A randomized, double‐blind, placebo‐controlled trial of lenalidomide in the treatment of moderately severe active Crohn’s disease

Summary Background Therapy targeted at tumour necrosis factor‐α has an established role in Crohn’s disease. Lenalidomide, an analogue of thalidomide, is an oral immunomodulatory agent with powerful antitumour necrosis factor‐α properties. It is licensed for myeloma and myelodysplastic syndrome. Bas...

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Published in:	Alimentary Pharmacology and Therapeutics Vol. 26; no. 3; pp. 421 - 430
Main Authors:	MANSFIELD, J. C., PARKES, M., HAWTHORNE, A. B., FORBES, A., PROBERT, C. S. J., PEROWNE, R.C., COOPER, A., ZELDIS, J. B., MANNING, D. C., HAWKEY, C. J.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-08-2007 Blackwell
Subjects:	Adolescent Adult Aged Biological and medical sciences Crohn Disease - drug therapy Digestive system Double-Blind Method Female Gastroenterology. Liver. Pancreas. Abdomen Humans Immunosuppressive Agents - therapeutic use Male Medical sciences Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Placebos Severity of Illness Index Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Thalidomide - analogs & derivatives Thalidomide - therapeutic use Treatment Outcome Venous Thrombosis - chemically induced Crohn disease Randomization Treatment Lenalidomide Placebo Double blind study Digestive diseases Intestinal disease Clinical trial Inflammatory disease
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Summary:	Summary Background Therapy targeted at tumour necrosis factor‐α has an established role in Crohn’s disease. Lenalidomide, an analogue of thalidomide, is an oral immunomodulatory agent with powerful antitumour necrosis factor‐α properties. It is licensed for myeloma and myelodysplastic syndrome. Based upon reports of thalidomide efficacy, lenalidomide was evaluated in Crohn’s disease. Aim To evaluate the efficacy and safety of lenalidomide in subjects with moderately severe active Crohn’s disease. Methods In a multicentre, double‐blind, placebo‐controlled parallel group study 89 subjects were randomized to lenalidomide 25 mg daily, 5 mg daily or placebo. Subjects were treated for 12 weeks. The primary end point was a 70‐point reduction in Crohn’s Disease Activity Index. Results The overall clinical response rate was not significantly different between the three groups: lenalidomide 25 mg 26%, lenalidomide 5 mg 48% and placebo 39%. Lenalidomide was generally well tolerated with only one serious adverse event, a deep vein thrombosis, being attributed to treatment. Conclusion Lenalidomide, an oral agent with antitumour necrosis factor‐α properties, was not effective in active Crohn’s disease in contrast to reports of benefit from thalidomide. The reasons for this lack of efficacy are speculative, other physiological activities may offset its action on inflammatory cytokines, or its antitumour necrosis factor‐α action without apoptosis may be insufficient for activity in Crohn’s disease.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0269-2813 1365-2036 0953-0673
DOI:	10.1111/j.1365-2036.2007.03385.x