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Expert Review of Clinical Immunology Volume 11, 2015 - Issue 12
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Drug Profile

Apremilast for the treatment of psoriatic arthritis

Alejandro SoutoRheumatology Unit, Rheumatology Department, Complejo Hospitalario de Santiago de Compostela, Santiago, Spain;IDIS “Ramon Dominguez”, Complejo Hospitalario de Santiago de Compostela, Santiago, SpainCorrespondence[email protected]
&
Juan J Gómez-ReinoRheumatology Unit, Rheumatology Department, Complejo Hospitalario de Santiago de Compostela, Santiago, Spain;IDIS “Ramon Dominguez”, Complejo Hospitalario de Santiago de Compostela, Santiago, Spain;Department of Medicine, Medical School, Universidad de Santiago, Santiago de Compostela, Spain
Pages 1281-1290 | Published online: 26 Oct 2015

References

  • * Of interest
  • ** Of considerable interest
  • Foundation NP. Report on the psycho-social impacts of psoriasis. Portland (OR): National Psoriasis Foundation; 2009.
  • Gladman DD, Stafford-Brady F, Chang CH, et al. Longitudinal study of clinical and radiological progression in psoriatic arthritis. J Rheumatol. 1990;17(6):809–812.
  • McHugh NJ, Balachrishnan C, Jones SM. Progression of peripheral joint disease in psoriatic arthritis: a 5-yr prospective study. Rheumatol (Oxford). 2003;42(6):778–783.
  • Wallenius M, Skomsvoll JF, Koldingsnes W, et al. Work disability and health-related quality of life in males and females with psoriatic arthritis. Ann Rheum Dis. 2009;68(5):685–689.
  • Christophers E, Barker J, Griffiths C, et al. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J Eur Acad Dermatol Venereol. 2010;24:548–554.
  • Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl 2):ii14–17.
  • Zachariae H. Prevalence of joint disease in patients with psoriasis: implications for therapy. Am J Clin Dermatol. 2003;4(7):441–447.
  • Fiocco U ea, Accordi B, Martini V, et al. JAK/STAT/PKCδ molecular pathways in synovial fluid T lymphocytes reflect the in vivo T helper-17 expansion in psoriatic arthritis. Immunol Res. 2014; 58(1);61–69.
  • Fiocco U ea, Sfriso P, Oliviero F, et al. Blockade of intra-articular TNF in peripheral spondyloarthritis: its relevance to clinical scores, quantitative imaging and synovial fluid and synovial tissue biomarkers. Joint Bone Spine. 2013;80(2):165–170.
  • Man HW, Schafer P, Wong LM, et al. Discovery of (S)-N-[2-[1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-1,3-dioxo-2,3-dihy dro-1H-isoindol-4-yl] acetamide (apremilast), a potent and orally active phosphodiesterase 4 and tumor necrosis factor-alpha inhibitor. J Med Chem 2009; 26;52(6):1522–1524
  • Schafer PH, Parton A, Capone L, et al. Apremilast is a selective PDE4 inhibitor with regulatory effects on innate immunity. Cellular Signalling. 2014;26(9):2016–2029.

** Reference of considerable importance, mechanism of action

  • Schafer PH, Parton A, Gandhi AK, et al. Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol. 2010;159(4):842–855.
  • Schett G, Sloan VS, Stevens RM, et al. Apremilast: a novel PDE4 inhibitor in the treatment of autoimmune and inflammatory diseases. Ther Adv Musculoskelet Dis. 2010;2(5):271–278.
  • Scarpa R, Peluso R, Atteno M, et al. The effectiveness of a traditional therapeutical approach in early psoriatic arthritis: results of a pilot randomised 6-month trial with methotrexate. Clin Rheumatol. 2008;27(7):823–826.
  • Willkens RF, Williams HJ, Ward JR, et al. Randomized, double-blind, placebo controlled trial of low-dose pulse methotrexate in psoriatic arthritis. Arthritis Rheum. 1984;27(4):376–381.
  • Kingsley GH, Kowalczyk A, Taylor H, et al. A randomized placebo-controlled trial of methotrexate in psoriatic arthritis. Rheumatol (Oxford). 2012;51(8):1368–1377.
  • Dougados M. Methotrexate in peripheral spondyloarthritis including psoriatic arthritis: a need for further evaluation. Rheumatol (Oxford). 2012;51(8):1343–1344.
  • Baranauskaite A, Raffayova H, Kungurov NV, et al. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis. 2012;71(4):541–548.
  • Chandran V, Schentag CT, Gladman DD. Reappraisal of the effectiveness of methotrexate in psoriatic arthritis: results from a longitudinal observational cohort. J Rheumatol. 2008;35(3):469–471.
  • Lie E, Van Der Heijde D, Uhlig T, et al. Effectiveness and retention rates of methotrexate in psoriatic arthritis in comparison with methotrexate-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2010;69(4):671–676.
  • Kaltwasser JP, Nash P, Gladman D, et al. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: a multinational, double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum. 2004;50(6):1939–1950.
  • Liang GC, Barr WG. Open trial of leflunomide for refractory psoriasis and psoriatic arthritis. J Clin Rheumatol. 2001;7(6):366–370.
  • Thami GP, Garg G. Leflunomide in psoriasis and psoriatic arthritis: a preliminary study. Arch Dermatol. 2004;140(10):1288–1289.
  • Salvarani C, Macchioni P, Olivieri I, et al. A comparison of cyclosporine, sulfasalazine, and symptomatic therapy in the treatment of psoriatic arthritis. J Rheumatol. 2001;28(10):2274–2282.
  • Fraser AD, van Kuijk AW, Westhovens R, et al. A randomised, double blind, placebo controlled, multicentre trial of combination therapy with methotrexate plus ciclosporin in patients with active psoriatic arthritis. Ann Rheum Dis. 2005;64(6):859–864.
  • Farr M, Kitas GD, Waterhouse L, et al. Sulphasalazine in psoriatic arthritis: a double-blind placebo-controlled study. Br J Rheumatol. 1990;29(1):46–49.
  • Fraser SM, Hopkins R, Hunter JA, et al. Sulphasalazine in the management of psoriatic arthritis. Br J Rheumatol. 1993;32(10):923–925.
  • Gupta AK, Grober JS, Hamilton TA, et al. Sulfasalazine therapy for psoriatic arthritis: a double blind, placebo controlled trial. J Rheumatol. 1995;22(5):894–898.
  • Clegg DO, Reda DJ, Mejias E, et al. Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. Arthritis Rheum 1996;39(12):2013–2020. A Department of Veterans Affairs Cooperative Study.
  • Combe B, Goupille P, Kuntz JL, et al. Sulphasalazine in psoriatic arthritis: a randomized, multicentre, placebo-controlled study. Br J Rheumatol. 1996 Jul;35(7):664–668.
  • Mease P. Update on treatment of psoriatic arthritis. Bull NYU Hosp Jt Dis. 2012;70(3):167–171.
  • Mease PJ. Spondyloarthritis: Is methotrexate effective in psoriatic arthritis? Nat Rev Rheumatol. 2012;8(5):251–252.
  • Antoni CE, Kavanaugh A, Kirkham B, et al. 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. 2005;52(4):1227–1236.
  • Kavanaugh A, McInnes I, Mease P, et al. 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. 2009;60(4):976–986.
  • Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48–55.
  • Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279–3289.
  • Mease PJ, Goffe BS, Metz J, et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000;356(9227):385–390.
  • Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009;373(9664):633–640
  • McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780–789
  • Ritchlin C, Rahman P, Kavanaugh A, et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990–999.
  • Tzellos T, Kyrgidis A, Trigoni A, et al. Association of ustekinumab and briakinumab with major adverse cardiovascular events: an appraisal of meta-analyses and industry sponsored pooled analyses to date. Dermatoendocrinol. 2012;4(3):320–323.
  • Mease PJ, Genovese MC, Greenwald MW, et al. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med 2014;370(24):2295–2306
  • McInnes I, Mease P, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis: 24-week efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebo-controlled study using subcutaneous dosing. Late breaking oral presentation at: ACR/ARHP Annual Meeting; 2014 Nov 18; Boston (MA). Arthritis Rheum. Presentation number L1.
  • Mease P, McInnes I, Kirkham B, et al. Secukinumab, a human anti–interleukin-17A monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a Phase 3 randomized, multicenter, double-blind, placebo-controlled study. Arthritis Rheum. 2014;66(Suppl):S423. Abstract 953.
  • McInnes IB, Sieper J, Braun J, et al. Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial. Ann Rheum Dis. 2014;73(2):349–356.
  • Menter A, Papp KA, Tan H, et al. Efficacy of tofacitinib, an oral janus kinase inhibitor, on clinical signs of moderate-to-severe plaque psoriasis in different body regions. J Drugs Dermatol. 2014;13(3):252–256.
  • Papp KA, Menter A, Strober B, et al. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. British J Dermatology. 2012;167(3):668–677.
  • Hoffmann M, Kumar G, Schafer P, et al. Disposition, metabolism and mass balance of [(14)C]apremilast following oral administration. Xenobiotica. 2011;41(12):1063–1075.
  • Gottlieb AB, Strober B, Krueger JG, et al. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast. Curr Med Res Opin. 2008;24(5):1529–1538.
  • Schett G, Wollenhaupt J, Papp K, et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012;64(10):3156–3167.

** Reference of considerable importance, Phase II clinical trial

  • Strand V, Schett G, Hu C, et al. Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study. J Rheumatol. 2013;40(7):1158–1165.

* Reference of importance, Phase II clinical trial

  • Cutolo M, Mease P, Gladman D, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (52-week) improvement in tender and swollen joint counts in patients with psoriatic arthritis: results from three phase 3, randomized, controlled trials. American College of Rheumatology, annual meeting. Arthritis Rheum. 2013;65(10):S135.
  • Kavanaugh A, Adebajo A, Gladman D, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (104-week) improvements in patients with psoriatic arthritis: results from a phase 3, randomized, controlled trial. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S702–S703.
  • Kavanaugh A, Mease P, Gomez-Reino J. Apremilast, an oral Phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results of a phase 3, randomised, controlled trial. Arthritis Rheum. 2012;64(S10):S118.
  • Kavanaugh A, Mease P, Gomez-Reino J. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results of a phase 3, randomised, controlled trial. Arthritis Rheum. 2012;64:(S10):S118.
  • Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Longterm (52-week) Results of a Phase III Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis. J Rheumatol. 2015;42(3):479–488.

** Reference of considerable importance, Phase III clinical trial

  • Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014;73(6):1020–1026.
  • Schafer PH, Chen P, Fang L, et al. The pharmacodynamic impact of apremilast, an oral phosphodiesterase 4 inhibitor, on circulating levels of inflammatory biomarkers in patients with psoriatic arthritis: substudy results from a phase III, randomized, placebo-controlled trial (PALACE 1). J Immunol Res. 2015;2015:906349.
  • Cutolo M, Myerson G, Fleischmann R, et al. Long-term (52-week) results of a phase 3, randomized, controlled trial of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis (PALACE 2). American College of Rheumatology, annual meeting. Arthritis Rheum. 2013;65(S10):S346–S347.
  • Kavanaugh A, Cutolo M, Mease P, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (52-week) improvement in measures of disease activity in patients with psoriatic arthritis: results from 3 phase 3, randomized, controlled trials. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S239–S240.
  • Edwards C, Blanco F, Crowley J, et al. Long-term (52-week) results of a phase 3, randomized, controlled trial of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement (PALACE 3). American College of Rheumatology, annual meeting. Arthritis Rheum. 2013;65(S10):S132.
  • Edwards C, Aelion J, Adebajo A, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (52-week) improvements in enthesitis and dactylitis in patients with psoriatic arthritis: results from a phase 3, randomized, controlled trial. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S694–S695.
  • Wells A, Adebajo A, Aelion J, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, is associated with long-term (52-week) improvement in the signs and symptoms of psoriatic arthritis in DMARD-Naive patients: results from a phase 3, randomized, controlled trial. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S680.
  • Wells A, Aelion J, Adebajo A, et al. A phase 3, randomized, controlled trial of apremilast, an oral phosphodiesterase 4 inhibitor, for treatment of psoriatic arthritis: long-term (52-week) improvements in physical function. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S264.
  • Wells AF, Edwards C, Adebajo A, et al. Apremilast in the Treatment of DMARD-Naı¨ve Psoriatic Arthritis Patients: results of a Phase 3 Randomized, Controlled Trial (PALACE 4). 77th Annual Scientific Meeting of the American College of Rheumatology (ACR) and the 48th Annual Meeting of the Association of Rheumatology Health Professionals (ARHP); 2013 Oct 30; San Diego (CA): Abstract #L4.
  • Mease P, Kavanaugh A, Gladman D, et al. Long-term safety and tolerability of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: pooled safety analysis of three phase 3, randomized, controlled trials [abstract 310]. Arthritis Rheum. 2013;65(Suppl 10):S131–S132.

* Reference of importance, safety in clinical trials

  • O’Donnell JM, Zhang HT. Antidepressant effects of inhibitors of cAMP phosphodiesterase (PDE4). Trends Pharmacol Sci. 2004;25(3):158–163.
  • Mease P, Adebajo A, Gladman D, et al. Long-term (104-week) safety profile of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results from a Phase 3, randomized, controlled trial and open-label extension. American College of Rheumatology, annual meeting. Arthritis Rheum. 2014;66(S10):S690–S691.
  • Liu Y, Zhou S, Nissel J, et al. The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis. Clin Pharmacol Drug Dev. 2014;3(6):456–465.

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