What is the role of Apremilast (Otezla) in the treatment of Behcet's disease?

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Last updated: February 15, 2025View editorial policy

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From the Guidelines

Apremilast (Otezla) can be used in the treatment of Behcet's disease, particularly for patients with recurrent mucocutaneous lesions who have not responded to colchicine.

Treatment Options for Behcet's Disease

  • Colchicine is the initial treatment for acute arthritis and mucocutaneous involvement in Behcet's disease, due to its safety and good tolerability 1.
  • For patients with chronic recurrent lesions or severe forms, systemic measures such as retinoids, azathioprine, thalidomide, interferon-alpha, tumour necrosis factor alpha inhibitors (TNFis), or apremilast can be used 1.
  • The choice of immunomodulatory or immunosuppressive drug depends on individual patient characteristics, safety, cost, availability, and patient preferences.

Role of Apremilast

  • Apremilast is considered an option for patients with mucocutaneous involvement who have not responded to colchicine, due to its immunomodulatory properties.
  • The use of apremilast in Behcet's disease is based on expert opinion and uncontrolled observational evidence, as there are no randomized controlled trials (RCTs) specifically evaluating its efficacy in this condition 1.

From the Research

Role of Apremilast in Behcet's Disease

  • Apremilast (Otezla) is indicated for the treatment of oral ulcers associated with Behcet's disease in some countries, including the USA and Japan 2.
  • The oral phosphodiesterase 4 inhibitor apremilast has been shown to reduce the number and pain of oral ulcers and disease activity relative to placebo in phase 2 and 3 trials in adults with Behcet's disease 2, 3.

Efficacy of Apremilast

  • Apremilast has been found to be effective in treating oral ulcers, which are the cardinal manifestation of Behcet's syndrome 3.
  • The drug has also been shown to improve health-related quality of life (HR-QOL) and reduce disease activity in patients with Behcet's disease 2.
  • Apremilast has been found to be effective in refractory orogenital ulcers and other manifestations of Behcet's disease, including arthralgia/arthritis, folliculitis/pseudofolliculitis, and erythema nodosum 4, 5.

Benefits and Tolerability

  • Apremilast has been found to be generally well tolerated, with gastrointestinal adverse events being among the most common tolerability issues 2, 3.
  • The benefits of apremilast have been seen regardless of baseline patient/disease characteristics and in Japanese patients, and have been sustained over up to 64 weeks of treatment 2.
  • Emerging real-world data also support the use of apremilast in the treatment of Behcet's disease 2.

Positioning of Apremilast in Treatment

  • Apremilast is considered a potential treatment option for Behcet's disease, particularly for oral ulcers, which are the most common symptom of the disease 6.
  • The drug's mechanism of action, which involves the modulation of multiple signaling pathways in both innate and adaptive immunocompetent cells, may contribute to its efficacy in treating Behcet's disease 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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