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Mucosal Healing With Thalidomide in Refractory Crohn’s Disease Patients Intolerant of Anti-TNF-α Drugs: Report of 3 Cases and Literature Review

Scribano, Maria Lia MD*; Cantoro, Laura MD; Marrollo, Marzia MD*; Cosintino, Rocco MD*; Kohn, Anna MD*

Journal of Clinical Gastroenterology: July 2014 - Volume 48 - Issue 6 - p 530–533
doi: 10.1097/MCG.0000000000000122

Thalidomide is an oral immunomodulatory and anti-inflammatory drug with antitumor necrosis factor-α (TNF-α) activity. Several case reports and some clinical trials have demonstrated its efficacy in the treatment of refractory Crohn’s disease (CD). We report the effect and tolerability of thalidomide in 3 patients with moderate-to-severe CD who were not responsive to anti-TNF-α therapies, and review the relevant literature. The first case is of a 28-year-old female affected by Crohn’s colitis complicated by a severe fistulizing perianal disease; she was treated with infliximab, adalimumab, and certolizumab pegol, which were stopped because of intolerance. The second case is of a 39-year-old female with fistulizing ileocolitis complicated by severe arthralgias and perianal disease with loss of response to infliximab and intolerance of certolizumab pegol. The third case is of a 39-year-old male with gastric and ileocolonic CD refractory to immunosuppressors and intolerant of infliximab. All the 3 cases achieved complete clinical remission and endoscopic healing of mucosal lesions at a low dose of thalidomide (50 to 150 mg/d). In our CD patients who experienced loss of response or were unable to tolerate anti-TNF-α drugs, thalidomide was an effective and well-tolerated therapy for inducing and maintaining long-term remission.

*Gastroenterology Operative Unit, Azienda Ospedaliera San Camillo-Forlanini

Department of Digestive Diseases, Campus Bio-Medico, University of Rome, Rome, Italy

The authors declare that they have nothing to disclose.

Reprints: Maria Lia Scribano, MD, Gastroenterology Operative Unit, Azienda Ospedaliera San Camillo-Forlanini, Circonvallazione Gianicolense, 87 - 00152 Rome, Italy (e-mail:

© 2014 by Lippincott Williams & Wilkins