Details

Autor(en) / Beteiligte

• Vasiliauskas, Eric A.
• Kam, Lori Y.
• Abreu-Martin, Maria T.
• Hassard, Philip V.
• Papadakis, Kostas A.
• Yang, Huiying
• Zeldis, Jerome B.
• Targan, Stephan R.

Titel

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

Ist Teil von

• Gastroenterology (New York, N.Y. 1943), 1999-12, Vol.117 (6), p.1278-1287

Ort / Verlag

New York, NY: Elsevier Inc

Erscheinungsjahr

1999

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Background & 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. GASTROENTEROLOGY 1999;117:1278-1287