Initial experience combining methotrexate with biologic agents for treating rheumatoid arthritis

Journal of Rheumatology

Volumn 23, Issue SUPPL. 44, 1996, Pages 78-83

  Moreland, Larry W ^a,b,c  

^a University of Alabama at Birmingham   (United States)

^b Arthr Clinical Intervention Program   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

Biologics; Combination therapy; Methotrexate; Rheumatoid arthritis; Treatment

Indexed keywords

AZATHIOPRINE; METHOTREXATE; MONOCLONAL ANTIBODY; OKT 4; PREDNISONE; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT; CD4 ANTIGEN;

CLINICAL TRIAL; CONFERENCE PAPER; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; IMMUNOLOGY; IMMUNOTHERAPY; REVIEW;

ANTIBODIES, MONOCLONAL; ANTIGENS, CD4; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; HUMANS; IMMUNOTHERAPY; METHOTREXATE;

EID: 0030090091     PISSN: 0315162X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (74)

1. Moreland LW, Bucy RP, Tilden A, et al Use of a chimeric monoclonal anti-CD4 antibody in patients with refractory rheumatoid arthritis. Arthritis Rheum 1993;36:307-18.
2. Pratt PW, Bucy RP, Moreland LW, Koopman WJ. Thymic processing appears to contibute to repopulation of CD4 lymphocytes after depletion with chimeric CD4 antibody in refractory rheumatoid arthritis (abstr) Arthritis Rheum 1992;(suppl)35 S-105
3. Moreland LW, Pratt PW, Bucy P, Jackson B, Feldman J, Koopman WJ: Clinical status of rheumatoid arthritis patients 18 months after treatment with chimeric anti-CD4 antibody. Arthritis Rheum 1994;37:834-8.
4. Van Boxel JA, Paget SA: Predominantly T-cell infiltrate in rheumatoid synovial membrane N Engl J Med 1975;293 517-20.
5. Burmester GR, Yu DTY, Irani AM, Kunkel HG, Winchester RJ: Ia+ T-cells in synovial fluid and tissue of patients with rheumatoid arthritis Arthritis Rheum 1986;24:1370-6.
6. Stastny P: Association of the B-cell alloantigen DRw4 with rheumatoid arthritis. N Engl J Med 1978;298:869-71.
7. Schiff B, Mizrachi Y, Orgad S, Yaron M, Gaxit E: Association of HLA-A231 and HLA-DR1 with adult rheumatoid arthritis. Ann Rheum Dis 1982;41:403-4.
8. Gregersen PK, Silver J, Winchester RJ: The shared epitope hypothesis. An approach to understanding the molecular genetics of susceptibility to rheumatoid arthritis Arthritis Rheum 1987;30:1205-13.
9. Nepom GT, Byers P, Seyfried C, et al: HLA genes associated with rheumatoid arthritis Arthrins Rheum 1989;32:14-21
10. Weyand CM, Hicok KC, Conn DL, Goronzy JJ: The influence of HLA-DRB1 genes on disease severity in rheumatoid arthritis. Ann Intern Med 1992;117:501-6.
11. Calabrese LH, Wilske WS, Parkins AD, Tubbs RR. Rheumatoid arthritis complicated by infection with human immunodeficiency virus and the development of Sjogren's syndrome Arthritis Rheum 1989;32 1453-7.
12. Paulus HE, Machleder HI, Levine S, Yu DTY, MacDonald NS. Lymphocyte involvement in rheumatoid arthritis: Studies during thoracic duct drainage. Arthritis Rheum 1977;20:1249-62
13. Strober S, Tanary A, Field E, et al: Efficacy of total lymphoid irradiation in intractable rheumatoid arthritis: A double-blind, randomized trial. Ann Intern Med 1985;102:441-9.
14. Tugwell P, Bombardier C, Gent M, et al: Low-dose cyclosporine versus placebo in patients with rheumatoid arthritis. Lancet 1990;335:1051-5.
15. Stein CM, Pincus, T, Brooks RH, et al: Combination therapy with cyctosporine and methotrexate: Results of a 24 week extension study subsequent to a 24 week double-blind study (abstr) Arthritis Rheum 1994;(suppl)37:S252.
16. Bensen W, Tugwell P, Roberts RM, et al: Combination therapy of cyclosporine with methotrexate and gold in rheumatoid arthritis (2 pilot studies) J Rheumatol 1994;21:2034-8.
17. Ranges GE, Sriram S, Cooper SM: Prevention of type II collagen-induced arthritis by in vivo treatment with anti-L3T4. J Exp Med 1985;162:1105-10.
18. Wofsy D, Seaman WE: Reversal of advanced murine lupus in NZB/NZW F1 mice by treatment with monoclonal antibody to L3T4. J Immunol 1987;138:3247-53.
19. Christadoss P, Dauphinee MJ: Immunotherapy for myasthenia gravis: A murine model. J Immunol 1986;136:2437-40.
20. Waldor MK, Sriram S, Hardy R, et al: Reversal of experimental allergic encephalomyelitis with monoclonal antibody to a T-cell subset marker. Science 1985;22:415-7.
21. Koike T, Itoh Y, Ishii T, et al: Preventive effect of monoclonal anti-L3T4 antibody on development of diabetes in NOD mice Diabetes 1987;36:539-41.
22. Herzog C, Walker C, Pichler W, et al: Monoclonal anti-CD4 in arthritis. Lancet 1987;2:1461-2.
23. Wendling D, Wijdenes J, Racadot E, Morel-Fourrier B: Therapeutic use of monoclonal anti-CD4 antibody in rheumatoid arthritis. J Rheumatol 1991;18:325-7.
24. Rieter C, Kakavand B, Rieber EP, Schattenkirchner M, Riethmuller G, Kruger K: Treatment of rheumatoid arthritis with monoclonal CD4 antibody M-T151. Clinical results and immunopharmacologic effects in an open study, including repeated administration. Arthritis Rheum 1991;24:525-36.
25. Horneff G, Burmester GR, Emminch F, Kalden JR: Treatment of rheumatoid arthritis with an anti-CD4 monoclonal antibody. Arthritis Rheum 1991;34:129-40.
26. Herzog C, Walker C, Muller W, et al: Anti CD4 treatment of patients with rheumatoid arthritis I Effect on clinical course and circulating T-cells J Autoimmun 1989;2:627-42.
27. Horneff G, Winkler T, Kalden JR, Emmrich F, Burmester GR: Human anti-mouse antibody response induced by anti-CD4 monoclonal antibody therapy in patients with rheumatoid arthritis. Clin Immunol Immunopathol 1991;59:89-103.
28. Goldberg D, Morel P, Chatenoud L, et al: Immunological effects of high dose administration of anti-CD4 antibody in rheumatoid arthritis patients. J Autoimmun 1991;4:617-30.
29. Sperling RI, Benincaso AI, Anderson RJ, Coblyn JS, Austen F, Weinblatt ME: Acute and chronic suppression of leukotriene B4 synthesis ex viva in neutrophils from patients with rheumatoid arthritis beginning treatment with methotrexate. Arthritis Rheum 1992;35:376-84.
30. Cronstein BN, Eberle MA, Gruber HE, Levin RI: Methotrexate inhibits neutrophil function by stimulating adenosine release from connective tissue cells. Proc Nat Acad Sci USA 1991;88:2441-5.
31. Chang D-M, Baptiste P, Schur PH: The effect of antirheumatic drugs on interleukin-1 (IL-1) activity and IL-1 and IL-1 inhibitor production by human monocytes. J Rheumatol 1990;17:1148-57.
32. Alarcón GS, Schroehnloher RE, Bartolucci AA, Ward JR, Williams HJ, Koopman WJ: Suppression of rheumatoid factor production by methotrexate in patients with rheumatoid arthritis. Evidence for differential influences of therapy and clinical status on IgM and IgA rheumatoid factor expression. Arthritis Rheum 1990;33:1156-61
33. Segal R, Yaron M, Tartakovsky B: Methotrexate: Mechanism of action in rheumatoid arthritis. Semin Arthritis Rheum 1990;20:190-9.
34. Gibbons JJ Jr, Lucas J: Immunomodulation by low dose methotrexate. I. Methotrexate selectively inhibits Lyt-2+ cells in murine acute graft-versus-host reactions J Immunol 1989;142:1867-73.
35. Olsen NJ, Murray LM: Antiproliferative effects of methotrexate on peripheral blood mononuclear cells. Arthritis Rheum 1989;32:375-8.
36. Calabrese LH, Taylor JV, Wilke WS, Segal AM, Valenzuela R, Clough JD: Response of immunoregulatory lymphocyte subsets to methotrexate in rheumatoid arthritis Cleve Clin J Med 1990;57:232-41.
37. Rosenthal GJ, Germolec DR, Lamm KR, Ackermann MF, Luster MI: Comparative effects on the immune system of methotrexate and trimetrexate. Int J Immunopharmacol 1987;9:793-801.
38. Seitz M, Dewald B, Ceska M, Gerber N, Baggiolini M: Interleukin-8 in inflammatory rheumatic disease: Synovial fluid levels, relation to rheumatoid factors, production by mononuclear cells, and effects of gold sodium thiomalate and methotrexate. Rheumatol Int 1992;12:159-64.
39. Firestein GS, Paine MM, Boyle DL: Mechanisms of methotrexate action in rheumatoid arthritis: Selective decrease in synovial collagenase gene expression. Arthritis Rheum 1994;37:193-200.
40. Asako H, Kubes P, Baethge BA, Wolf RE, Granger DN: Colchicine and methotrexate reduce leukocyte adherence and emigration in rat mesenteric venules. Inflammation 1992;16:45-56.
41. Leroux JL, Damon M, Chavis C, De Paulet AC, Blotman F: Effects of a single dose of methotrexate on 5 and 12-lipoxygenase products in patients with rheumatoid arthritis. J Rheumatol 1992;19:863-6.
42. Hirata S, Matsubara T, Saura R, Tateishi H, Hirohata K: Inhibition of in vitro vascular endothelial proliferation and in vivo neovascularization by low-dose methotrexate. Ann Rheum Dis 1989;32:1065-73
43. Tsai V, Firestein GS, Arend W, Zvaifler NJ. Cytokine induced differentiation of cultured nonadherent macrophages. Cell Immunol 1992;144:203-16.
44. O'Callaghan JW, Bretscher P, Russell AS: The effect of low dose chronic intermittent parenteral methotrexate on delayed type hypersensitivity and acute inflammation in a mouse model. J Rheumatol 1986;13:710-14.
45. Johnston CA, Russell AS, Kovithavongs T, Dasgupta M: Measures of immunologic and inflammatory responses in vitro in rheumatoid patients treated with methotrexate. J Rheumatol 1986;13:294-6.
46. Cream JJ, Pole D: The effect of methotrexate and hydroxyurea on neutrophil chemotaxis. Br J Dermatol 1993;102:557-63
47. Marhaugh G, Bratlid D, Moe PJ: Effect of methotrexate on phagocytosis and killing of staphylococcus aureus and human granulocytes. Scand J Infect Dis 1980;12:61-5.
48. Rosenthal GJ, Weigand GW, Germolec DR, Blank JA, Luster MI: Suppression of B cell function by methotrexate and trimetrexate. Evidence for inhibition by purine biosynthesis as a major mechanism of action. J Immunol 1988;141:410-6
49. Baggott JE, Morgan SL, Ha TS, Alarcon GS, Koopman WJ, Krumdieck CL: Antifolates in rheumatoid arthritis: A hypothetical mechanism of action. Clin Exp Rheumatol 1993;(suppl) 11:S101-5.
50. Connolly KM, Stecher VJ, Danis E, Pruden DJ, Labrie T: Alteration of interleukin-1 production and the acute phase response following medication of adjuvant arthritic rats with cyclosporin-A or methotrexate. Int J Immunopharmacol 1988;10:717-28.
51. Hu SK, Mitcho YL, Oronsky AL, Kerwar SS: Studies on the effect of methotrexate on macrophage function. J Rheumatol 1988;15:206-9.
52. Anderson PA, West SG, O'Dell JR, Via CS, Claypool RG, Kotzin BL: Weekly pulse methotrexate in rheumatoid arthritis: Clinical and immunologic effects in a randomized double-blind study. Ann Intern Med 1985;103:489-96.
53. Rosenthal GJ, Germolec DR, Lamon KR, Ackerman MF, Luster MI: Comparative effects on the immune system of methotrexate and trimetrexate. Int J Immunopharmacol 1987;9:793-801.
54. Lindsey JW, Hodgkinson S, Mehta R, et al: Phase I clinical trial of repeated treatment with chimeric anti-CD4 antibody in multiple sclerosis. Neurology 1994;44:413-9.
55. Moreland LW, Bucy RP, Koopman WJ: Repopulation of CD4+ T-cells in patients with rheumatoid arthritis following treatment with CM-T412. N Engl J Med 1995;332:1651-2.
56. Roberts-Thomson IC, Whittingham S, Youngchaiyud U, Mackay IR: Aging, immune response, and mortality. Lancet 1974;2:368-70.
57. Fleming AL, Field EH, Tolaymat N, Cowdery JS: Age influences recovery of systemic and mucosal immune responses following acute depletion of CD4 T-cells. Clin Immunol Immunopathol 1993;69:285-91.
58. van der Lubbe PA, Reiter C, Breedveld FC, et al: Chimeric CD4 monoclonal antibody CM-T412 as a therapeutic approach to rheumatoid arthritis. Arthritis Rheum 1993;36:1375-9.
59. Moreland LW, Pratt PW, Mayes M, et al: Double-blind, placebo controlled multicenter trial using chimeric monoclonal anti-CD4 antibody in rheumatoid arthritis patients receiving concomitant methotrexate. Arthritis Rheum 1995;38:1581-8.
60. van der Lubbe PA, Dijkmans BAC, Markusse HM, Nässander U, Breedveld FC: A randomized double-blind, placebo-controlled study of CD4 monoclonal antibody therapy in early rheumatoid arthritis. Arthritis Rheum 1995;38:1097-106.
61. Olsen NJ, Cush JJ, Lipsky PE, et al: Multicenter trial of an anti-CD5 immunoconjugate in rheumatoid arthritis (abstr). Arthritis Rheum 1994;(suppl)37:S295.
62. Isaacs JD, Watts RA, Hazleman BL, et al: Humanized monoclonal antibody therapy for rheumatoid arthritis. Lancet 1992;340:748-52.
63. Weinblatt ME, Maddison PJ, Bulpitt KJ, et al: CAMPATH-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. An intravenous dose-escalation study. Arthritis Rheum 1995;38:1589-94.
64. Connolly K, Roubinian JR, Wofsy D: Development of murine lupus in CD4 depleted NZB/NZW mice: Sustained inhibition of residual CD4+ T-cells is required to suppress autoimmunity. J Immunol 1992;149:3083-8.
65. Gutstem NL, Wofsy D: Administration of F(ab′)2 fragments of monoclonal antibody to L3T4 inhibits humoral immunity in mice without depleting L3T4+ cells. J Immunol 1986;137:3414-9.
66. Carteron NL, Wofsy D, Seaman WE: Induction of immune tolerance during administration of monoclonal antibody to L3T4 does not depend on depletion of L3T4+ cells. J Immunol 1988; 140:713-6.
67. Moreland LW, Bucy RP, Knowles RW, Wacholtz MC, Haverty TP, Koopman WJ: Treating rheumatoid arthritis with a non-depleting anti-CD4 monoclonal antibody (Mab) (abstr). J Invest Med 1995;43:362A.
68. Strand V, Lipsky PE, Cannon GW, et al: Effects of administration of an anti-CD5 plus immunoconjugate in rheumatoid arthritis. Results of two phase II studies. Arthritis Rheum 1993;36:620-30.
69. Finck BK, Linsley PS, Wofsy D: Treatment of murine lupus with CTLA4 Ig. Science 1994;265:1225-7.
70. Sander O, Herborn G, Rau R: Tumor necrosis factor alpha blockade enhances methotrexate response in patients with rheumatoid arthritis (abstr). Arthritis Rheum 1995;(suppl)38:S266.
71. Williams RO, Mason LJ, Feldman M, Maini RN: Synergy between anti-CD4 and anti-tumor necrosis factor in the amelioration of established collaged induced arthritis. Proc Nat Acad Sci USA 1994;91:2762-6.
72. Campion GV: The prospect for cytokine based therapeutic strategies in rheumatoid arthritis. Ann Rheum Dis 1994;53:485-7.
73. Van den Berg WS, Joosten LAB, Helsen MA, van Lent PLEM, Van de Lou FAJ: Cytokine profile dependent on the type of arthritis. Dominant role of IL-1 in cartilage destruction (abstr). Arthritis Rheum 1994;(suppl)37:S193.
74. Russell D, Tucker K, Kohno H, Thompson RC, Schwab J: Inhibition of tumor necrosis factor is effective alone or in combination with inhibition of interleukin-1 in reducing joint swelling in rodent bacterial cell wall-induced arthritis (abstr). Arthritis Rheum 1994;(suppl)37:S279.