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Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
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Oral Roflumilast for Long-term Management of Behçet Spectrum Disorders: A Multicenter Observational Analysis.

R Peñuelas Leal1, J A Peñuelas Ruiz2, Á González García1

  • 1Dermatology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.

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|December 14, 2025
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Summary

Roflumilast effectively treats Behçet spectrum disorders (BSD), including recurrent aphthous stomatitis (RAS) and Behçet

Keywords:
ApremilastBehçetBehçet spectrum disordersBehçet's diseaseGenital ulcerOral ulcerPhosphodiesterase 4 inhibitorRecurrent aphthous stomatitisRoflumilast

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Area of Science:

  • Immunodermatology
  • Oral Medicine
  • Pharmacology

Background:

  • Recurrent aphthous stomatitis (RAS) and Behçet's disease (BD) are part of Behçet spectrum disorders (BSD), characterized by recurrent oral ulcers.
  • No systemic treatments are currently approved for RAS or incomplete BD, significantly impacting patient quality of life.

Purpose of the Study:

  • To evaluate the efficacy of roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, in patients with BSD.
  • To compare treatment responses between RAS and BD patients.

Main Methods:

  • An analytical observational study involving 33 BSD patients (22 RAS, 11 BD) across 5 Spanish centers.
  • Data collected retrospectively and prospectively over 52 weeks, assessing ulcer frequency, pain, and duration.
  • Statistical models used to compare outcomes before and after treatment.

Main Results:

  • Roflumilast significantly reduced ulcer frequency, pain, and duration in BSD patients, with sustained long-term efficacy.
  • Minimal and clinically insignificant differences in response were observed between RAS and BD groups.
  • Adverse events occurred in 63% of patients, mostly mild and manageable; 6.25% discontinued due to adverse events.

Conclusions:

  • Roflumilast demonstrates efficacy and a favorable safety profile for managing BSD, addressing unmet needs in RAS and BD.
  • The drug's long-term effectiveness supports its integration into routine clinical practice for BSD management.