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Review Article

Chronic inflammatory diseases: Do immunological patterns drive the choice of biotechnology drugs? A critical review

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Pages 287-306 | Received 23 Dec 2013, Accepted 17 Feb 2014, Published online: 03 Apr 2014

References

  • American Autoimmune Related Diseases Association, Inc. 2011. The cost burden of autoimmune disease: the latest front in the war on healthcare spending. Available at: http://www.aarda.org/pdf/cbad.pdf
  • Vizcarra, C., and D. Belcher. 2006. Management of the patient receiving parenteral biologic therapy. J. Infus. Nurs. 29: 63–71
  • Marquardt, J. L., Jr. R. H. Begent, K. Chester, et al. 2012. IBC's 23rd Antibody Engineering and 10th Antibody Therapeutics Conferences and the Annual Meeting of the Antibody Society: December 2–6, 2012, San Diego, CA. MAbs. 4: 648–652
  • Reichert, J. M. 2013. Which are the antibodies to watch in 2013? MAbs. 5: 1–4
  • Ackermann, C., and A. Kavanaugh. 2007. Tumor necrosis factor as a therapeutic target of rheumatologic disease. Expert Opin. Ther. Targets. 11: 1369–1384
  • Chang, J. T., and G. R. Lichtenstein. 2006. Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease. Nat. Clin. Pract. Gastroenterol. Hepatol. 3: 220–228
  • Myers, W. A., A. B. Gottlieb, and P. Mease. 2006. Psoriasis and psoriatic arthritis: clinical features and disease mechanisms. Clin. Dermatol. 24: 438–447
  • Bennett, A. N., A. L. Tan, L. C. Coates, et al. (2008). Sustained response to anakinra in ankylosing spondylitis. Rheumatology (Oxford). 47: 223–224
  • Haibel, H., M. Rudwaleit, J. Listing, and J. Sieper. 2005. Open label trial of anakinra in active ankylosing spondylitis over 24 weeks. Ann. Rheum. Dis. 64: 296–298
  • Kiltz, U., F. Heldmann, X. Baraliakos, and J. Braun. 2012. Treatment of ankylosing spondylitis in patients refractory to TNF-inhibition: are there alternatives? Curr. Opin. Rheumatol. 24: 252–260
  • Shealy, D., A. Cai, K. Staquet, et al. 2010. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α. MAbs. 2: 428–439
  • Blick, S. K., and M. P. Curran. 2007. Certolizumab pegol: in Crohn's disease. BioDrugs. 21: 195–201; discussion 202–203
  • Kerensky T. A., A. B. Gottlieb, S. Yaniv, and S. C. Au. 2012. Etanercept: efficacy and safety for approved indications. Expert Opin. Drug Saf. 11: 121–139
  • Trinchard-Lugan, I., Q. Ho-Nguyen, W. M. Bilham, et al. 2001. Safety, pharmacokinetics and pharmacodynamics of recombinant human tumour necrosis factor-binding protein-1 (Onercept) injected by intravenous, intramuscular and subcutaneous routes into healthy volunteers. Eur. Cytokine Netw. 12: 391–398
  • Papp, K. 2010. Clinical development of onercept, a tumor necrosis factor binding protein, in psoriasis. Curr. Med. Res. Opin. 26: 2287–2300
  • Tracey, D., L. Klareskog, E. H. Sasso, et al. 2008. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol. Ther. 117: 244–279
  • Okuda, Y. 2008. Review of tocilizumab in the treatment of rheumatoid arthritis. Biologics. 2: 75–82
  • Smolen, J. S., M. M. Schoels, N. Nishimoto, et al. 2013. Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. Ann. Rheum. Dis. 72: 482–492
  • Buch, M. H., J. S. Smolen, N. Betteridge, et al.; Rituximab Consensus Expert Committee. 2011. Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann. Rheum. Dis. 70: 909–920
  • Genovese, M. C., E. Lee, J. Satterwhite, et al. 2013. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann. Rheum. Dis. 72: 1453–1460
  • Schiff, M., M. Keiserman, C. Codding, et al. 2008. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann. Rheum. Dis. 67: 1096–1103
  • Keystone, E. C., J. M. Kremer, A. Russell, et al. 2012. Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study. Ann. Rheum. Dis. 71: 857–861
  • Mease, P. J., D. D. Gladman, E. C. Keystone, and Alefacept in Psoriatic Arthritis Study Group. 2006. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 54: 1638–1645
  • Talamonti, M., G. Spallone, A. Di Stefani, et al. 2011. Efalizumab. Expert Opin. Drug Saf. 10: 239–251
  • Tak, P. P., A. Balanescu, V. Tseluyko, et al. 2013. Chemokine receptor CCR1 antagonist CCX354-C treatment for rheumatoid arthritis: CARAT-2, a randomised, placebo controlled clinical trial. Ann. Rheum. Dis. 72: 337–344
  • Kane, S. V., S. Horst, W. J. Sandborn, et al. 2012. Natalizumab for moderate to severe Crohn's disease in clinical practice: the Mayo Clinic Rochester experience. Inflamm. Bowel Dis. 18: 2203–2208
  • Leonardi, C. L., A. B. Kimball, K. A. Papp, et al.; PHOENIX 1 study investigators. 2008. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 371: 1665–1674
  • Papp, K. A., R. G. Langley, M. Lebwohl, et al.; PHOENIX 2 study investigators. 2008. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 371: 1675–1684
  • Gottlieb, A., A. Menter, A. Mendelsohn, et al. 2009. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 373: 633–640
  • EMA. 2006. Questions and answers on biosimilar medicines (similar biological medicinal products). Available at: www.emea.europa.eu/pdfs/human/pcwp/7456206en.pdf
  • Rathore, A. S. 2009. Follow-on protein products: scientific issues, developments and challenges. Trends Biotechnol. 27: 698–705
  • Garces, S., J. Demengeot, and E. Benito-Garcia. 2013. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann. Rheum. Dis. 72: 1947–1955
  • Vincent, F. B., E. F. Morand, K. Murphy, et al. 2013. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann. Rheum. Dis. 72: 165–178
  • Robinson, C. J., and C. Jones. 2011. Quality control and analytical techniques for biopharmaceuticals. Bioanalysis. 3: 81–95
  • Lee, J. F., J. B. Litten, and G. Grampp. 2012. Comparability and biosimilarity: considerations for the healthcare provider. Curr. Med. Res. Opin. 28: 1053–1058
  • Sahoo, N., K. Choudhury, and P. Manchikanti. 2009. Manufacturing of biodrugs: need for harmonization in regulatory standards. BioDrugs. 23: 217–229
  • Kozlowski, S., and P. Swann. 2009. Considerations for biotechnology product quality by design. In Quality by Design for Biopharmaceuticals: Principles and Case Studies. A. S. Rathore and R. Mhatre, eds. Wiley Interscience, NJ, USA. p. 9–30
  • Schellekens, H. 2005. Follow-on biologics: challenges of the “next generation”. Nephrol. Dial. Transplant. 20: iv31–36
  • Walsh, G., and R. Jefferis. 2006. Post-translational modifications in the context of therapeutic proteins. Nat. Biotechnol. 24: 1241–1252
  • Barosi, G., A. Bosi, M. P. Abbracchio, et al. 2011. Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica. 96: 937–942
  • Mellstedt, H., D. Niederwieser, and H. Ludwig. 2008. The challenge of biosimilars. Ann. Oncol. 19: 411–419
  • Bartelds, G. M., C. A. Wijbrandts, M. T. Nurmohamed, et al. 2010. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann. Rheum. Dis. 69: 817–821
  • Breban, M., P. Ravaud, P. Claudepierre, et al.; French Ankylosing Spondylitis Infliximab Network. 2008. Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomized controlled trial comparing systematic versus on-demand treatment. Arthritis Rheum. 58: 88–97
  • Kuhlmann, M., and A. Covic. 2006. The protein science of biosimilars. Nephrol. Dial. Transplant. 21: v4–8
  • US Department of Health and Human Service, FDA. 2006. Guidance for Industry: Q9 Quality Risk Management. Available at: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073511.pdf
  • Covic, A., J. Cannata-Andia, G. Cancarini, et al. 2008. Biosimilars and biopharmaceuticals: what the nephrologists need to know–a position paper by the ERA-EDTA Council. Nephrol. Dial. Transplant. 23: 3731–3737
  • No author listed. 2008. Quality risk management for aseptic processes. Technical report No. 44. PDA J. Pharm. Sci.Technol. 62: 2–39
  • Schellekens, H. 2009. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2: i27–i36
  • Nakajima, K. 2012. Critical role of the interleukin-23/T-helper 17 cell axis in the pathogenesis of psoriasis. J. Dermatol. 39: 219–224
  • Gottlieb, S. L., P. Gilleaudeau, R. Johnson, et al. 1995. Response of psoriasis to a lymphocyte-selective toxin (DAB389IL-2) suggests a primary immune, but not keratinocyte, pathogenic basis. Nat. Med. 1: 442–447
  • Wrone-Smith, T., and B. J. Nickoloff. 1996. Dermal injection of immunocytes induces psoriasis. J. Clin. Invest. 98: 1878–1887
  • Kess, D., T. Peters, J. Zamek, et al. 2003. CD4+ T cell-associated pathophysiology critically depends on CD18 gene dose effects in a murine model of psoriasis. J. Immunol. 171: 5697–5706
  • Rivas Bejarano, J. J., and W. C. Valdecantos. 2013. Psoriasis as autoinflammatory disease. Dermatol. Clin. 31: 445–460
  • Foulkes, A. C., D. J. Grindlay, C. E. Griffiths, and R. B. Warren. 2011. What's new in psoriasis? An analysis of guidelines and systematic reviews published in 2009–2010. Clin. Exp. Dermatol. 36: 585–589 (quiz 588–589)
  • Davidovici, B. B., N. Sattar, J. Prinz, et al. 2010. Psoriasis and systemic inflammatory diseases: potential mechanistic links between skin disease and co-morbid conditions. J. Invest. Dermatol. 130: 1785–1796
  • Gladman, D. D., C. Antoni, P. Mease, et al. 2005. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann. Rheum. Dis. 64: ii14–17
  • Kurd, S. K., A. B. Troxel, P. Crits-Christoph, and J. M. Gelfand. 2010. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch. Dermatol. 146: 891–895
  • Christophers, E., J. N. Barker, C. E. Griffiths, et al. 2010. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J. Eur. Acad. Dermatol. Venereol. 24: 548–554
  • Wolff, K., R. A. Johson, and D. Suurmond. 2005. Fitzpatrick’s Color Atlas & Synopsis of Clinical Dermatology. 5th ed., McGraw-Hill, New York
  • Lowes, M. A., T. Kikuchi, J. Fuentes-Duculan, et al. 2008. Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells. J. Invest. Dermatol. 128: 1207–1211
  • Nograles, K. E., R. D. Brasington, and A. M. Bowcock. 2009. New insights into the pathogenesis and genetics of psoriatic arthritis. Nat. Clin. Pract. Rheumatol. 5: 83–91
  • Lowes, M. A., A. M. Bowcock, and J. G. Krueger. 2007. Pathogenesis and therapy of psoriasis. Nature. 445: 866–873
  • Nestle, F. O., C. Conrad, A. Tun-Kyi, et al. 2005. Plasmacytoid predendritic cells initiate psoriasis through interferon-alpha production. J. Exp. Med. 202: 135–143
  • Nograles, K. E., L. C. Zaba, E. Guttman-Yassky, et al. 2008. Th17 cytokines interleukin (IL)-17 and IL-22 modulate distinct inflammatory and keratinocyte-response pathways. Br. J. Dermatol. 159: 1092–1102
  • Zaba, L. C., I. Cardinale, P. Gilleaudeau, et al. 2007. Amelioration of epidermal hyperplasia by TNF inhibition is associated with reduced Th17 responses. J. Exp. Med. 204: 3183–3194
  • Prieto-Pérez, R., T. Cabaleiro, E. Daudén, et al. 2013. Genetics of psoriasis and pharmacogenetics of biological drugs. Autoimmune Dis. 2013: 613086
  • Puig, L., J. M. Carrascosa, G. Carretero, et al.; Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology. 2013. Spanish evidence-based guidelines on the treatment of psoriasis with biologic agents, 2013. Part 1: on efficacy and choice of treatment. Actas. Dermosifiliogr. 104: 694–709
  • Nast, A., W. H. Boehncke, U. Mrowietz, et al.; Deutsche Dermatologische Gesellschaft (DDG); Berufsverband Deutscher Dermatologen (BVDD). 2012. S3 - Guidelines on the treatment of psoriasis vulgaris (English version). Update. J. Dtsch. Dermatol. Ges. 10: S1–S95
  • Salvarani, C., N. Pipitone, A. Marchesoni, et al.; Italian Society for Rheumatology. 2011. Recommendations for the use of biologic therapy in the treatment of psoriatic arthritis: update from the Italian Society for Rheumatology. Clin. Exp. Rheumatol. 29: S28–S41
  • Gossec, L., J. S. Smolen, C. Gaujoux-Viala, et al.; European League Against Rheumatism. 2012. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann. Rheum. Dis. 71: 4–12
  • Smith, C. H., A. V. Anstey, J. N. Barker, et al.; (Chair of Guideline Group). 2009. British Association of Dermatologists' guidelines for biologic interventions for psoriasis 2009. Br. J. Dermatol. 161: 987–1019
  • Hsu, S., K. A. Papp, M. G. Lebwohl, et al.; National Psoriasis Foundation Medical Board. 2012. Consensus guidelines for the management of plaque psoriasis. Arch. Dermatol. 148: 95–102
  • Reich, K. 2012. The concept of psoriasis as a systemic inflammation: implications for disease management. J. Eur. Acad. Dermatol. Venereol. 26: 3–11
  • Turesson, C., W. M. O'Fallon, C. S. Crowson, et al. 2003. Extra-articular disease manifestations in rheumatoid arthritis: incidence trends and risk factors over 46 years. Ann. Rheum. Dis. 62: 722–727
  • Pisetsky, D. S., and M. M. Ward. 2012. Advances in the treatment of inflammatory arthritis. Best Pract. Res. Clin. Rheumatol. 26: 251–261
  • Aletaha, D., T. Neogi, A. J. Silman, et al. 2010. Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 62: 2569–2581
  • Arnett, F. C., S. M. Edworthy, D. A. Bloch, et al. 1988. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 31: 315–324
  • Bultink, I. E., M. Vis, I. E. van der Horst-Bruinsma, and W. F. Lems. 2012. Inflammatory rheumatic disorders and bone. Curr. Rheumatol. Rep. 14: 224–230
  • Inman, R. D., and H. S. El-Gabalawy. 2009. The immunology of ankylosing spondylitis and rheumatoid arthritis: a tale of similarities and dissimilarities. Clin. Exp. Rheumatol. 27: S26–S32
  • Finnegan, A., S. Ashaye, and K. M. Hamel. 2012. B effector cells in rheumatoid arthritis and experimental arthritis. Autoimmunity. 45: 353–363
  • Lundy, S. K., S. Sarkar, L. A. Tesmer, and D. A. Fox. 2007. Cells of the synovium in rheumatoid arthritis. T lymphocytes. Arthritis Res. Ther. 9: 202
  • Aggarwal, A., A. Sharma, and A. Bhatnagar. 2013. Bi(o)communications among peripheral blood fractions: a focus on NK and NKT cell biology in rheumatoid arthritis. Autoimmunity. 46: 238–250
  • Choi, S. I., and E. Brahn. 2010. Rheumatoid arthritis therapy: advances from bench to bedside. Autoimmunity. 43: 478–492
  • Ruderman, E. M., K. M. Nola, S. Ferrell, et al. 2012. Incorporating the treat-to-target concept in rheumatoid arthritis. J. Manag. Care Pharm. 18: 1–18
  • Atzeni, F., M. Benucci, S. Salli, et al. 2013. Different effects of biological drugs in rheumatoid arthritis. Autoimmun. Rev. 12: 575–579
  • Ozgocmen, S., and M. A. Khan. 2012. Current concept of spondyloarthritis: special emphasis on early referral and diagnosis. Curr. Rheumatol. Rep. 14: 409–414
  • Poddubnyy, D., and M. Rudwaleit. 2012. Early spondyloarthritis. Rheum. Dis. Clin. North Am. 38: 387–403
  • Rudwaleit, M., D. van der Heijde, R. Landewe. 2009. The development of Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann. Rheum. Dis. 68: 777–783
  • Rudwaleit, M., D. van der Heijde, R. Landewe, et al. 2011. The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general. Ann. Rheum. Dis. 70: 25–31
  • Amor, B., M. Dougados, and M. Mijiyawa. 1990. Criteria of the classification of spondylarthropathies. Rev. Rhum. Mal. Osteoartic. 57: 85–89
  • Dougados, M., S. van der Linden, R. Juhlin, et al. 1991. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 34: 1218–1227
  • van der Heijde, D., J. Sieper, W. P. Maksymowych, et al.; Assessment of SpondyloArthritis International Society. 2011. 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann. Rheum. Dis. 70: 905–908
  • Braun, J., R. van den Berg, X. Baraliakos, et al. 2011. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann. Rheum. Dis. 70: 896–904
  • Elewaut D., and M. Matucci-Cerinic. 2009. Treatment of ankylosing spondylitis and extra-articular manifestations in everyday rheumatology practice. Rheumatology (Oxford). 48: 1029–1035
  • Sherlock, J. P., C. D. Buckley, and D. J. Cua. 2014. The critical role of interleukin-23 in spondyloarthropathy. Mol. Immunol. 57: 38–43
  • Robinson P. C., and M. A. Brown. 2013. The genetics of ankylosing spondylitis and axial spondyloarthritis. Rheum. Dis. Clin. North Am. 38: 539–553
  • Seregin, S. S., D. P. Rastall, I. Evnouchidou, et al. 2013. Endoplasmic reticulum aminopeptidase-1 alleles associated with increased risk of ankylosing spondylitis reduce HLA-B27 mediated presentation of multiple antigens. Autoimmunity. 46: 497–508
  • Baraliakos X. and J. Braun. 2011. Spondyloarthritides. Best Pract. Res. Clin. Rheumatol. 25: 825–842
  • Zochling, J., D. van der Heijde, R. Burgos-Vargas, et al.; ‘ ASsessment in AS' international working group; European League Against Rheumatism. 2006. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann. Rheum. Dis. 65: 442–452
  • Adams, K., C. Bombardier, and D. van der Heijde. 2012. Safety and efficacy of on-demand versus continuous use of nonsteroidal antiinflammatory drugs in patients with inflammatory arthritis: a systematic literature review. J. Rheumatol. Suppl. 90: 56–58
  • Baraliakos, X., and J. Braun. 2012. Biologic therapies for spondyloarthritis: what is new? Curr. Rheumatol. Rep. 14: 422–427
  • Scarpa, R., A. Cuocolo, R. Peluso, et al. 2008. Early psoriatic arthritis: the clinical spectrum. J. Rheumatol. 35: 137–141
  • Ruiz, D. G., M. N. Azevedo, and O. L. Santos. 2012. Psoriatic arthritis: a clinical entity distinct from psoriasis? Rev. Bras. Reumatol. 52: 630–638
  • Taylor, W., D. Gladman, P. Helliwell, et al.; CASPAR Study Group. 2006. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 54: 2665–2673
  • Hsieh, J., S. Kadavath, and P. Efthimiou. 2013. Can traumatic injury trigger psoriatic arthritis? A review of the literature. Clin. Rheumatol. [Epub ahead of print]
  • Maeda, S., Y. Hayami, T. Naniwa, and R. Ueda. 2012. The Th17/IL-23 Axis and natural immunity in psoriatic arthritis. Int. J. Rheumatol. 2012: 539683
  • Kavanaugh, A. F., C. T. Ritchlin, and G. T. G. Committee. 2006. Systematic review of treatments for psoriatic arthritis: an evidence based approach and basis for treatment guidelines. J. Rheumatol. 33: 1417–1421
  • Chang, C. A., A. B. Gottlieb, and P. F. Lizzul. 2011. Management of psoriatic arthritis from the view of the dermatologist. Nat. Rev. Rheumatol. 7: 588–598
  • Barr, A., and A. Keat. 2010. Spondyloarthritides: evolving therapies. Arthritis Res. Ther. 12: 221
  • Soriano, E. R. 2012. The actual role of therapy with traditional disease-modifying antirheumatic drugs in psoriatic arthritis. J. Rheumatol. 89: 67–70
  • Ash, Z., C. Gaujoux-Viala, L. Gossec, et al. 2012. A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis. Ann. Rheum. Dis. 71: 319–326
  • Mease, P. J., B. S. Goffe, J. Metz, et al. 2000. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 356: 385–390
  • Mease, P. J., A. J. Kivitz, F. X. Burch, et al. 2004. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 50: 2264–2272
  • Antoni, C. E., A. Kavanaugh, B. Kirkham, et al. 2005. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum. 52: 1227–1236
  • Mease, P. J., D. D. Gladman, C. T. Ritchlin, et al.; Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. 2005. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 52: 3279–3289
  • Kavanaugh, A., I. McInnes, P. Mease, et al. 2009. 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. 60: 976–986
  • Atzeni, F., P. Sarzi-Puttini, and G. A. Vena. 2009. Resistant cases of psoriatic arthritis: how to manage them. J. Rheumatol. 83: 73–75
  • Gottlieb, A., and K. Narang. 2013. Ustekinumab in the treatment of psoriatic arthritis: latest findings and clinical potential. Ther. Adv. Musculoskelet. Dis. 5: 277–285
  • Atzeni, F., D. Ventura, A. Batticciotto, et al. 2012. Interleukin 6 blockade: tocilizumab in psoriatic arthritis. J. Rheumatol. 89: 97–99
  • Schafer, P. 2012. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem. Pharmacol. 83: 1583–1590
  • Podolsky, D. K. 2002. Inflammatory bowel disease. N. Engl. J. Med. 347: 417–429
  • Baumgart, D. C., and W. J. Sandborn. 2012. Crohn's disease. Lancet. 380: 1590–1605
  • Ordas, I., L. Eckmann, M. Talamini, et al. 2012. Ulcerative colitis. Lancet. 380: 1606–1619
  • Silverberg, M. S., J. Satsangi, T. Ahmad, et al. 2005. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can. J. Gastroenterol. 19: 5–36
  • Khor, B., A. Gardet, and R. J. Xavier. 2011. Genetics and pathogenesis of inflammatory bowel disease. Nature. 474: 307–317
  • Raza, A., W. Yousaf, R. Giannella, and M. T. Shata. 2012. Th17 cells: interactions with predisposing factors in the immunopathogenesis of inflammatory bowel disease. Expert Rev. Clin. Immunol. 8: 161–168
  • Cosnes, J., C. Gower-Rousseau, P. Seksik, and A. Cortot. 2011. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 140: 1785–1794
  • Hoivik, M. L., T. Bernklev, I. C. Solberg, et al.; IBSEN Study Group. 2012. Patients with Crohn's disease experience reduced general health and vitality in the chronic stage: ten-year results from the IBSEN study. J. Crohns Colitis. 6: 441–453
  • McGovern, D., and F. Powrie. 2007. The IL23 axis plays a key role in the pathogenesis of IBD. Gut. 56: 1333–1336
  • Ivanov, I. I., L. Frutos Rde, N. Manel, et al. 2008. Specific microbiota direct the differentiation of IL-17-producing T-helper cells in the mucosa of the small intestine. Cell Host Microbe. 4: 337–349
  • Monteleone, G., I. Monteleone, D. Fina, et al. 2005. Interleukin-21 enhances T-helper cell type I signaling and interferon-gamma production in Crohn's disease. Gastroenterology. 128: 687–694
  • Shih, D. Q., S. R. Targan, and D. McGovern. 2008. Recent advances in IBD pathogenesis: genetics and immunobiology. Curr. Gastroenterol. Rep. 10: 568–575
  • Hisamatsu, T., T. Kanai, Y. Mikami, et al. 2013. Immune aspects of the pathogenesis of inflammatory bowel disease. Pharmacol. Ther. 137: 283–297
  • Danese, S. 2012. New therapies for inflammatory bowel disease: from the bench to the bedside. Gut. 61: 918–932
  • Orlando, A., A. Armuzzi, C. Papi, et al.; Italian Society of Gastroenterology; Italian Group for the study of Inflammatory Bowel Disease. 2011. The Italian Society of Gastroenterology (SIGE) and the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) Clinical Practice Guidelines: The use of tumor necrosis factor-alpha antagonist therapy in inflammatory bowel disease. Dig. Liver Dis. 43: 1–20
  • Dignass, A., G. Van Assche, J. O. Lindsay, et al.; European Crohn's and Colitis Organisation (ECCO). 2010. The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: current management. J. Crohns Colitis. 4: 28–62
  • Dignass, A., J. O. Lindsay, A. Sturm, et al. 2012. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J. Crohns Colitis. 6: 991–1030
  • Ford, A. C., W. J. Sandborn, K. J. Khan, et al. 2011. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am. J. Gastroenterol. 106: 644–659. (quiz 660)
  • Schnitzler, F., H. Fidder, M. Ferrante, et al. 2009. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: results from a single-centre cohort. Gut. 58: 492–500
  • Ferrante, M., S. Vermeire, H. Fidder, et al. 2008. Long-term outcome after infliximab for refractory ulcerative colitis. J. Crohns Colitis. 2: 219–225
  • Tozer, P., S. C. Ng, M. R. Siddiqui, et al. 2012. Long-term MRI-guided combined anti-TNF-alpha and thiopurine therapy for Crohn's perianal fistulas. Inflamm. Bowel Dis. 18: 1825–1834
  • Tonelli, F., F. Giudici, and C. R. Asteria. 2012. Effectiveness and safety of local adalimumab injection in patients with fistulizing perianal Crohn's disease: a pilot study. Dis. Colon Rectum. 55: 870–875
  • Seow, C. H., A. Newman, S. P. Irwin, et al. 2010. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 59: 49–54
  • Pariente, B., G. Pineton de Chambrun, R. Krzysiek, et al. 2012. Trough levels and antibodies to infliximab may not predict response to intensification of infliximab therapy in patients with inflammatory bowel disease. Inflamm. Bowel Dis. 18: 1199–1206
  • Vande Casteele, N., V. Ballet, G. Van Assche, et al. 2012. Early serial trough and antidrug antibody level measurements predict clinical outcome of infliximab and adalimumab treatment. Gut. 61: 321 (author reply 322)
  • D'Haens, G. R., R. Panaccione, P. D. Higgins, et al. 2011. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am. J. Gastroenterol. 106: 199–212 (quiz 213)
  • Louis, E., J. Y. Mary, G. Vernier-Massouille, et al.; Groupe D'etudes Therapeutiques Des Affections Inflammatoires Digestives. 2012. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 142: 63–70 e65 (quiz e31)
  • Colombel, J. F., W. J. Sandborn, W. Reinisch, et al.; SONIC Study Group. 2010. Infliximab, azathioprine, or combination therapy for Crohn's disease. N. Engl. J. Med. 362: 1383–1395
  • Panaccione, R., S. Ghosh, S. Middleton, et al. 2011. Infliximab, azathioprine, or infliximab + azathioprine for treatment of moderate to severe ulcerative colitis: The UC SUCCESS trial. Gastroenterology. 140: S–134
  • Van Assche, G., J. D. Lewis, G. R. Lichtenstein, et al. 2011. The London position statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: safety. Am. J. Gastroenterol. 106: 1594–1602 (quiz 1593, 1603)
  • Epis, O. M., L. Giacomelli, S. Deidda, and E. Bruschi. 2012. Tight control applied to the biological therapy of rheumatoid arthritis. Autoimmun. Rev. 12: 839–841
  • Pink, A. E., A. Fonia, M. H. Allen, et al. 2010. Antinuclear antibodies associate with loss of response to antitumour necrosis factor-alpha therapy in psoriasis: a retrospective, observational study. Br. J. Dermatol. 162: 780–785
  • Bartelds, G. M., C. A. Wijbrandts, M. T. Nurmohamed, et al. 2007. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann. Rheum. Dis. 66: 921–926
  • Moots, R. J., and B. Naisbett-Groet. 2012. The efficacy of biologic agents in patients with rheumatoid arthritis and an inadequate response to tumour necrosis factor inhibitors: a systematic review. Rheumatology (Oxford). 51: 2252–2261
  • Finckh, A., A. Ciurea, L. Brulhart, et al. 2010. Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab versus alternative anti-tumour necrosis factor (TNF) agents after previous failure of an anti-TNF agent? Ann. Rheum. Dis. 69: 387–393
  • Jamnitski, A., G. M. Bartelds, M. T. Nurmohamed, et al. 2011. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann. Rheum. Dis. 70: 284–288
  • ADOI-ISS. 2013. Linee guida – Il trattamento della Psoriasi nell'adulto. Milano: Zadig
  • de Vries, M. K., I. E. van der Horst-Bruinsma, M. T. Nurmohamed, et al. 2009. Immunogenicity does not influence treatment with etanercept in patients with ankylosing spondylitis. Ann. Rheum. Dis. 68: 531–535
  • Bendtzen, K., P. Geborek, M. Svenson, et al. 2006. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 54: 3782–3789
  • Papp, K. A., C. E. Griffiths, K. Gordon, et al.; PHOENIX 1 Investigators; PHOENIX 2 Investigators; ACCEPT Investigators. 2013. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br. J. Dermatol. 168: 844–854
  • Zhu, Y., C. Hu, M. Lu, et al. 2009. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J. Clin. Pharmacol. 49: 162–175
  • Mulleman, D., E. Ducourau, G. Paintaud, et al. 2012. Should anti-TNF-alpha drug levels and/or anti-drug antibodies be assayed in patients treated for rheumatoid arthritis? Joint Bone Spine. 79: 109–112
  • Todoerti, M., N. Pipitone, M. Matucci-Cerinic, et al.; Italian Society for Rheumatology. 2011. Recommendations for the use of biologic therapy from the Italian Society for Rheumatology: off-label use. Clin. Exp. Rheumatol. 29: S42–S62
  • Talamonti, M., E. Botti, M. Galluzzo, et al. 2013. Pharmacogenetics of psoriasis: HLA-Cw6 but not LCE3B/3C deletion nor TNFAIP3 polymorphism predisposes to clinical response to interleukin 12/23 blocker ustekinumab. Br. J. Dermatol. 169: 458–463

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