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Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease.

ABSTRACT: Apremilast is an oral nonbiologic medication approved for the treatment of adult patients with active psoriatic arthritis and for patients with moderate to severe plaque psoriasis. This article summarizes the efficacy and safety of apremilast and provides characterization of the novel medication with clinical perspectives to successfully incorporate this therapy into practice for appropriate patients.A review and synthesis of the results from the ESTEEM (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis) phase 3 clinical studies evaluating the efficacy, safety, and tolerability of apremilast for the treatment of moderate to severe plaque psoriasis was conducted.Results from the ESTEEM clinical trial program demonstrate that apremilast significantly reduces the severity of moderate to severe plaque psoriasis, has an acceptable safety profile, and is generally well tolerated.The novel mechanism of action, convenience of oral administration, and acceptable side effect profile make this medication an attractive choice for clinicians treating patients with plaque psoriasis.

SUBMITTER: Young M

PROVIDER: S-EPMC5157723 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease.

Young Melodie M Roebuck Heather L HL

Journal of the American Association of Nurse Practitioners 20161121 12

<h4>Background and purpose</h4>Apremilast is an oral nonbiologic medication approved for the treatment of adult patients with active psoriatic arthritis and for patients with moderate to severe plaque psoriasis. This article summarizes the efficacy and safety of apremilast and provides characterization of the novel medication with clinical perspectives to successfully incorporate this therapy into practice for appropriate patients.<h4>Data sources</h4>A review and synthesis of the results from t ...[more]

PMID: 27869356

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Project description:IntroductionPsoriatic arthritis (PsA) is a spondyloarthritis that occurs in up to 30% of psoriasis patients. Patients with PsA are at risk for decreased quality of life due to both joint and skin symptoms, impaired physical function and disease progression. Treatments include non-steroidal anti-inflammatory drugs, conventional systemic disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, and biologic agents, including tumor necrosis factor-? inhibitors. The most recently introduced treatment option is apremilast, an oral phosphodiesterase 4 inhibitor.MethodsThis review provides an in-depth discussion of apremilast's mechanism of action, and evidence of its clinical efficacy and safety from the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) phase III pivotal clinical trials (PALACE 1, 2, and 3).ResultsThese trials demonstrate that apremilast is effective for the treatment of active PsA, despite prior conventional DMARDs or biologic treatment. The primary efficacy end point, a 20% improvement from baseline in modified American College of Rheumatology response criteria at Week 16, was achieved by significantly greater proportions of patients treated with apremilast 20 mg twice daily (BID) and apremilast 30 mg BID versus placebo in PALACE 1, 2, and 3. Improvements in this and other clinical and patient-reported end points, including swollen and tender joint counts, Psoriasis Area and Severity Index score, physical function, and quality of life, were maintained, extending over 52 weeks of treatment among patients initially randomized to apremilast. Apremilast's safety profile has been acceptable, with diarrhea and nausea being the most common adverse events, with no evidence for an increased risk of infection or need for laboratory monitoring. The PALACE pivotal data indicate that apremilast presents a new option for the treatment of PsA that may be appropriate for use early in the treatment ladder. Ongoing PALACE open-label extension trials of up to 4 years will characterize the long-term clinical effects and safety of apremilast therapy.FundingCelgene Corporation, Summit, NJ, USA.

Project description:ObjectivesApremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy.MethodsIn the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16.ResultsAt week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed.ConclusionsApremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated.Clinical trial registration numberNCT01172938.

Project description:Apremilast, a specific inhibitor of phosphodiesterase 4, modulates pro-inflammatory and anti-inflammatory cytokine production.Apremilast's effect on patient-reported outcomes (PROs) in patients with moderate to severe psoriasis was evaluated in a phase IIb randomized, controlled trial (NCT00773734).In this 16-week, placebo-controlled study, 352 patients with moderate to severe plaque psoriasis received placebo or apremilast (10, 20, or 30 mg BID). PROs included Dermatology Life Quality Index (DLQI), pruritus visual analog scale (VAS), and Short-Form Health Survey (SF-36) to assess health-related quality of life (HRQOL). Changes from baseline and patients reporting improvements ?minimum clinically important differences (MCID) were analyzed. Correlations between changes across various PRO instruments were explored.Baseline DLQI (>10 points) and SF-36 MCS and domain scores indicated impairments in HRQOL. At 16 weeks, greater improvements from baseline in DLQI scores were reported with apremilast 20 (-5.9) and 30 mg BID (-4.4) compared with placebo (1.9; P?0.005 for both), and a greater proportion of patients reported improvements ?MCID (20 mg BID, 49.4%, 30 mg BID, 44.3%) versus placebo (25.0%; P<0.04). Greater improvements from baseline in pruritus VAS scores were reported with apremilast 20 (-35.5%) and 30 mg BID (-43.7%) versus placebo (-6.1%; P?0.005). Significant and clinically meaningful improvements in SF-36 mental component summary scores (P?0.008) and Bodily Pain, Mental Health, and Role-Emotional domains were reported with all apremilast doses (P<0.05), and Social Functioning with 20 and 30 mg BID (P<0.05) and Physical Functioning with 20 mg BID (P<0.03). Correlations between SF-36 scores and DLQI were moderate (r>0.30 and ?0.60) and low between SF-36 and pruritus VAS (r?0.30), indicating they measure different aspects of the disease.Apremilast treatment resulted in improved HRQOL, including DLQI and pruritus VAS over 16 weeks of treatment, in patients with moderate to severe psoriasis.

Project description:ObjectivesWe examined nurse practitioners' use and opinions of recommended communication techniques for the promotion of oral health as part of a Maryland state-wide oral health literacy assessment. Use of recommended health-literate and patient-centered communication techniques have demonstrated improved health outcomes.MethodsA 27-item self-report survey, containing 17 communication technique items, across 5 domains, was mailed to 1,410 licensed nurse practitioners (NPs) in Maryland in 2010. Use of communication techniques and opinions about their effectiveness were analyzed using descriptive statistics. General linear models explored provider and practice characteristics to predict differences in the total number and the mean number of communication techniques routinely used in a week.ResultsMore than 80% of NPs (N = 194) routinely used 3 of the 7 basic communication techniques: simple language, limiting teaching to 2-3 concepts, and speaking slowly. More than 75% of respondents believed that 6 of the 7 basic communication techniques are effective. Sociodemographic provider characteristics and practice characteristics were not significant predictors of the mean number or the total number of communication techniques routinely used by NPs in a week. Potential predictors for using more of the 7 basic communication techniques, demonstrating significance in one general linear model each, were: assessing the office for user-friendliness and ever taking a communication course in addition to nursing school.ConclusionsNPs in Maryland self-reported routinely using some recommended health-literate communication techniques, with belief in their effectiveness. Our findings suggest that NPs who had assessed the office for patient-friendliness or who had taken a communication course beyond their initial education may be predictors for using more of the 7 basic communication techniques. These self-reported findings should be validated with observational studies. Graduate and continuing education for NPs should increase emphasis on health-literate and patient-centered communication techniques to increase patient understanding of dental caries prevention. Non-dental healthcare providers, such as NPs, are uniquely positioned to contribute to preventing early childhood dental caries through health-literate and patient-centered communication.

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Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease.

Publications

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor: A novel treatment option for nurse practitioners treating patients with psoriatic disease.

Similar Datasets

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