Hiepe F, Hummel M, et al. Antigen-driven clonal proliferation of B cells within the target tissue of an autoimmune disease. The salivary glands of patients with Sjogren's syndrome. J Clin Invest 1998;102:938-46 (Pubitemid 28419239)
76. Aziz KE, McCluskey PJ, Wakefield D. Characterisation of follicular dendritic cells in labial salivary glands of patients with primary Sjogren syndrome: comparison with tonsillar lymphoid follicles. Ann Rheum Dis 1997;56:140-3 (Pubitemid 27119611)
77. Jonsson MV, Skarstein K, Jonsson R, Brun JG. Serological implications of germinal center-like structures in primary Sjogren's syndrome. J Rheumatol 2007;34:2044-9 (Pubitemid 47548208)
78. Barone F, Bombardieri M, Manzo A, et al. Association of CXCL13 and CCL21 expression with the progressive organization of lymphoid-like structures in Sjogren's syndrome. Arthritis Rheum 2005;52:1773-84 (Pubitemid 40852886)
79. Barone F, Bombardieri M, Rosado MM, et al. CXCL13, CCL21, and CXCL12 expression in salivary glands of patients with Sjogren's syndrome and MALT lymphoma: association with reactive and malignant areas of lymphoid organization. J Immunol 2008;180:5130-40
80. Salomonsson S, Jonsson MV, Skarstein K, et al. Cellular basis of ectopic germinal center formation and autoantibody production in the target organ of patients with Sjogren's syndrome. Arthritis Rheum 2003;48:3187-201 (Pubitemid 37409331)
81. Amft N, Curnow SJ, Scheel-Toellner D, et al. Ectopic expression of the B cell-attracting chemokine BCA-1 (CXCL13) on endothelial cells and within lymphoid follicles contributes to the establishment of germinal center-like structures in Sjogren's syndrome. Arthritis Rheum 2001;44:2633-41 (Pubitemid 33049341)
82. Xanthou G, Polihronis M, Tzioufas AG, et al. "Lymphoid" chemokine messenger RNA expression by epithelial cells in the chronic inflammatory lesion of the salivary glands of Sjogren's syndrome patients: possible participation in lymphoid structure formation. Arthritis Rheum 2001;44:408-18
83. Spachidou MP, Bourazopoulou E, Maratheftis CI, et al. Expression of functional Toll-like receptors by salivary gland epithelial cells: increased mRNA expression in cells derived from patients with primary Sjogren's syndrome. Clin Exp Immunol 2007;147:497-503 (Pubitemid 46208051)
84. Deshmukh US, Nandula SR, Thimmalapura PR, et al. Activation of innate immune responses through Toll-like receptor 3 causes a rapid loss of salivary gland function. J Oral Pathol Med 2009;38:42-7
85. Kawakami A, Nakashima K, Tamai M, et al. Toll-like receptor in salivary glands from patients with Sjogren's syndrome: functional analysis by human salivary gland cell line. J Rheumatol 2007;34:1019-26 (Pubitemid 46774848)
86. Steinfeld SD, Demols P, Salmon I, et al. Infliximab in patients with primary Sjogren's syndrome: a pilot study. Arthritis Rheum 2001;44:2371-5 (Pubitemid 32977506)
87. Steinfeld SD, Demols P, Appelboom T. Infliximab in primary Sjogren's syndrome: one-year followup. Arthritis Rheum 2002;46:3301-3 (Pubitemid 35453540)
88. Zandbelt MM, de Wilde P, van Damme P, et al. Etanercept in the treatment of patients with primary Sjogren's syndrome: a pilot study. J Rheumatol 2004;31:96-101 (Pubitemid 38067529)
89. Mariette X, Ravaud P, Steinfeld S, et al. Inefficacy of infliximab in primary Sjogren's syndrome: results of the randomized, controlled Trial of Remicade in Primary Sjogren's Syndrome (TRIPSS). Arthritis Rheum 2004;50(4):1270-6 (Pubitemid 38488821)
90. Sankar V, Brennan MT, Kok MR, et al. Etanercept in Sjogren's syndrome: a twelve-week randomized, double-blind, placebo-controlled pilot clinical trial. Arthritis Rheum 2004;50:2240-5 (Pubitemid 38930815)
91. Somer BG, Tsai DE, Downs L, et al. Improvement in Sjogren's syndrome following therapy with rituximab for marginal zone lymphoma. Arthritis Rheum 2003;49:394-8 (Pubitemid 36682408)
92. Ring T, Kallenbach M, Praetorius J, et al. Successful treatment of a patient with primary Sjogren's syndrome with Rituximab. Clin Rheumatol 2006;25:891-4 (Pubitemid 44473162)
93. Pijpe J, van Imhoff GW, Vissink A, et al. Changes in salivary gland immunohistology and function after rituximab monotherapy in a patient with Sjogren's syndrome and associated MALT lymphoma. Ann Rheum Dis 2005;64:958-60 (Pubitemid 40733928)
94. Pijpe J, van Imhoff GW, Spijkervet GW, et al. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label Phase II study. Arthritis Rheum 2005;52:2740-50 (Pubitemid 41369102)
95. Pijpe J, Meijer JM, Bootsma H, et al. Clinical and histologic evidence of salivary gland restoration supports the efficacy of rituximab treatment in Sjogren's syndrome. Arthritis Rheum 2009;60:3251-6
96. Meijer JM, Meiners PM, Vissink A, et al. Effectiveness of rituximab treatment in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010;62:960-8
97. Gottenberg JE, Guillevin L, Lambotte O, et al. Tolerance and short term efficacy of rituximab in 43 patients with systemic autoimmune diseases. Ann Rheum Dis 2005;64:913-20 (Pubitemid 40733918)
98. Seror R, Sordet C, Guillevin L, et al. Tolerance and efficacy of rituximab and changes in serum B cell biomarkers in patients with systemic complications of primary Sjogren's syndrome. Ann Rheum Dis 2007;66:351-7 (Pubitemid 46579637)
99. Ahmadi-Simab K, Lamprecht P, Nolle B, et al. Successful treatment of refractory anterior scleritis in primary Sjogren's syndrome with rituximab. Ann Rheum Dis 2005;64(7):1087-8 (Pubitemid 40909530)
100. Voulgarelis M, Giannouli S, Tzioufas AG, Moutsopoulos HM. Long term remission of Sjogren's syndrome associated aggressive B cell non-Hodgkin's lymphomas following combined B cell depletion therapy and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Ann Rheum Dis 2006;65:1033-7 (Pubitemid 44133265)
101. Devauchelle-Pensec V, Pennec Y, Morvan J, et al. Improvement of Sjogren's syndrome after two infusions of rituximab (anti-CD20). Arthritis Rheum 2007;57:310-17 (Pubitemid 47164095)
102. Dass S, Bowman SJ, Vital EM, et al. Reduction of fatigue in Sjogren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study. Ann Rheum Dis 2008;67:1541-4
103. Shih WJ, Ghesani N, Hongming Z, et al. F-18 FDG positron emission tomography demonstrates resolution of non-Hodgkin's lymphoma of the parotid gland in a patient with Sjogren's syndrome: before and after anti-CD20 antibody rituximab therapy. Clin Nucl Med 2002;27:142-3 (Pubitemid 34075882)
104. Meijer JM, Pijpe J, Vissink A, et al. Treatment of primary Sjogren syndrome with rituximab: extended follow-up, safety and efficacy of retreatment. Ann Rheum Dis 2009;68:284-5
105. Voulgarelis M, Giannouli S, Anagnostou D, Tzioufas AG. Combined therapy with rituximab plus cyclophosphamide/doxorubicin/ vincristine/prednisone (CHOP) for Sjogren's syndrome-associated B-cell aggressive non-Hodgkin's lymphomas. Rheumatology (Oxford) 2004;43:1050-3 (Pubitemid 39144455)
106. Quartuccio L, Fabris M, Salvin S, et al. Controversies on rituximab therapy in sjogren syndrome-associated lymphoproliferation. Int J Rheumatol 2009;2009:424935
107. Quartuccio L, Fabris M, Moretti M, et al. Resistance to rituximab therapy and local BAFF overexpression in Sjogren's syndrome-related myoepithelial sialadenitis and low-grade parotid B-cell lymphoma. Open Rheumatol J 2008;2:38-43
108. Sanchez-Cano D, Callejas-Rubio JL, Lara-Jimenez MA, et al. Successful use of rituximab in acquired C1 inhibitor deficiency secondary to Sjogren's syndrome. Lupus 2008;17:228-9 (Pubitemid 351588947)
109. University Hospital, Brest. Tolerance and Efficacy of Rituximab in Sjogren's Disease. ClinicalTrials.gov NCT00740948. Available from: http://clinicaltrials.gov/ct2/show/ NCT00740948? term=NCT00740948&rank=1
110. Steinfeld SD, Tant L, Burmester GR, et al. Epratuzumab (humanised anti-CD22 antibody) in primary Sjogren's syndrome: an open-label phase I/II study. Arthritis Res Ther 2006;8:R129
111. Cummins MJ, Papas A, Kammer GM, Fox PC. Treatment of primary Sjogren's syndrome with low-dose human interferon alfa administered by the oromucosal route: combined Phase III results. Arthritis Rheum 2003;49:585-93 (Pubitemid 36988314)
112. Ferraccioli GF, Salaffi F, De Vita S, et al. Interferon alpha-2 (IFN alpha 2) increases lacrimal and salivary function in Sjogren's syndrome patients. Preliminary results of an open pilot trial versus OH-chloroquine. Clin Exp Rheumatol 1996;14:367-71 (Pubitemid 26257587)
113. Shiozawa S, Tanaka Y, Shiozawa K. Single-blinded controlled trial of low-dose oral IFN-alpha for the treatment of xerostomia in patients with Sjogren's syndrome. J Interferon Cytokine Res 1998;18:255-62 (Pubitemid 28176009)
114. Ship JA, Fox PC, Michalek JE, et al. Treatment of primary Sjogren's syndrome with low-dose natural human interferon-alpha administered by the oral mucosal route: A Phase II clinical trial. IFN Protocol Study Group. J Interferon Cytokine Res 1999;19:943-51 (Pubitemid 29406651)
115. Khurshudian AV. A pilot study to test the efficacy of oral administration of interferon-alpha lozenges to patients with Sjogren's syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2003;95:38-44 (Pubitemid 36886720)
116. Yamada S, Mori K, Matsuo K, et al. Interferon alfa treatment for Sjogren's syndrome associated neuropathy. J Neurol Neurosurg Psychiatry 2005;76:576-8 (Pubitemid 40486588)
117. Unoki H, Moriyama A, Tabaru A, et al. Development of Sjogren's syndrome during treatment with recombinant human interferon-alpha-2b for chronic hepatitis C. J Gastroenterol 1996;31:723-7 (Pubitemid 26345542)
118. Moore PA, Belvedere O, Orr A, et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science 1999;285:260-3 (Pubitemid 29330000)
119. Schneider P, MacKay F, Steiner V, et al. BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth. J Exp Med 1999;189:1747-56 (Pubitemid 29272691)
120. Ittah M, Miceli-Richard C, Gottenberg JE, et al. Viruses induce high expression of BAFF by salivary gland epithelial cells through TLRand type-I IFN-dependent and-independent pathways. Eur J Immunol 2008;38:1058-64
121. Pers JO, Devauchelle V, Daridon C, et al. BAFF-modulated repopulation of B lymphocytes in the blood and salivary glands of rituximab-treated patients with Sjogren's syndrome. Arthritis Rheum 2007;56:1464-77 (Pubitemid 46764075)
122. Lavie F, Miceli-Richard C, Ittah M, et al. Increase of B cell-activating factor of the TNF family (BAFF) after rituximab treatment: insights into a new regulating system of BAFF production. Ann Rheum Dis 2007;66:700-3 (Pubitemid 46707145)
123. Wallace DJ, Stohl W, Furie RA, et al. A Phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 2009;61:1168-78
124. University of Udine. Efficacy and Safety of Belimumab in Primary Sjogren's Syndrome. ClinicalTrials.gov NCT01008982. Available from: http:// clinicaltrials.gov/ct2/show/ NCT01008982?term=NCT01008982& rank=1
125. Assistance Publique-Hopitaux de Paris. Efficacy and Safety of Belimumab in Subjects With Primary Sjogren's Syndrome. ClinicalTrials.gov NCT01160666. Available from: http://clinicaltrials.gov/ct2/show/ NCT01160666?term= NCT01160666& rank=1
126. Bracewell C, Isaacs JD, Emery P, Ng WF. Atacicept, a novel B cell-targeting biological therapy for the treatment of rheumatoid arthritis. Expert Opin Biol Ther 2009;9:909-19
127. Pena-Rossi C, Nasonov E, Stanislav M, et al. An exploratory dose-escalating study investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous atacicept in patients with systemic lupus erythematosus. Lupus 2009;18:547-55
128. Bissonnette R, Papp K, Maari C, et al. A randomized, double-blind, placebo-controlled, phase I study of MEDI-545, an anti-interferon-alfa monoclonal antibody, in subjects with chronic psoriasis. J Am Acad Dermatol 2010;62:427-36
129. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis 2009;68:1580-4
130. Helse Stavanger HF. Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome. ClinicalTrials.gov NCT00683345. Available from: http://clinicaltrials.gov/ ct2/show/NCT00683345?term= NCT00683345&rank=1
131. Westhovens R, Kremer JM, Moreland LW, et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended Phase IIB study. J Rheumatol 2009;36:736742
132. Goules A, Tzioufas AG, Manousakis MN, et al. Elevated levels of soluble CD40 ligand (sCD40L) in serum of patients with systemic autoimmune diseases. J Autoimmun 2006;26:165-71 (Pubitemid 43737334)
133. Dimitriou ID, Kapsogeorgou EK, Moutsopoulos HM, Manoussakis MN. CD40 on salivary gland epithelial cells: high constitutive expression by cultured cells from Sjogren's syndrome patients indicating their intrinsic activation. Clin Exp Immunol 2002;127:386-92 (Pubitemid 34233948)
134. Boumpas DT, Furie R, Manzi S, et al. A short course of BG9588 (anti-CD40 ligand antibody) improves serologic activity and decreases hematuria in patients with proliferative lupus glomerulonephritis. Arthritis Rheum 2003;48:719-27 (Pubitemid 36302008)
135. Kalunian KC, Davis JC Jr, Merrill JT, et al. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:3251-8 (Pubitemid 35453534)
136. Aziz KE, McCluskey PJ, Wakefield D. Expression of selectins (CD62 E,L,P) and cellular adhesion molecules in primary Sjogren's syndrome: questions to immunoregulation. Clin Immunol Immunopathol 1996;80:55-66 (Pubitemid 26227833)
137. Turkcapar N, Sak SD, Saatci M, et al. Vasculitis and expression of vascular cell adhesion molecule-1, intercellular adhesion molecule-1, and E-selectin in salivary glands of patients with Sjogren's syndrome. J Rheumatol 2005;32:1063-70 (Pubitemid 40828080)
138. Mikulowska-Mennis A, Xu B, Berberian JM, Michie SA. Lymphocyte migration to inflamed lacrimal glands is mediated by vascular cell adhesion molecule-1/alpha4beta1 integrin, peripheral node addressin/l-selectin, and lymphocyte function-associated antigen-1 adhesion pathways. Am J Pathol 2001;159:671-81 (Pubitemid 32751097)
139. Cauli A, Yanni G, Pitzalis C, et al. Cytokine and adhesion molecule
140. National Institute of Dental and Craniofacial Research (NIDCR). Raptiva to Treat Sjogren's Syndrome. ClinicalTrials.gov NCT00344448. Available from: http://clinicaltrials.gov/ ct2/show/NCT00344448? term=NCT00344448&rank=1
141. Nishiyama T, Mishima K, Obara K, et al. Amelioration of lacrimal gland inflammation by oral administration of K-13182 in Sjogren's syndrome model mice. Clin Exp Immunol 2007;149:586-95 (Pubitemid 47256162)
142. Ng WF, Isaccs JD. From mice to men: the challenges of developing tolerance-inducing biological drugs for the clinic. In: Graca L, editor, The immune synapse as a novel target for therapy (progress in inflammation research). Birkhauser, Basel; 2008. p. 169-85
143. Herold KC, Hagopian W, Auger JA, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002;346(22):1692-8 (Pubitemid 34547482)
144. Barrat FJ, Coffman RL. Development of TLR inhibitors for the treatment of autoimmune diseases. Immunol Rev 2008;223:271-83 (Pubitemid 351986175)
145. Proudfoot AE, Power CA, Schwarz MK. Anti-chemokine small molecule drugs: a promising future? Expert Opin Investig Drugs 2010;19:345-55
146. Dixon WG, Hyrich KL, Watson KL, et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR). Ann Rheum Dis 2010;69:522-8
147. Salliot C, Dougados M, Gossec L. Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials. Ann Rheum Dis 2009;68:25-32
148. Furst DE. Serum immunoglobulins and risk of infection: how low can you go? Semin Arthritis Rheum 2009;39:18-29
149. Morrison T. Ocrelizumab Hits Endpoint in RA Trial; Safety Questions Remain. BioWorld Today: published online 14 December 2009: Available from: http://www.bioworld.com/servlet/com. accumedia.web.Dispatcher?next= bioWorldHeadlines-article& forceid=53000
150. Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy: a national estimate of frequency in systemic lupus erythematosus and other rheumatic diseases. Arthritis Rheum 2009;60:3761-5
151. Bowman SJ, Booth DA, Platts RG. Measurement of fatigue and discomfort in primary Sjogren's syndrome using a new questionnaire tool. Rheumatology (Oxford) 2004;43:758-64 (Pubitemid 38807434)
152. Bowman SJ, Booth DA, Platts RG, et al. Validation of the Sicca Symptoms Inventory for clinical studies of Sjogren's syndrome. J Rheumatol 2003;30:1259-66 (Pubitemid 36666351)
153. Bowman SJ, Hamburger J, Richards A, et al. Patient-reported outcomes in primary Sjogren's syndrome: comparison of the long and short versions of the Profile of Fatigue and Discomfort-Sicca Symptoms Inventory. Rheumatology (Oxford) 2009;48:140-3
154. Seror R, Ravaud P, Bowman SJ, et al. EULAR Sjogren's syndrome disease activity index: development of a consensus systemic disease activity index for primary Sjogren's syndrome. Ann Rheum Dis 2010;69:1103-9
155. Vitali C, Palombi G, Baldini C, et al. Sjogren's syndrome disease damage index and disease activity index: scoring systems for the assessment of disease damage and disease activity in Sjogren's syndrome, derived from an analysis of a cohort of Italian patients. Arthritis Rheum 2007;56:2223-31 (Pubitemid 47173570)
156. Bowman SJ, Sutcliffe N, Isenberg DA, et al. Sjogren's Systemic Clinical Activity Index (SCAI)-a systemic disease activity measure for use in clinical trials in primary Sjogren's syndrome. Rheumatology (Oxford) 2007;46:1845-51 (Pubitemid 350168303)
157. Barry RJ, Sutcliffe N, Isenberg DA, et al. The Sjogren's syndrome damage index-a damage index for use in clinical trials and observational studies in primary Sjogren's syndrome. Rheumatology (Oxford) 2008;47:1193-8 (Pubitemid 352038225)
158. Kalk WW, Vissink A, Spijkervet FK, et al. Sialometry and sialochemistry: diagnostic tools for Sjogren's syndrome. Ann Rheum Dis 2001;60:1110-16 (Pubitemid 33096075)
159. Kalk WW, Vissink A, Stegenga B, et al. Sialometry and sialochemistry: a non-invasive approach for diagnosing Sjogren's syndrome. Ann Rheum Dis 2002;61:137-44 (Pubitemid 34098429)
160. Pijpe J, Kalk WW, Bootsma H, et al. Progression of salivary gland dysfunction in patients with Sjogren's syndrome. Ann Rheum Dis 2007;66:107-112 (Pubitemid 46044868)
161. Hu S, Wang J, Meijer J, et al. Salivary proteomic and genomic biomarkers for primary Sjogren's syndrome. Arthritis Rheum 2007;56:3588-600 (Pubitemid 350100692)
162. Hu S, Gao K, Pollard R, et al. Preclinical validation of salivary biomarkers for primary Sjogren's syndrome. Arthritis Care Res (Hoboken) 2010;62:1633-8
163. Hu S, Zhou M, Jiang J, et al. Systems biology analysis of Sjogren's syndrome and mucosa-associated lymphoid tissue lymphoma in parotid glands. Arthritis Rheum 2009;60:81-92
164. Devauchelle-Pensec V, Cagnard N, Pers JO, et al. Gene expression profile in the salivary glands of primary Sjogren's syndrome patients before and after treatment with rituximab. Arthritis Rheum 2010;62:2262-71
165. Ng WF, Bowman SJ, Griffiths B. United Kingdom Primary Sjogren's Syndrome Registry-a united effort to tackle an orphan rheumatic disease. Rheumatology (Oxford) 2011;50:32-39