Thalidomide: A remarkable comeback

Expert Opinion on Pharmacotherapy

Volumn 1, Issue 4, 2000, Pages 849-863

  Jacobson, Jeffrey M ^a  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Anti angiogenesis; Aphthous ulcers; HIV; Immunomodiilation; Leprosy; Neoplasm; Sedative; Thalidomide; Tnf a

Indexed keywords

ANGIOGENESIS INHIBITOR; IMMUNOSUPPRESSIVE AGENT; THALIDOMIDE;

ANIMAL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; NEOPLASM; REVIEW;

ANGIOGENESIS INHIBITORS; ANIMALS; HIV INFECTIONS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; NEOPLASMS; THALIDOMIDE;

EID: 0034189370     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.1.4.849     Document Type: Article

References (101)

1. TSENG S, PAK G, WASHENIK K et al.: Rediscovering thalidomidc: a review of its mechanism of action, side effects and potential uses. / Am. Acad. Dermatol. (1996) 35:969-979.
2. ERIKSSON T, BJORKMAN S, ROTH B et al.: Hydroxylated metabolites of thalidomidc: formation in vitro and in vivo In man./ Pbann. Pbannacol. (1998) 50:1409-1416.
3. MCFADYEN RE: Thalidomide in America: a brush with tragedy. Clio Medica. (1976) ll(2):79-93-
4. LENZ W: Thalidomide and congenital abnormalities. Lancet (.1962) 1:45. • The first report of thalidomide's teratogenicity.
5. EISEN T, BOSHPFF C, VAUGHAN MM et al.: Anti-angiogenlc treatment of metastatic melanoma, renal cell, ovarian and breast cancers with thalidomidc: a Phase II study. Proceedings of ASCO, (1998) 17:44la. Abstract 1699.
6. LASAGNA L: Congress, the PDA and new drug development: before and after 1962. Persp. Biol. Med. (1989) 32(3):322-343-
7. SHESKIN J: Thalidomide in the treatment of lepra reactions. Clin. Pbarmacol. Tber. (1965) 6:303-306. • The first report of thalidomide's clinical potential as an immunomodulator.
8. SAMPAIO EP, SARNO EN, GALILLY R et al: Thalidomidc selectively inhibits tumour necrosis factor a production by stimulated human monocytes. J. Exp. Med. (1991) 173:699-703. • A study that reported thalidomide's anti-TNF-ct effect.
9. PETERSON PK, HU S, SHENG WS et al.: Thalidomidc inhibits tumour necrosis factor-alpha production by lipopolysaccharide- and lipoarabinomannanstimulatcd human microglial cells./ Infect. Dis. (1995) 172:1137-1140.
10. MAKONKAWKEYOON S, LIMSON-POBRE RNR, MOREIRA AL, SCHAUFV, KAPLAN G : Thalidomidc inhibits replication of human immunodeficiency virus Type 1. Proc. Natl. Acad. Sei. USA (1993) 90:5974-5978.
11. SAMPAIO EP, MORIERIA AL, SARNO EN et al: Prolonged treatment with recombinant intcrfcroii y induces erythema nodosum leprosum in lepromatous leprosy patients./ Exp. Med. (1992) 175:1729-1737.
12. TRAMONTANA JM, UTAIPAT U, MOOLOY A et al: Thalidomidc treatment reduces tumour necrosis factor a production and enhances weight gain in patients with pulmonary tuberculosis. Mol. Med. (1995) 1:384-397.
13. SAMPAIO EP, KAPLAN G, MIRANDA A et al: The influence of thalidomidc on the clinical and immunologie manifestation of erythma nodosum leprosum./ Infect. Dis. (1993) 168:408-14.
14. KLAUSNER JD, MAKONKAWKEYOON S, AKARASEWI P et al: The effect of thalidomide on the pathogenesis of human immunodeficiency virus Type 1 and M. tuberculosis infection. / Acquir. Immune Defic. Syndr. Hum. Retroviml. (1996) 11:247-257.
15. SHIBATA Y, SASAKI H, HASHIMOTO Y, IWASAKI S: Tumor necrosis factor-a production enhancers with a phenylphthalimide skeleton. Biochem Biopbys Res. Commun. (1994) 205:1992-1997.
16. D'AMATO RJ, LOUGHMAN MS, FLYNN E et al: Thalidomide is an inhibitor of angiogenesis. Proc. Natl. Acad. Sei. USA (1994) 91:4082-4085. • A study reporting thalidomide's anti-angiogene activity.
17. BAUER KS, DIXON SC, FIGG WD: Inhibition of angiogenesis by thalidomidc requires metabolic activation, which is species-dependent. Biochem. Pbarmacol. (1998) 55:1827-1834.
18. MORIERA AL, SAMPAIO EP, ZMUIDZINAS A et al: Thalidomide exerts its inhibitory action on inhibits tumour necrosis factor a by enhancing mRNA degradation./ Exp. Med. (1993) 177:1675-1680. • A study that reported thalidomide's mechanism of TNF-a inhibition.
19. JACOBSON JM, GREENSPAN JS, SPRITZLER J et al: Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. M Engl.JMed. (1997) 336:1487-1493. • A study definitively establishing thalidomide's effectiveness in treating oral aphthous ulcers in HIV-infected patients. It showed no systemic anti-TNF-a effect of thalidomide and an enhancing effect of thalidomide on HIV viraemia.
20. JACODSON JM, SPRITZLER J, FOX L: Thalidomide for the treatment of csophageal aphthous ulcers in patients with human immunodeficiency virus infection. J. Infect. Dis. (1999) 180(l);6l-67. • Report of a study establishing thalidomide's effectiveness in treating oesophageal aphthous ulcers in HIV-infected patients.
21. MCHUGH SM, RIFKIN IR, DEIGHTON J et al.: The immunosuppressivc drug thalidomide induces T helper cell Type 2 (Th2> and concomitantly inhibits Thl cytokine production la mitogen- and antigenstimulated human peripheral blood tnononuclear cell cultures. Clin. Exp. Immunol. (1995) 99:160-167.
22. HASLETT PA, CORRAL LG, ALVERT M, KAPLAN G: Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production and cytotoxic responses in the CD8+ subset/ Exp. Med. (1998) 187:1885-1892.
23. HASLETT P, HEMPSTEAD M, SE1DMAN C et ai..- The metabolic and immunologie effects of short-term thalidomide treatment of patients infected with the human immunodeficiency virus. AIDS Res. Hum. Retroviruses. (1997) 13:1047-1054.
24. SHANNON EJ, SANDOVAL F: Thalidomide increases the synthesis of 1L-2 in cultures of human mononuclear cells stimulated with Concanavalin-A, staphylococcal cntcrotoxin A and purified protein derivative. Immunopbannacology (1995) 31:109-116.
25. MOLLER DR, WYSOCKA M, GREENLEE BM et al.-. Inhibition of IL-12 production by thalidomide. / Immunol. (1997) 159:5157-5161.
26. FAURE M, THIVOLET J, GAUCHERAND M: Inhibition of PMN leukocytes chtmotaxis by thalidomide. Arch. Dermatol. Res. (1980) 269:275-280.
27. ZWINGENBERGER K, WENDT S: Inununomodulation by thalidomide: systematic review of the literature and of unpublished observations. J. Inflamm. (1995-96) 46:177-211. • A good review of thalidomide's immunomodulation activities.
28. NOGUEIRA AC, GRAFE M, NEUBERT R: Effect of thalidomide and some derivatives on the adhesion of lymphocytes to endothelial cells. Naunyn-Scbmiedebergs Arch Pbannacol. (1995) 35KSuppl.):R130.
29. GEITZ H, HANDT S, ZWINGENBERGER K: Thalidomide selectively modulates the density of cell surface molecules involved in the adhesion cascade. Immunopbarmacology(.l996') 31:213-221.
30. SCHEFFLER MR, COLBURN W, KOOK KA et ah Thalidomide does not alter estrogen-progesterone hormone single dose pharmacoklnctics. Clin. Pbannacol. Tber. (1999) 65:597-602.
31. CHEN TL, VOGELSANG GB, PETTY BG et al.-. Plasma pharmacokinetics and urinary excretion of thalidomide after oral dosing in healthy male volunteers. Drug Metab. Dispos. (1989) 17:402-405.
32. NOORMOHAMED F, YOULE MS, HIGGS CJ etal.: Pharmacokinctics and hemodynamic effects of single oral doses of thalidomidc in asymptomatic human immunodeficiency virus-infected subjects. AIDS Res. Hum. Retroviruses (1999) 15:1047-1052.
33. TRAPNELL CD, DONAUE SR, COLLINS JM et al.-. Thalidomidc does not alter the pharmacokinetics of cthinyl estradiol and norethindronc. Clin. Phannacol. Tber. (1998) 64:597-602.
34. PISCITEIXI SC, FIGG WD, HAHN B et al: Single dose pharmacokinetics of thalidomide in human immunodeficiency virus-infected patients. Antimicrob. Agents Cbemother. 1997 41:2797-2799.
35. FIGG \VD, RAJE S, BAUER KS et al.-. Pharmacokinetics of thalidomide in an elderly prostate cancer population. J. Pbarm. Sei. (1999) 88:121-125.
36. ERIKKSON T, BJORKMAN S, ROTH B et al.: Enantiomers of thalidomide: blood distribution and the influence of serum albumin on chiral inversion and hydrolysis. Cbirality(\998) 10:223-228.
37. SCHULER U, EHNINGER G: Thalidomide: rationale for renewed use in immunological disorders. Dnig. Saf. (1995) 12:364-369.
38. GORDON GB, SPIELBERG SP, BLAKE DA et al.: Thalidomide teratogenesis: evidence for a toxic arene oxide metabolite. Proc. Natl. Acad. Sei. USA (1981) 78:2545-2548.
39. GUNZLER V: Thalidomide in human immunodeficiency virus (HIV) patients. A review of safety considerations. Drug Saf. (1992) 7:116-134. • A good thalidomide review.
40. BHARGAVA P, MAL KULDEEP C, MATHUR NK: Erythema nodosum leprosum in subgroups of lepromatous leprosy. Lepr. Rev. (1998) 68:373-385.
41. MEYERSON MS: Erythema nodosum leprosum. Int. J. Dermatol. (1996) 35:389-392.
42. WILLCOX ML: The impact of multiple drug therapy on leprosy disabilities. Lepr. Rev. (1997) 68:350-366.
43. PARTIDA-SANCHEZ S, FAVILA-CASTILLO L, PEDRAZASANCHEZ S et al: IgG antibody subclasses, tumour necrosis factor and IFN-y levels in patients with Type U lepra reaction on thalidomide treatment. Int. Arch. Allergy Immunol. (1998) 116:60-66.
44. SHESKIN J, CONVTT J: Results of a double blind study of the influence of thalidomide on the lepra reaction. Int. J. Lept. Other Mycobact. Dis. (1969) 37:135-146. • Report of a controlled study establisliing thalidomide's effectiveness in treating ENL.
45. IYER CG, LANGUILLON J, RAMANUJAM K et al: WHO co-ordinated short-term double-blind trial with thalidomidc hi the treatment of acute lepra reactions in male lepromatous patients. Bull. World Health Organ. (1971) 45:719-732.
46. CELGENE (WARREN NJ): Thalidomide® (thalidomide) capsules prescribing information (1998).
47. SARNO EN, GRAU GE, VIEIRA LMM, NERY JA: Serum levels of tumour necrosis factor-alpha and intcrleukin I during leprosy reactional states. Clin. Exp. Immunol. (1991) 84:103-108.
48. YOULE M, CLARBOUR J, FARTHING C et al- Treatment of resistant aphthous ulcération with thalidomide in patients positive for HIV antibody. Br. Med. J. (1989) 298:432.
49. GORIN I, VILETTEB,GEHANNOP,ESCANDEJP: Thalidomide in hyperalgic pharyngeal ulcération of AIDS. Lancet (1990) 335:1343.
50. GEORGHIOU PR, KEMP RJ: HIV-associated esophageal ulcers treated with thalidomide. Med. J. Aitst. (1990) 152:382-383.
51. PATERSON DL, GEORGHIOU PR, ALLWORTH AM, KEMP RJ: Thalidomide as treatment of refractory aphthous ulcération related to human immunodeficiency virus infection. Clin Infect Dis. (1995) 20:250-254.
52. MASCARO JM, LECHA M, TORRAS H: Thalidomide in the treatment of recurrent, necrotic and giant mucocutaneous aphthae and aphthosis. Arch. Dennatol. (1979) 115:636-637.
53. JENKINS JS, POWELL RJ, ALLEN BR et al.: Thalidomide in severe orogcnital ulcération. LancetW&i) 2:1424-1426.
54. GRINSPAN D: Significant response of oral aphthosis to thalidomide treatment. J. Am. Acad. Dennatol. (1985) 12:85-90.
55. REVUZ J, GUILLAUME J-C, JANIER M et al.: Crossover study of thalidomide vs. placebo in severe recurrent aphthous stomatitis. Arch. Dennatol. (1990) 126:923-927.
56. HAMURYUDAN V, MAT CEM, SAIP SEBAHATTAIN et al: Thalidomide in the treatment of the mucocutaneous lesions of the Behcet syndrome - a randomized, double-blind, placebo-controlled trial. Ann. Intern. Med. (1998) 128:443-450.
57. JORIZZO JL, SCHMALSTIEG FC, SOLOMON AR, JR. et ah Thalidomide effects in Behcet's syndrome and pustular vasculitis. Arch. Intern. Med. (1986) 146:878-881.
58. GRUNFELD C, FEINGOLD KR: Metabolic disturbances and wasting in the acquired Immunodeficiency syndrome. N. Engl.J. Med. (1992) 327:329-337.
59. REYES-TERAN G, SIERRA-MADERO JG et al.: Effects if thalidomide on HIV-associatcd wasting syndrome: a randomized, double-blind, placebo-controlled clinical trial. ,4/05(1996) 10:1501-1507.
60. KAPLAN G, SCHAMBELAN M, GOTTLIEB M et al.: Thalidomide reverses cachexia in HIV-wasting syndrome. 5th Conférence on Retroiintses and Opportunistic Infections. Chicago, USA (1998). Abstract 476.
61. SHARPSTONE DR, ROWBOTTOM AW, NELSON NM, GAZZARD B: The treatment of microsporidial diarrhea with thalidomide. AIDS (1995) 9:658-659.
62. QUINONES F, SIERRA-MADERO J, CALVA-MERCADO JJ, RUIZ-PALACIOS GM: Thalidomide in patients with HIV infection and chronic diarrhoea: double blind placebo controlled clinical trial. 4th Conference on Retroviruses and Opportunistic Infections. Wasliington, DC, USA (1997). Abstract 682.
63. KAPLAN G, FREEDMAN VH: The role of cytoklnes in the immune response to tuberculosis. Res. Immnnol. (1996) 147:565-572.
64. KAPLAN G: Thalidomidc treatment reduces TNF-α production and enhances weight gain in patients with pulmonary tuberculosis. J. Cell. Biochem. (1995) 57(Suppl. 19B):6l. Abstract B3-018.
65. SAURAT JH, CAMENZIND M, HELG C, CHAPUIS B: Thalidomidc for graft-rerstts-host disease after bone marrow transplantation [letter], lancet. (1988) 1:359.
66. LIM SH, MCWHANNELL A. VORA AJ, BOUGHTON BJ: Successful treatment with thalidomide of acute graft-persus-host disease after bone-marrow transplantation [letter]. Lancet. (1988) 1:117.
67. HENEY D, NORFOLK DR, WHEELDON J et ah Thalidomidc treatment for chronic graft-rer.SMS-host disease. Br.J. Haematol. (1991) 78:23-27.
68. VOGELSANG GB, FARMER ER, HESS AD et al.: Thalidomidc for the treatment of chronic graft-fersMS-host disease. N. Engl.J. Med. (1992) 326:1055-1058. • An uncontrolled study reporting thalidomide's effectiveness in treating chronic GVHD.
69. CHAO NJ, PARKER PM, NILAN JC etal.: Paradoxical effect of thalidomide prophylaxis on chronic graft-fersus-host disease. Biol. Blood Marrow Transplant. (1996) 2:86-92.
70. VAN DEN BROEK H: Treatment of prurigo nodularis with thalidomide. Arch. Dcrmatol. (1980) 116:571-572.
71. FERRANDIZ C, CARRASCOSAJM, JUST M étal: Sequential combined therapy with thalidomide and narrow-band (TL01) UVB in the treatment of prurigo nodularis. Dermatology (1997) 195:359-361.
72. SHESKIN J: Zur thérapie der prurigo nodularis hyde mit thalidomid. Der Hautarzt. (1975) 26:215-217.
73. WINKELMANN RK, CONNOLLY SM, DOYLE JA, PADILHAGONCALVES A: Thalidomide treatment of prurigo nodularis. Acta. Derm. Venereal. (1984) 64:412-417.
74. JOHNKE H, ZACHARIAE H: Thalidomide treatment of prurigo nodularis. UgeskrLaeger. (1993) 155:3028-3030.
75. KNOP J, BONSMANN G, HAPPLE R et al.: Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus. Br.J. Rbeumatol. (1983) 108:461-466.
76. STEVENS RJ, ANDUJAR C, EDWARDS CJ et al.: Thalidomidc in the treatment of the cutaneous manifestations of lupus erythematosus: experience in sixteen consecutive patients. Br.J. Rbeumatol. (1997) 36:353-359.
77. GUTIERREZ-RODRIGUEZ O, STARUSTA-BACAL P, GUTIERREZ-MONTES O: Treatment of rheumatoid arthritis - the thalidomide experience. / Rbeumatol. (1989) 16:158-163.
78. KEESAL N, WASSERMAN MJ, BOOKMAN A et ah Thalidomide in the treatment of refractory rheumatoid arthritis./ Rbeumatol. (1999) 26(11):2344-2347.
79. STAMBE C, WICKS IP: TNF-alpha and response of treatment-resistant adult-onset Still's disease to thalidomide. Lancet (1998) 352:544-545.
80. BREBAN M, GOMBERT B, AMOR B, DOUGADOS M: Efficacy of thalidomide in the treatment of refractory ankylosing spondylitis. Arthritis Rheum. (1999) 42(3):580-581.
81. EHRENPREIS ED, KAIS SV, COHEN LB, COHEN RD AND HAMMER SB: Thalidomide Therapy for Patients With Refractory Crohn's Disease: An Open-Label Trial. Gastmenterology (1999) 117:1271-77.
82. VASILIAUKIS EA, KAM LY, ABREU-MARTIN MT et al.: An Open-Label Pilot Study of Low Dose Thalidomide in Chronically Active, Steroid-Dependent Crohn's Disease. Gastroenterology (1999) 117:1278-87.
83. ROUSSEAU L, BEYLOT-BARRY M, DOUTRE MS et al.: Cutaneous sarcoidosis successfully treated with low doses of thalidomide. Arch. Dermatol. (1998) 134:1045-1046.
84. WATERS MF, LAING AB, AMBIKAPATHY A et al.: Treatment of ulcerative colitis with thalidomide. Br. Med.J. (1979) 1:792.
85. SOLER RA, HOWARD M, BRINK NS et al.: Regression of AIDS-related Kaposi's sarcoma during therapy -with thalidomide. Clin. Infect. Dis. (1996) 23:501-503.
86. WELLER L, LITTLE R, QYVILL K et ah Preliminary results of Phase II study of oral thalidomide hi patients with HIV infection and Kaposis's sarcoma (KS). J. Acquir. Immune Defic. Synd. Hum. Retrovirol. (1997) 14:A21. Abstract 20.
87. BOWER M, HOWARD M.GRACIE F et al: A Phase H study of thalidomide for Kaposi's sarcoma: activity and correlation with KSHV DNA load. / Acquir. Immune Deflc. Synd. Hum. Retrovirol. (1997) l4iA35. Abstract 76.
88. SEEMA SINGHAL, MEHTA J, DESIKAN R et al.: Antitumor activity of thalidomide in refractory multiple myeloma. N. Engl.J. Med. (1999) 341:1565-1571.' • A report of an uncontrolled study showing thalidomide's activity in the therapy of treatment-resistant multiple myeloma.
89. NGUYEN M, TRAN C, BARKY S et al.: Thalidomide and chemotherapy combination: preliminary results of preclinical and clinical studies. Int. J. Oncol. (1997) 10:965-969.
90. SMITHELLS RW, NEWMAN CG: Recognition of thalidomide defects./ Med. Genet. (1992) 29:716-723.
91. VANCHIERI C: Preparing for thalidomide's comeback. Ann. Intent. Med. (1997) 127:951-952.
92. CLEMMENSEN OJ, OLSEN PZ, ANDERSEN KE: Thalidomide neurotoxicity. Arch. Dermatol. (1984) 120:338-341.
93. WULFF CH, HOYER H, ASBOE-HANSEN G et al.: Development of polyrieuropathy during thalidomide therapy. Br.}. Dermatol. (1985) 112:475-480.
94. OCHONISKT S, VERROUST J, BASTUJI-GARIN S et al: Thalidomide neuropathy incidence and clinicoclectrophysiologic findings in 42 patients. Arch. Dermatol. (1994) 130:66-69.
95. ARONSON IK, YU R, WEST DP et al.: Thalidomide-induccd peripheral neuropathy. Arch. Dermatol. (1984) 120:1466-1470.
96. CALABRESE L, RESZTAK K: Thalidomide revisited: pharmacology and clinical applications. Exp. Opin. Invest. Drugs. (1998) 7(12):2043-2060.
97. FULLERTON PM, O'SULLIVAN DJ: Thalidomlde neuropathy: a clinical, electrophysiological and histological follow-up study. J. Neural. Neurosurg. Psy. (1968) 31:543.
98. BONNETHLANE JM, ROYER C, BEDANE C: Thalidomide and recurrent aphthous stomatitis: a follow-up study. Dermatology(1996) 193:321-323.
99. HASLETT P, TRAMONTANA J, BURROUGHS M et al.: Adverse reactions to thalidomide in patients infected with human immunodeficiency virus. Clin. Infect. Dis. (1997) 24:1223-1227.
100. GARDNER-MEDWIN JMM, SMITH NJ, POWELL RJ: Clinical experience with thalidomide in the management of severe oral and genital ulcération in conditions such as Bchcct's disease: use of neurophysiological studies to detect thalidomide neuropathy. Ann. Rheum. Dis. (1994) 53:828-832.
101. ZELDISJB, WILLIAMS BA, THOAMS SD et ai: S.T.E.P.S. ®: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther. (1999) 21:319-330.