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Apremilast, an Oral Phosphodiesterase 4 (PDE4) Inhibitor: a Novel Treatment Option for Nurse Practitioners Treating Patients

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Apremilast, an Oral Phosphodiesterase 4 (PDE4) Inhibitor: a Novel Treatment Option for Nurse Practitioners Treating Patients SUPPLEMENT ARTICLE Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease Melodie Young, MSN, A/GNP-BC, DcNP (Nurse Practitioner)1,2 & Heather L. Roebuck, DNP, FNP-BC, FAANP (Nurse Practitioner)3 1Modern Dermatology–Aesthetics Center Dallas, Dallas, Texas 2Modern Research Associates, Dallas, Texas 3RoebuckDERM, West Bloomfield, Michigan Keywords Abstract Dermatology; psoriasis; medications; patient; treatment. Background and purpose: Apremilast is an oral nonbiologic medication ap- proved for the treatment of adult patients with active psoriatic arthritis and for Correspondence patients with moderate to severe plaque psoriasis. This article summarizes the ef- Melodie Young, MSN, A/GNP-BC, DcNP, Modern ficacy and safety of apremilast and provides characterization of the novel medica- Dermatology–Aesthetics Center Dallas, 9101 N tion with clinical perspectives to successfully incorporate this therapy into prac- Central Expy # 160, Dallas, TX 75231. tice for appropriate patients. Tel: 214-265-1818; Fax: 214-265-1806; Data sources: A review and synthesis of the results from the ESTEEM (Efficacy E-mail: [email protected] and Safety Trial Evaluating the Effects of Apremilast in Psoriasis) phase 3 clin- Received: 5 May 2016; ical studies evaluating the efficacy, safety, and tolerability of apremilast for the revised: 9 September 2016; treatment of moderate to severe plaque psoriasis was conducted. accepted: 14 September 2016 Conclusions: Results from the ESTEEM clinical trial program demonstrate that doi: 10.1002/2327-6924.12428 apremilast significantly reduces the severity of moderate to severe plaque psori- asis, has an acceptable safety profile, and is generally well tolerated. Disclosure Implications for practice: The novel mechanism of action, convenience of Melodie Young’s potential conflicts of interest oral administration, and acceptable side effect profile make this medication an include advisory boards, clinical trials, speaker’s bureaus, or other consulting relationships with attractive choice for clinicians treating patients with plaque psoriasis. Abbvie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, and Valeant. Heather Roebuck’s potential conflicts of interest include advisory boards, clinical trials, speaker’s bureaus, or other consulting relationships with Abbvie, Bayer, Celgene, Lilly, Novartis, Pfizer, and Valeant. Introduction significant impairments in patients’ quality of life (Kimball, Jacobson, Weiss, Vreeland, & Wu, 2005; Weiss et al., Psoriasis is a chronic, immune-mediated, inflammatory 2002). Furthermore, psoriasis is associated with multi- disease characterized by distinctive, red, raised skin lesions ple physical and psychological comorbidities, and afflicted with adherent silvery scales (Nestle, Kaplan, & Barker, patients have a higher risk than the general population 2009). This disorder affects approximately 1%–3% of for conditions such as psoriatic arthritis, metabolic syn- the population worldwide (Parisi, Symmons, Griffiths, & drome, and cardiovascular disease (Garshick & Kimball, Ashcroft, 2013). Psoriasis lesions most commonly appear 2015; Gottlieb & Dann, 2009). on the elbows, knees, scalp, and trunk and may persist Psoriasis is a lifelong recurrent disease that often re- for months, for years, or throughout the patient’s life quires ongoing treatment to reduce disease symptoms, (Johnson & Armstrong, 2013; Myers, Gottlieb, & Mease, improve quality of life, and maintain remission (Van 2006). These lesions can cause physical symptoms of itch- Voorhees et al., 2016). Management strategy depends ing, flaking, redness, and pain (Lebwohl et al., 2014; Mar- on the severity of disease and comorbidities, and should tin et al., 2015). Visually apparent skin lesions and the as- account for the specific needs of the patient (Blome sociated discomfort caused by these plaques contribute to et al., 2016). The present armamentarium, comprised C 2016 The Authors. Journal of the American Association of Nurse Practitioners published by Wiley Periodicals, Inc. on behalf of American Association of Nurse Practitioners. 1 This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Nurse practitioners treating patients with psoriatic disease M. Young & H. L. Roebuck of topical medications, phototherapy, conventional sys- inhibiting PDE4 (Figure 1; Man et al., 2009; Schafer, temic medications, and biologic agents, offers excellent 2012). PDE4 degrades intracellular cyclic adenosine options for the treatment of psoriasis. Despite the avail- monophosphate (cAMP). As a secondary messenger ability of various treatments and strategies, results of re- within the cell, cAMP regulates inflammation by sup- cent surveys have demonstrated widespread nontreat- pressing or inhibiting the expression of proinflammatory ment and undertreatment of patients with psoriasis, cytokines, such as tumor necrosis factor-alpha (TNF-α), regardless of disease severity (Armstrong, Robertson, Wu, interferon-gamma (IFN-γ ), and interleukin 23 (IL-23), Schupp, & Lebwohl, 2013; Lebwohl, Kavanaugh, Arm- and by promoting the release of anti-inflammatory cy- strong, & Van Voorhees, 2016). Treatment dissatisfaction tokines such as IL-10 (Houslay, Schafer, & Zhang, 2005; resulting in poor treatment adherence and discontinua- Schafer et al., 2010). PDE4 inhibition increases cAMP, tion among patients with psoriasis hinders the achieve- which in turn causes inflammation responses within T- ment of optimal outcomes. Lack of clinical response, helper cell 1 (Th1), Th17, and type 1 IFN pathways to be loss of therapeutic response over time, and safety and downregulated. In addition, elevated cAMP modulates the tolerability concerns are common reasons for discontin- production of IL-10 (Schafer et al., 2014). uation of conventional systemic and biologic therapies The effect of apremilast on inflammatory mediators was (Lebwohl et al., 2016; Levin, Gottlieb, & Au, 2014). demonstrated in a phase 2 open-label study by analyzing Adherence improves when treatments are efficacious, pro- inflammatory markers found in lesional skin biopsies from tocols are easy to follow, the treatment or medication is patients receiving apremilast 20 mg twice daily (BID; Got- convenient, and safety concerns about medications are tlieb et al., 2013). At weeks 4 and 12, significant reduc- minimal (Bewley & Page, 2011). The development of tions were observed in several inflammatory markers, in- orally available small molecules that regulate the produc- cluding IL-12/IL-23p40 (week 4: p = .025; week 12: p = tion of inflammatory mediators within the psoriasis signal- .039) and IL-17A (week 4: p = .021; week 12: p = .031; ing pathway may address unmet needs for patients who Gottlieb et al., 2013). Levels of the anti-inflammatory me- are intolerant of conventional nonbiologic therapies or diator IL-10 were increased in patients who were classified who are not candidates for biologic treatments (Alwan & as responders (patients who achieved ࣙ75% improvement Nestle, 2015; Schafer, 2012). in Psoriasis Area and Severity Index [PASI-75]) but de- creased in nonresponders (Gottlieb et al., 2013). Similar Introduction to apremilast pharmacodynamic impacts of apremilast were found in a phase 3 psoriatic arthritis clinical trial substudy (Schafer, Apremilast is a small-molecule (nonbiologic) oral phos- Chen, Fang, Wang, & Chopra, 2015). Plasma samples from phodiesterase 4 (PDE4) inhibitor that works intracellu- 150 randomized patients were collected at weeks 4, 16, larly to regulate production of pro- and anti-inflammatory 24, and 40 and assessed for a broad array of inflam- mediators implicated in the pathogenesis of psoriasis and matory biomarkers. At 40 weeks, IL-6, IL-17, and IL-23 psoriatic arthritis (Schafer et al., 2010). It is an effective showed significant inhibition in patients receiving apremi- and well-tolerated medication for the treatment of psori- last 30 mg BID treatment, and IL-10 had a significant in- asis. In 2014, apremilast was approved by the U.S. Food crease from baseline levels (Schafer et al., 2015). Addition- and Drug Administration for the treatment of adult pa- ally, during the placebo-controlled period (weeks 0–24) in tients with active psoriatic arthritis and for patients with the apremilast treatment arms, reductions in multiple in- moderate to severe plaque psoriasis who are candidates flammatory biomarkers (TNF-α, IL-8, and macrophage in- for phototherapy or systemic therapy (Celgene Corpora- hibitory protein-1β) were seen as early as week 4 in pa- tion, 2015). Apremilast has since been approved in multi- tients receiving apremilast compared with placebo (p ࣘ ple countries, including the European Union, Canada, and .0527). These effects were consistent through week 24 Australia (Celgene, Inc., 2015; Celgene Pty Limited, 2015; (Schafer et al., 2015). These data indicate that apremi- European Medicines Agency, 2015). As the first and only last may impact innate and Th1 inflammation in the early selective PDE4 inhibitor approved for patients with these stage of treatment followed by regulation of components conditions, apremilast provides clinicians with a new ther- of the systemic Th17 immune response after continued apeutic option for patients in need of alternative medica- treatment (Schafer et al., 2015). tions to manage the symptoms of psoriatic disease.
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