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Long-term effectiveness and safety of secukinumab for treatment of refractory mucosal and articular Behçet’s phenotype: a multicentre study
  1. Filippo Fagni1,
  2. Alessandra Bettiol2,
  3. Rosaria Talarico3,
  4. Giuseppe Lopalco4,
  5. Elena Silvestri1,
  6. Maria Letizia Urban1,
  7. Paul A J Russo5,
  8. Gerardo Di Scala1,
  9. Giacomo Emmi1,
  10. Domenico Prisco1
  1. 1 Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy
  2. 2 Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Firenze, Firenze, Italy
  3. 3 Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
  4. 4 Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
  5. 5 Chandlers Hill Surgery, Adelaide, South Australia, Australia
  1. Correspondence to Dr Gerardo Di Scala, Department of Experimental and Clinical Medicine, University of Florence, Firenze 50121, Italy; discalagerardo{at}


Objective To evaluate the effectiveness and safety of secukinumab in patients with a mucosal and articular Behçet’s phenotype resistant to conventional and biologic treatment.

Methods A multicentre retrospective study was performed on 15 patients with a mucosal and articular phenotype of Behçet’s syndrome fulfilling the International Criteria for Behçet’s Disease and refractory to treatment with colchicine, disease-modifying antirheumatic drugs and at least one antitumour necrosis factor-α agent. Minimum follow-up was set at 6 months. Six patients with a polyarticular involvement were treated with secukinumab 300 mg/month, while all other cases received secukinumab 150 mg/month. Dose increase from 150 to 300 mg per month and shortening of administration frequency were allowed for poor disease control. Response evaluation was based on the number of oral ulcers in the previous 28 days and Disease Activity Score-28 for articular manifestations.

Results At 3 months of follow-up, nine (66.7%) patients achieved a response (complete or partial), and this proportion further increased to 86.7% at 6 months, 76.9% at 12 months, 90.0% at 18 months and 100.0% after 24 months. Notably, all patients who started with secukinumab 300 mg/month achieved complete response by month 6. Seven (46.7%) patients could achieve a response only after switching to a higher dosage.

Conclusions Our study suggests that secukinumab at a dose of 150 and 300 mg per month is safe and effective for the long-term treatment of patients with Behçet’s syndrome with a mucosal and articular phenotype refractory to previous treatments. Notably, secukinumab 300 mg/month resulted in superior complete mucosal and articular responses with no serious or dose-related adverse effects.

  • Behcet's disease
  • DMARDs (biologic)
  • arthritis
  • DAS28
  • treatment

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  • GE and DP are joint senior authors.

  • Handling editor Josef S Smolen

  • FF and AB contributed equally.

  • Contributors Study conception and design: FF, AB, GDS, GE. Acquisition of data: RT, GL, ES, MLU, PAJR. Analysis and interpretation of data: FF, AB, GDS, GE, DP. All the authors approved the final version of the manuscript.

  • 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.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval The study is approved by the Ethics Committee of Area Vasta Centro (competent for the Azienda Ospedaliero Universitaria Careggi), and was conducted in accordance with the Declaration of Helsinki.

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.