Biologics in Crohn's disease: searching indicators for outcome

Bibliography

• PAPADAKIS KA, TARGAN SR: Role of cytokines in the pathogenesis of inflammatory bowel disease. Ann. Rev. Med. (2000) 51:289-298.
   PubMed Web of Science ®Google Scholar
• NEURATH MF: Mucosal immunity in Crohn's disease. Inflamm. Bowel Dis. (2004) 10(Suppl.1):29-31.
   Google Scholar
• LICHTENBERGER GS, FLAVELL RA, ALEXOPOULOU L: Innate immunity and apoptosis in IBD. Inflamm. Bowel Dis. (2004) 10(Suppl. 1):S58-S62.
   PubMed Web of Science ®Google Scholar
• NEURATH MF, FINOTTO S, FUSS I et al.: Regulation of T-cell apoptosis in inflammatory bowel disease: to die or not to die, that is the mucosal question. Trends Immunol. (2001) 22:21-26.
   PubMed Web of Science ®Google Scholar
• COHEN PS, NAKSHATRI H, DENNIS J et al.: CNI-1493 inhibits monocyte/macrophage TNF by suppression of translation efficiency. Proc. Natl. Acad. Sci. USA (1996) 93:3967-3971.
   PubMed Web of Science ®Google Scholar
• HOMMES D, VAN DEN BRINK B, PLASSE T et al.: Inhibition of stress-activated MAP kinases induces clinical improvement in moderate to severe Crohn's disease. Gastroenterology (2002) 122:7-14.
   PubMed Web of Science ®Google Scholar
• SCHREIBER S, NIKOLAUS S, HAMPE J: Activation of nuclear factor κB inflammatory bowel disease. Gut (1998) 42:477-484.
   PubMed Web of Science ®Google Scholar
• ROGLER G, BRAND K, VOGL D et al.: Nuclear factor κB is activated in macrophages and epithelial cells of inflamed intestinal mucosa. Gastroenterology (1998) 115:357-369.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, RAGAN SR: Biologic therapy of inflammatory bowel disease. Gastroenterology (2002) 122:1592-1608.
   PubMed Web of Science ®Google Scholar
• NEURATH MF: IL-23: a master regulator in Crohn disease. Nat. Med. (2007) 1:26-28.
   Google Scholar
• PORTER ME, OLMSTED TEISBERG E: Redefining healthcare. ISBN 1-59139-778-2. Harvard Business School Press, Cambridge, MA, USA (2006).
   Google Scholar
• VERMEIRE S, VAN ASSCHE G, RUTGEERTS P: Review article: altering the natural history of Crohn's disease – evidence for and against current therapies. Aliment. Pharmacol. Ther. (2007) 25:3-12.
   PubMed Web of Science ®Google Scholar
• BAERT F, NOMAN M, VERMEIRE S et al.: Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. (2003) 348:601-608.
   PubMed Web of Science ®Google Scholar
• SCALLON BJ, MOORE MA, TRINH H et al.: Chimeric anti-TNF-α monoclonal antibody cA2 binds recombinant transmembrane TNF-α and activates immune effector functions. Cytokine (1995) 7:251-259.
   PubMed Web of Science ®Google Scholar
• VAN DEN BRANDE JMH, BRAAT H, VAN DEN BRINK GR et al.: Infliximab but not etanercept induces apoptosis in lamina propria T-lymphocytes from patients with Crohn's disease. Gastroenterology (2003) 124:1774-1785.
   PubMed Web of Science ®Google Scholar
• LUGERING A, SCHMIDT M, LUGERING N et al.: Infliximab induces apoptosis in monocytes from patients with chronic active Crohn's disease by using a caspase-dependent pathway. Gastroenterology (2001) 121:1145-1157.
   PubMed Web of Science ®Google Scholar
• SHEN C, VAN ASSCHE G, COLPAERT S et al.: Adalimumab induces apoptosis of human monocytes: a comparative study with infliximab and etanercept. Aliment. Pharmacol. Ther. (2005) 21(3):251-258.
   PubMed Web of Science ®Google Scholar
• NESBITT AM, HENRY AJ: High affinity and potency of the pegylated FAB' fragment CDP870 – a direct comparison with other anti-TNF agents. Am. J. Gastroenterol. (2004) 99:S253.
   Web of Science ®Google Scholar
• FOSSATI G, NESBITT A: Effect of the anti-TNF agents, adalimumab, etanercept, infliximab, and certolizumab PEGOL (CDP870) on the induction of apoptosis in activated peripheral blood lymphocytes and monocytes. Am. J. Gastroenterol. (2005) 100(Suppl.):S298-S299.
   Google Scholar
• MUDTER J, NEURATH MF: Apoptosis of T cells and the control of inflammatory bowel disease: therapeutic implications. Gut (2007) 56:293-303.
   PubMed Web of Science ®Google Scholar
• 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(15):1029-1035.
   PubMed Web of Science ®Google Scholar
• HANAUER SB, FEAGAN BG, LICHTENSTEIN GR et al.: Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet (2002) 359:1541-1549.
   PubMed Web of Science ®Google Scholar
• HOMMES DW, BAERT F, VAN ASSCHE G et al.: The ideal management of Crohn's disease: top down versus step up strategie, a randomized controlled trial. Gastroenterology (2006) 130:A108 (Abstract).
   Google Scholar
• LICHTENSTEIN GR, FEAGAN BG, COHEN RD et al.: Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin. Gastroenterol. Hepatol. (2006) 4(5):621-630.
   PubMed Web of Science ®Google Scholar
• HANAUER SB, WAGNER CL, BALA M et al.: Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin. Gastroenterol. Hepatol. (2004) 2(7):542-553.
   PubMed Web of Science ®Google Scholar
• VERMEIRE S, NORMAN M, VAN ASSCHE G, BAERT F, D'HAENS G, RUTGEERTS PJ: The effectiveness of concomitant immunosuppressive therapy to suppress formation of antibodies to infliximab in Crohn's disease. Gut (2007) (In Press).
   Google Scholar
• GEBOES K, RUTGEERTS P, OPDENAKKER G et al.: Endoscopic and histologic evidence of persisitent mucosal healing and correlation with clinical improvement following sustained infliximab treatment for Crohn's disease. Curr. Med. Res.Opin. (2005) 21:1741-1754.
   PubMed Web of Science ®Google Scholar
• RUTGEERTS P, DIAMOND RH, BALA M et al.: Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest. Endosc. (2006) 63(3):433-442.
   PubMed Web of Science ®Google Scholar
• SCHREIBER S, RUTGEERTS P, FEDORAK RN et al.: A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology (2005) 129:807-818.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, FEAGAN BG, STOINOV S et al.: Certolizumab pegol administered subcutaneously is effective and well tolerated in patients with active Crohn's disease: results from a 26-week, placebo-controlled Phase III study (Precise 1). Gastroenterology (2006) 130:A107.
   Google Scholar
• SCHREIBER S, KHALIQ-KAREEMI M, LAWRANCE I et al.: Certolizumab pegol, a humanised anti-TNF pegylated FAb' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a Phase III study (Precise). Gut (2005) 54(Suppl. VII):A82.
   Web of Science ®Google Scholar
• HANAUER SB, SANDBORN WJ, RUTGEERTS P et al.: Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology (2006) 130:323-333.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, HANAUER SB, LUKAS M et al.: Maintenance of remission over 1 year inpatients with active Crohn's disease treated with adalimumab: results of CLASSIC II, a blinded, placebo-controlled study. Gut (2007) (In Press).
   Google Scholar
• PAPADAKIS KA, SHAYE OA, VASILAUSKAS EA et al.: Safety and efficacy of adalimumab (D2E7) in Crohn's disease patients with an attenuated response to infliximab. Am. J. Gastroenterol. (2005) 100:75-79.
   PubMed Web of Science ®Google Scholar
• SANDBORN W, HANAUER S, LUKAS M: Induction and maintenance of clinical remission and response in subjects with Crohn's disease treated during a 6-month open-label period with fully human anti-TNF-α monoclonal antibody adalimumab (humira®). Gastroenterology (2005) 128(Suppl.):A111.
   Google Scholar
• SANDBORN WJ, HANAUER S, LOFTUS EV et al.: An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn's disease. Am. J. Gastroenterol. (2004) 99:1984-1989.
   PubMed Web of Science ®Google Scholar
• COLOMBEL J, SANDBORN WJ, RUTGEERTS P et al.: Adalimumab for maintenance of clinical response in patients with Crohn's disease: the CHARM trial. Gastroenterology (2007) 1:52-56.
   Google Scholar
• FEAGAN BG, SANDBORN WJ, BAKER JP et al.: A randomized, double-blind, placebo-controlled trial of CDP571, a humanized monoclonal antibody to TNF-α, in patients with corticosteroid-dependent Crohn's disease. Aliment. Pharmacol. Ther. (2005) 21:373-384.
   PubMed Web of Science ®Google Scholar
• STACK WA, MANN SD, ROY AJ et al.: Randomised controlled trial of CDP571 antibody to TNF-α in Crohn's disease. Lancet (1997) 349:521-524.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, FEAGAN B, RADFORD-SMITH G et al.: CDP571, a humanised monoclonal antibody to TNF-a alpha, for moderate to severe Crohn's disease: a randomised, double blind, placebo controlled trial. Gut (2004) 53:1485-1493.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, FEAGAN BG, HANAUER SB et al.: An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial. Gastroenterology (2001) 120:1330-1338.
   PubMed Web of Science ®Google Scholar
• GORDON FH, LAI CW, HAMILTON MI et al.: A randomized placebo-controlled trial of a humanized monoclonal antibody to α4 integrin in active Crohn's disease. Gastroenterology (2001) 121:268-274.
   PubMed Web of Science ®Google Scholar
• GHOSH S, GOLDIN E, GORDON FH et al.: Natalizumab for active Crohn's disease. N. Engl. J. Med. (2003) 348:24-32.
   PubMed Web of Science ®Google Scholar
• SANDBORN WJ, COLOMBEL JF, ENNS R et al.: Natalizumab induction and maintenance therapy for Crohn's disease. N. Engl. J. Med. (2005) 353:1912-1925.
   PubMed Web of Science ®Google Scholar
• VAN ASSCHE G, VAN RANST M, SCIOT R et al.: Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N. Engl. J. Med. (2005) 353:362-368.
   PubMed Web of Science ®Google Scholar
• LANGER-GOULD A, ATLAS SW, GREEN AJ, BOLLEN AW, PELLETIER D: Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N. Engl. J. Med. (2005) 353:375-381.
   PubMed Web of Science ®Google Scholar
• KLEINSCHMIDT-DEMASTERS BK, TYLER KL: Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and IFN β-1a for multiple sclerosis. N. Engl. J. Med. (2005) 353:369-374.
   PubMed Web of Science ®Google Scholar
• FEAGAN BG, GREENBERG G, WILD G et al.: Efficacy and safety of a humanized [α]4[β]7 antibody in active Crohn's disease (CD). Gastroenterol. Suppl. (2003):A178 (Abstract 178).
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• SCHREIBER S, NIKOLAUS S, MALCHOW H et al.: Absence of efficacy of subcutaneous antisense ICAM-1 treatment of chronic active Crohn's disease. Gastroenterology (2001) 120:1339-1346.
   PubMed Web of Science ®Google Scholar
• YACYSHYN BR, CHEY WY, GOFF J et al.: Double blind, placebo controlled trial of the remission inducing and steroid sparing properties of an ICAM-1 antisense oligodeoxynucleotide, alicaforsen (ISIS 2302), in active steroid dependent Crohn's disease. Gut (2002) 51:30-36.
   PubMed Web of Science ®Google Scholar
• YACYSHYN B, CHEY WY, WEDEL MK et al.: A randomized, double-masked, placebo-controlled study of alicaforsen , an anti-sense inhibitor of intracellular adhesion molecule 1, for the treatment of subjects with Crohn's disease. Clin. Gastroenterol. Hepatol. (2007) 5:215-220.
   PubMed Web of Science ®Google Scholar
• LOWENBERG M, VERHAAR A, VAN DEN BLINK B et al.: Specific inhibition of c-Raf activity by semapimod induces clinical remission in severe Crohn's disease. J. Immunol. (2005) 175:2293-2300.
   PubMed Web of Science ®Google Scholar
• HOMMES D, VAN DEN BLINK B, PLASSE T et al.: Inhibition of stress-activated MAP kinases induces clinical improvement in moderate to severe Crohn's disease. Gastroenterology (2002) 122:7-14.
   PubMed Web of Science ®Google Scholar
• DOTAN I, VAN DER WOUDE J, SCHREIBER S et al.: A randomized, double blind, placebo-controlled Phase II study with long-term open-label extension of semapimod (CNI-1493) for treatment of moderate to severe Crohn's disease. Gut (2006) (Suppl. V):A22.
   Google Scholar
• SCHREIBER S, FEAGAN B, D'HAENS G: Oral p38 mitogen-activated protein kinase inhibition with BIRB 796 for active Crohn's Disease: a randomized, double-blind, placebo-controlled trial. Clin. Gastroenterol. Hepatol. (2006) 4:325-334.
   PubMed Web of Science ®Google Scholar
• HOMMES DW, MIKHAJLOVA TL, STOINOV S et al.: Fontolizumab (Huzaf), a humanized anti-IFN-γ antibody, demonstrates safety and clinical activity in patients with moderate to severe Crohn's disease. Gut (2006) 55:1131-1137.
   PubMed Web of Science ®Google Scholar
• DE VILLIERS W, KATZ S, SALZBERG BA et al.: Chronic dosing of fontolizumab (Huzaf), a humanized anti-IFN-γ antibody, in patients with moderate to severe Crohn's disease. Gastroenterology (2005) 128:A111.
   Google Scholar
• REINISCH W, HOMMES DW, VAN ASSCHE G: A dose escalating, placebo controlled, double blind, single dose and multidose, safety and tolerability study of fontolizumab, a humanized anti-IFN γ antibody, in patients with moderate to severe Crohn's disease. Gut (2006) 55:1138-1144.
   PubMed Web of Science ®Google Scholar
• MANNON PJ, FUSS IJ, MAYER L et al.: Anti-IL-12 antibody for active Crohn's disease. N. Engl. J. Med. (2004) 351:2069-2079.
   PubMed Web of Science ®Google Scholar
• BURAKOFF R, BARISH CF, RIFF D et al.: A Phase I/II trial of STA 5326, an oral IL-12/23 inhibitor, in patients with active moderate to severe Crohn's disease. Inflamm. Bowel Dis. (2006) 12:558-565.
   PubMed Web of Science ®Google Scholar
• ITO H, TAKAZOE M, FUKUDA Y et al.: A pilot randomized trial of a human anti-IL-6 receptor monoclonal antibody in active Crohn's disease. Gastroenterology (2004) 126:989-996.
   PubMed Web of Science ®Google Scholar
• VAN DEVENTER SJH, ELSON CH, FEDORAK RN: Multiple doses of intravenous IL-10 in steroid-refractory Crohn's disease. Gastroenterology (1997) 113:383-389.
   PubMed Web of Science ®Google Scholar
• FEDORAK RN, GANGL A, ELSON CO et al.: Recombinant human IL-10 in the treatment of patients with mild to moderately active Crohn's disease. The IL-10 Inflammatory Bowel Disease Cooperative Study Group. Gastroenterology (2000) 119:1473-1482.
   PubMed Web of Science ®Google Scholar
• SCHREIBER S, FEDORAK RN, NIELSEN OH et al.: Safety and efficacy of recombinant human IL-10 in chronic active Crohn's disease. Crohn's Disease IL-10 Cooperative Study Group. Gastroenterology (2000) 119:1461-1472.
   PubMed Web of Science ®Google Scholar
• SANDS BE, WINSTON BD, SALZBERG B et al.: Randomized, controlled trial of recombinant human IL-11 in patients with active Crohn's disease. Aliment. Pharmacol. Ther. (2002) 16:399-406.
   PubMed Web of Science ®Google Scholar
• HERRLINGER KR, WITTHOEFT T, RAEDLER A et al.: Randomized, double blind, double-dummy, controlled trial of subcutaneous recombinant human IL-11 vs prednisolone in active Crohn's disease. Gut (2004) 53:A49.
   Web of Science ®Google Scholar
• SLONIM AE, BULONE L, DAMORE MB et al.: Preliminary study of growth hormone therapy for Crohn's disease. N. Engl. J. Med. (2000) 342:1633-1637.
   PubMed Web of Science ®Google Scholar
• KORZENIK JR, DIECKGRAEFE BK, VALENTINE JF et al.: Sargramostim for active Crohn's disease. N. Engl. J. Med. (2005) 26:2193-2201.
   Google Scholar
• VALENTINE J, STONE C, KORZENIK J et al.: Repeated cycles of sargramostim for active Crohn's disease (CD): update from an open label trial (n.o.v.e.l. 5). Gastroenterology (2005) 128:A111.
   Google Scholar