An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease

Phase I study to determine the safety, tolerability and immunostimulatory activity of thalidomide analogue CC-5013 in patients with metastatic malignant melanoma and other advanced cancers

“…Thalidomide has also been shown to be a useful drug in a wide range of other clinical conditions for which there is little other treatment option (Marriott et al, 1999;Raje and Anderson, 1999). These include rheumatoid arthritis (Schuler and Ehninger, 1995), the inflammatory and wasting effects of chronic tuberculosis (Klausner et al, 1996), Behcet's disease (Hamuryudan et al, 1998), Crohn's disease (Wettstein and Meagher, 1997;Ehrenpreis et al, 1999;Vasiliauskas et al, 1999) aphthous ulcers (Youle et al, 1989;Alexander and Wilcox, 1997;Jacobson et al, 1997), cachexia (wasting) associated with HIV infection (Sharpstone et al, 1995;Reyes-Teran et al, 1996) and AIDS-related Kaposi's sarcoma (Fife et al, 1998). There is also a wide body of evidence from large-scale clinical trials showing the effectiveness of thalidomide as a treatment for refractory or relapsed multiple myeloma (MM) (Singhal et al, 1999;Hideshima et al, 2000;Juliusson et al, 2000;Kneller et al, 2000;Zomas et al, 2000), and this extends to the treatment of a number of other tumours (Eisen et al, 2000;Fine et al, 2000;Gutheil and Finucane, 2000;Patt et al, 2000;Tseng et al, 2001;Eisen, 2002).…”

Effect of thalidomide on the healing of colonic anastomosis, in rats

“…30 Regarding drugs, thalidomide, although banned several decades back due to its teratogenic effects, has been pointed out in recent papers as beneficial for the treatment of Crohn's disease resistant to corticotherapy and of difficult clinical management with conventional drugs. 31,32 Thalidomide has an important immunomodulatory action, inhibiting the action of tumor necrosis factor (TNF) and having anti-angiogenic activity, among others. 33 In view of the difficult clinical management of Crohn's disease refractory to traditional treatment, and considering the biochemical actions of thalidomide and the good results obtained with it by some authors in controlled studies, this drug may gain a place in the therapeutic arsenal in the near future.…”

Thalidomide in inflammatory bowel disease: Too little, too soon

“…This was the most common side-effect in the other reports as well. 5,6 Intractable insomnia after cessation of thalidomide in a patient with Crohn's colitis has also been described. 10 Peripheral neuropathy is another issue, as it can be found in up to 70% of patients, independent of dose or duration of therapy.…”

“…In the second report, 12 male patients with active Crohn's disease (CDAI ≥ 250) received either 50 mg or 100 mg of thalidomide at night for the same period of 12 weeks. 6 At the end of the 12 weeks, two patients had withdrawn because of persisting symptoms. Seven of the remaining 10 had responded, but there were only two in remission, an overall rate of 17%.…”

“…16 These figures are not dissimilar to the remission rates with thalidomide. 6 Although promising, the observational studies of thalidomide in inflammatory bowel disease should not be taken as an indication for greater uncontrolled use of the drug.They are a call for proper scientific placebocontrolled trials, which should be established by the authors as soon as possible. There are a number of issues to be clarified apart from just efficacy.…”