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Published in: BMC Medicine 1/2013

Open Access 01-12-2013 | Review

Biologic therapy for autoimmune diseases: an update

Authors: Ziv Rosman, Yehuda Shoenfeld, Gisele Zandman-Goddard

Published in: BMC Medicine | Issue 1/2013

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Abstract

Biologic therapies for rheumatologic diseases, which are targeted at molecules involved in the mechanisms of the immune system, provide an alternative to the existing treatment methods of disease-modifying anti-rheumatic drugs and other immunosuppressive medications. However, the current drawbacks of biologic therapies, including the inconvenience of intravenous administration, the high costs of these drugs, and the adverse events associated with them, prevent their wide use as first-line medications. This review provides an update of the recent literature on the new biologic therapies available. The review concentrates on nine drugs: tocilizumab, rituximab, ofatumumab, belimumab, epratuzumab, abatacept, golimumab, certolizumab, and sifalimumab, which are used as therapies for rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, systemic sclerosis, or vasculitis.
Literature
1.
go back to reference Burmester GR, Feist E, Kellner H, Braun J, Iking KC, Roth AR: Effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 weeks in patients with active rheumatoid arthritis: the first phase IIIb real-life study (TAMARA). Ann Rheum Dis. 2011, 70: 755-759. 10.1136/ard.2010.139725.CrossRefPubMed Burmester GR, Feist E, Kellner H, Braun J, Iking KC, Roth AR: Effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 weeks in patients with active rheumatoid arthritis: the first phase IIIb real-life study (TAMARA). Ann Rheum Dis. 2011, 70: 755-759. 10.1136/ard.2010.139725.CrossRefPubMed
2.
3.
go back to reference Nisar MK, Östör JKA: The role of tocilizumab monotherapy in the management of rheumatoid arthritis: a review. Int J Clin Rheumatol. 2012, 7: 9-19. 10.2217/ijr.11.66.CrossRef Nisar MK, Östör JKA: The role of tocilizumab monotherapy in the management of rheumatoid arthritis: a review. Int J Clin Rheumatol. 2012, 7: 9-19. 10.2217/ijr.11.66.CrossRef
4.
go back to reference Uchiyama Y, Yorozu K, Hashizume M, Moriya Y, Mihara M: Tocilizumab, a humanized anti-interleukin-receptor antibody, ameliorates joint swelling in established monkey collagen-induced arthritis. Biol Pharm Bull. 2008, 31: 1159-1163. 10.1248/bpb.31.1159.CrossRefPubMed Uchiyama Y, Yorozu K, Hashizume M, Moriya Y, Mihara M: Tocilizumab, a humanized anti-interleukin-receptor antibody, ameliorates joint swelling in established monkey collagen-induced arthritis. Biol Pharm Bull. 2008, 31: 1159-1163. 10.1248/bpb.31.1159.CrossRefPubMed
5.
go back to reference Levi M, Grange S, Frey N: Exposure-response relationship of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in a large population of patients with rheumatoid arthritis. J Clin Pharmacol. 2012, Feb 14. [Epub ahead of print] Levi M, Grange S, Frey N: Exposure-response relationship of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in a large population of patients with rheumatoid arthritis. J Clin Pharmacol. 2012, Feb 14. [Epub ahead of print]
6.
go back to reference Ogata A, Tanaka T: Tocilizumab for the treatment of rheumatoid arthritis and other systemic autoimmune diseases: current perspectives and future directions. Int J Rheumatol. 2012, 2012: 946048.CrossRefPubMedPubMedCentral Ogata A, Tanaka T: Tocilizumab for the treatment of rheumatoid arthritis and other systemic autoimmune diseases: current perspectives and future directions. Int J Rheumatol. 2012, 2012: 946048.CrossRefPubMedPubMedCentral
7.
go back to reference Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J: Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009, 68: 1580-1584. 10.1136/ard.2008.092866.CrossRefPubMed Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J: Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009, 68: 1580-1584. 10.1136/ard.2008.092866.CrossRefPubMed
8.
go back to reference Bergman GJD, Hochberg MC, Boers M, Wintfeld N, Kielhorn A, Jansen JP: Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs. Semin Arthritis Rheum. 2010, 39: 425-441. 10.1016/j.semarthrit.2009.12.002.CrossRefPubMed Bergman GJD, Hochberg MC, Boers M, Wintfeld N, Kielhorn A, Jansen JP: Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs. Semin Arthritis Rheum. 2010, 39: 425-441. 10.1016/j.semarthrit.2009.12.002.CrossRefPubMed
10.
go back to reference Schiff MH, Kremer JM, Jahreis A, Vernon E, Isaacs JD, Van Vollenhoven RF: Integrated safety in tocilizumab clinical trials. Arthritis Res Ther. 2011, 13: R141-10.1186/ar3455.CrossRefPubMedPubMedCentral Schiff MH, Kremer JM, Jahreis A, Vernon E, Isaacs JD, Van Vollenhoven RF: Integrated safety in tocilizumab clinical trials. Arthritis Res Ther. 2011, 13: R141-10.1186/ar3455.CrossRefPubMedPubMedCentral
11.
go back to reference Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, Filippini G, Skoetz N, Francis D, Lopes LC, Guyatt GH, Schmitt J, La Mantia L, Weberschock T, Roos JF, Siebert H, Hershan S, Lunn MP, Tugwell P, Buchbinder R: Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011, 16: CD008794. Singh JA, Wells GA, Christensen R, Tanjong Ghogomu E, Maxwell L, Macdonald JK, Filippini G, Skoetz N, Francis D, Lopes LC, Guyatt GH, Schmitt J, La Mantia L, Weberschock T, Roos JF, Siebert H, Hershan S, Lunn MP, Tugwell P, Buchbinder R: Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011, 16: CD008794.
12.
go back to reference Verweij CL, Vosslamber S: New insight in the mechanism of action of rituximab: the interferon signature towards personalized medicine. Discov Med. 2011, 12: 229-236.PubMed Verweij CL, Vosslamber S: New insight in the mechanism of action of rituximab: the interferon signature towards personalized medicine. Discov Med. 2011, 12: 229-236.PubMed
13.
go back to reference Mease PJ, Cohen S, Gaylis NB, Chubick A, Kaell AT, Greenwald M, Agarwal S, Yin M, Kelman A: Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE Trial. J Rheumatol. 2010, 37: 917-927. 10.3899/jrheum.090442.CrossRefPubMed Mease PJ, Cohen S, Gaylis NB, Chubick A, Kaell AT, Greenwald M, Agarwal S, Yin M, Kelman A: Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE Trial. J Rheumatol. 2010, 37: 917-927. 10.3899/jrheum.090442.CrossRefPubMed
14.
go back to reference Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert MV, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U, RAVE-ITN Research Group: Rituximab versus Cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010, 363: 221-232. 10.1056/NEJMoa0909905.CrossRefPubMedPubMedCentral Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert MV, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U, RAVE-ITN Research Group: Rituximab versus Cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010, 363: 221-232. 10.1056/NEJMoa0909905.CrossRefPubMedPubMedCentral
15.
go back to reference Palau J, Jarque I, Sanz MA: Long-term management of chronic immune thrombocytopenic purpura in adults. Int J Gen Med. 2010, 3: 305-311.PubMedPubMedCentral Palau J, Jarque I, Sanz MA: Long-term management of chronic immune thrombocytopenic purpura in adults. Int J Gen Med. 2010, 3: 305-311.PubMedPubMedCentral
16.
go back to reference Cianchini G, Lupi F, Masini C, Corona R, Puddu P, De Pità O: Therapy with rituximab for autoimmune pemphigus: results from a single-center observational study on 42 cases with long-term follow-up. J Am Acad Dermatol. 2012, 67: 617-622. 10.1016/j.jaad.2011.11.007.CrossRefPubMed Cianchini G, Lupi F, Masini C, Corona R, Puddu P, De Pità O: Therapy with rituximab for autoimmune pemphigus: results from a single-center observational study on 42 cases with long-term follow-up. J Am Acad Dermatol. 2012, 67: 617-622. 10.1016/j.jaad.2011.11.007.CrossRefPubMed
17.
go back to reference Daoussis D, Liossis SN, Yiannopoulos G, Andonopoulos AP: B-cell depletion therapy in systemic sclerosis: experimental rationale and update on clinical evidence. Int J Rheumatol. 2011, 2011: 214013.CrossRefPubMedPubMedCentral Daoussis D, Liossis SN, Yiannopoulos G, Andonopoulos AP: B-cell depletion therapy in systemic sclerosis: experimental rationale and update on clinical evidence. Int J Rheumatol. 2011, 2011: 214013.CrossRefPubMedPubMedCentral
18.
go back to reference Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG: Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010, 62: 222-233. 10.1002/art.27233.CrossRefPubMedPubMedCentral Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG: Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010, 62: 222-233. 10.1002/art.27233.CrossRefPubMedPubMedCentral
19.
go back to reference Tew GW, Rabbee N, Wolslegel K, Hsieh HJ, Monroe JG, Behrens TW, Brunetta PG, Keir ME: Baseline autoantibody profiles predict normalization of complement and anti-dsDNA autoantibody levels following rituximab treatment in systemic lupus erythematosus. Lupus. 2010, 19: 146-157. 10.1177/0961203309350752.CrossRefPubMed Tew GW, Rabbee N, Wolslegel K, Hsieh HJ, Monroe JG, Behrens TW, Brunetta PG, Keir ME: Baseline autoantibody profiles predict normalization of complement and anti-dsDNA autoantibody levels following rituximab treatment in systemic lupus erythematosus. Lupus. 2010, 19: 146-157. 10.1177/0961203309350752.CrossRefPubMed
21.
go back to reference Van Vollenhoven RF, Emery P, Bingham CO, Keystone EC, Fleischmann R, Furst DE, Macey K, Sweetser M, Kelman A, Rao R: Long term safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010, 37: 558-567. 10.3899/jrheum.090856.CrossRefPubMed Van Vollenhoven RF, Emery P, Bingham CO, Keystone EC, Fleischmann R, Furst DE, Macey K, Sweetser M, Kelman A, Rao R: Long term safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol. 2010, 37: 558-567. 10.3899/jrheum.090856.CrossRefPubMed
22.
go back to reference Fonseca JE, Bernardes M, Canhão H, Santos MJ, Quintal A, Malcata A, Neto A, Cordeiro A, Rodrigues A, Mourão AF, Ribeiro AS, Cravo AR, Barcelos A, Cardoso A, Vilar A, Braña A, Faustino A, Silva C, Duarte C, Araújo D, Nour D, Sousa E, Simões E, Godinho F, Brandão F, Ventura F, Sequeira G, Figueiredo G, Cunha I, Matos JA: Portuguese guidelines for the use of biological agents in rheumatoid arthritis - October 2011 update. Acta Reumatol Port. 2011, 36: 385-388.PubMed Fonseca JE, Bernardes M, Canhão H, Santos MJ, Quintal A, Malcata A, Neto A, Cordeiro A, Rodrigues A, Mourão AF, Ribeiro AS, Cravo AR, Barcelos A, Cardoso A, Vilar A, Braña A, Faustino A, Silva C, Duarte C, Araújo D, Nour D, Sousa E, Simões E, Godinho F, Brandão F, Ventura F, Sequeira G, Figueiredo G, Cunha I, Matos JA: Portuguese guidelines for the use of biological agents in rheumatoid arthritis - October 2011 update. Acta Reumatol Port. 2011, 36: 385-388.PubMed
23.
go back to reference Isvy A, Meunier M, Gobeaux-Chenevier C, Maury E, Wipff J, Job-Deslandre C, Kahan A, Allanore Y: Safety of rituximab in rheumatoid arthritis: a long-term prospective single-center study of gammaglobulin concentrations and infections. Joint Bone Spine. 2012, 79: 365-369. 10.1016/j.jbspin.2011.12.004.CrossRefPubMed Isvy A, Meunier M, Gobeaux-Chenevier C, Maury E, Wipff J, Job-Deslandre C, Kahan A, Allanore Y: Safety of rituximab in rheumatoid arthritis: a long-term prospective single-center study of gammaglobulin concentrations and infections. Joint Bone Spine. 2012, 79: 365-369. 10.1016/j.jbspin.2011.12.004.CrossRefPubMed
24.
go back to reference Ostergaard M, Baslund B, Rigby W, Rojkovich B, Jorgensen C, Dawes PT, Wiell C, Wallace DJ, Tamer SC, Kastberg H, Petersen J, Sierakowski S: Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. Arthritis Rheum. 2010, 62: 2227-2238. 10.1002/art.27524.CrossRefPubMed Ostergaard M, Baslund B, Rigby W, Rojkovich B, Jorgensen C, Dawes PT, Wiell C, Wallace DJ, Tamer SC, Kastberg H, Petersen J, Sierakowski S: Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, phase I/II study. Arthritis Rheum. 2010, 62: 2227-2238. 10.1002/art.27524.CrossRefPubMed
25.
go back to reference Taylor PC, Quattrocchi E, Mallett S, Kurrasch R, Petersen J, Chang DJ: Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis. 2011, 70: 2119-2125. 10.1136/ard.2011.151522.CrossRefPubMedPubMedCentral Taylor PC, Quattrocchi E, Mallett S, Kurrasch R, Petersen J, Chang DJ: Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis. 2011, 70: 2119-2125. 10.1136/ard.2011.151522.CrossRefPubMedPubMedCentral
26.
go back to reference Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW: A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009, 61: 1168-1178. 10.1002/art.24699.CrossRefPubMedPubMedCentral Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW: A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009, 61: 1168-1178. 10.1002/art.24699.CrossRefPubMedPubMedCentral
27.
go back to reference Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA, BLISS-52 Study Group: Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011, 377: 721-731. 10.1016/S0140-6736(10)61354-2.CrossRefPubMed Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, León MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA, BLISS-52 Study Group: Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011, 377: 721-731. 10.1016/S0140-6736(10)61354-2.CrossRefPubMed
28.
go back to reference Traczewski P, Rudnicka L: Treatment of systemic lupus erythematosus with epratuzumab. Br J Clin Pharmacol. 2011, 71: 175-182. 10.1111/j.1365-2125.2010.03767.x.CrossRefPubMedPubMedCentral Traczewski P, Rudnicka L: Treatment of systemic lupus erythematosus with epratuzumab. Br J Clin Pharmacol. 2011, 71: 175-182. 10.1111/j.1365-2125.2010.03767.x.CrossRefPubMedPubMedCentral
29.
go back to reference Dörner T, Goldenberg DM: Targeting CD22 as a strategy for treating systemic autoimmune diseases. Ther Clin Risk Manag. 2007, 3: 953-959.PubMedPubMedCentral Dörner T, Goldenberg DM: Targeting CD22 as a strategy for treating systemic autoimmune diseases. Ther Clin Risk Manag. 2007, 3: 953-959.PubMedPubMedCentral
30.
go back to reference Wallace DJ, Kalunian KC, Petri MA, Strand V, Kilgallen B, Barry A, Gordon C: Epratuzumab demonstrates clinically meaningful improvements in patients with moderate to severe systemic lupus erythematosus (SLE): results from Emblem™, a phase IIb study. [abstract]. 9th International Congress on Systemic Lupus Erythematosus. June 24–27. 2010, , Vancouver, Canada Wallace DJ, Kalunian KC, Petri MA, Strand V, Kilgallen B, Barry A, Gordon C: Epratuzumab demonstrates clinically meaningful improvements in patients with moderate to severe systemic lupus erythematosus (SLE): results from Emblem™, a phase IIb study. [abstract]. 9th International Congress on Systemic Lupus Erythematosus. June 24–27. 2010, , Vancouver, Canada
31.
go back to reference Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, Steinfeld S, Tindall E, Becker JC, Li T, Nuamah IF, Aranda R, Moreland LW: Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005, 52: 2263-2271. 10.1002/art.21201.CrossRefPubMed Kremer JM, Dougados M, Emery P, Durez P, Sibilia J, Shergy W, Steinfeld S, Tindall E, Becker JC, Li T, Nuamah IF, Aranda R, Moreland LW: Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005, 52: 2263-2271. 10.1002/art.21201.CrossRefPubMed
32.
go back to reference Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P: The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010, 62: 3077-3087. 10.1002/art.27601.CrossRefPubMed Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P: The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010, 62: 3077-3087. 10.1002/art.27601.CrossRefPubMed
33.
go back to reference Nogid A, Pham DQ: Role of abatacept in the management of rheumatoid arthritis. Clin Ther. 2006, 28: 1764-1778. 10.1016/j.clinthera.2006.11.020.CrossRefPubMed Nogid A, Pham DQ: Role of abatacept in the management of rheumatoid arthritis. Clin Ther. 2006, 28: 1764-1778. 10.1016/j.clinthera.2006.11.020.CrossRefPubMed
34.
go back to reference Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, Birbara C, Box J, Natarajan K, Nuamah I, Li T, Aranda R, Hagerty DT, Dougados M: Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005, 353: 1114-1123. 10.1056/NEJMoa050524.CrossRefPubMed Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, Birbara C, Box J, Natarajan K, Nuamah I, Li T, Aranda R, Hagerty DT, Dougados M: Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005, 353: 1114-1123. 10.1056/NEJMoa050524.CrossRefPubMed
35.
go back to reference Kremer JM, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Westhovens R, Li T, Zhou X, Becker JC, Aranda R, Peterfy C, Genant HK: Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis. 2011, 70: 1826-1830. 10.1136/ard.2010.139345.CrossRefPubMedPubMedCentral Kremer JM, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Westhovens R, Li T, Zhou X, Becker JC, Aranda R, Peterfy C, Genant HK: Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis. 2011, 70: 1826-1830. 10.1136/ard.2010.139345.CrossRefPubMedPubMedCentral
36.
go back to reference Inman RD, Davis JC, van der Heijde D, Diekman L, Sieper J, Kim SI, Mack M, Han J, Visvanathan S, Xu Z, Hsu B, Beutler A, Braun J: 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: 3402-3412. 10.1002/art.23969.CrossRefPubMed Inman RD, Davis JC, van der Heijde D, Diekman L, Sieper J, Kim SI, Mack M, Han J, Visvanathan S, Xu Z, Hsu B, Beutler A, Braun J: 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: 3402-3412. 10.1002/art.23969.CrossRefPubMed
37.
go back to reference Kavanaugh A, Mcinnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, Papp K, Zrubek J, Mudivarthy S, Mack M, Visvanathan S, Beutler A: Golimumab, a new human tumor necrosis factor α 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: 976-986. 10.1002/art.24403.CrossRefPubMed Kavanaugh A, Mcinnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, Papp K, Zrubek J, Mudivarthy S, Mack M, Visvanathan S, Beutler A: Golimumab, a new human tumor necrosis factor α 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: 976-986. 10.1002/art.24403.CrossRefPubMed
38.
go back to reference Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, Pazdur J, Bae SC, Palmer W, Zrubek J, Wiekowski M, Visvanathan S, Wu Z, Rahman MU: Golimumab, a human antibody to TNF- α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate: the GO-FORWARD Study. Ann Rheum Dis. 2009, 68: 789-796. 10.1136/ard.2008.099010.CrossRefPubMed Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, Pazdur J, Bae SC, Palmer W, Zrubek J, Wiekowski M, Visvanathan S, Wu Z, Rahman MU: Golimumab, a human antibody to TNF- α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate: the GO-FORWARD Study. Ann Rheum Dis. 2009, 68: 789-796. 10.1136/ard.2008.099010.CrossRefPubMed
39.
go back to reference Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, Nash P, Amante EJ, Churchill M, Park W, Pons-Estel BA, Doyle MK, Visvanathan S, Xu W, Rahman MU: Golilumab, a human anti-tumor necrosis factor a monoclonal antibody, injected subcutaneously every four weeks in methotrexate naïve patients with rheumatoid arthritis. Arthritis Rheum. 2009, 60: 2272-2283. 10.1002/art.24638.CrossRefPubMed Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, Nash P, Amante EJ, Churchill M, Park W, Pons-Estel BA, Doyle MK, Visvanathan S, Xu W, Rahman MU: Golilumab, a human anti-tumor necrosis factor a monoclonal antibody, injected subcutaneously every four weeks in methotrexate naïve patients with rheumatoid arthritis. Arthritis Rheum. 2009, 60: 2272-2283. 10.1002/art.24638.CrossRefPubMed
40.
go back to reference Ash Z, Emery P: Golilumab- a new tool in the armoury against inflammatory arthritis. Ann Med. 2011, 43: 133-141. 10.3109/07853890.2010.549148.CrossRefPubMed Ash Z, Emery P: Golilumab- a new tool in the armoury against inflammatory arthritis. Ann Med. 2011, 43: 133-141. 10.3109/07853890.2010.549148.CrossRefPubMed
41.
go back to reference Smolen J, Landewé RB, Mease P: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009, 68: 797-804. 10.1136/ard.2008.101659.CrossRefPubMed Smolen J, Landewé RB, Mease P: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009, 68: 797-804. 10.1136/ard.2008.101659.CrossRefPubMed
42.
go back to reference Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009, 68: 805-811. 10.1136/ard.2008.099291.CrossRefPubMed Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009, 68: 805-811. 10.1136/ard.2008.099291.CrossRefPubMed
43.
go back to reference Yao Y, Richman L, Higgs BW, Morehouse CA, De Los Reyes M, Brohawn P, Zhang J, White B, Coyle AJ, Kiener PA, Jallal B: Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum. 2009, 60: 1785-1796. 10.1002/art.24557.CrossRefPubMed Yao Y, Richman L, Higgs BW, Morehouse CA, De Los Reyes M, Brohawn P, Zhang J, White B, Coyle AJ, Kiener PA, Jallal B: Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum. 2009, 60: 1785-1796. 10.1002/art.24557.CrossRefPubMed
44.
go back to reference Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B, Lupus Interferon Skin Activity (LISA) Study Investigators: Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011, 70: 1905-1913. 10.1136/ard.2010.144485.CrossRefPubMed Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B, Lupus Interferon Skin Activity (LISA) Study Investigators: Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011, 70: 1905-1913. 10.1136/ard.2010.144485.CrossRefPubMed
45.
go back to reference Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Hawkins PN, Tran TA, Bader-meunier B, Hoyer J, Gattorno M, Gul A, Smith J, Leslie KS, Jimenez S, Morell-Dubois S, Davis N, Patel N, Widmer A, Preiss R, Lachmann HJ: Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011, 70: 2095-2102. 10.1136/ard.2011.152728.CrossRefPubMed Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Hawkins PN, Tran TA, Bader-meunier B, Hoyer J, Gattorno M, Gul A, Smith J, Leslie KS, Jimenez S, Morell-Dubois S, Davis N, Patel N, Widmer A, Preiss R, Lachmann HJ: Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011, 70: 2095-2102. 10.1136/ard.2011.152728.CrossRefPubMed
46.
go back to reference Hoffman HM, Throne ML, Amar NJ, Cartwright RC, Kivitz AJ, Soo Y, Weinstein SP: Long-term efficacy and safety profile of rilonacept in the treatment of cryopyrin-associated periodic syndromes: results of a 72-week open-label extension study. Clin Ther. 2012, 34: 2091-2103. 10.1016/j.clinthera.2012.09.009.CrossRefPubMed Hoffman HM, Throne ML, Amar NJ, Cartwright RC, Kivitz AJ, Soo Y, Weinstein SP: Long-term efficacy and safety profile of rilonacept in the treatment of cryopyrin-associated periodic syndromes: results of a 72-week open-label extension study. Clin Ther. 2012, 34: 2091-2103. 10.1016/j.clinthera.2012.09.009.CrossRefPubMed
47.
go back to reference So A, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V: Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010, 62: 3064-3076. 10.1002/art.27600.CrossRefPubMed So A, De Meulemeester M, Pikhlak A, Yücel AE, Richard D, Murphy V: Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: results of a multicenter, phase II, dose-ranging study. Arthritis Rheum. 2010, 62: 3064-3076. 10.1002/art.27600.CrossRefPubMed
48.
go back to reference Kivity S, Katz U, Daniel N, Nussinovitch U, Papageorgiou N, Shoenfeld Y: Evidence for the use of intravenous immunoglobulins–a review of the literature. Clin Rev Allergy Immunol. 2010, 38: 201-269. 10.1007/s12016-009-8155-9.CrossRefPubMed Kivity S, Katz U, Daniel N, Nussinovitch U, Papageorgiou N, Shoenfeld Y: Evidence for the use of intravenous immunoglobulins–a review of the literature. Clin Rev Allergy Immunol. 2010, 38: 201-269. 10.1007/s12016-009-8155-9.CrossRefPubMed
49.
go back to reference Katz U, Zandman-Goddard G: Update on intravenous immunoglobulins (IVIg) mechanisms of action and off-label use in autoimmune diseases. Curr Pharm Des. 2011, 17: 3166-3175. 10.2174/138161211798157540.CrossRefPubMed Katz U, Zandman-Goddard G: Update on intravenous immunoglobulins (IVIg) mechanisms of action and off-label use in autoimmune diseases. Curr Pharm Des. 2011, 17: 3166-3175. 10.2174/138161211798157540.CrossRefPubMed
50.
go back to reference Zandman-Goddard G, Krauthammer A, Levy Y, Langevitz P, Shoenfeld Y: Long-term therapy with intravenous immunoglobulin is beneficial in patients with autoimmune diseases. Clin Rev Allergy Immunol. 2012, 42: 247-255. 10.1007/s12016-011-8278-7.CrossRefPubMed Zandman-Goddard G, Krauthammer A, Levy Y, Langevitz P, Shoenfeld Y: Long-term therapy with intravenous immunoglobulin is beneficial in patients with autoimmune diseases. Clin Rev Allergy Immunol. 2012, 42: 247-255. 10.1007/s12016-011-8278-7.CrossRefPubMed
51.
go back to reference Rosman Z, Zandman-Goddard G: Intravenous immunoglobulin therapy for SLE. Future Medicine. 2012, 10.2217/ebo.11.328. Rosman Z, Zandman-Goddard G: Intravenous immunoglobulin therapy for SLE. Future Medicine. 2012, 10.2217/ebo.11.328.
52.
go back to reference Sherer Y, Kuechler S, Jose Scali J, Rovensky J, Levy Y, Zandman-Goddard G, Shoenfeld Y: Low dose intravenous immunoglobulin in systemic lupus erythematosus: analysis of 62 cases. Isr Med Assoc J. 2008, 10: 55-57.PubMed Sherer Y, Kuechler S, Jose Scali J, Rovensky J, Levy Y, Zandman-Goddard G, Shoenfeld Y: Low dose intravenous immunoglobulin in systemic lupus erythematosus: analysis of 62 cases. Isr Med Assoc J. 2008, 10: 55-57.PubMed
53.
go back to reference Levy Y, Sherer Y, Ahmed A, Langevitz P, George J, Fabbrizzi F, Terryberry J, Meissner M, Lorber M, Peter JB, Shoenfeld Y: A study of 20 SLE patients with intravenous immunoglobulin–clinical and serologic response. Lupus. 1999, 8: 705-712. 10.1191/096120399678841007.CrossRefPubMed Levy Y, Sherer Y, Ahmed A, Langevitz P, George J, Fabbrizzi F, Terryberry J, Meissner M, Lorber M, Peter JB, Shoenfeld Y: A study of 20 SLE patients with intravenous immunoglobulin–clinical and serologic response. Lupus. 1999, 8: 705-712. 10.1191/096120399678841007.CrossRefPubMed
54.
go back to reference Zandman-Goddard G, Levy Y, Shoenfeld Y: Intravenous immunoglobulin therapy and systemic lupus erythematosus. Clin Rev Allergy Immunol. 2005, 29: 219-228. 10.1385/CRIAI:29:3:219.CrossRefPubMed Zandman-Goddard G, Levy Y, Shoenfeld Y: Intravenous immunoglobulin therapy and systemic lupus erythematosus. Clin Rev Allergy Immunol. 2005, 29: 219-228. 10.1385/CRIAI:29:3:219.CrossRefPubMed
55.
go back to reference Orbach H, Tishler M, Shoenfeld Y: Intravenous immunoglobulin and the kidney–a two-edged sword. Semin Arthritis Rheum. 2004, 34: 593-601. 10.1016/j.semarthrit.2004.06.003.CrossRefPubMed Orbach H, Tishler M, Shoenfeld Y: Intravenous immunoglobulin and the kidney–a two-edged sword. Semin Arthritis Rheum. 2004, 34: 593-601. 10.1016/j.semarthrit.2004.06.003.CrossRefPubMed
56.
go back to reference Zandman-Goddard G, Krauthammer A, Shoenfeld Y: The steroid-sparing effect of intravenous immunoglobulin in patients with autoimmune diseases. Expert Rev Clin Immunol. 2007, 3: 773-780. 10.1586/1744666X.3.5.773.CrossRefPubMed Zandman-Goddard G, Krauthammer A, Shoenfeld Y: The steroid-sparing effect of intravenous immunoglobulin in patients with autoimmune diseases. Expert Rev Clin Immunol. 2007, 3: 773-780. 10.1586/1744666X.3.5.773.CrossRefPubMed
57.
go back to reference Levy Y, Uziel Y, Zandman-Goddard G, Rotman P, Amital H, Sherer Y, Langevitz P, Goldman B, Shoenfeld Y: Response of vasculitic peripheral neuropathy to intravenous immunoglobulin. Ann N Y Acad Sci. 2005, 1051: 779-786. 10.1196/annals.1361.121.CrossRefPubMed Levy Y, Uziel Y, Zandman-Goddard G, Rotman P, Amital H, Sherer Y, Langevitz P, Goldman B, Shoenfeld Y: Response of vasculitic peripheral neuropathy to intravenous immunoglobulin. Ann N Y Acad Sci. 2005, 1051: 779-786. 10.1196/annals.1361.121.CrossRefPubMed
58.
go back to reference Katz U, Achiron A, Sherer Y, Shoenfeld Y: Safety of intravenous immunoglobulin (IVIG) therapy. Autoimmun Rev. 2007, 6: 257-259. 10.1016/j.autrev.2006.08.011.CrossRefPubMed Katz U, Achiron A, Sherer Y, Shoenfeld Y: Safety of intravenous immunoglobulin (IVIG) therapy. Autoimmun Rev. 2007, 6: 257-259. 10.1016/j.autrev.2006.08.011.CrossRefPubMed
59.
go back to reference Katz U, Zandman-Goddard G: Drug-induced lupus: an update. Autoimmun Rev. 2010, 10: 46-50. 10.1016/j.autrev.2010.07.005.CrossRefPubMed Katz U, Zandman-Goddard G: Drug-induced lupus: an update. Autoimmun Rev. 2010, 10: 46-50. 10.1016/j.autrev.2010.07.005.CrossRefPubMed
Metadata
Title
Biologic therapy for autoimmune diseases: an update
Authors
Ziv Rosman
Yehuda Shoenfeld
Gisele Zandman-Goddard
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Medicine / Issue 1/2013
Electronic ISSN: 1741-7015
DOI
https://doi.org/10.1186/1741-7015-11-88

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