Biologic therapy for autoimmune diseases: An update

BMC Medicine

Volumn 11, Issue 1, 2013, Pages

  Rosman, Ziv ^a   Shoenfeld, Yehuda ^b,c   Zandman Goddard, Gisele ^a,c  

^a WOLFSON MEDICAL CENTER   (Israel)

^b SHEBA MEDICAL CENTER   (Israel)

^c TEL AVIV UNIVERSITY   (Israel)

Author keywords

Anti TNF; Autoimmune diseases; B cell depletion; Biologics; Rheumatoid arthritis; Spondyloarthritis; Systemic lupus erythematosus; Systemic sclerosis; Vasculitis

Indexed keywords

ABATACEPT; ANTIHISTAMINIC AGENT; BELIMUMAB; C REACTIVE PROTEIN; CANAKINUMAB; CERTOLIZUMAB PEGOL; CHOLESTEROL; EPRATUZUMAB; GOLIMUMAB; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; IMMUNOGLOBULIN; INTERLEUKIN 6; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METHOTREXATE; METHYLPREDNISOLONE; OFATUMUMAB; PARACETAMOL; PREDNISONE; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RITUXIMAB; SIFALIMUMAB; TOCILIZUMAB;

AUTOIMMUNE DISEASE; BACKACHE; BIOLOGICAL THERAPY; CYSTITIS; DIARRHEA; DISEASE ACTIVITY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPNEA; FATIGUE; FEVER; FLUSHING; FOLLOW UP; GASTROENTERITIS; GASTROINTESTINAL INFECTION; HEART DISEASE; HUMAN; HYPERTENSION; IDIOPATHIC THROMBOCYTOPENIC PURPURA; IMMUNOGENICITY; INFLAMMATION; JUVENILE RHEUMATOID ARTHRITIS; LEUKOPENIA; LIMB PAIN; LONG TERM CARE; LOW DRUG DOSE; MICROSCOPIC POLYANGIITIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PEMPHIGUS VULGARIS; PNEUMONIA; PRURITUS; PSORIATIC ARTHRITIS; RASH; RECOMMENDED DRUG DOSE; REMISSION; REVIEW; RHEUMATOID ARTHRITIS; RHINITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SJOEGREN SYNDROME; SKIN TUMOR; SPONDYLARTHRITIS; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC SCLEROSIS; TREATMENT INDICATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VASCULITIS; WEGENER GRANULOMATOSIS;

AUTOIMMUNE DISEASES; BIOLOGICAL THERAPY; HUMANS; IMMUNOSUPPRESSIVE AGENTS; IMMUNOTHERAPY;

EID: 84875687447     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-11-88     Document Type: Review

References (59)

1. 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, 3070275, 21187298.
2. Hashizume M, Mihara M. The roles of interleukin-6 in the pathogenesis of rheumatoid arthritis. Arthritis 2011, 2011:765624. 10.1155/2011/765624, 3199948, 22046525.
3. 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.
4. 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, 18520048.
5. 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. 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. 3270395, 22315615.
7. 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, 2732899, 19019888.
8. 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, 20223500.
9. Tak PP, Kalden JR. Advances in rheumatology: new targeted therapeutics. Arthritis Res Ther 2011, 13:S5. 3123966, 21624184.
10. 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, 3308069, 21884601.
11. 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. 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.
13. 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, 20194448.
14. 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, 3137658, 20647199, RAVE-ITN Research Group.
15. Palau J, Jarque I, Sanz MA. Long-term management of chronic immune thrombocytopenic purpura in adults. Int J Gen Med 2010, 3:305-311. 2962326, 21042569.
16. 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, 22243765.
17. 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. 3150146, 21826145.
18. 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, 20039413.
19. 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, 19946034.
20. Wallace DJ. Advances in drug therapy for systemic lupus erythematosus. BMC Med 2010, 8:77. 10.1186/1741-7015-8-77, 3009611, 21114845.
21. 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, 20110520.
22. 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.
23. 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, 22285615.
24. 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, 20506254.
25. 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, 3212699, 21859685.
26. 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, 2758229, 19714604.
27. 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, 21296403, BLISS-52 Study Group.
28. 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, 3040537, 21219397.
29. Dörner T, Goldenberg DM. Targeting CD22 as a strategy for treating systemic autoimmune diseases. Ther Clin Risk Manag 2007, 3:953-959. 2376077, 18473018.
30. 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 3261257, 21505771.
31. 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, 16052582.
32. 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, 20533545.
33. 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, 17212998.
34. 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, 16162882.
35. 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, 3171107, 21893583.
36. 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, 18975305.
37. 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, 19333944.
38. 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, 2674549, 19066176.
39. 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, 19644849.
40. 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, 21244218.
41. 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, 2674556, 19015207.
42. 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, 2674555, 19015206.
43. 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, 19479852.
44. 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, 21798883, Lupus Interferon Skin Activity (LISA) Study Investigators.
45. 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, 21859692.
46. 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, 23031624.
47. 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, 20533546.
48. 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, 19590986.
49. 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, 21864262.
50. 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, 21732045.
51. Rosman Z, Zandman-Goddard G. Intravenous immunoglobulin therapy for SLE. Future Medicine 2012,.
52. 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.
53. 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, 10602441.
54. 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, 16391397.
55. 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, 15609263.
56. 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, 20477027.
57. 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, 16127015.
58. 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, 17317619.
59. Katz U, Zandman-Goddard G. Drug-induced lupus: an update. Autoimmun Rev 2010, 10:46-50. 10.1016/j.autrev.2010.07.005, 20656071.