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P183. Thalidomide in immunosuppressors and anti-TNF unresponsive Crohn's disease patients: Efficacy and side effects

M.L. Scribano, L. Cantoro, R. Mangiarotti, C. Prantera, A. Kohn

Azienda Ospedaliera “S.Camillo-Forlanini”, Roma, Italy

Aim: Thalidomide, a drug with anti-tumor necrosis factor alpha (TNF-α) activity, is also a potent inhibitor of angiogenesis. Several case reports and some open-label clinical trials have demonstrated its efficacy in the treatment of refractory Crohn's disease (CD). We assessed the efficacy and tolerability of thalidomide in CD patients unresponsive and/or intolerant to immunosuppressors and/or anti-TNF therapy.

Materials and Methods: Sixteen patients were included in this evaluation. Thalidomide was started at a dose variable from 50 to 200 mg at bedtime and increased stepwise if tolerated. Crohn's Disease Activity Index (CDAI) was employed to assess clinical remission (CDAI < 150) and clinical response, defined by a CDAI decrease ≥ 100 points from baseline. Before treatment all patients signed an informed consent and agreed to practice contraception.

Results: All patients (six males, 10 females; mean age 40.8 years, range 19–72 years; mean duration of disease 14.7 years, range 3–31 years) received thalidomide at a dosage between 50 and 300 mg daily. Concomitant treatments included immunosuppressors in four patients. Six patients were treated because of chronic intestinal bleeding related to CD, and ten patients because of chronic clinical activity. Fourteen of 16 patients were resistant and/or intolerant to anti-TNF therapy. Mean CDAI at baseline was 289 (range 165–370). Mean treatment period was 112.7 weeks (range 1–336 weeks). Currently, 10 patients are still under treatment. Five out of 10 patients with chronic clinical activity had a clinical response and four of them achieved clinical remission; in five patients thalidomide was started recently and therefore evaluable data are not yet available. One out of five patients with chronic intestinal bleeding reported a clinical remission, while four failed to respond to treatment. One patient with chronic clinical activity achieved clinical remission. Five patients discontinued the therapy because of severe side effects that disappeared when treatment was stopped. Side effects were reported by seven patients (43.7%); two patients developed a peripheral neuropathy at two and seven weeks, two patients developed skin rush at 12 and 13 weeks, one patient experienced mood disturbance at five weeks and one patient myalgia requiring dose reduction, leucopenia occurred in one patient requiring dose reduction and a short steroid treatment. Drowsiness was commonly reported by almost all patients and improved spontaneously or by reducing thalidomide dose.

There were no variables predictive of response.

Conclusion: Thalidomide appears to be an effective treatment for some patients with refractory CD. Side effects are frequent, and often responsible for drug discontinuation.