Disease-modifying antirheumatic drug therapy for spondyloarthropathies: Advances in treatment

Current Opinion in Rheumatology

Volumn 15, Issue 3, 2003, Pages 205-212

  Mease, Philip J ^a  

^a Seattle Rhumatology Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALEFACEPT; ANTISENSE OLIGONUCLEOTIDE; AUROTHIOMALATE; BISPHOSPHONIC ACID DERIVATIVE; CELECOXIB; CORTICOSTEROID; CYCLOOXYGENASE 2 INHIBITOR; EFALIZUMAB; ETANERCEPT; ETORICOXIB; INFLIXIMAB; ISIS 2303; LEFLUNOMIDE; METHOTREXATE; NONSTEROID ANTIINFLAMMATORY AGENT; OM 89; ONERCEPT; PAMIDRONIC ACID; PREDNISOLONE; PYROPHOSPHORIC ACID DERIVATIVE; RITUXIMAB; SALAZOSULFAPYRIDINE; THALIDOMIDE; TUMOR NECROSIS FACTOR BINDING PROTEIN; UNCLASSIFIED DRUG;

ANKYLOSING SPONDYLITIS; BACTERIAL INFECTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CROHN DISEASE; DEMYELINATING DISEASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; GASTROINTESTINAL TOXICITY; HUMAN; INJECTION SITE; LIVER TOXICITY; LOW DRUG DOSE; MULTICENTER STUDY; NEUROTOXICITY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PSORIASIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL; REVIEW; RHEUMATOID ARTHRITIS; SKIN MANIFESTATION; SPONDYLOARTHROPATHY; TUBERCULOSIS;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, PSORIATIC; ARTHRITIS, REACTIVE; CHRONIC DISEASE; CLINICAL TRIALS; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; SEVERITY OF ILLNESS INDEX; SPONDYLARTHROPATHIES; SPONDYLITIS, ANKYLOSING; TREATMENT OUTCOME;

EID: 0038070221     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002281-200305000-00006     Document Type: Review

References (114)

1. Benjamin M, Ralphs JR: The cell and developmental biology of tendons and ligaments. Int Rev Cytol 2000, 196:85-130.
2. McGonagle D, Gibbon W, Emery P: Classification of inflammatory arthritis by enthesitis. Lancet 1998, 352:1137-1140.
3. Bukulmez H, Dunn RS, Pratt RG, et al.: Magnetic resonance imaging (MRI) in HLA-B27 transgenic rat model of spondyloarthropathy: image findings prior to clinically detectable arthritis. Arthritis Rheum 2002, 46:S380. This study used an animal moder of spondyloarthropathy together with contrast-enhanced MRI and demonstrated that inflammatory changes in tissues, such as the enthesium, precede synovitis and clinical arthritis.
4. McGonagle D, Gibbon W, O'Connor P, et al.: Characteristic magnetic resonance imaging entheseal changes of knee synovitis in spondyloarthropathy. Arthritis Rheum 1998, 41:694-700.
5. Ahlstrom H, Feltelius N, Nyman R, et al.: Magnetic resonance imaging of sacroiliac joint inflammation. Arthritis Rheum 1990, 33:1763-1769.
6. Braun J, Baraliakos X, Golder W, et al.: Ankylosing spondylitis (AS)-development and evaluation of a spinal scoring system (ASspiMRI) using magnetic resonance imaging (MRI) in patients with active disease. Arthritis Rheum 2002, 46:S426.
7. Braun J, Baraliakos X, Golder W, et al.: Improvement of spinal inflammation in ankylosing spondylitis (AS) by infliximab therapy as assessed by a magnetic resonance imaging (MRI) using a novel evaluated spinal scoring system - results of a double-blind placebo-controlled trial. Arthritis Rheum 2002, 46:S426-S427. These two studies expand the role of MRI in ankylosing spondylitis by demonstrating its ability to sensitively document disease activity, disease progression, and response to therapy.
8. Klauser A, Springer P, Frauscher F, et al.: Comparison between magnetic resonance imaging, unenhanced and contrast enhanced ultrasound in the diagnosis of active sacroiliitis. Arthritis Rheum 2002, 46:S426.
9. Alcade M, Cruz M, Bordoy C, et al.: Assessment of entheseal injury in ankylosing spondylitis by ultrasound. Arthritis Rheum 2002, 46:S427.
10. Kamel M, Mansour R, Eid H, et al.: Ultrasound detection of patellar enthesitis: a comparison with MRI. Arthritis Rheum 2002, 46:S104.
11. Bollow M, Fischer T, Reisshauer H, et al.: Quantitative analyses of sacroiliac biopsies in spondyloarthropathies: T cells and macrophages predominate in early and active sacroiliitis-cellularity correlates with the degree of enhancement detected by magnetic resonance imaging. Ann Rheum Dis 2000, 59:135-140.
12. Yu D: Spondylarthropathies. In Kelley's Textbook of Rheumatology, 6th ed. Edited by Ruddy S, Harris ED, Sledge CB. Philadelphia: WB Saunders; 2000:1039-1053.
13. Dougados M, Behier JM, Jolchine I, et al.: Efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis: a sixweek controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug. Arthritis Rheum 2001, 44:180-185.
14. Melian A, van der Heijde D, James MK, et al.: Etoricoxib in the treatment of ankylosing spondylitis (AS). Arthritis Rheum 2002, 46:S432.
15. Dougados M, vam der Linden S, Leirisalo-Repo M, et al.: Sulfasalazine in the treatment of spondylarthropathy. A randomized, multicenter, double-blind, placebo-controlled study. Arthritis Rheum 1995, 38:618-627.
16. Nissila M, Lehtinen K, Leirisalo-Repo M, et al.: Sulfasalazine in the treatment of ankylosing spondylitis. A twenty-six- week, placebo-controlled clinical trial. Arthritis Rheum 1988, 31:1111-1116.
17. Clegg DO, Reda DJ, Mejias E, et al.: Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A Department of Veterans Affairs Cooperative Study. Arthritis Rheum 1996, 39:2013-2020.
18. Clegg DO, Reda DJ, Abdellatif M: Comparison of sulfasalazine and placebo for the treatment of axial and peripheral articular manifestations of the sero-negative spondylarthropathies: a Department of Veterans Affairs cooperative study. Arthritis Rheum 1999, 42:2325-2329.
19. Mosneaga-Zoltur AA, Groppa LG, Mosneaga MG: Clinical immunological data in prolonged administration of sulfasalazine at patients with ankylosing spondylitis. Ann Rheum Dis 2002, 61:418.
20. Chepeleva SN, Sigidin YA, Loukina GV: The results of the comparative study of sulphasalazine and methotrexate in ankylosing spondylitis. Ann Rheum Dis 2002, 61:299-300.
21. Gonzalez-Lopez L, Garcia-Gonzalez A, Vazquez-del-Mercado M, et al.: Efficacy of methotrexate in ankylosing spondylitis: a randomized, placebo-controlled, double-blind trial. Arthritis Rheum 2002, 46:S433.
22. Whiting-O'Keefe QE, Fye KH, Sack KD: Methotrexate and histologic hepatic abnormalities: a meta-analysis. Am J Med 1991, 90:711-716.
23. Haibel H, Rudwaleit M, Braun J, et al.: Therapy of active ankyrosing spondylitis with leflunomide. Ann Rheum Dis 2002, 61;301.
24. Gratacos J, Collado A, Filella X, et al.: Serum cytokines (IL-6, TNF-alpha, IL-1 beta and IFN-gamma) in ankylosing spondylitis: a close correlation between serum IL-6 and disease activity and severity. Br J Rheumatol 1994, 33:927-931.
25. Toussirot E, Lafforgue P, Boucraut J, et al.: Serum levels of interleukin 1-beta, tumor necrosis factor-alpha, soluble interleukin 2 receptor and soluble CD8 in seronegative spondylarthropathies. Rheumatol Int 1994, 13;175-180.
26. Canete JD, Llena J, Collado A, et al.: Comparative cytokine gene expression in synovial tissue of early rheumatoid arthritis and seronegative spondyloarthropathies. Br J Rheumatol 1997, 36:38-42.
27. Grom AA, Murray KJ, Luyrink L, et al.; Patterns of expression of tumor necrosis factor alpha, tumor necrosis factor beta, and their receptors in synovia of patients with juvenile rheumatoid arthritis and juvenile spondylarthropathy. Arthritis Rheum 1996, 39:1703-1710.
28. Partsch G, Steiner G, Leeb BF, et al.: Highly increased levels of tumor necrosis factor-alpha and other proinflammatory cytokines in psoriatic arthritis synovial fluid. J Rheumatol 1997, 24:518-523.
29. Partsch G, Wagner E, Leeb BF, et al.: T cell derived cytokines in psoriatic arthritis synovial fluids. Ann Rheum Dis 1998, 57:691-693.
30. Danning CL, Illei GG, Hitchon C, et al.: Macrophage-derived cytokine and nuclear factor kappaB p65 expression in synovial membrane and skin of patients with psoriatic arthritis. Arthritis Rheum 2000, 43:1244-1256.
31. Ritchlin C, Haas-Smith SA, Hicks D, et al.: Patterns of cytokine production in psoriatic synovium. J Rheumatol 1998, 25:1544-1552.
32. Braun J, Sieper J: The sacroiliac joint in the spondyloarthropathies. Curr Opin Rheumatol 1996, 8:275-287.
33. Gorman JD, Sack KE, Davis JC, Jr.: Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002, 346:1349-1356. This randomized, placebo-controlled, double-masked study found etanercept to be safe and effective in ankylosing spondylitls, with a rapid and sustained response during 4 months of therapy.
34. Stone M, Salonen D, Lax M, et al.: Clinical and imaging correlates of response to treatment with infliximab in patients with ankylosing spondylitis. J Rheumatol 2001, 28:1605-1614.
35. Brandt J, Haibel H, Cornely D, et al.: Successful treatment of active ankylosing spondylitis with the anti-tumor necrosis factor alpha monoclonal antibody infliximab. Arthritis Rheum 2000, 43:1346-1352.
36. Mease PJ, Goffe BS, Metz J, et al.: Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet 2000, 356:385-390.
37. Reiff A, Henrickson M: Prolonged efficacy of etanercept in refractory juvenile ankylosing spondylitis (JAS). Arthritis Rheum 2001, 44:S292.
38. Meador RJ, Hsia EC, Kitumnuaypong T, et al.: Is etanercept (Enbrel) effective in the treatment of reactive and undifferentiated arthritis? Arthritis Rheum 2001, 44:S348.
39. Braun J, Brandt J, Listing J, et al.: Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet 2002, 359:1187-1193. This placebo-controlled, multicenter study found infliximab to be effective in regressing disease activity of ankylosing spondylitis.
40. Antoni C, Kavanaugh A, Kirkham B, et al.: The infliximab multinational psoriatic arthritis controlled trial (IMPACT), Arthritis Rheum 2002, 46:S381. This placebo-controlled, phase 2 trial demonstrated the efficacy of infliximab in psoriatic arthritis and psoriasis.
41. Moreland LW, Baumgartner SW, Schiff MH, et al.: Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor (p75)-Fc fusion protein. N Engl J Med 1997, 337:141-147.
42. Maini R, St Clair EW, Breedveld F, et al.: Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group, Lancet 1999, 354:1932-1939.
43. Moreland LW, Cohen SB, Baumgartner SW, et al.: Long-term safety and efficacy of etanercept in patients with rheumatoid arthritis. J Rheumatol 2001, 28:1238-1244.
44. Mease P, Kivitz A, Burch F, et al.: Improvement in disease activity in patients with psoriatic arthritis receiving etanercept (Enbrel): results of a phase 3 multicenter clinical trial. Arthritis Rheum 2001, 44:S90. This phase 3, multicenter, placebo-controlled, double-masked study found etanercept to be a safe and effective treatment for psoriatic arthritis and psoriasis.
45. Mease PJ, Goffe BS, Metz J, et al.: Enbrel (etanercept) in patients with psoriatic arthritis and psoriasis. Arthritis Rheum 2000, 43:S403.
46. Mease PJ, Goffe BS, Metz J, et al.: Enbrel (etanercept) in patients with psoriatic arthritis and psoriasis. Ann Rheum Dis 2001, 60:146. This open-label, 6-month extension of the placebo-controlled trial of etanercept in psoriatic arthritis [36] demonstrated continued efficacy in joints and further improvement in skin lesions and the ability to decrease or discontinue concomitantly used methotrexate and/or prednisone.
47. Fredrikksson T, Petterson U: Severe psoriais: oral therapy with a new retinoid. Dermatologica 1978, 157:238-244.
48. Sharp JT, Young DY, Bluhm GB, et al.: How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis? Arthritis Rheum 1985, 28:1326-1335.
49. Ory P, Sharp JT, Salonen D, et al.: Etanercept (Enbrel) inhibits radiographic progression in patients with psoriatic arthritis. Arthritis Rheum 2002, 46:S196. This 1-year, open-label, placebo-controlled trial found etanercept to inhibit structural damage of joints in patients with psoriatic arthritis by radiography.
50. Wanke LA, Gottlieb AB, Mease PJ, et al.: Etanercept (Enbrel) improves health-related quality of life in patients with psoriatic arthritis. Arthritis Rheum 2002, 46;S76.
51. Yazici Y, Erkan D, Lockshin MD; Etanercept in the treatment of severe, resistant psoriatic arthritis; Continued efficacy and changing patterns of use after 2 years. Ann Rheum Dis 2002, 61:396.
52. Brandt J, Kariouzov A, Listing J, et al.: Six months results of a German double-blind placebo controlled, phase-III clinical trial of etanercept in active ankylosing spondylitis. Arthritis Rheum 2002, 46:S429. This European phase 3 trial further confirms the efficacy and safety of etanercept in ankylosing spondylitis.
53. Targan SR, Hanauer SB, van Deventer SJ, et al.: A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med 1997, 337:1029-1035.
54. Present DH, Rutgeerts P, Targan S, et al.: Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999, 340:1398-1405.
55. Elliott MJ, Maini RN, Feldmann M, et al.: Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet 1994, 344:1105-1110.
56. Baeten D, Kruithof E, Van Den Bosch F, et al.: Immunomodulatory effects of anti-tumor necrosis factor alpha therapy on synovium in spondylarthropathy: histologic findings in eight patients from an open-label pilot study. Arthritis Rheum 2001, 44:186-195.
57. Kruithof E, Baeten D, Van Den Bosch F, et al.: Differential effect of infliximab on the T and B cell synovial infiltration in spondyloarthropathy: histological evaluation of peripheral arthritis in 15 patients. Arthritis Rheum 2002, 46:S430.
58. Van Den Bosch F, Kruithof E, Baeten D, et al.: Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor alpha (infliximab) in spondyloarthropathy; an open pilot study. Ann Rheum Dis 2000, 59:428-433.
59. Kruithof E, Van Den Bosch F, Baeten D, et al.: Repeated infusions of infliximab, a chimeric anti-TNFalpha monoclonal antibody, in patients with active spondyloarthropathy: one year follow up. Ann Rheum Dis 2002, 61:207-212.
60. Van Den Bosch F, Kruithof E, Baeten D, et al.; Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum 2002, 46:755-765. This short-term, placebo-controlled study demonstrates the efficacy and relative safety of infliximab in a mixed group of patients with spondyloarthropathy.
61. Maksymowych WP, Jhangri GS, Lambert RG, et al.: Infliximab in ankylosing spondylitis: a prospective observational inception cohort analysis of efficacy and safety. J Rheumatol 2002, 29:959-965.
62. Brandt J, Listing J, Alten R, et al.: One year results of a double-blind placebo controlled, phase III clinical trial of infliximab in active ankylosing spondylitis. Ann Rheum Dis 2002, 61:292. This phase 3 study demonstrates the sustained efficacy of infliximab in ankylosing spondylitis for 1 year. Rare but potentially serious adverse events are noted with infliximab therapy, including one case of tuberculosis.
63. Wollina U, Konrad H: Treatment of recalcitrant psoriatic arthritis with anti-tumor necrosis factor-alpha antibody. J Eur Acad Dermatol Venereol 2002, 16:127-129.
64. Bray VJ, Huffstutter JE, Schwartzman S: Emerging role of infliximab (Remicade) in psoriatic arthritis patients resistant to disease-modifying antirheumatic drugs: case studies. Arthritis Rheum 2001, 44:S121.
65. Antoni C, Dechant C, Hanns-Martin Lorenz PD, et al.: Open-label study of infliximab treatment for psoriatic arthritis; clinical and magnetic resonance imaging measurements of reduction of inflammation. Arthritis Rheum 2002, 47:506-512. This 54-week, open label study found infliximab to safe and effective in 10 patients with psoriatic arthritis and psoriasis.
66. Salvarani C, Cantini F, Olivieri I, et al.: Efficacy of infliximab in treatment of refractory psoriatic arthritis. Ann Rheum Dis 2002, 61:309.
67. Cherouvim EP, Boki KA, Moutsopoulos HM: Efficacy of infliximab in active and refractory psoriatic arthritis. Preliminary results of an open-label study. Ann Rheum Dis 2002, 61:308.
68. Provenzano G, Termini A, Peri V, et al.: Efficacy of treatment with infliximab in psoriatic arthritis resistant to conventional DMARDs therapy. Ann Rheum Dis 2002, 61:308-309.
69. Feletar MH, Brockbank JE, Schentag CT, et al.: Treatment of recalcitrant psoriatic arthritis patients with infliximab-a 12 month observational study of 16 patients (abst SY15). American College of Rheumatology 66th Annual Scientific Meeting, 2002.
70. Brandt J, Haibel H, Reddig J, et al.: Successful short term treatment of severe undifferentiated spondyloarthropathy with the anti-tumor necrosis factor-alpha monoclonal antibody infliximab. J Rheumatol 2002, 29:118-122.
71. Mikuls TR, Moreland LW: TNF blockade in the treatment of rheumatoid arthritis: infliximab versus etanercept. Exp Opin Pharmacother 2001, 2:75-84.
72. Keane J, Gershon S, Wise RP, et al.: Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001, 345:1098-1104. This study underscores the importance of surveillance for opportunistic infections, especially tuberculosis, with infliximab therapy.
73. Pennanen N, Lapinjoki S, Urtti A, et al.: Effect of liposomal and free bisphosphonates on the IL-1 beta, IL-6 and TNF alpha secretion from RAW 264 cells in vitro. Pharm Res 1995, 12:916-922.
74. Sansoni P, Passeri G, Fagnoni F, et al.: Inhibition of antigen-presenting cell function by alendronate in vitro. J Bone Miner Res 1995, 10:1719-1725.
75. Maksymowych WP, Lambert R, Jhangri GS, et al.: Clinical and radiological amelioration of refractory peripheral spondyloarthritis by pulse intravenous pamidronate therapy. J Rheumatol 2001, 28:144-155. This study highlights the potential immunomodulatory role of bisphosphonates.
76. Maksymowych WP, Beaudet F, Buenviaje H, et al.: Intravenous pamidronate therapy suppresses markers of articular cartilage degradation/turnover in patients with ankylosing spondylitis (AS). Arthritis Rheum 2002, 46:S433.
77. Haibel H, Brandt J, Rudwaleit M, et al.: Therapie og (sic) active ankylosing spondylitis with pamidronate. Arthritis Rheum 2001, 44:S92.
78. Munoz-Villanueva MC, Perez VC, Castro MC, et al.: Potential biological and clinical improvement of refractory ankylosing spondylitis with intravenous pamidronate therapy. Ann Rheum Dis 2002, 61:305.
79. Dumoulin C, Mehsen N, Bentaberry F, et al.: Effect of intravenous pamidronate therapy in refractory spondyloarthropathies. Results of an open study. Arthritis Rheum 2002, 46:S432.
80. Moreira AL, Sampaio EP, Zmuidzinas A, et al.: Thalidomide exerts its inhibitory action on tumor necrosis factor alpha by enhancing mRNA degradation. J Exp Med 1993, 177:1675-1680.
81. Breban M, Gombert B, Amor B, et al: Efficacy of thalidomide in the treatment of refractory ankylosing spondylitis. Arthritis Rheum 1999, 42:580-581.
82. Lee L, Lawford IR, McNeil HP: The efficacy of thalidomide in severe refractory seronegative spondylarthropathy: comment on the letter by Breban et al. Arthritis Rheum 2001, 44:2456-2458.
83. El Hassani S, Dougados M, Gombert B, et al.: Treatment of severe refractory spondyloarthropathy (SPA) with thalidomide: Results of an open study. Arthritis Rheum 1999, 42:S373.
84. Huang F, Gu J, Zhao W, et al.: Therapeutic effect and molecular targets of thalidomide in refractory ankylosing spondylitis (AS). Arthritis Rheum 2001, 44:S275.
85. Lehman T, Striegal KH, Onel KB: Thalidomide treatment for corticosteroid dependent systemic onset juvenile rheumatoid arthritis. Arthritis Rheum 2001, 44:S272.
86. Schwartz KH, Agle LMA, Lehman TJA; Thalidomide therapy of systemic onset JIA: continued success. Arthritis Rheum 2002, 46:S480-S481.
87. Rau IR: Adalimumab (a fully human anti-tumour necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials. Ann Rheum Dis 2002, 61 (suppl 2):1170-1173.
88. Den Broeder AA, Joosten LA, Saxne T, et al.: Long term anti-tumour necrosis factor alpha monotherapy in rheumatoid arthritis: effect on radiological course and prognostic value of markers of cartilage turnover and endothelial activation. Ann Rheum Dis 2002, 61:311-318.
89. Keystone E, Kavanaugh AF, Sharp J, et al.: Adalimumab (D2E7), a fully human anti-TNF-alpha monoclonal antibody, inhibits the progression of structural joint damage in patients with active RA despite concomitant methotrexate therapy. Arthritis Rheum 2002, 46:S205.
90. Barrera P, van der Maas A, van Ede AE, et al.: Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-alpha antibody compared with methotrexate in long-standing rheumatoid arthritis. Rheumatology (Oxford) 2002, 41:430-439.
91. van Riel PLC, van de Putte LBA, Rau R, et al.: Long-term treatment with adalimumab (D2E7) using background methotrexate in active rheumatoid arthritis: results of a 3 year study. Arthritis Rheum 2002, 46:S534.
92. Trinchard-Lugan I, Ho-Nguyen Q, Bilham WM, et al.: Safety, pharmacokinetics and pharmacodynamics of recombinant human tumour necrosis factor-binding protein-1 (Onercept) injected by intravenous, intramuscular and sub-cutaneous routes into healthy volunteers. Eur Cytokine Netw 2001, 12:391-398.
93. Kaltwasser P, Nash P, Gladman D, et al.: Efficacy and safety of leflunomide in the treatment of psoriatic arthritis: results from the TOPAS study (abst LB04). American College of Rheumatology 66th Annual Scientific Meeting, 2002. This placebo-controlled, double-masked study identifies leflunomide as an effective and well-tolerated treatment option for patients with psoriatic arthritis and psoriasis.
94. Bloemendal A, Van Der Zee IR, Rutten VP, et al.: Experimental immunization with anti-rheumatic bacterial extract OM-89 induces T cell responses to heat shock protein (hsp)60 and hsp70; modulation of peripheral immunological tolerance as its possible mode of action in the treatment of rheumatoid arthritis (IRA). Clin Exp Immunol 1997, 110:72-78.
95. Granfors K, Marker-Hermann E, De Keyser F, et al.: The cutting edge of spondylarthropathy research in the millennium. Arthritis Rheum 2002, 46:606-613.
96. van den Berg WB: Lessons for joint destruction from animal models. Curr Opin Rheumatol 1997, 9:221-228.
97. Nuki G, Bresnihan B, Bear MB, et al.: Long-term safety and maintenance of clinical improvement following treatment with anakinra (recombinant human IL-1 receptor antagonist) in patients with rheumatoid arthritis: Extension phase of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002, 46:2838-2846.
98. Nishimoto N, Yoshizaki K, Miyasaka N, et al.: A multi-center, randomized, double-blind, placebo-controlled trial of humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody (MRA) in rheumatoid arthritis. Arthritis Rheum 2002, 46;S559.
99. Grool TA, van Dullemen H, Meenan J, et al.: Anti-inflammatory effect of interleukin-10 in rabbit immune complex- induced colitis. Scand J Gastroenterol 1998, 33:754-758.
100. Steidler L, Hans W, Schotte L, et al.: Treatment of murine colitis by Lactococcus lactis secreting interleukin-10. Science 2000, 289:1352-1355.
101. van Deventer SJ, Elson CO, Fedorak IRN: Multiple doses of intravenous interreukin 10 in steroid-refractory Crohn's disease. Crohn's Disease Study Group. Gastroenterology 1997, 113:383-389.
102. Edwards JCW, Szczepanski L, Szechinski J, et al.: Efficacy and safety of rituximab, a B-cell targeted chimeric monoclonal antibody: a randomized, pracebo-controlled trial in patients with rheumatoid arthritis. Arthritis Rheum 2002, 46:S197.
103. Moreland L, Alten IR, Leon M, et al.: A multi-center, randomized, double-blind, placebo controlled study to evaluate the safety and preliminary clinical activity of multiple doses of CTLA41g and LEA29Y administered intravenously to subjects with rheumatoid arthritis. Arthritis Rheum 2001, 44:S274.
104. Weinblatt M, Schiff M, Goldman M, et al.: A pilot, multi-center, randomized, double-blind, placebo controlled of a co-stimulation blocker CTLA41g (2 mg/kg) given monthly in combination with etanercept in active rheumatoid arthritis. Arthritis Rheum 2002, 46:S204.
105. Kremer J, Westhovens IR, Leon M, et al.: A phase 2B multi-center, randomized, double-blind, placebo controlled study to evaluate the safety and efficacy of two different doses of CTLA41g administered intravenously to subjects with active rheumatoid arthritis while receiving methotrexate. Arthritis Rheum 2002, 46:S203.
106. Ellis CN, Krueger GG: Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med 2001, 345:248-255.
107. Krueger G, Vaishnaw AK: 987 alefacept (human LFA-3/IgG1 fusion protein) is non-immunogenic in two randomized, placebo-controlled phase III trials for chronic plaque psoriasis. J Allergy Clin Immunol 2002, 109:S320.
108. Dinant HJ, van Kuijk AWIR, Goedkoop AY, et al.: Alefacept (LFA3-IgG1 fusion protein, LFA3TIP) reduces synovial inflammatory infiltrate and improves outcome in psoriatic arthritis. Arthritis Rheum 2001, 44:S91.
109. Gottlieb AB, Vaishnaw AK: Alefacept (Amevive) does not blunt primary or secondary immune responses. Arthritis Rheum 2001, 44:S91.
110. Gottlieb AB, Krueger JG, Wittkowski K, et al.: Psoriasis as a model for T-cell-mediated disease: immunobiologic and clinical effects of treatment with multiple doses of Efalizumab, an anti-CD11a antibody. Arch Dermatol 2002, 138:591-600.
111. Utset TO, Auger JA, Peace D, et al.: Modified anti-CD3 therapy in psoriatic arthritis: a phase I/II clinical trial. J Rheumatol 2002, 29:1907-1913.
112. Yacyshyn BR, Bowen-Yacyshyn MB, Jewell L, et al.: A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease. Gastroenterology 1998, 114:1133-1142.
113. Bennett CF, Condon TP, Grimm S, et al.: Inhibition of endothelial cell adhesion molecule expression with antisense oligonucleotides. J Immunol 1994, 152:3530-3540.
114. Bernstein CN, Sargent M, Gallatin WM: β2 integrin/ICAM expression in Crohn's disease. Clin Immunol Immunopathol 1998, 86:147-160.