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Published in: Medical Oncology 2/2011

01-06-2011 | Original Paper

Golimumab and malignancies: true or false association?

Authors: Ines Zidi, Aicha Bouaziz, Wissem Mnif, Aghleb Bartegi, Nidhal Ben Amor

Published in: Medical Oncology | Issue 2/2011

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Abstract

Malignancy is one of the comorbidities linked to golimumab, a biological TNF-α blocker. In this systematic review and meta-analysis, we searched different databases and analyzed original publications to elucidate the remaining open question about the real association of malignancies with golimumab therapy. The most frequent cancer in patients treated with golimumab, in association or not with methotrexate, is the lung adenocarcinoma. However, lymphoma is not very commonly represented in these patients. We show that there is no major and evident risk of malignancies associated with golimumab in current scientific literature. An increased risk of malignancies may be associated with golimumab, but this warrants further clinical confirmation. Also, this risk mentioned in different studies must be taken with caution because of number of limits and biases.
Literature
1.
go back to reference Krueger G, Callis K. Potential of tumor necrosis factor inhibitors in psoriasis and psoriatic arthritis. Arch Dermatol. 2004;140:218–25.PubMedCrossRef Krueger G, Callis K. Potential of tumor necrosis factor inhibitors in psoriasis and psoriatic arthritis. Arch Dermatol. 2004;140:218–25.PubMedCrossRef
2.
go back to reference Moreland LW, Curtis JR. Systemic nonarticular manifestations of rheumatoid arthritis: focus on inflammatory mechanisms. Semin Arthritis Rheum. 2008;39:132–43.PubMedCrossRef Moreland LW, Curtis JR. Systemic nonarticular manifestations of rheumatoid arthritis: focus on inflammatory mechanisms. Semin Arthritis Rheum. 2008;39:132–43.PubMedCrossRef
3.
go back to reference Dommasch E, Gelfand JM. Is there truly a risk of lymphoma from biologic therapies? Dermatol Ther. 2009;22:418–30.PubMedCrossRef Dommasch E, Gelfand JM. Is there truly a risk of lymphoma from biologic therapies? Dermatol Ther. 2009;22:418–30.PubMedCrossRef
4.
go back to reference Ferrandiz C, Carrascosa JM, Boada A. A new era in the management of psoriasis? The biologics: facts and controversies. Clin Dermatol. 2010;28:81–7.PubMedCrossRef Ferrandiz C, Carrascosa JM, Boada A. A new era in the management of psoriasis? The biologics: facts and controversies. Clin Dermatol. 2010;28:81–7.PubMedCrossRef
5.
go back to reference Smolen JS, Weinblatt ME. When patients with rheumatoid arthritis fail tumour necrosis factor inhibitors: what is the next step? Ann Rheum Dis. 2008;67:1497–8.PubMedCrossRef Smolen JS, Weinblatt ME. When patients with rheumatoid arthritis fail tumour necrosis factor inhibitors: what is the next step? Ann Rheum Dis. 2008;67:1497–8.PubMedCrossRef
7.
go back to reference Hutas G. Golimumab, a fully human monoclonal antibody against TNF-alpha. Curr Opin Mol Ther. 2008;10:393–406.PubMed Hutas G. Golimumab, a fully human monoclonal antibody against TNF-alpha. Curr Opin Mol Ther. 2008;10:393–406.PubMed
9.
go back to reference Kay J, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate. Arthritis Rheum. 2008;58:964–75.PubMedCrossRef Kay J, et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate. Arthritis Rheum. 2008;58:964–75.PubMedCrossRef
10.
go back to reference Emery P, et al. Golimumab, a human anti-tumor necrosis factor monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of Golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272–83.PubMedCrossRef Emery P, et al. Golimumab, a human anti-tumor necrosis factor monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of Golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272–83.PubMedCrossRef
11.
go back to reference Keystone EC, et al. Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy : the GO-FORWARD Study. Ann Rheum Dis. 2009;68:789–96.PubMedCrossRef Keystone EC, et al. Golimumab, a human antibody to tumour necrosis factor alpha given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy : the GO-FORWARD Study. Ann Rheum Dis. 2009;68:789–96.PubMedCrossRef
12.
go back to reference Smolen JS, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374:210–21.PubMedCrossRef Smolen JS, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet. 2009;374:210–21.PubMedCrossRef
14.
go back to reference Oldfield V, Plosker GL. Golimumab in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Biodrugs. 2009;23(2):125–35.PubMedCrossRef Oldfield V, Plosker GL. Golimumab in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Biodrugs. 2009;23(2):125–35.PubMedCrossRef
15.
go back to reference Kavanaugh A, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in Psoriatic Arthritis : twenty-Four-Week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976–86.PubMedCrossRef Kavanaugh A, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in Psoriatic Arthritis : twenty-Four-Week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976–86.PubMedCrossRef
16.
go back to reference Xu Z, et al. Population pharmacokinetics of Golimumab, an anti-tumor necrosis factor-α human monoclonal antibody, in patients with psoriatic arthritis. J Clin Pharmacol. 2009;49:1056–70.PubMedCrossRef Xu Z, et al. Population pharmacokinetics of Golimumab, an anti-tumor necrosis factor-α human monoclonal antibody, in patients with psoriatic arthritis. J Clin Pharmacol. 2009;49:1056–70.PubMedCrossRef
17.
go back to reference Inman RD, et al. Efficacy and safety of Golimumab in patients with ankylosing spondylitis: results of a randomized, double-Blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402–12.PubMedCrossRef Inman RD, et al. Efficacy and safety of Golimumab in patients with ankylosing spondylitis: results of a randomized, double-Blind, placebo-controlled, phase III trial. Arthritis Rheum. 2008;58(11):3402–12.PubMedCrossRef
18.
19.
go back to reference Gaga M, Zervas E, Chanez P. Update on severe asthma: what we know and what we need. Eur Respir Rev. 2009;18:58–65.PubMedCrossRef Gaga M, Zervas E, Chanez P. Update on severe asthma: what we know and what we need. Eur Respir Rev. 2009;18:58–65.PubMedCrossRef
20.
go back to reference Wenzel SE, et al. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009;179(7):549–58.PubMedCrossRef Wenzel SE, et al. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009;179(7):549–58.PubMedCrossRef
22.
go back to reference Shealy D, et al. Characterization of golimumab (CNTO 148), a novel fully human monoclonal antibody specific for human TNF alpha. Ann Rheum Dis. 2007;66 (Suppl 2):ii151. Shealy D, et al. Characterization of golimumab (CNTO 148), a novel fully human monoclonal antibody specific for human TNF alpha. Ann Rheum Dis. 2007;66 (Suppl 2):ii151.
24.
go back to reference Saraceno R, Chimenti S. How to manage infections in the era of biologics? Dermatol Ther. 2008;21:180–6.PubMedCrossRef Saraceno R, Chimenti S. How to manage infections in the era of biologics? Dermatol Ther. 2008;21:180–6.PubMedCrossRef
25.
go back to reference Hussar DA. Newdrugs: golimumab, besifloxacin hydrochloride, and artemether/lumefantrine. J Am Pharm Assoc. 2009;49(4):570–4.CrossRef Hussar DA. Newdrugs: golimumab, besifloxacin hydrochloride, and artemether/lumefantrine. J Am Pharm Assoc. 2009;49(4):570–4.CrossRef
26.
go back to reference Bongartz T, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295:2275–85.PubMedCrossRef Bongartz T, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006;295:2275–85.PubMedCrossRef
27.
go back to reference Setoguchi S, et al. Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54(9):2757–64.PubMedCrossRef Setoguchi S, et al. Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54(9):2757–64.PubMedCrossRef
28.
go back to reference Dewan P, et al. Melanoma in patients with rheumatoid arthritis treated with antitumour necrosis factor: cause or coincidence? Report of two cases. Br J Dermatol. 2009;161:1412–4.PubMedCrossRef Dewan P, et al. Melanoma in patients with rheumatoid arthritis treated with antitumour necrosis factor: cause or coincidence? Report of two cases. Br J Dermatol. 2009;161:1412–4.PubMedCrossRef
29.
go back to reference Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy. Arthritis Rheum. 2007;56(9):2886–95.PubMedCrossRef Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy. Arthritis Rheum. 2007;56(9):2886–95.PubMedCrossRef
30.
go back to reference Kornbluth A. Infliximab approved for use in Crohn’s disease: a report on the FDA GI Advisory Committee conference. Inflamm Bowel Dis. 1998;4:328–9.PubMedCrossRef Kornbluth A. Infliximab approved for use in Crohn’s disease: a report on the FDA GI Advisory Committee conference. Inflamm Bowel Dis. 1998;4:328–9.PubMedCrossRef
31.
go back to reference Mahe E, et al. CD30 + T-cell lymphoma in patient with psoriasis treated with ciclosporin and infliximab. Br J Dermatol. 2003;149:170–3.PubMedCrossRef Mahe E, et al. CD30 + T-cell lymphoma in patient with psoriasis treated with ciclosporin and infliximab. Br J Dermatol. 2003;149:170–3.PubMedCrossRef
32.
go back to reference Nyfors A, Jensen H. Frequency of malignant neoplasms in 248 long-term methotrexate-treated psoriatics. A preliminary study. Dermatologica. 1983;167:260–1.PubMedCrossRef Nyfors A, Jensen H. Frequency of malignant neoplasms in 248 long-term methotrexate-treated psoriatics. A preliminary study. Dermatologica. 1983;167:260–1.PubMedCrossRef
33.
go back to reference Salliot C, van der Heijde D. Methotrexate monotherapy in rheumatoid arthritis patients. A systematic literature research. Ann Rheumatic Dis. 2009;68:1100–4.CrossRef Salliot C, van der Heijde D. Methotrexate monotherapy in rheumatoid arthritis patients. A systematic literature research. Ann Rheumatic Dis. 2009;68:1100–4.CrossRef
34.
go back to reference Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-tumor necrosis factor therapy in 18, 572 patients. Arthritis Rheum. 2004;50:1740–51.PubMedCrossRef Wolfe F, Michaud K. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-tumor necrosis factor therapy in 18, 572 patients. Arthritis Rheum. 2004;50:1740–51.PubMedCrossRef
35.
go back to reference Geborek P, et al. Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may ba associated with an increased risk of lymphomas. Ann Rheum Dis. 2005;64:699–703.PubMedCrossRef Geborek P, et al. Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may ba associated with an increased risk of lymphomas. Ann Rheum Dis. 2005;64:699–703.PubMedCrossRef
36.
go back to reference Askling J, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Ann Rheum Dis. 2005;64:1421–6.PubMedCrossRef Askling J, et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with tumour necrosis factor antagonists. Ann Rheum Dis. 2005;64:1421–6.PubMedCrossRef
37.
go back to reference Rozenblit M, Lebwohl M. New biologics for psoriasis and psoriatic arthritis. Dermatol Ther. 2009;22:56–60.PubMedCrossRef Rozenblit M, Lebwohl M. New biologics for psoriasis and psoriatic arthritis. Dermatol Ther. 2009;22:56–60.PubMedCrossRef
38.
go back to reference Soriano ER, Rosa J. Update on the treatment of peripheral arthritis in psoriatic arthritis. Curr Rheumatol Rep. 2009;11:270–7.PubMedCrossRef Soriano ER, Rosa J. Update on the treatment of peripheral arthritis in psoriatic arthritis. Curr Rheumatol Rep. 2009;11:270–7.PubMedCrossRef
39.
go back to reference Antoni CE, et al. Two-year efficacy and safety of Infliximab treatment in patients with active psoriatic arthritis: findings of the Inliximab Multinational psoriatic arthritis controlled trial (IMPACT). J Rheumatol. 2008;35:869–76.PubMed Antoni CE, et al. Two-year efficacy and safety of Infliximab treatment in patients with active psoriatic arthritis: findings of the Inliximab Multinational psoriatic arthritis controlled trial (IMPACT). J Rheumatol. 2008;35:869–76.PubMed
40.
go back to reference Mease PJ, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712–721. Mease PJ, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712–721.
41.
go back to reference Mease PJ, et al. Adalimumab for long-term treatment of psoriasis arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68:702–9.PubMedCrossRef Mease PJ, et al. Adalimumab for long-term treatment of psoriasis arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009;68:702–9.PubMedCrossRef
42.
go back to reference Davis JC, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis : a randomized, controlled trial. Arthritis Rheum. 2003;48:3230–6.PubMedCrossRef Davis JC, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis : a randomized, controlled trial. Arthritis Rheum. 2003;48:3230–6.PubMedCrossRef
43.
go back to reference Van der Heijde D, et al. Efficacy and safety of Infliximab in patients with ankylosing spondylitis: results of a randomized, placebo controlled-trial (ASSERT). Arthritis Rheum. 2005;52:582–91.PubMedCrossRef Van der Heijde D, et al. Efficacy and safety of Infliximab in patients with ankylosing spondylitis: results of a randomized, placebo controlled-trial (ASSERT). Arthritis Rheum. 2005;52:582–91.PubMedCrossRef
44.
go back to reference Van der Heijde D, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis : results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006;54:2136–46.PubMedCrossRef Van der Heijde D, et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis : results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006;54:2136–46.PubMedCrossRef
45.
go back to reference Zhou H, et al. Pharmacokinetics and safety of Golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with Rheumatoid Arthritis. J Clin Pharmacol. 2007;47:383–96.PubMedCrossRef Zhou H, et al. Pharmacokinetics and safety of Golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with Rheumatoid Arthritis. J Clin Pharmacol. 2007;47:383–96.PubMedCrossRef
48.
go back to reference Cohen RB, Dittrich KA. Anti-TNF therapy and malignancy- a critical review. Can J Gastroenterol. 2001;15(6):376–84.PubMed Cohen RB, Dittrich KA. Anti-TNF therapy and malignancy- a critical review. Can J Gastroenterol. 2001;15(6):376–84.PubMed
51.
go back to reference Naldi L. Malignancy concerns with psoriasis treatments using phototherapy, methotrexate, cyclosporin, and biologics: facts and controversies. Clin Dermatol. 2010;28:88–92.PubMedCrossRef Naldi L. Malignancy concerns with psoriasis treatments using phototherapy, methotrexate, cyclosporin, and biologics: facts and controversies. Clin Dermatol. 2010;28:88–92.PubMedCrossRef
53.
go back to reference Furst DE, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases. Ann Rheum Dis. 2008;67:iii2–iii25. Furst DE, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases. Ann Rheum Dis. 2008;67:iii2–iii25.
54.
go back to reference Mariette X, et al. Lymphomas in rheumatoid arthritis patients treated with methotrexate : a 3-year prospective study in France. Blood. 2002;99(11):3909–15.PubMedCrossRef Mariette X, et al. Lymphomas in rheumatoid arthritis patients treated with methotrexate : a 3-year prospective study in France. Blood. 2002;99(11):3909–15.PubMedCrossRef
55.
go back to reference Stone JH, et al. Solid malignancies among patients in the Wegener’s Granulomatosis Etanercept trial. Arthritis Rheum. 2006;54(5):1608–18.PubMedCrossRef Stone JH, et al. Solid malignancies among patients in the Wegener’s Granulomatosis Etanercept trial. Arthritis Rheum. 2006;54(5):1608–18.PubMedCrossRef
56.
go back to reference Van den Born BE, et al. No increased risk of malignancies and mortality in cyclosporin A-treated patients with rheumatoid arthritis. Arthritis Rheum. 1998;41:1930–7.CrossRef Van den Born BE, et al. No increased risk of malignancies and mortality in cyclosporin A-treated patients with rheumatoid arthritis. Arthritis Rheum. 1998;41:1930–7.CrossRef
57.
go back to reference Kremer J, et al. Golimumab, a new human anti-TNFα antibody, administered intravenously in patients with active rheumatoid arthritis: 48-week efficacy and safety results of a phase 3, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010. doi:10.1002/art.27348. Kremer J, et al. Golimumab, a new human anti-TNFα antibody, administered intravenously in patients with active rheumatoid arthritis: 48-week efficacy and safety results of a phase 3, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010. doi:10.​1002/​art.​27348.
Metadata
Title
Golimumab and malignancies: true or false association?
Authors
Ines Zidi
Aicha Bouaziz
Wissem Mnif
Aghleb Bartegi
Nidhal Ben Amor
Publication date
01-06-2011
Publisher
Springer US
Published in
Medical Oncology / Issue 2/2011
Print ISSN: 1357-0560
Electronic ISSN: 1559-131X
DOI
https://doi.org/10.1007/s12032-010-9490-7

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