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Drug Profile

Apremilast for the management of moderate to severe plaque psoriasis

&
Pages 349-360 | Received 31 Oct 2016, Accepted 07 Feb 2017, Published online: 17 Feb 2017

References

  • Boehncke WH , Schon MP. Psoriasis. Lancet. 2015;386:983–994.
  • Korman AM , Hill D , Alikhan A , et al. Impact and management of depression in psoriasis patients. Expert Opin Pharmacother. 2016;17(2):147–152.
  • Deng Y , Chang C , Lu Q. The inflammatory response in psoriasis: a comprehensive review. Clin Rev Allergy Immunol. 2016;50(3):1–13.
  • Malakouti M , Brown GE , Wang E , et al. The role of IL-17 in psoriasis. J Dermatolog Treat. 2015;26(1):41–44.
  • Cai Y , Fleming C , Yan J . New insights of T cells in the pathogenesis of psoriasis. Cell Mol Immunol. 2012;9(4):302–309. DOI:10.1038/cmi.2012.15
  • Elder JT . Genome-wide association scan yields new insights into the immunopathogenesis of psoriasis. Genes Immun. 2009;10:201–209.
  • Shen S , O’Brien T , Yap LM , et al. The use of methotrexate in dermatology: a review. Australasian J Dermatol. 2012;53:1–18.
  • Menter A , Korman NJ , Elmets CA , et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Derm. 2009;61(3):451–485.
  • Lapolla W , Yentzer BA , Bagel J , et al. A review of phototherapy protocols for psoriasis treatment. J Am Acad Dermatol. 2011;64(5):936–949.
  • Maza A , Montaudie H , Sbidian E , et al. Oral cyclosporine in psoriasis:
a systematic review on treatment modalities, risk of kidney toxicity and evidence for use in non-plaque psoriasis. J Eur Acad Dermatol Venereol. 2011;25(Suppl 2):19–27.
  • Zachariae H , Kragballe K , Hansen HE , et al. Renal biopsy findings in long-term cyclosporin treatment of psoriasis. Br J Dermatol. 1997;136:531–535.
  • BarOz B , Hackman R , Einarson T , et al. Pregnancy outcome after cyclosporine therapy during pregnancy: a meta-analysis. Transplantation. 2001;71:1051–1055.
  • Geiger JM . Efficacy of acitretin in severe psoriasis. Skin Therapy Lett. 2003;8:1–3 7.
  • DiGiovanna JJ . Isotretinoin effects on bone. J Am Acad Dermatol. 2001;45(5):S176–S182.
  • 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 Derm. 2008;58(5):826–850.
  • Levin AA , Gottlieb AB , Au SC . A comparison of psoriasis drug failure rates and reasons for discontinuation in biologics vs conventional systemic therapies. J Drugs Dermatol. 2014;13(7):848–853.
  • Nelson DR , Lim HL , Marousis CG , et al. Activation of tumor necrosis factor-alpha system in chronic hepatitis C virus infection. Dig Dis Sci. 1997;42:2487–2494.
  • Infliximab[package insert] . Available from: http://www.fda.gov/cder/foi/label/2007/103772s5189lbl.pdf. Accessed February 27, 2008.
  • Desai SB , Furst DE . Problems encountered during anti-tumor necrosis factor therapy. Best Pract Res. 2006;20:757–790.
  • Mohan N , Edwards ET , Cupps TR , et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis Rheum. 2001;44:2862–2869.
  • Robinson WH , Genovese MC , Moreland LW . Demyelinating and neurologic events reported in association with tumor necrosis factor alpha antagonism: by what mechanisms could tumor necrosis factor alpha antagonists improve rheumatoid arthritis but exacerbate multiple sclerosis? Arthritis Rheum. 2001;44:1977–1983.
  • Sicotte NL , Voskuhl RR . Onset of multiple sclerosis associated with anti-TNF therapy. Neurology. 2001;57(10):1885–1888.
  • Shakoor N , Michalska M , Harris CA , et al. Drug-induced systemic lupus erythematosus associated with etanercept therapy. Lancet. 2002;359:579–580.
  • Wolfe F , Michaud K . Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study. Arthritis Rheum. 2007;56:2886–2895.
  • Bongartz T , Sutton AJ , Sweeting MJ , et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. Jama. 2006;295:2275–2285.
  • 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):1665–1674.
  • 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):1675–1684.
  • 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):326–338.
  • Griffiths CE , Reich K , Lebwohl M , et al. 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):541–551.
  • Gordon KB , Blauvelt A , Papp KA . Phase 3 trials of ixekizumab in moderate-to-severe plaque posriasis. N Engl J Med. 2016 Jul 28;375(4):345–356.
  • Chi CC , Wang SH . Efficacy and cost-efficacy of biologic therapies for moderate to severe psoriasis: a meta-analysis and cost-efficacy analysis using the intention-to-treat principle. Biomed Res Int. 2014;2014:862851.
  • Di Lernia V , Bardazzi F . Tofacitinib citrate and its potential in the treatment of moderate-to-severe chronic plaque psoriasis. Drug Des Devel Ther. 2016;10:533–539.
  • Papp K , Menter A , Abe M , et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015;173(4):949–961.
  • Dowty ME , Lin J , Ryder TF , et al. The pharmacokinetics, metabolism, and clearance mechanisms of tofacitinib, a janus kinase inhibitor, in humans. Drug Metab Dispos. 2014;42(4):759–773.
  • Korman AM , Hill D , Alikhan A , et al. Oral tofacitinib for the treatment of adults with moderate to severe chronic plaque psoriasis. Expert Rev Clin Pharmacol. Mar 2016;7:1–15. Epub ahead of print
  • Bachelez H , van de Kerkhof PC , Strohal R , et al. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non- inferiority trial. Lancet. 2015;386(9993):552–561. DOI:10.1016/S0140-6736(14)62113-9
  • Papp KA , Menter MA , Abe M , et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo- controlled, phase III trials. Br J Dermatol. 2015;173(4):949–961. DOI:10.1111/bjd.14018
  • XELJANZ ®(tofacitinib) [package insert] . Pfizer Laboratories Div Pfizer Inc., NY, NY; 2015.Retrieved from http://labeling.pfizer.com/ShowLabeling.aspx?id=959
  • Kofoed K , Skov L , Zachariae C . New drugs and treatment targets in psoriasis. ACTA Derm Ven. 2015;95(2):133–139.
  • Kim CH , Lee JM , Yoo JK . Inhibitory effect of imiquimod-induced psoriasis-like skin inflammation in mice by histamine H4 receptor agonist 4-methylhistamine. Scand J Immunol. 2016 Jun;83(6):409–417.
  • Chiricozzi A , Caposiena D , Garofalo V , et al. A new therapeutic for the treatment of moderate-to-severe plaque psoriasis: apremilast. Expert Review of Clinical Immunology. 2016;12(3):237–249.
  • Conti M , Richter W , Mehats C , et al. Cyclic AMP-specific-PDE4 phosphodiesterases as critical components of cyclic AMP signaling. J Biol Chem. 2003;278:5493–5496.
  • Odingo JO . Inhibitors of PDE4: a review of recent patent literature. Exp Opin Ther Pat. 2005;15:773–787.
  • Loretta Fala . Otezla (Apremilast), an oral PDE-4 inhibitor, receives FDA approval for the treatment of patients with active psoriatic arthritis and plaque psoriasis. Am Health Drug Benefits. 2015;8(Spec Feature):105–110.
  • Apremilast . 2015. Available from: http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4805 Apremilast approved for treatment of psoriasis and/or psoriatic arthritis (PsA) in multiple countries, including Canada and the EU. Accessed 1 May 2016.
  • Apremilast in Clinical Trials . https://clinicaltrials.gov/ct2/results?term=apremilast&Search=Search. Accessed 1 May 2016.
  • Celgene Corporation . Otezla (apremilast) tablets, for oral use: US prescribing information. 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf. Accessed 1 May 2016.
  • Gottlieb AB , Strober B , Krueger J . 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;24:1529–1538.
  • Hoffmann M , Kumar G , Schafer P . Disposition, metabolism, and mass balance of [14C] apremilast following oral administration. Xenobiotica. 2011;41:1063–1075.
  • 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.
  • Gottlieb AB , Matheson RT , Menter A , et al. Efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis: a phase II open-label study. J Drugs Dermatol. 2013;12(8):888–897.
  • Papp KA , Kaufmann R , Thai D , et al. Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study. J Eur Acad Dermatol Venereol. 2013 Mar;27(3):e376–83.
  • Papp KA , Cather JC , Rosoph L , et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomized controlled trial. Lancet. 2012 Aug 25;380(9843):738–746.
  • Strand V, Fiorentino D, Hu C, Day RM, et al . Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study. Health Qual Life Outcomes. 2013;11:82.
  • 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):1387–1399.
  • Reich K , Gooderham M , Green L , et al. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venerol. 2016 Oct 21. [Epub ahead of print]
  • Papp KA , 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):37–49..
  • Nguyen CM , Leon A , Danesh M , et al. improvement of nail and scalp psoriasis using apremilast in patients with chronic psoriasis: phase 2b and 3, 52-week randomized, placebo-controlled trial results. j drugs dermatol. 2016;3(15):272.
  • Bissonnette R , Pariser DM , Wasel NR , et al. Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis. J Am Acad Dermatol. 2016 Mar 24;75(1). pii: S0190-9622(16)01400-6.
  • Feldman S , Thaci D , Ling M , et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: pruritus and DLQI correlations at week 16 (ESTEEM 1 and 2) [abstract no. 1092]. J Am Acad Dermatol. 2015;72(5Suppl 1):AB226.
  • Kuznik A , Li S , Wu J . Estimating the proportion of patients who achieve a clinically meaningful benefit from apremilast therapy in the ESTEEM trials [abstract no. 1190]. J Am Acad Dermatol. 2015;72(5 Suppl 1):AB235.
  • Papp KA , Reich K , Sobell J , et al. Two-year safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: results from a phase 3, randomized, controlled trial (ESTEEM 1) [abstract no. 1055]. J Am Acad Derm. 2015;72(5Suppl 1):AB256.
  • Reich K , Sobell J , Stevens R , et al. Change in weight with apremilast, an oral phosphodiesterase 4 inhibitor: pooled analysis of the ESTEEM 1 and ESTEEM 2 trials [abstract no. 1162]. J Am Acad Dermatol. 2015;72(5Suppl 1):AB227.
  • Oba Y , Lone NA . Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Ther Adv Respir Dis. 2013;7(1):13–24.
  • Liu Y , Zhou S , Wan Y , et al. The impact of co-administration of ketoconazole and rifampicin on the pharmacokinetics of apremilast in healthy volunteers. Br J Clin Pharmacol. 2014 Nov;78(5):1050–1057.
  • 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 Nov;3(6):456–465.
  • 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. Annals Rheumatic Diseases Jun. 2014;73(6):1020–1026.
  • AbuHilal M , Walsh S , Shear N . Use of apremilast in combination with other therapies for treatment of chronic plaque psoriasis: a retrospective study. J Cutan Med Surg. 2016 Feb 4;20:313–316.
  • Danesh MJ , Beroukhim K , Nguyen C , et al. Apremilast and adalimumab: a novel combination therapy for recalcitrant psoriasis. Dermatology Online Journal. 2015 Jun;21:6.
  • Combe B , Behrens F , McHugh N , et al. Comparison of etanercept monotherapy and combination therapy with methotrexate in psoriatic arthritis: results from 2 clinical trials. J Rheumatol. 2016 May 1;43:1063–1067.
  • Kingsley GH , Kowalczyk A , Taylor H , et al. A randomized placebo-controlled trial of methotrexate in psoriatic arthritis. Rheumatology (Oxford). 2012 Aug;51(8):1368–1377.
  • Smith RL . Pediatric psoriasis treated with apremilast. JAAD Case Reports. 2016 Jan;2(1):89–91.
  • Rich P , Gooderham M , Bachelez H , et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-o-treat nail and scalp psoriasis: results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatfeol. 2016 Jan;74(1):134–142.
  • Nguyen CM , Leon A , Danesh M , et al. improvement of nail and scalp psoriasis using apremilast in patients with chronic psoriasis: phase 2b and 3, 52-week randomized, placebo-controlled trial results. J Drugs Dermatol: JDD. 2016 Mar 1;15(3):272–276.
  • Volf EM , Au SC , Dumont N , et al. A phase 2, open-label, investigator-initiated study to evaluate the safety and efficacy of apremilast in subjects with recalcitrant allergic contact or atopic dermatitis. J Drugs Dermatol: JDD. 2012 Mar;11(3):341–346.
  • Samrao A , Berry TM , Goreshi R , et al. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Archives of Dermatology. 2012 Aug;148(8):890–897.
  • Thompson BJ , Furniss M , Zhao W , et al. An oral phosphodiesterase inhibitor (apremilast) for inflammatory rosacea in adults: a pilot study. JAMA Dermatology. 2014 Sep;150(9):1013–1014.
  • Paul J , Foss CE , Hirano SA , et al. An open-label pilot study of apremilast for the treatment of moderate to severe lichen planus: a case series. J Am Acad Dermatol. 2013 Feb;68(2):255–261.
  • De Souza A , Strober BE , Merola JF , et al. Apremilast for discoid lupus erythematosus: results of a phase 2, open-label, single-arm, pilot study. J Drugs Dermatol: JDD. 2012 Oct;11(10):1224–1226.
  • Hatem i G, Melikoglu M, Tunc R, et al. Apremilast for Behcet’s syndrome–a phase . 2, placebo-controlled study. N Engl J Med. 2015 Apr 16;372(16):1510–1518.
  • Baughman RP, Judson MA, Ingledue R, Craft NL, Lower EE . Efficacy and safety of apremilast in chronic cutaneous sarcoidosis. Archives of Dermatology. 2012 Feb;148(2):262–264.

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