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

E. A. Vasiliauskas, L. Y. Kam, M. T. Abreu-Martin, P. V. Hassard, Konstantinos Papadakis, H. Yang, J. B. Zeldis, S. R. Targan

Research output: Contribution to journalArticle

273 Citations (Scopus)

Abstract

Background and Aims: Thalidomide decreases production of tumor necrosis factor α, a proinflammatory cytokine associated with Crohn's disease (CD). In this study the safety, tolerance, and efficacy of low-dose thalidomide were evaluated for treatment of moderate-to-severe, steroid-dependent CD. Methods: Twelve adult male patients with Crohn's Disease Activity Index (CDAI) scores of ≥250 and ≤500 despite ≥20 mg prednisone/day were enrolled. The first 6 patients received 50 mg thalidomide every night, the next 6 received 100 mg every night. Steroid doses were stable during the first 4 weeks of treatment, then tapered during weeks 5-12. CDAI was used to assess response. Results: (1) Disease activity improved consistently in all patients during weeks 1-4: 58% response, 17% remission. (2) Clinical improvement was generally maintained despite steroid taper during weeks 5-12. All patients were able to reduce steroids by ≥50%. Forty-four percent discontinued steroids entirely. In weeks 5-12, 70% of patients responded and 20% achieved remission. (3) Side effects were mild and mostly transient, with the most common being drowsiness, peripheral neuropathy, edema, and dermatitis. Conclusions: Low-dose thalidomide appears to be well tolerated and effective over a 12-week period. Results of this pilot study support the need for controlled multicenter trials of thalidomide for treatment of CD.

Original languageEnglish (US)
Pages (from-to)1278-1287
Number of pages10
JournalGastroenterology
Volume117
Issue number6
DOIs
StatePublished - Jan 1 1999
Externally publishedYes

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Thalidomide
Crohn Disease
Steroids
Sleep Stages
Peripheral Nervous System Diseases
Dermatitis
Prednisone
Multicenter Studies
Edema
Therapeutics
Tumor Necrosis Factor-alpha
Cytokines
Safety

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Vasiliauskas, E. A., Kam, L. Y., Abreu-Martin, M. T., Hassard, P. V., Papadakis, K., Yang, H., ... Targan, S. R. (1999). An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease. Gastroenterology, 117(6), 1278-1287. https://doi.org/10.1016/S0016-5085(99)70277-5

An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease. / Vasiliauskas, E. A.; Kam, L. Y.; Abreu-Martin, M. T.; Hassard, P. V.; Papadakis, Konstantinos; Yang, H.; Zeldis, J. B.; Targan, S. R.

In: Gastroenterology, Vol. 117, No. 6, 01.01.1999, p. 1278-1287.

Research output: Contribution to journalArticle

Vasiliauskas, EA, Kam, LY, Abreu-Martin, MT, Hassard, PV, Papadakis, K, Yang, H, Zeldis, JB & Targan, SR 1999, 'An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease', Gastroenterology, vol. 117, no. 6, pp. 1278-1287. https://doi.org/10.1016/S0016-5085(99)70277-5
Vasiliauskas, E. A. ; Kam, L. Y. ; Abreu-Martin, M. T. ; Hassard, P. V. ; Papadakis, Konstantinos ; Yang, H. ; Zeldis, J. B. ; Targan, S. R. / An open-label pilot study of low-dose thalidomide in chronically active, steroid-dependent Crohn's disease. In: Gastroenterology. 1999 ; Vol. 117, No. 6. pp. 1278-1287.
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AU - Papadakis, Konstantinos

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