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P334. Thalidomide associated with anti-TNF-α therapy in Crohn's disease patients who lost response to anti-TNF-α: a case series

M.L. Scribano1, L. Cantoro2, M. Daperno3, R. Monterubbianesi1, A. Kohn1, 1A.O. San Camillo-Forlanini, Gastroenterology Unit, Rome, Italy, 2Campus Bio-Medico, University of Rome, Department of Digestive Diseases, Rome, Italy, 3A.O. Ordine Mauriziano, Gastroenterology Unit, Turin, Italy

Background

Thalidomide is an immunomodulatory agent with anti-tumor necrosis factor-alpha (TNF-α) and anti-angiogenetic properties, that has shown its efficacy in the treatment of refractory Crohn's disease (CD). We report the efficacy and tolerability of a combination of thalidomide with anti-TNF-α therapy in CD patients who have lost response to anti-TNF-α.

Methods

From March 2011 to August 2013 all patients treated with thalidomide in association with anti-TNF-α drugs for active CD or chronic intestinal bleeding related to CD, who lost response to anti-TNF-α therapy were included in this evaluation. Thalidomide was administered at a dose variable from 50 to 200 mg at night. Harvey–Bradshaw Index (HBI) was employed to assess clinical remission (HBI <5), and clinical response, defined by HBI decrease ≥3 points from baseline. All subjects were required to give written informed consent and to practice contraception.

Results

Eight patients entered the study (five males; mean age 30 years, range 16–44 years; mean duration of disease 12.7 years, range 5–31 years). Four patients were treated because of chronic intestinal bleeding related to CD, and four patients because of chronic clinical activity. Five patients were receiving adalimumab and three patients infliximab. All patients had been previously treated with another anti-TNF-α, discontinued due to intolerance or loss of response. Thalidomide was added after a mean period of anti-TNF-α treatment of 48.5 weeks (range 16–104 weeks), at a mean daily dose of 100 mg daily (range 50–200 mg). At baseline mean HBI was 7.5 (range 5–10), and mean C reactive protein 13.0 mg/L (range 0.1–83 mg/L). Mean treatment period with both therapies was 32.5 weeks (range 1–100 weeks). Concomitant treatments included immunosuppressors in two patients. Three out of four patients with chronic intestinal bleeding reported a clinical response and two of them achieved clinical remission, while one failed to respond to treatment. Two out of four patients with chronic clinical activity responded, and one of them obtained a clinical remission; one patient discontinued thalidomide after one week and one patient after four weeks because of intolerance. Currently, three patients are still under combined treatment and one patient only under thalidomide since anti-TNF-α therapy was stopped due to adverse events. One patient developed paresthesia and dizziness, requiring thalidomide dose reduction. No infections have been reported.

Conclusion

To our knowledge, this is the first case report of a treatment with thalidomide and anti-TNF-α drugs in CD patients who lost response to anti-TNF-α. This combination appears to be safe and effective and deserves further evaluation.