Alimentary Pharmacology and Therapeutics Invited Editorials 6. Sabate JM, Villarejo J, Lemann M, Bonnet J, Allez M, Modigliani R. An open-label study of thalidomide for maintenance therapy in responders to infliximab in chronically active and fistulizing refractory Crohn’s disease. Aliment Pharmacol Ther 2002; 16: 1117–24. 7. Gerich ME, Yoon JL, Targan SR, Ippoliti AF, Vasiliauskas EA. Long-term outcomes of thalidomide in refractory Crohn’s disease. Aliment Pharmacol Ther 2015; 41: 429–37.
8. Lazzerini M, Martelossi S, Magazzu G, et al. Effect of thalidomide on clinical remission in children and adolescents with refractory Crohn disease: a randomized clinical trial. JAMA 2013; 310: 2164–73. 9. Akobeng AK, Stokkers PC. Thalidomide and thalidomide analogues for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev 2009; (2): CD007351.
Editorial: is thalidomide a good option for patients with refractory Crohn’s disease? Authors’ reply
although the median duration of response was only 5 months, 30% of responders (15% of all treated patients) maintained response out to at least 1 year. While a partial response is certainly less than ideal, it may be better than the alternatives – such as ongoing steroid use or further bowel resections. Even if benefits are temporary, thalidomide can serve as a bridge to buy needed time until other agents with potential for longterm benefit become available. So, although its long-term use is often limited by toxicity, we tend to agree with Plamondon et al. that thalidomide can serve as an effective short- to medium-term treatment in a select group of Crohn’s patients.6
M. Gerich, J. Yoon & E. Vasiliauskas Cedars Sinai Medical Center, Los Angeles, CA, USA. E-mail: [email protected] doi:10.1111/apt.13136
We would like to thank Professor Rogler for his comments regarding the results of our study and the potential for thalidomide to provide significant benefit to patients with long-standing, refractory Crohn’s disease.1 We agree that the role of thalidomide as a long-term maintenance therapy appears to be fairly limited – in large part due to adverse events, which led over onethird of responders to discontinue thalidomide in our study.2 Yet, while steroid-free clinical remission is certainly desirable for all patients, the unfortunate reality is that it is seldom achievable, even following the introduction of biologic therapies. The results of clinical trials demonstrate that the addition of anti-TNF agents, natalizumab or vedolizumab induces long-term remission in less than a third of Crohn’s patients who are treated.3–5 Despite significant therapeutic advances, this inability to achieve long-term remission remains an issue, particularly among patients with long-standing disease that have already failed one or more biological therapies, which is exactly the type of patients who opted to be treated with thalidomide in our study. Notably, however, approximately two-thirds of these refractory patients were able to reduce or discontinue steroids altogether and,
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ACKNOWLEDGEMENT The authors’ declarations of personal and financial interests are unchanged from those in the original article.2 REFERENCES 1. Rogler G. Editorial: is thalidomide a good option for patients with refractory Crohn’s disease? Aliment Pharmacol Ther 2015; 41: 785–6. 2. Gerich ME, Yoon JL, Targan SR, Ippoliti AF, Vasiliauskas EA. Long-term outcomes of thalidomide in refractory Crohn’s disease. Aliment Pharmacol Ther 2015; 41: 429–37. 3. Peyrin-Biroulet L, Lemann M. Review article: remission rates achievable by current therapies for inflammatory bowel disease. Aliment Pharmacol Ther 2011; 33: 870–9. 4. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med 2005; 353: 1912–25. 5. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013; 369: 711–21. 6. Plamondon S, Ng SC, Kamm MA. Thalidomide in luminal and fistulizing Crohn’s disease resistant to standard therapies. Aliment Pharmacol Ther 2007; 25: 557–67.
Aliment Pharmacol Ther 2015; 41: 785–788 ª 2015 John Wiley & Sons Ltd
Copyright of Alimentary Pharmacology & Therapeutics is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
8. Lazzerini M, Martelossi S, Magazzu G, et al. Effect of thalidomide on clinical remission in children and adolescents with refractory Crohn disease: a randomized clinical trial. JAMA 2013; 310: 2164–73. 9. Akobeng AK, Stokkers PC. Thalidomide and thalidomide analogues for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev 2009; (2): CD007351.
Editorial: is thalidomide a good option for patients with refractory Crohn’s disease? Authors’ reply
although the median duration of response was only 5 months, 30% of responders (15% of all treated patients) maintained response out to at least 1 year. While a partial response is certainly less than ideal, it may be better than the alternatives – such as ongoing steroid use or further bowel resections. Even if benefits are temporary, thalidomide can serve as a bridge to buy needed time until other agents with potential for longterm benefit become available. So, although its long-term use is often limited by toxicity, we tend to agree with Plamondon et al. that thalidomide can serve as an effective short- to medium-term treatment in a select group of Crohn’s patients.6
M. Gerich, J. Yoon & E. Vasiliauskas Cedars Sinai Medical Center, Los Angeles, CA, USA. E-mail: [email protected] doi:10.1111/apt.13136
We would like to thank Professor Rogler for his comments regarding the results of our study and the potential for thalidomide to provide significant benefit to patients with long-standing, refractory Crohn’s disease.1 We agree that the role of thalidomide as a long-term maintenance therapy appears to be fairly limited – in large part due to adverse events, which led over onethird of responders to discontinue thalidomide in our study.2 Yet, while steroid-free clinical remission is certainly desirable for all patients, the unfortunate reality is that it is seldom achievable, even following the introduction of biologic therapies. The results of clinical trials demonstrate that the addition of anti-TNF agents, natalizumab or vedolizumab induces long-term remission in less than a third of Crohn’s patients who are treated.3–5 Despite significant therapeutic advances, this inability to achieve long-term remission remains an issue, particularly among patients with long-standing disease that have already failed one or more biological therapies, which is exactly the type of patients who opted to be treated with thalidomide in our study. Notably, however, approximately two-thirds of these refractory patients were able to reduce or discontinue steroids altogether and,
786
ACKNOWLEDGEMENT The authors’ declarations of personal and financial interests are unchanged from those in the original article.2 REFERENCES 1. Rogler G. Editorial: is thalidomide a good option for patients with refractory Crohn’s disease? Aliment Pharmacol Ther 2015; 41: 785–6. 2. Gerich ME, Yoon JL, Targan SR, Ippoliti AF, Vasiliauskas EA. Long-term outcomes of thalidomide in refractory Crohn’s disease. Aliment Pharmacol Ther 2015; 41: 429–37. 3. Peyrin-Biroulet L, Lemann M. Review article: remission rates achievable by current therapies for inflammatory bowel disease. Aliment Pharmacol Ther 2011; 33: 870–9. 4. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med 2005; 353: 1912–25. 5. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013; 369: 711–21. 6. Plamondon S, Ng SC, Kamm MA. Thalidomide in luminal and fistulizing Crohn’s disease resistant to standard therapies. Aliment Pharmacol Ther 2007; 25: 557–67.
Aliment Pharmacol Ther 2015; 41: 785–788 ª 2015 John Wiley & Sons Ltd
Copyright of Alimentary Pharmacology & Therapeutics is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
