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4CPS-139 Study assessing the use of high-cost off-label drugs in the treatment of atopic dermatitis
  1. P Pelegrin Torres,
  2. C de Gorostiza,
  3. FJ Bécares,
  4. EM Martin,
  5. L García,
  6. M Hernandez,
  7. MA Arias
  1. Hospital Fundación Jimenez Díaz, Pharmacy, Madrid, Spain


Background After several years without new drugs for atopic dermatitis, some clinical trials with monoclonal antibodies are underway. We have found it interesting to review the health results of the high cost of off-label drugs used until now, in patients refractory to available treatments.

Purpose Biologic therapies have been employed in the off-label treatment of dermatologic disease. Nevertheless, there are numerous case reports detailing successful and unsuccessful treatment of atopic dermatitis with these agents.

Material and methods Retrospective study from January 2010 to March 2017. The variables were: age, sex, date of start and finish (and reason) with study treatment and previous treatments.

Results A total of 13 requests were approved. The drugs request were: ustekinumab (15.4%), apremilast (23.1%) and omalizumab (61.5%). The median age was 29 years, and 53.8% of patients were females. Previous treatments were oral and topical corticosteroids (100%), cyclosporine (85%), phototherapy (69%), azathioprine (46%), tacrolimus (31%), methotrexate (15%) and mycophenolate (8%).

Among the patients receiving apremilast (three), one had to discontinue it due to intolerance, while the other two continue treatment. One of them has received it at 8 months with good response, but the other patient has only received it at 1 month, so it is early to evaluate any result.

Two patients were treated with ustekinumab during a 13 month period, one stopped it due to loss of response and the other is still in treatment with stable disease.

Eight patients were treated with omalizumab (61.5%). The median duration with it was 9 months. Among these patients, four of them were discontinued due to inefficacy, one was discontinued due to resolution of dermatitis and another was suspended for an adverse event. One patient never started treatment and one patient moved to another country.

Conclusion Patients in this study continued to have flares despite treatment, and eventually had to receive steroids. Based on the results, and other cases published in the literature with similar results, we encourage the development of large clinical trials with adequate power with these off-label treatments to support their use. This is because its cost for the healthcare system is huge and the evidence of its effectiveness is low.

No conflict of interest

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