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Apremilast retention rate in clinical practice: observations from an Italian multi-center study

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Abstract

Objective

There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence.

Methods

In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan–Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant.

Results

The 356 enrolled patients (median age 60 [interquartile range IQR 52–67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7–34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96–0.99; p = 0.048 and 0.54 IQR 0.31–0.95; p = 0.03).

Conclusion

Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities.

Key Points

• Apremilast retention rates in this real-life cohort and trials are comparable.

• The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years).

• No different or more prevalent adverse events were observed.

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Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

References

  1. Taylor W, Gladman D, Helliwell P et al (2006) Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 54:2665–2673

    Article  Google Scholar 

  2. Gossec L, Baraliakos X, Kerschbaumer A et al (2020) EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis 79:700–712

    PubMed  Google Scholar 

  3. Kavanaugh A, Mease PJ, Gómez-Reino JJ et al (2014) Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis 73:1020–1026

    Article  CAS  Google Scholar 

  4. Cutolo M, Myerson GE, Fleischmann RM et al (2016) A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol 43:1724–1734

    Article  Google Scholar 

  5. Edwards CJ, Blanco FJ, Crowley J et al (2016) Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis 75:1065–1073

    Article  CAS  Google Scholar 

  6. Mease PJ, Gladman DD, Gómez-Reino JJ et al (2020) Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials. ACR Open Rheumatol 2:459–470

    PubMed  PubMed Central  Google Scholar 

  7. Abignano G, Fadl N, Merashli M et al (2018) Apremilast for the treatment of active psoriatic arthritis: a single-centre real-life experience. Rheumatology (Oxford) 57:578–580

    Article  Google Scholar 

  8. Favalli EG, Conti F, Atzeni F et al (2018) Comments on “Short-term reasons for withdrawal and adverse events associated with apremilast therapy for psoriasis in real-world practice compared with in clinical trials: A multicenter retrospective study.” J Am Acad Dermatol 79:e119–e120

    Article  Google Scholar 

  9. Favalli EG, Conti F, Selmi C et al (2020) Retrospective evaluation of patient profiling and effectiveness of apremilast in an Italian multicentric cohort of psoriatic arthritis patients. Clin Exp Rheumatol 38:19–26

    PubMed  Google Scholar 

  10. Schoels M, Aletaha D, Funovits J et al (2010) Application of the DAREA/DAPSA score for assessment of disease activity in psoriatic arthritis. Ann Rheum Dis 69:1441–1447

    Article  Google Scholar 

  11. Healy PJ, Helliwell PS (2008) Measuring clinical enthesitis in psoriatic arthritis: assessment of existing measures and development of an instrument specific to psoriatic arthritis. Arthritis Rheum 59:686–691

    Article  Google Scholar 

  12. Porta S, Otero-Losada M, Kölliker-Frers RA et al (2020) Adipokines, Cardiovascular Risk, and Therapeutic Management in Obesity and Psoriatic Arthritis. Front Immunol 11:590749

    Article  CAS  Google Scholar 

  13. Klingberg E, Bilberg A, Björkman S et al (2019) Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther 21:17–10

    Article  Google Scholar 

  14. Papadavid E, Rompoti N, Theodoropoulos K et al (2018) Real-world data on the efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol 32:1173–1179

    Article  CAS  Google Scholar 

  15. Wong TH, Sinclair S, Smith B et al (2017) Real-world, single-centre experience of apremilast for the treatment of moderate to severe psoriasis. Clin Exp Dermatol 42:675–676

    Article  CAS  Google Scholar 

  16. Gladman DD, Ye JY, Chandran V et al (2021) Oligoarticular vs Polyarticular Psoriatic Arthritis: A Longitudinal Study Showing Similar Characteristics. J Rheumatol 48:1824–1829

    Article  Google Scholar 

  17. Stekhoven D, Scherer A, Nissen MJ et al (2017) Hypothesis-free analyses from a large psoriatic arthritis cohort support merger to consolidated peripheral arthritis definition without subtyping. Clin Rheumatol 36:2035–2043

    Article  Google Scholar 

  18. Mekhail C, Chouk M, Prati C et al (2020) Prognostic factors of good response to DMARDs in psoriatic arthritis: a narrative review. Expert Rev Clin Pharmacol 13:505–519

    Article  CAS  Google Scholar 

  19. Schett G, Wollenhaupt J, Papp K et al (2012) Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 64:3156–3167

    Article  CAS  Google Scholar 

  20. Ogdie A, Liu M, Glynn M et al (2021) Descriptive Comparisons of the Effect of Apremilast and Methotrexate Monotherapy in Oligoarticular Psoriatic Arthritis: The Corrona Psoriatic Arthritis/Spondyloarthritis Registry Results. J Rheumatol 48:693–697

    Article  CAS  Google Scholar 

  21. Lucchetti R, Ceccarelli F, Cipriano E et al (2021) Application of Ultrasound in the Assessment of Oligoarticular Psoriatic Arthritis Subset: Results from Patients Treated with Apremilast. Isr Med Assoc J 23:412–415

    PubMed  Google Scholar 

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Authors and Affiliations

  1. Internal Medicine and Rheumatology Unit, University Hospital of Parma, Parma, Italy

    Alarico Ariani, Eleonora Di Donato, Gianluca Lucchini, Daniele Santilli, Flavio Mozzani & Andrea Becciolini

  2. Rheumatology Department, Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino, Turin, Italy

    Simone Parisi & Enrico Fusaro

  3. Rheumatology Outpatient Clinic, Internal Medicine Unit, Civitanova Marche Hospital, Civitanova Marche, Italy

    Patrizia Del Medico

  4. Internal Medicine Unit, Rheumatology Outpatient Clinic, Ospedale “A. Murri”, Fermo, Italy

    Antonella Farina

  5. Rheumatology Unit, Policlinico San Marco University Hospital of Catania, Catania, Italy

    Elisa Visalli, Giorgio Amato, Francesco De Lucia & Rosario Foti

  6. Rheumatology Unit, Azienda Ospedaliera Papardo, Messina, Italy

    Aldo Biagio Molica Colella

  7. Rheumatology Unit, Azienda USL of Modena and University Hospital, “Policlinico Di Modena”, Modena, Italy

    Federica Lumetti

  8. Department of Biotechnology and Medical-Surgical Sciences, Sapienza University of Rome, Polo Pontino, Latina, Italy

    Rosalba Caccavale & Marino Paroli

  9. Unit of Internal Medicine and Rheumatology, “Nuovo Regina Margherita / S. Spirito” Hospital, ASL Roma 1, Rome, Italy

    Palma Scolieri & Vincenzo Bruzzese

  10. Internal Medicine Unit, Imperia Hospital, Imperia, Italy

    Romina Andracco

  11. Rheumatology Unit, Ospedale GB Morgagni - L Pierantoni, Forlì, Italy

    Francesco Girelli

  12. Internal Medicine and Rheumatology Unit, Ospedale G. Da Saliceto, Piacenza, Italy

    Elena Bravi, Ilaria Platè & Eugenio Arrigoni

  13. Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology Unit, Ospedale Santa Maria della Scaletta, Imola, Italy

    Matteo Colina

  14. Unit of Rheumatology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy

    Alessandro Volpe & Antonio Marchetta

  15. Rheumatology Outpatient Unit, ASL Novara, Novara, Italy

    Aurora Ianniello

  16. UOC Oncologia Medica Azienda Ospedaliera Papardo, Messina, Italy

    Veronica Franchina

  17. Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria, Policlinico Di Modena, Modena, Italy

    Carlo Salvarani & Gilda Sandri

  18. Internal Medicine Unit, University of Milano-Bicocca, Milan, Italy

    Francesco Molica Colella

  19. Unit of Diagnostic and Interventional Radiology, Santa Corona Hospital, Pietra Ligure, Italy

    Giulio Ferrero

Authors
  1. Alarico Ariani
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  2. Simone Parisi
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  3. Patrizia Del Medico
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  4. Antonella Farina
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  5. Elisa Visalli
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  6. Aldo Biagio Molica Colella
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  7. Federica Lumetti
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  18. Eleonora Di Donato
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  19. Giorgio Amato
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  21. Gianluca Lucchini
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  22. Francesco De Lucia
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  32. Marino Paroli
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  34. Andrea Becciolini
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Corresponding author

Correspondence to Alarico Ariani.

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Competing interests

A Ariani has received honoraria as a speaker and an advisory board member of Amgen, Bristol-Myers Squibb, Boeringher, Bruno Farmaceutici, Janssen, Lilly, Novartis, Novo Nordisk, Sanofi, and Zentiva.

F Lumetti has received honoraria as an advisory board member of Amgen.

None of the other authors has any potential conflicts of interest to disclose in relation to this work.

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Ariani, A., Parisi, S., Del Medico, P. et al. Apremilast retention rate in clinical practice: observations from an Italian multi-center study. Clin Rheumatol 41, 3219–3225 (2022). https://doi.org/10.1007/s10067-022-06255-3

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  • DOI: https://doi.org/10.1007/s10067-022-06255-3

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