Ustekinumab in chronic immune-mediated diseases: A review of long term safety and patient improvement

Patient Preference and Adherence

Volumn 7, Issue , 2013, Pages 369-377

  Toussirot, Éric ^a,b   Michel, Fabrice ^a   Béreau, Matthieu ^a   Binda, Delphine ^a,c  

^a UNIVERSITY HOSPITAL OF BESANÇON   (France)

^b UNIVERSITÉ DE FRANCHE COMTÉ   (France)

^c RIGHT Interactions Hôte Greffon Tumeur Ingénierie Cellulaire et Génique   (France)

Author keywords

Autoimmune diseases; IL 23; Psoriasis; Quality of life

Indexed keywords

CELL SURFACE RECEPTOR; ETANERCEPT; INFLIXIMAB; INTERLEUKIN 12; INTERLEUKIN 17; INTERLEUKIN 23; PLACEBO; USTEKINUMAB;

ARTICLE; ATOPY; CARDIOVASCULAR DISEASE; CROHN DISEASE; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; HELPER CELL; HISTOPLASMOSIS; HUMAN; IMMUNOMODULATION; INJECTION SITE REACTION; MALIGNANT NEOPLASTIC DISEASE; MULTIPLE SCLEROSIS; MYALGIA; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; PATIENT SATISFACTION; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PROTEIN PROTEIN INTERACTION; PSORIASIS; PSORIATIC ARTHRITIS; QUALITY OF LIFE; RESPIRATORY TRACT INFECTION; RHINOPHARYNGITIS; SORE THROAT; SYMPTOM; TH17 CELL; TREATMENT RESPONSE;

EID: 84877083150     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S33162     Document Type: Article

References (43)

1. Tobin AM, Kirby B. TNF alpha inhibitors in the treatment of psoriasis and psoriatic arthritis. Bio Drugs. 2005;19(1):47-57.
2. Peyrin-Biroulet L, Deltenre P, de Suray N, Branche J, Sandborn WJ, Colombel JF. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2008;6(6):644-653.
3. Miossec P, Korn T, Kuchroo VK. Interleukin-17 and type 17 helper T cells. N Engl J Med. 2009;361(9):888-898.
4. Romagnani R. Human Th17cells. Arthritis Res Ther. 2008; 10(2):206.
5. Toussirot E. The IL-23/Th17 pathway as a therapeutic target in chronic inflammatory diseases. Inflamm Allergy Drugs Targets. 2012;11(2):159-168.
6. McGeachy MJ, Cua DJ. The link between IL-23 and Th17 cell-mediated immune pathologies. Semin Immunol. 2007;19(6):372-376.
7. Langrish CL, Chen Y, Blumenschein WM, etal. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005;201(1):233-240.
8. Elliott M, Benson J, Blank M, etal. Ustekinumab: lessons learned from targeting interleukin-12/23p40in immune-mediated diseases. Ann N Y Acad Sci. 2009;1182:97-110.
9. Kurzeja M, Rudnicka L, Olszewska M. New interleukin-23 pathway inhibitors in dermatology. Am J Clin Dermatol. 2011;12(2):113-125.
10. Cingoz O. Ustekinumab. MAbs. 2009;1(3):216-221.
11. Croxtall JD. Ustekinumab: a review of its use in the management of moderate to severe plaque psoriasis. Drugs. 2011;71(13):1733-1753.
12. Gee K, Guzzo C, Che Mat NF, Ma W, Kumar A. The IL-12 family of cytokines in infection, inflammation and autoimmune disorders. Inflam Allergy-Drug Targets. 2009;8(1):40-52.
13. Kikly R, Liu L, Na S, Sedwick JD. The IL-23/Th17 axis: therapeutic target for autoimmune inflammation. Curr Opin Immunol. 2006;18(6): 670-675.
14. Iwakura Y, Ishigame H. The IL-23/IL-17 axis in inflammation. J Clin Invest. 2006;116(5):1218-1222.
15. Tang C, Chen S, Qian H, Huanh W. IL-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012;135(2):112-124.
16. Miossec P. IL-17 and Th17cells in human inflammatory diseases. Microbes Infections. 2009;11(5):625-630.
17. Pappu R, Ramirez-Carrozzi V, Sambandam A. The interleukin-17 cytokine family: critical players in host defence and inflammatory diseases. Immunology. 2011;134(1):8-16.
18. Shaker OG, Moustafa W, Essmat S, Abdel-Halim M, El-Komy M. The role of interleukin-12in the pathogenesis of psoriasis. Clin Biochem. 2006;39(2):119-125.
19. Lee E, Trepicchio WL, Oestreicher JL, etal. Increased expression of interleukin 23 p19 and p40in lesional skin of patients with psoriasis vulgaris. J Exp Med. 2004;199(1):125-130.
20. Krueger GG, Langley RG, Leonardi C, etal. A human interleukin 12/23monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007;356(6):580-592.
21. Leonardi CL, Kimball AB, Papp KA, etal. Efficacy and safety of ustekinumab, a human interleukin-12/23monoclonal antibody in patients with psoriasis: 76 week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625): 1665-1674.
22. Papp KA, Langley RG, Lebwohl M, etal. Efficacy and safety of ustekinumab, a human interleukin-12/23monoclonal antibody in patients with psoriasis: 52 week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625): 1675-1684.
23. Griffiths CEM, Strober B, van de Kerkhof P, etal. Comparison of ustekinumab and etanercept for moderate to severe psoriasis. N Engl J Med. 2010;362(2):118-128.
24. Ritchlin C, Haas-Smith SA, Hicks D, etal. Patterns of cytokine production in psoriatic synovium. J Rheumatol. 1998;25(8):1544-1552.
25. Gottlieb A, Menter A, Mendelsohn A, etal. Ustekinumab, a human interleukin-12/23monoclonal antibody for psoriatic arthritis: randomised, double-blind, placebo-controlled, cross-over trial. Lancet. 2009;373(9664):633-640.
26. Kavanaugh A, McInnes I, Gottlieb A, etal. Ustekinumab in patients with active psoriatic arthritis: results of the phase 3, multicentre, double-blind, placebo-controlled Psummit I study. Arthritis Rheum. 2012;64(Suppl 10):S1083-S1084.
27. Ritchlin CT, Gottlieb A, McInnes I, etal. Ustekinumab in active psoriatic arthritis including patients previously treated with anti-TNF agents: results of a phase 3, multicentre, double-blind, placebo-controlled study. Arthritis Rheum. 2012;64(Suppl 10):S1080-S1081.
28. Scherl EJ, Kumar S, Warren RU. Review on the safety and efficacy of ustekinumab. Ther Adv Gastroenterol. 2010;3(5):321-328.
29. Fujino S, Andoh A, Bamba S, etal. Increased expression of interleukin 17 in inflammatory bowel disease. Gut. 2003;52(1):65-70.
30. Elson CO, Cong Y, Weaver CT, etal. Monoclonal anti-interleukin 23reverses active colitis in a T cell-mediated model in mice. Gastroenterology. 2007;132(7):2359-2370.
31. Sandborn WJ, Feagan BG, Fedorak RN, etal. A randomized trial of ustekinumab, a human interleukin-12/23monoclonal antibody in patients with moderate to severe Crohn's disease. Gastroenterology. 2008;135(4):1130-1141.
32. Sandborn WJ, Gasink C, Gao LL, etal. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012;367(16):1519-1528.
33. Cua D, Sherlock J, Chen Y, etal. Intereukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain. Nature. 2003;421(6924):744-748.
34. Chen Y, Langrish CL, McKenzie B, etal. Anti-IL-23 therapy inhibits multiple inflammatory pathways and ameliorates autoimmune encephalomyelitis. J Clin Invest. 2006;116(5):1317-1326.
35. Segal BM, Constantinescu C, Raychaudhuri A, etal. Repeated subcutaneous injections of IL-12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose ranging study. Lancet Neurol. 2008;7(9):796-804.
36. Lebwohl M, Leonardi G, Griffiths CEM, etal. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (part I of II): results from analyses of general safety parameters from pooled phase 2 and 3 clinical trials. J Am Acad Dermatol. 2012;66(5):731-741.
37. Gordon KB, Papp KA, Langley RG, etal. Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials. J Am Acad Dermatol. 2012;66(5):742-751.
38. Tzellos T, Kyrgidis A, Zouboulis CC. Re-evaluation of the risk for major adverse cardiovascular events in patients treated with IL-12/23 biological agents for chronic plaque psoriasis: a meta-analysis of randomized controlled trials. J Eur Acad Dermatol Venereol. Epub March 8, 2012.
39. Puig L, Morales-Munera CE, Lopez-Ferrer A, Geli C. Ustekinumab treatment of TNF antagonist-induced paradoxical psoriasis flare in a patient with psoriatic arthritis: case report and review. Dermatology. 2012;225(1):14-17.
40. De Souza A, Ali-Shaw T, Redy SM, Fiorentino D, Strober BE. Inflammatory arthritis following ustekinumab treatment for psoriasis: a report of two cases. Br J Dermatol. 2013;168(1):210-212.
41. Lebwohl M, Papp K, Han C, etal. Ustekinumab improves health-related quality of life in patients with moderate to severe psoriasis: results from the PHOENIX I trial. Br J Dermatol. 2010;162(1):137-146.
42. Langley RG, Feldman SR, Han C, etal. Ustekinumab significantly improves symptoms of anxiety, depression, and skin related quality of life in patients with moderate to severe psoriasis: results from a randomized, double-blind, placebo controlled phase III trial. J Am Acad Dermatol. 2010;63(3):457-465.
43. Guenther L, Han C, Szapary P, etal. Impact of ustekinumab on health related quality of life and sexual difficulties associated with psoriasis: results from two phase III clinical trials. J Eur Acad Dermatol Venereol. 2011;25(7):851-857.