1,168
Views
37
CrossRef citations to date
0
Altmetric
Review

Association of ustekinumab and briakinumab with major adverse cardiovascular events

An appraisal of meta-analyses and industry sponsored pooled analyses to date

, , &
Pages 320-323 | Received 28 Nov 2012, Accepted 28 Nov 2012, Published online: 01 Jul 2012

References

  • Ryan C, Leonardi CL, Krueger JG, Kimball AB, Strober BE, Gordon KB, et al. Association between biologic therapies for chronic plaque psoriasis and cardiovascular events: a meta-analysis of randomized controlled trials. JAMA 2011; 306:864 - 71; http://dx.doi.org/10.1001/jama.2011.1211; PMID: 21862748
  • Tzellos T, Kyrgidis A, Zouboulis CC. Re-evaluation of the risk for major adverse cardiovascular events in patients treated with anti-IL-12/23 biological agents for chronic plaque psoriasis: a meta-analysis of randomized controlled trials. J Eur Acad Dermatol Venereol 2012; In press http://dx.doi.org/10.1111/j.1468-3083.2012.04500.x; PMID: 22404103
  • Gordon KB, Langley RG, Gottlieb AB, Papp KA, Krueger GG, Strober BE, et al. A phase III, randomized, controlled trial of the fully human IL-12/23 mAb briakinumab in moderate-to-severe psoriasis. J Invest Dermatol 2012; 132:304 - 14; http://dx.doi.org/10.1038/jid.2011.304; PMID: 22011907
  • Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol 2011; 165:652 - 60; http://dx.doi.org/10.1111/j.1365-2133.2011.10418.x; PMID: 21574983
  • Igarashi A, Kato T, Kato M, Song M, Nakagawa H, Japanese Ustekinumab Study Group. Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. J Dermatol 2012; 39:242 - 52; http://dx.doi.org/10.1111/j.1346-8138.2011.01347.x; PMID: 21955098
  • Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J, ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol 2008; 144:200 - 7; http://dx.doi.org/10.1001/archdermatol.2007.63; PMID: 18283176
  • Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, et al, CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 2007; 356:580 - 92; http://dx.doi.org/10.1056/NEJMoa062382; PMID: 17287478
  • Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y, et al, PHOENIX 1 study investigators. 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 2008; 371:1665 - 74; http://dx.doi.org/10.1016/S0140-6736(08)60725-4; PMID: 18486739
  • Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, et al, PHOENIX 2 study investigators. 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 2008; 371:1675 - 84; http://dx.doi.org/10.1016/S0140-6736(08)60726-6; PMID: 18486740
  • Strober BE, Crowley JJ, Yamauchi PS, Olds M, Williams DA. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol 2011; 165:661 - 8; http://dx.doi.org/10.1111/j.1365-2133.2011.10419.x; PMID: 21574984
  • Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, et al, PEARL Investigators. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci 2011; 63:154 - 63; http://dx.doi.org/10.1016/j.jdermsci.2011.05.005; PMID: 21741220
  • Bradburn MJ, Deeks JJ, Berlin JA, Russell Localio A. Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events. Stat Med 2007; 26:53 - 77; http://dx.doi.org/10.1002/sim.2528; PMID: 16596572
  • Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med 2002; 21:1575 - 600; http://dx.doi.org/10.1002/sim.1188; PMID: 12111921
  • Tzellos T, Kyrgidis A, Toulis K. Biologic therapies for chronic plaque psoriasis and cardiovascular events. JAMA 2011; 306:2095 - , author reply 2095-6; http://dx.doi.org/10.1001/jama.2011.1660; PMID: 22089716
  • Abuabara K, Lee H, Kimball AB. The effect of systemic psoriasis therapies on the incidence of myocardial infarction: a cohort study. Br J Dermatol 2011; 165:1066 - 73; http://dx.doi.org/10.1111/j.1365-2133.2011.10525.x; PMID: 21777216
  • Greenland S, Salvan A. Bias in the one-step method for pooling study results. Stat Med 1990; 9:247 - 52; http://dx.doi.org/10.1002/sim.4780090307; PMID: 2343220
  • Reich K, Langley RG, Lebwohl M, Szapary P, Guzzo C, Yeilding N, et al. Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies. Br J Dermatol 2011; 164:862 - 72; http://dx.doi.org/10.1111/j.1365-2133.2011.10257.x; PMID: 21332467
  • Reich K, Papp KA, Griffiths CE, Szapary PO, Yeilding N, Wasfi Y, et al, PHOENIX 1, PHOENIX 2, and ACCEPT investigators. An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. J Drugs Dermatol 2012; 11:300 - 12; PMID: 22395580
  • Griffiths CE, Strober BE, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, et al, ACCEPT Study Group. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010; 362:118 - 28; http://dx.doi.org/10.1056/NEJMoa0810652; PMID: 20071701
  • Barzi F, Patel A, Gu D, Sritara P, Lam TH, Rodgers A, et al, Asia Pacific Cohort Studies Collaboration. Cardiovascular risk prediction tools for populations in Asia. J Epidemiol Community Health 2007; 61:115 - 21; http://dx.doi.org/10.1136/jech.2005.044842; PMID: 17234869
  • Bastuji-Garin S, Deverly A, Moyse D, Castaigne A, Mancia G, de Leeuw PW, et al, Intervention as a Goal in Hypertension Treatment Study Group. The Framingham prediction rule is not valid in a European population of treated hypertensive patients. J Hypertens 2002; 20:1973 - 80; http://dx.doi.org/10.1097/00004872-200210000-00016; PMID: 12359975
  • Brindle P, Emberson J, Lampe F, Walker M, Whincup P, Fahey T, et al. Predictive accuracy of the Framingham coronary risk score in British men: prospective cohort study. BMJ 2003; 327:1267; http://dx.doi.org/10.1136/bmj.327.7426.1267; PMID: 14644971
  • Empana JP, Ducimetière P, Arveiler D, Ferrières J, Evans A, Ruidavets JB, et al, PRIME Study Group. Are the Framingham and PROCAM coronary heart disease risk functions applicable to different European populations? The PRIME Study. Eur Heart J 2003; 24:1903 - 11; http://dx.doi.org/10.1016/j.ehj.2003.09.002; PMID: 14585248
  • Hense HW, Schulte H, Löwel H, Assmann G, Keil U. Framingham risk function overestimates risk of coronary heart disease in men and women from Germany--results from the MONICA Augsburg and the PROCAM cohorts. Eur Heart J 2003; 24:937 - 45; http://dx.doi.org/10.1016/S0195-668X(03)00081-2; PMID: 12714025
  • Koller MT, Steyerberg EW, Wolbers M, Stijnen T, Bucher HC, Hunink MG, et al. Validity of the Framingham point scores in the elderly: results from the Rotterdam study. Am Heart J 2007; 154:87 - 93; http://dx.doi.org/10.1016/j.ahj.2007.03.022; PMID: 17584559
  • Lenz M, Mühlhauser I. [Cardiovascular risk assessment for informed decision making. Validity of prediction tools]. Med Klin (Munich) 2004; 99:651 - 61; http://dx.doi.org/10.1007/s00063-004-1097-3; PMID: 15583875
  • Marques-Vidal P, Rodondi N, Bochud M, Chiolero A, Pécoud A, Hayoz D, et al. Predictive accuracy of original and recalibrated Framingham risk score in the Swiss population. Int J Cardiol 2009; 133:346 - 53; http://dx.doi.org/10.1016/j.ijcard.2008.01.004; PMID: 18485502
  • Neuhauser HK, Ellert U, Kurth BM. A comparison of Framingham and SCORE-based cardiovascular risk estimates in participants of the German National Health Interview and Examination Survey 1998. Eur J Cardiovasc Prev Rehabil 2005; 12:442 - 50; http://dx.doi.org/10.1097/01.hjr.0000183909.52118.9f; PMID: 16210930
  • Reich K, Langley RG, Papp KA, Ortonne J-P, Unnebrink K, Kaul M, et al. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med 2011; 365:1586 - 96; http://dx.doi.org/10.1056/NEJMoa1010858; PMID: 22029980
  • Langley RGB, Papp KA, Gottlieb AB, Krueger GG, Gordon KB, Williams DA, et al. Safety Results from a Pooled Analysis of Randomized, Controlled Phase II and III Clinical Trials and Interim Data from an Open-Label Extension Trial of the Interleukin-12/23 Monoclonal Antibody, Briakinumab, in Moderate to Severe Psoriasis. Journal of European Academy of Dermatology Venereology 2012; In press http://dx.doi.org/10.1111/j.1468-3083.2012.04705.x
  • Reddy M, Torres G, McCormick T, Marano C, Cooper K, Yeilding N, et al. Positive treatment effects of ustekinumab in psoriasis: analysis of lesional and systemic parameters. J Dermatol 2010; 37:413 - 25; http://dx.doi.org/10.1111/j.1346-8138.2010.00802.x; PMID: 20536646
  • Husted JA, Thavaneswaran A, Chandran V, Eder L, Rosen CF, Cook RJ, et al. Cardiovascular and other comorbidities in patients with psoriatic arthritis: a comparison with patients with psoriasis. Arthritis Care Res (Hoboken) 2011; 63:1729 - 35; http://dx.doi.org/10.1002/acr.20627; PMID: 21905258
  • Oxman AD, Clarke MJ, Stewart LA. From science to practice. Meta-analyses using individual patient data are needed. JAMA 1995; 274:845 - 6; http://dx.doi.org/10.1001/jama.1995.03530100085040; PMID: 7650811
  • Concato J. Is it time for medicine-based evidence?. JAMA 2012; 307:1641 - 3; http://dx.doi.org/10.1001/jama.2012.482; PMID: 22511693
  • Kent DM, Shah ND. Risk models and patient-centered evidence: should physicians expect one right answer?. JAMA 2012; 307:1585 - 6; http://dx.doi.org/10.1001/jama.2012.469; PMID: 22511683