ADDITIONAL RESOURCES

Transcription

1 ADDITIONAL RESOURCES

2 CURRENT MODEL OF PSORIASIS IMMUNOPATHOGENESIS IL-17 A/FIL-22 GM-CSF Stressed keratinocytes TNF-α Myeloid dendritic cell Keratinocytes Activation IL-23 IL-12 T cells IL-1 BIL-6 TNF-α GM-CSF=granulocyte/macrophage-colony stimulating factor. Keijsers RR et al. Br J Dermatol. 2013;168: Lin AM et al. J Immunol. 2011;187: Res PCM et al. PloS ONE. 2010;5:e Taylor PR et al. Nat Immunol. 2014;15:

3 REFERENCES Armstrong AW, Siegel MP, Bagel J, et al. From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis. J Am Acad Dermatol. 2017;76(2): Blauvelt A, Reich K, Tsai TF, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017;76(1): Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda AP. Adalimumab: long-term safety in patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn s disease. Ann Rheum Dis. 2013; 72(4): Chan ES, Cronstein BN. Molecular action of methotrexate in inflammatory diseases. Arthritis Res. 2002;4(4): Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet. 2001;357(9271): Cosentyx [US package insert]. East Hanover, NJ: Novartis Pharmaceuticals, Accessed January 5, Dixon WG, Watson KD, Lunt M, et al; British Society For Rheumatology Biologics Register Control Centre Consortium; British Society for Rheumatology Biologics Register. Influence of anti-tumor necrosis factor therapy on cancer incidence in patients with rheumatoid arthritis who have had a prior malignancy: results from the British Society for Rheumatology Biologics Register. Arthritis Care Res (Hoboken). 2010;62(6): Ellis CN, Fradin MS, Messana JM, et al. Cyclosporine for plaque-type psoriasis. Results of a multidose, double-blind trial. N Engl J Med. 1991;324(5): Fiorentino D, Langley R, Fakharzadeh S, Ho V. Malignancy events in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study: Current status of observations. J Am Acad Dermatol. 2014;70(5)(suppl 1):AB175. Abstract P Fréling E, Baumann C, Cuny JF, et al. Cumulative incidence of, risk factors for, and outcome of dermatological complications of anti-tnf therapy in inflammatory bowel disease: a 14-year experience. Am J Gastroenterol. 2015; 110(8): Gaspari AA, Tyring S. New and emerging biologic therapies for moderate-to-severe plaque psoriasis: mechanistic rationales and recent clinical data for IL-17 and IL-23 inhibitors. Dermatol Ther. 2015;28(4): Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016;375(4): Gordon KB, Duffin KC, Bissonnette R, et al. A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. N Engl J Med. 2015;373(2): Gordon KB, Papp KA, Hamilton TK, et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA. 2003;290(23): Gordon KB, Papp KA, Langley RG, et al. 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):

4 REFERENCES (CONT.) Gottlieb AB, Gerdes S, Lacour JP, et al. Ixekizumab in patients with moderate to severe psoriasis who have or have not received prior biologic therapies: an integrated analysis of 2 phase 3 studies Fall Clinical Dermatology Conference. Las Vegas, Nevada; October 20 23, Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139(12): ; discussion Griffiths CE, Reich K, Lebwohl M, et al; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993): Griffiths C, Papp K, Zaldivar ER, et al. Secukinumab shows efficacy in subjects regardless of previous exposure to biologic therapy: A pooled subanalysis from four phase 3 clinical trials in psoriasis. J Am Acad Dermatol. 2015; 72(5)(suppl 1): AB251. Abstract Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362(2): Gubner R, August S, Ginsberg V. Therapeutic suppression of tissue reactivity. II. Effect of aminopterin in rheumatoid arthritis and psoriasis. Am J Med Sci. 1951;221(2): Hueber W, Sands BE, Lewitzky S, et al. Secukinumab in Crohn s Disease Study Group. Secukinumab, a human anti-il-17a monoclonal antibody, for moderate to severe Crohn s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61: Hsu S, Papp KA, Lebwohl MG, et al; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012;148(1): Keijsers RR, van der Velden HM, van Erp PE, et al. Balance of Treg vs. T-helper cells in the transition from symptomless to lesional psoriatic skin. Br J Dermatol. 2013;168(6): Kragballe K, Jansen CT, Geiger JM, et al. A double-blind comparison of acitretin and etretinate in the treatment of severe psoriasis. Results of a Nordic multicentre study. Acta Derm Venereol. 1989;69(1): Krueger GG, Papp KA, Stough DB, Loven KH, Gulliver WP, Ellis CN. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2002;47(6): Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mab BI for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015;136(1): e117. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014;371(4): Lebwohl M, Strober B, Menter A, et al. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015;373(14): Lebwohl MG, Kavanaugh A, Armstrong AW, Van Voorhees AS. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016;17(1): Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. Am J Clin Dermatol. 2011;12(5):

5 REFERENCES (CONT.) Leonardi CL, Kimball AB, Papp KA, et al. 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(9625): Li WQ, Han JL, Chan AT, Qureshi AA. Psoriasis, psoriatic arthritis and increased risk of incident Crohn s disease in US women. Ann Rheum Dis. 2013;72(7): Lin AM, Rubin CJ, Khandpur R, et al. Mast cells and neutrophils release IL-17 through extracellular trap formation in psoriasis. J Immunol. 2011;187(1): Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol. 2008;58(1): Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5): Montesinos MC, Desai A, Delano D, et al. Adenosine A2A or A3 receptors are required for inhibition of inflammation by methotrexate and its analog MX-68. Arthritis Rheum. 2003;48(1): Morgan SL, Oster RA, Lee JY, Alarcon GS, Baggott JE. The effect of folic acid and folinic acid supplements on purine metabolism in methotrexate-treated rheumatoid arthritis. Arthritis Rheum. 2004;50(10): Mrowietz U, Leonardi CL, Girolomoni G, et al; SCULPTURE Study Group. Secukinumab retreatment-asneeded versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1): National Cancer Institute: Surveillance, Epidemiology, and End Results Program. Overview of the SEER program. Available at: Accessed January 5, New head-to-head data shows significantly higher response rates for Lilly s Taltz (ixekizumab) compared to Stelara (ustekinumab) in patients with moderate-to-severe plaque psoriasis [press release]. Indianapolis, IN: Eli Lilly and Company; March 4, cfm?releaseid= Accessed March 7, O Connor W Jr, Kamanaka M, Booth CJ, et al. A protective function for interleukin 17A in T cell-mediated intestinal inflammation. Nat Immunol. 2009;10: Papp K, Gottlieb AB, Naldi L, et al. Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Drugs Dermatol. 2015;14(7): Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1): Papp K, Thaci D, Reich K, et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015;173(4): Papp KA, Griffiths CE, Gordon K, et al; PHOENIX 1 Investigators; PHOENIX 2 Investigators; ACCEPT Investigators. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013; 168(4):

6 REFERENCES (CONT.) Papp KA, Langley RG, Lebwohl M, et al. 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(9625): Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67(2): Paul C, Cather J, Gooderham M, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol. 2015;173(6): Reich K, Papp KA, Griffiths CE, 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(3): Res PC, Piskin G, de Boer OJ, et al. Overrepresentation of IL-17A and IL-22 producing CD8 T cells in lesional skin suggests their involvement in the pathogenesis of psoriasis. PLoS One. 2010;5(11):e Rubin AI, Chen EH, Ratner D. Basal-cell carcinoma. N Engl J Med. 2005;353(21): Singh S, Heien HC, Sangaralingham LR, et al. Comparative effectiveness and safety of anti-tumor necrosis factor agents in biologic-naive patients with Crohn s disease. Clin Gastroenterol Hepatol. 2016;14(8): Skroza N, Proietti I, Pampena R, et al. Correlations between psoriasis and inflammatory bowel diseases. Biomed Res Int. 2013;2013: Sorensen EP, Fanucci KA, Saraiya A, et al. Tumor necrosis factor inhibitor primary failure predicts decreased ustekinumab efficacy in psoriasis patients. J Drugs Dermatol. 2015;14(8): Strangfeld A, Hierse F, Rau R, et al. Risk of incident or recurrent malignancies among patients with rheumatoid arthritis exposed to biologic therapy in the German biologics register RABBIT. Arthritis Res Ther. 2010;12(1):R5. Strober B, Papp KA, Leonardi C, et al. Integrated safety of ixekizumab in patients with moderate-to-severe psoriasis: results from a pooled analysis of 7 clinical trials Fall Clinical Dermatology Conference. Las Vegas, Nevada; October 20 23, 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(3): Taylor PR, Roy S, Leal SM, Jr., et al. Activation of neutrophils by autocrine IL-17A-IL-17RC interactions during fungal infection is regulated by IL-6, IL-23, RORgammat and dectin-2. Nat Immunol. 2014;15(2): Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. 2015;73(3): van de Kerkhof PC, Griffiths CE, Reich K, et al. Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2016;75(1): Whittle SL, Hughes RA. Folate supplementation and methotrexate treatment in rheumatoid arthritis: a review. Rheumatology (Oxford). 2004;43(3):