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Real-world effectiveness of apremilast in multirefractory mucosal involvement of Behçet’s disease
  1. Giuseppe Lopalco1,
  2. Vincenzo Venerito1,
  3. Pietro Leccese2,
  4. Giacomo Emmi3,
  5. Luca Cantarini4,
  6. Nancy Lascaro2,
  7. Gerardo Di Scala5,
  8. Claudia Fabiani6,
  9. Donato Rigante7,
  10. Florenzo Iannone1
  1. 1 Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari, Italy
  2. 2 Rheumatology Institute of Lucania (IRel), Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza, Italy
  3. 3 Department of Experimental and Clinical Medicine, University of Firenze, Florence, Italy
  4. 4 Research Centre of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Centre, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
  5. 5 Department of Experimental and Clinical Medicine, University of Firenze, Firenze, Italy
  6. 6 Ophthalmology Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy
  7. 7 Institute of Pediatrics, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy
  1. Correspondence to Dr Giuseppe Lopalco, Department of Emergency and Organ Transplantation, Rheumatology Unit, University of Bari, Bari 70124, Italy; glopalco{at}

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Relapsing oral and genital ulcers (OGUs) represent the stigmata of Behçet’s disease (BD) and may be very painful, affecting both quality of life and relationships. A wide number of topical and immunosuppressive drugs can be used to treat ulcers,1 but failures are commonly reported. The efficacy of the phosphodiesterase-4 inhibitor apremilast has been proven in OGUs of BD in two randomised clinical trials (RCTs),2 3 whereas only two case reports are available until now.4 5 We aimed at evaluating the real-world effectiveness of apremilast in BD patients with OGUs refractory to conventional and/or biological treatments.

We retrospectively evaluated patients classified as BD, according to International Criteria for BD6 and International Study Group7 criteria, who underwent apremilast (30 mg two times per day) for multirefractory OGUs from November 2017 to January 2019. The number of OGUs was assessed at baseline and either at 3 and 6 months. Pain from ulcers and BD activity were …

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  • Handling editor Josef S Smolen

  • GL and VV contributed equally.

  • Collaborators Marco Fornaro, Maria Grazia Giannotta, Elena Silvestri.

  • Contributors All authors approved the final version of the letter after being involved in drafting and revising the article for important intellectual content. As the corresponding author, GL had full access to the data and takes responsibility for the accuracy of the performed analysis and the integrity of data. GL, VV and FI were involved in the design of the study. Execution, analysis and writing of the manuscript were performed by GL and VV.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Ethics approval This study was performed according to the Declaration of Helsinki and obtained the approval by the Ethics Committee in the University of Bari, Italy.

  • Provenance and peer review Not commissioned; externally peer reviewed.