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Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands

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Abstract

Introduction

Psoriasis is a chronic inflammatory condition that can significantly impact the quality of life (QoL), regardless of the level of skin involvement. Apremilast is indicated for the treatment of moderate to severe psoriasis. Real-world data regarding the impact of apremilast on patient-reported outcomes in clinical practice in the Netherlands is lacking.

Methods

The prospective, multicenter observational Apremilast in Real-Life Psoriasis Treatment (APRIL) study enrolled patients ≥ 18 years old with moderate to severe plaque psoriasis receiving apremilast in clinical practice in the Netherlands. Patients were followed-up for 12 months, with assessments scheduled at 6 and 12 months. The primary outcome was Dermatology Life Quality Index (DLQI) response (score ≤ 5 or ≥ 5-point improvement from baseline) at 6 months. Secondary patient-reported outcomes included EQ-5D and skin-specific parameters; exploratory outcomes were Patient Benefit Index (PBI) and Work Productivity and Activity Impairment (WPAI).

Results

Of the 155 patients enrolled (February 2016–June 2019), 153 received apremilast; 69 (45%) and 39 (26%) continued treatment at 6 and 12 months, respectively. Psoriasis in special areas was common (scalp, 65%; nail, 51%; palmoplantar, 27%). Most patients (92%) had received prior systemic antipsoriatic therapies. Of the 151 patients with a baseline DLQI value, 56 (37%) achieved DLQI response at 6 months. Mean (standard deviation) PBI scores were 3.5 (1.2) and 3.8 (1.1) at 6 and 12 months, respectively. Improvements in DLQI, EQ-5D, and WPAI scores and disease signs and symptoms, including itch and special areas, were observed at 6 and 12 months. Adverse events were consistent with the known safety profile.

Conclusions

In the Netherlands, patients with moderate to severe psoriasis receiving apremilast for up to 12 months reported improved disease-related QoL, skin involvement, and patient-reported outcomes. These data add to the growing body of evidence demonstrating apremilast is an effective treatment for psoriasis, itch, and special areas (scalp and palms).

Trial Registration

ClinicalTrials.gov, NCT02652494.

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Data Availability

Qualified researchers may request data from Amgen clinical studies. Complete details are available at http://www.amgen.com/datasharing.

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Acknowledgements

We thank the participants of the study.

Medical Writing/Editorial Assistance.

Writing support was funded by Amgen Inc. and provided by Rebecca Lane, PhD, of Peloton Advantage, LLC, an OPEN Health company. Editorial support was provided by Claire Desborough, Amgen UK.

Funding

This study was sponsored by Celgene; Amgen Inc. acquired the worldwide rights to Otezla (apremilast) on November 21, 2019. Amgen B.V. funded the journal’s Rapid Service Fee.

Author information

Authors and Affiliations

  1. Radboud University Medical Center, Nijmegen, The Netherlands

    Juul M. P. A. van den Reek, Sarah E. Thomas & Elke M. G. J. de Jong

  2. Spaarne Gasthuis Hospital, Haarlem, The Netherlands

    Robert J. T. van der Leest

  3. Zuyderland Medisch Centrum, Limburg, The Netherlands

    Ruud Prevoo

  4. Amgen B.V., Breda, The Netherlands

    Margreet E. Plantenga

Authors
  1. Juul M. P. A. van den Reek
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Contributions

Conceptualization: Elke M.G.J. de Jong. Methodology: Juul van den Reek, Elke M.G.J. de Jong. Data collection: Juul M.P.A. van den Reek, Robert J.T. van der Leest, Ruud Prevoo, Elke M.G.J. de Jong. Data analysis and investigation: Sarah E. Thomas, Elke M.G.J. de Jong. Data interpretation: All authors. Writing – original draft preparation: Sarah E. Thomas. Writing – review and editing: Juul van den Reek, All authors.

Corresponding author

Correspondence to Juul M. P. A. van den Reek.

Ethics declarations

Conflict of interest

Juul M.P.A. van den Reek: Carried out clinical trials for AbbVie, Celgene, Almirall, and Janssen; has received speaking fees/attended advisory boards from AbbVie, Janssen, Bristol Myers Squibb, Almirall, LEO Pharma, Novartis, UCB, and Eli Lilly; received reimbursement for attending or chairing a symposium from Janssen, Pfizer, Celgene, and AbbVie. All funding is not personal but goes to the independent research fund of the Department of Dermatology, Radboud University Medical Centre (Radboudumc) Nijmegen, the Netherlands. Robert J.T. van der Leest: Nothing to disclose. Sarah E. Thomas: Carries out clinical trials for Janssen and Novartis. All funding is not personal but goes to the independent research fund of the Department of Dermatology, Radboud University Medical Centre (Radboudumc) Nijmegen, the Netherlands. Ruud Prevoo: Nothing to disclose. Margreet E. Plantenga: Employee of and stockholder in Amgen B.V. Elke M.G.J. de Jong: Received research grants for the independent research fund of the Department of Dermatology of the Radboud University Medical Center Nijmegen, the Netherlands from AbbVie, Bristol Myers Squibb, Janssen Pharmaceutica, LEO Pharma, Lilly, Novartis, and UCB; ZonMw, KCE, NWO, the National Psoriasis Foundation USA, RUMC/VGZ and RUMC/SMK. Has been a consultant, paid speaker, and/or participated in research for AbbVie, Amgen, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galapagos, Janssen Pharmaceutica, Lilly, Novartis, LEO Pharma, Sanofi, and UCB. All funding is not personal but goes to the Radboud University Medical Centre (Radboudumc), Nijmegen, the Netherlands.

Ethical Approval

This study was approved by the Code Geneesmiddelenreclame (CGR) and performed in accordance with Volume 9A of the Rules Governing Medicinal Products in the European Union, the Gedragscode Geneesmiddelenreclame of the CGR, and good pharmacovigilance practice. The study was approved by a national central ethics committee for observational studies in the Netherlands. nWMO statement given by the Regionale Toetsingscommissie Patiëntgebonden Onderzoek (RTPO) located in Leeuwarden, Netherlands, Ref. no. RTPO 959. Dutch Clinical Research Foundation (DCRF)   METC* 2015–119. All patients provided written informed consent before study initiation. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments.

Additional information

Prior Presentation: Interim analyses from the APRIL study were presented in a poster at EADV 2018, AAD 2019, and NVED 2020.

Supplementary Information

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van den Reek, J.M.P.A., van der Leest, R.J.T., Thomas, S.E. et al. Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands. Adv Ther 41, 1594–1605 (2024). https://doi.org/10.1007/s12325-023-02759-9

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